BE’s CORBEVAX Safe & Immunogenic in 5-18 Age Group

The phase II/III clinical trials results have been published by Vaccine, a peer-reviewed and reputed international journal

Hyderabad, November 3, 2022: Biological E. Limited (BE), a Hyderabad-based vaccine and pharmaceutical company, today announced the publication of CORBEVAX COVID-19 vaccine phase II/III clinical trials conducted in paediatric population (5 to <18 age group). The study results have been accepted and published in Vaccine, a peer-reviewed, reputed international journal. CORBEVAX India’s first indigenously developed Receptor Binding Domain (RBD) protein sub-unit vaccine for COVID-19 has demonstrated excellent safety

profile in children and adolescents. The vaccine also demonstrated excellent immunogenicity as measured by humoral and cellular immune responses. As per observed correlation between neutralizing antibody titers against the SARS-COV-2 virus and the vaccine effectiveness, the immune response generated by CORBEVAX is indicative of very high vaccine effectiveness in the 5 to 18 age-group; similar to what has been observed in the adult population.

Biological E. Limited conducted the trial in 624 children with two age cohorts, ≥12 to <18 years (n=312) and ≥5 to <12 years (n=312). Through an intramuscular route, both age groups were administered two doses of 0.5 ml of CORBEVAX , each separated by 28 days. In both the age groups, CORBEVAX vaccinated subjects showed significant immune response against Ancestral-Wuhan and Delta-strains. Cytokine Interferon-gamma expression analysis showed significant Th1 skewed cellular immune response generated from CORBEVAX . There were no severe adverse events (AEs) reported and the majority of reported adverse events (AEs) were mild in nature.

In February 2022, the Drugs Controller General of India (DCGI) approved CORBEVAX for restricted use in emergency situations for ages 12 to 18. On April 25, 2022, the apex drug regulator also approved the use of the vaccine in children between the ages of 5 and 12. The move came four days after the interim safety and immunogenicity data were presented to the Subject Expert Committee (SEC) on April 21, 2022. It recommended Biological E’s CORBEVAX® for restricted use in the said age group.

While many countries have vaccinated younger children, India has yet to start the vaccination drive for kids aged between 5 and 12. And CORBEVAX makes for an excellent option in terms of safety and effectiveness against COVID-19. As of now, over 7.36 crore CORBEVAX doses have been administered between the age group of 12-14 pan India during last seven months of roll-out in one of the largest pediatric vaccination campaigns globally.

Dr. Vikram Paradkar, Executive Vice President-Technical Operations, Biological E. Limited, said, “CORBEVAX getting approved for our pediatric population from 5 to 18 age-group was a major milestone for us and its subsequent Pan-India deployment for kids of 12-14 years was important in our fight against coronavirus. So far, approximately 74 million doses of CORBEVAX has been administered to kids in India and almost 33 million kids have completed two-dose primary vaccination, which represents one of the largest pediatric campaigns globally. We plan to eventually test the vaccine on infants as young as six months, based on the excellent safety record and consistent immunogenicity observed in pediatric trials and deployment. Publication of our clinical trial results in reputed journals like Lancet eBiomedicine and Elsevier-Vaccine journals represents the validation of CORBEVAX as an excellent choice for COVID-19 vaccine”

In August, CORBEVAX became the first vaccine in India to get DCGI approval for a COVID-19 heterologous booster shot. It is safer and induces better neutralization antibodies against different variants of coronavirus. It can be administered six months after two doses of COVISHIELD or COVAXIN for all adults.

About Biological E. Limited

Biological E. Limited (BE), a Hyderabad-based Pharmaceuticals & Biologics Company founded in 1953, is the first private sector biological products company in India and the first pharmaceutical company in Southern India. BE develops, manufactures and supplies vaccines and therapeutics. BE supplies its vaccines to more than 130 countries and its therapeutic products are sold in India and the USA, Europe. BE currently has 8 WHO-prequalified vaccines and 5 USFDA approved Injectables in its portfolio.

In recent years, BE has embarked on new initiatives for organizational expansion such as developing specialty injectable products for global markets, exploring synthetic biology and metabolic engineering as a means to manufacture APIs sustainably and developing novel vaccines for the global market.

Please follow us on Facebook, LinkedIn and Twitter

Media Contacts
Biological E. Limited
K. Vijay Amruth Raj
Email : Vijay.Kammari@biologicale.com
Phone: +91 83740 77433
www.biologicale.com/news

Biological E. Announces SEC (CDSCO) Recommendation of its 14-Valent Pneumococcal
Conjugate Vaccine for Infants

Subject Expert Committee(SEC) of Central Drugs Standard Control Organization (CDSCO) has recommended grant of permission to Biological E. Limited to manufacture the 14-valent investigational vaccine against Streptococcus pneumoniae Infection

Hyderabad, September 1, 2022: Biological E. Limited (BE), the Hyderabad-based vaccines manufacturer, announced today that the Subject Expert Committee of CDSCO reviewed and approved the Phase 3 infants clinical trial data and recommended for manufacture of its 14-valent paediatric vaccine (investigational pneumococcal polysaccharide conjugate vaccine PCV14) against S. pneumoniae infection in single-dose and multi-dose presentations. The PCV14 can be administered to infants at 6, 10 and 14 weeks of age.

Streptococcus pneumoniae infection continues to be a leading cause of child mortality under 5 years of age in India and in developing countries. With the PCV14 vaccine, Biological E hopes to contribute to the prevention of invasive pneumococcal disease and protect millions of lives globally.

BE’s PCV14 contains 14 serotypes, 12 of them same as in Prevnar13 from Pfizer (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F). In addition, BE’s PCV14 has 2 more Serotypes 22F and 33F for which there have been increasing cases of infections globally.

The primary immunogenicity objective of demonstrating non-inferiority with anti-PnCPS IgG antibody concentrations against each of the 12 common serotypes of BE-PCV14. Vaccine in terms of subjects seroconverted and the ratio of geometric mean concentrations against corresponding serotypes in Prevenar 13 was met. Non-inferiority was also demonstrated with anti-PnCPS IgG antibody concentrations against 22F and 33F unique serotypes specific to BE-PCV14.

The immune response to serotype 6A which is in Prevenar 13 (not there in BE’s PCV14 vaccine) was also achieved through cross protection from BE-PCV14 vaccine serotype 6B.

Biological E’s PCV14 vaccine elicited functional immune responses. One month after 3rd dose of vaccination, adequate increase in serotype-specific OPA GMTs were observed for all 14 PCV serotypes.

The safety analysis revealed that all the adverse events were mild to moderate in their intensity and with no grade-3 & 4 events reported. The safety comparison shows that BE-PCV14 vaccine was well tolerated and found to be safe.

BE’s PCV14 is comparable in terms of serotype coverage for infants to the two pneumococcal conjugate vaccines Prevnar13 and Merck’s VAXNEUVANCE which are currently approved globally.

Ms. Mahima Datla, Managing Director, Biological E. Limited, said “We are delighted with this remarkable development. BE’s PCV14 will protect millions of infants worldwide and contribute to the prevention of invasive pneumococcal disease. With this recommendation from SEC and the anticipated formal approval from DCGI thereafter, India will have yet another important lifesaving vaccine for paediatric use. Biological E. would be also working with WHO and other global regulatory agencies to make this vaccine available globally."

About Biological E. Limited

Biological E. Limited (BE), a Hyderabad-based Pharmaceuticals & Biologics Company founded in 1953, is the first private sector biological products company in India and the first pharmaceutical company in Southern India. BE develops, manufactures and supplies vaccines and therapeutics. BE supplies its vaccines to more than 130 countries and its therapeutic products are sold in India and the USA, Europe. BE currently has 8 WHO-prequalified vaccines and 5 USFDA approved Injectables in its portfolio.

Please follow us on Facebook, LinkedIn and Twitter

Media Contacts
Biological E. Limited
K. Vijay Amruth Raj
Email : Vijay.Kammari@biologicale.com
Phone: +91 83740 77433
www.biologicale.com/news

CORBEVAX Approved as India’s First Heterologous COVID-19 Booster Shot for 18 Years and Above

  • CORBEVAX is expected to be available as a Booster dose on the CoWIN App in Public and Private Vaccination Centres from August 12, 2022
  • Many countries have adopted the Heterologous Booster dose over the homologous booster dose to target better vaccination outcomes, particularly against emerging variants
  • CORBEVAX has demonstrated a significantly increased immune response to the Omicron strain

Hyderabad, August 11, 2022: Biological E. Limited (BE), a Hyderabad-based pharmaceutical and vaccines company, today announced that its COVID-19 vaccine CORBEVAX was approved by the Union Health

Ministry as a heterologous COVID-19 booster dose under emergency use authorization for individuals aged 18 years and above after 6 months of administration of primary vaccination (two doses) of COVAXIN or COVISHIELD vaccine.

The Union Health Ministry's approval is based on the recommendations made recently by the COVID-19 Working Group of the National Technical Advisory Group on Immunisation (NTAGI). This approval came after the Drug Controller General of India (DCGI) approved the vaccine for emergency use as a heterologous COVID-19 booster dose for individuals aged 18 years on June 4, 2022. CORBEVAX had received emergency use authorization as primary two-dose vaccination regimen in Adults, Adolescents and Children 5 years and above, in a series of approvals from December’21 to April’22. Biological E. Limited has delivered 10 crore doses of CORBEVAX to the Government of India till now. Pan-India roll-out of CORBEVAX in children 12-14 years of age was initiated on March 16, 2022 and till now almost 7 crore doses have been administered and 2.9 crore children have completed the two-dose vaccination regimen. Excellent safety profile of CORBEVAX has been confirmed in one of the largest paediatric COVID-19 vaccination campaigns in the world.

CORBEVAX has undergone comprehensive booster trials on Indian subjects and subsequently received approval from the Indian regulatory authority. BE's CORBEVAX is the first Indian vaccine to be approved as a heterologous COVID-19 booster dose. CORBEVAX uses a traditional recombinant protein-based technology, which is also used for vaccines such as Hepatitis B. The CORBEVAX heterologous booster-dose clinical trials demonstrated significant boosting of humoral immune response measured in terms of neutralization antibody titres against the ancestral as well as the omicron strain, binding antibody titres as well as cellular immune response along with minimal adverse events that were mild in nature.

Ms. Mahima Datla, Managing Director, Biological E. Limited, said “CORBEVAX has become the first vaccine in India to be approved as a heterologous COVID-19 booster. The approval by the Ministry of Health today is another important step in combating the pandemic. We are very pleased with this endorsement, which recognizes the safety and efficacy of our vaccine."

The price of CORBEVAX for private COVID-19 vaccination centres is Rs. 250, inclusive of GST. For the end-user, the price is Rs. 400, including taxes and administrative charges. CORBEVAX is expected to be available as a booster dose on the CoWIN App in public and private vaccination centres from August 12, 2022.

About Biological E. Limited

Biological E. Limited (BE), a Hyderabad-based Pharmaceuticals & Biologics Company founded in 1953, is the first private sector biological products company in India and the first pharmaceutical company in Southern India. BE develops, manufactures and supplies vaccines and therapeutics. BE supplies its vaccines to more than 130 countries and its therapeutic products are sold in India and the USA, Europe. BE currently has 8 WHO-prequalified vaccines and 5 USFDA approved Injectables in its portfolio.

In recent years, BE has embarked on new initiatives for organizational expansion such as developing specialty injectable products for global markets, exploring synthetic biology and metabolic engineering as a means to manufacture APIs sustainably and developing novel vaccines for the global market.

Please follow us on Facebook, LinkedIn and Twitter

Media Contacts
Biological E. Limited
K. Vijay Amruth Raj
Email : Vijay.Kammari@biologicale.com
Phone: +91 83740 77433
www.biologicale.com/news

USFDA Approves BE’s Pantoprazole Sodium for Injection

Hyderabad, June 06, 2022: Biological E. Limited (BE) is pleased to announce that it received final approval for an Abbreviated New Drug Application (ANDA) Pantoprazole Sodium for Injection 40 mg per Vial (Single-Dose Vial) from the U.S. Food and Drug Administration (USFDA) on May 18, 2022 following the expiry of the paediatric exclusivity on May 17, 2022. Pantoprazole Sodium for Injection was filed with the USFDA on April 30, 2021.

Pantoprazole Sodium is a Proton Pump Inhibitor (PPI) indicated in adults for the short-term treatment of

Gastroesophageal Reflux Disease (GERD) associated with a history of Erosive Esophagitis (EE) and pathological hypersecretion conditions, including Zollinger-Ellison (ZE) Syndrome.

About Biological E. Limited

Biological E. Limited (BE), a Hyderabad-based Pharmaceuticals & Biologics Company founded in 1953, is the first private sector biological products company in India and the first pharmaceutical company in Southern India. BE develops, manufactures and supplies vaccines and therapeutics. BE supplies its vaccines to more than 130 countries and its therapeutic products are sold in India and the USA, Europe. BE currently has 8 WHO-prequalified vaccines in its portfolio and 5 USFDA approved Injectables.

In recent years, BE has embarked on new initiatives for organizational expansion such as developing specialty injectable products for global markets, exploring synthetic biology and metabolic engineering as a means to manufacture APIs sustainably and developing novel vaccines for the global market.

Please follow us on Facebook, LinkedIn and Twitter

Media Contacts
Biological E. Limited
K. Vijay Amruth Raj
Email : Vijay.Kammari@biologicale.com
Phone: +91 83740 77433
www.biologicale.com/news

CORBEVAX Gets DCGI Nod as a Heterologous COVID-19 Booster Dose

CORBEVAX is the first vaccine in India to get DCGI approval for a heterologous COVID-19 booster shot

People who are 18 years and above and have already taken two doses of either COVISHIELD or

COVAXIN can now receive a dose of CORBEVAX as a heterologous COVID-19 booster

Hyderabad, June 04, 2022: Biological E. Limited (BE), a Hyderabad-based pharmaceutical and vaccines company, today announced that its CORBEVAX COVID-19 vaccine has been approved by the Drug Controller General of India (DCGI) as a heterologous COVID-19 booster dose to individuals aged 18 years

and above after 6 months of administration of primary vaccination (two doses) of COVAXIN or COVISHIELD vaccines for restricted use in emergency situation. BE’s CORBEVAX is the first such vaccine in India to be approved as a heterologous COVID-19 booster.

Recently, BE has furnished its clinical trials data to the DCGI who after a detailed evaluation and deliberations with Subject Experts Committee, granted their approval for administering CORBEVAX vaccine as a heterologous booster dose to people who have already taken two doses of either COVISHIELD or COVAXIN. BE's clinical trial data showed that CORBEVAX booster dose provided significant enhancement in immune response and excellent safety profile required for an effective booster.

Ms. Mahima Datla, Managing Director, Biological E. Limited, said, "We are very happy with this approval, which will address the need for COVID-19 booster doses in India. We have crossed yet another milestone in our COVID-19 vaccination journey. This approval reflects once again the sustained world class safety standards and high immunogenicity of CORBEVAX .”

BE has conducted a multicentre Phase III placebo controlled heterologous booster clinical trial in 416 subjects from 18 to 80 years of age who were previously vaccinated with two doses of either COVISHIELD or COVAXIN at least 6 months prior to the administration of CORBEVAX as a booster dose.

The booster dose of CORBEVAX® increased the neutralizing antibody titers in the COVISHIELD and COVAXIN groups significantly when compared to placebo.

In a subset of subjects evaluated for nAb against the Omicron variant, the CORBEVAX booster shot resulted in a significant increase in the nAb titers against the Omicron variant. After the booster dose of CORBEVAX®, Omicron nAbs were observed in 91% and 75% of subjects who had received primary vaccination by COVISHIELD and COVAXIN respectively.

CORBEVAX booster dose also resulted in significant Th1 skewed cellular immune response as indicated by cytokine expression analysis post stimulation of the T-cells.

The CORBEVAX heterologous booster vaccine was well tolerated and safe. There were no severe or adverse events of interest for 3 months of follow-up after the booster dose was administered.

The CORBEVAX vaccination slot can be booked through the Co-WIN app or Co-WIN portal. So far, 51.7 million doses of CORBEVAX have been administered to children across the country, including 17.4 million who have completed the two-dose regimen. BE has supplied 100 million doses of CORBEVAX to the Government of India.

CORBEVAX is entirely developed and manufactured by Biological E. Limited in association with Texas Children's Hospital and Baylor College of Medicine as a recombinant protein sub-unit vaccine against COVID-19.

About Biological E. Limited

Biological E. Limited (BE), a Hyderabad-based Pharmaceuticals & Biologics Company founded in 1953, is the first private sector biological products company in India and the first pharmaceutical company in Southern India. BE develops, manufactures and supplies vaccines and therapeutics. BE supplies its vaccines to more than 130 countries and its therapeutic products are sold in India and the USA, Europe. BE currently has 8 WHO-prequalified vaccines in its portfolio and 5 USFDA approved Injectables.

In recent years, BE has embarked on new initiatives for organizational expansion such as developing specialty injectable products for global markets, exploring synthetic biology and metabolic engineering as a means to manufacture APIs sustainably and developing novel vaccines for the global market.

Please follow us on Facebook, LinkedIn and Twitter

Media Contacts
Biological E. Limited
K. Vijay Amruth Raj
Email : Vijay.Kammari@biologicale.com
Phone: +91 83740 77433
www.biologicale.com/news

Biological E. Limited Reduces CORBEVAX Price to Rs.250 a Dose

The reduced price aims at protecting the maximum number of children against the virus
The move comes a few weeks after receiving the EUA for children between the ages of 5 and 12

Hyderabad, May 16, 2022: Biological E. Limited (BE), a Hyderabad-based vaccine and pharmaceutical company, today announced that it has reduced the price of its COVID-19 Vaccine CORBEVAX , from Rs.840 to Rs.250 a dose inclusive of GST, for Private COVID-19 Vaccination Centres. For the end user, the price would be Rs.400 a dose, including taxes and administration charges.

BE has lowered the price of its vaccine with the aim of making it more affordable and help increase the reach to protect maximum number of children against the virus. The decision comes within weeks of Biological E. Limited received Emergency Use Authorization (EUA) for children between 5 and 12 years of age. The previous private market price for the vaccine was Rs.990 a dose including taxes and vaccine administration charges.

CORBEVAX is also offered in a single-dose vial, making it more convenient for vaccine administration. It eliminates vaccine wastage, which is a major advantage for private hospitals.

The CORBEVAX vaccination slot can be booked through the Co-WIN app or the Co-WIN portal for children aged 12 to 17. So far, 43.9 Million doses of CORBEVAX have been administered to children across the country and Biological E. Limited has supplied close to 100 Million doses to the Government of India.

Biological E. Limited, in collaboration with Texas Children's Hospital and Baylor College of Medicine, has developed a recombinant protein sub-unit vaccine for the novel coronavirus, CORBEVAX . Prior to receiving EUA for vaccination, the company conducted Phase II and III multicentre clinical trials in 624 children aged 5-12 and 12-18.

About Biological E. Limited

Biological E. Limited (BE), a Hyderabad-based Pharmaceuticals & Biologics Company founded in 1953, is the first private sector biological products company in India and the first pharmaceutical company in Southern India. BE develops, manufactures and supplies vaccines and therapeutics. BE supplies its vaccines to more than 130 countries and its therapeutic products are sold in India and the USA, Europe. BE currently has 8 WHO-prequalified vaccines in its portfolio and 5 USFDA approved Injectables.

In recent years, BE has embarked on new initiatives for organizational expansion such as developing specialty injectable products for global markets, exploring synthetic biology and metabolic engineering as a means to manufacture APIs sustainably and developing novel vaccines for the global market.

Please follow us on Facebook, LinkedIn and Twitter

Media Contacts
Biological E. Limited
K. Vijay Amruth Raj
Email : Vijay.Kammari@biologicale.com
Phone: +91 83740 77433
www.biologicale.com/news

BE’s CORBEVAXTM Gets DCGI Nod for Emergency Use in 5-12 Years

The approval comes soon after CORBEVAXTM was given the nod for 12-15-year group

As part of its Phase 2/3 clinical trials in 312 children aged between 5 and 12 years, Biological E administered two doses of 0.5 ml each of CORBEVAXTM or Placebo in 28 days’ gap

Hyderabad, India – April 26, 2022: Biological E. Limited (BE), one of the world’s largest vaccine manufacturers, has today announced that its COVID-19 vaccine CORBEVAXTM has received a nod from the Drugs Controller General of India (DCGI) for emergency use authorisation for the 5-12-year age group.

The approval comes after the Subject Expert Committee (SEC) recommendation based on the review of interim safety and immunogenicity data of CORBEVAXTM for this age bracket. This approval comes a month after CORBEVAXTM was given the nod for children between 12 and 15 years.

BE has developed India’s first Indigenous Sub-unit COVID-19 against the novel coronavirus. The company performed a multi-centric, Phase 2/3 clinical trial in 624 children aged between 5 and 18 in two age sub-sets, i.e., ≥12 to <18 years and ≥5 to <12 years. As a part of the trial, children were administered two doses of 0.5 ml each of the vaccine or placebo in a gap of 28 days.

BE submitted the interim safety data and immunogenicity data to regulatory agencies. For both the age sub-sets, the trial showed a significant increase in the anti-RBD IgG antibodies and neutralizing antibodies (nAb) against ancestral strain and Delta variant. The nAb titers observed post vaccination with CORBEVAXTM in the paediatric cohorts were comparable to the adult cohort evaluated in earlier clinical trial and the vaccine showed excellent safety for both age groups.

Ms. Mahima Datla, Managing Director, Biological E. Limited, said, “As many of us would be aware, the SEC had already given a positive recommendation for our vaccine’s use in the 5-12 age group. In continuation of the same, we were very happy to receive the formal approval from the DCGI making this an extremely safe and effective intervention available, particularly for the age groups 5 years onwards. This is a great opportunity to get back to some level of normalcy in our continuing fight against the prevalent pandemic situation as CORBEVAXTM is the first indigenous COVID-19 vaccine in the country that addresses the vaccination needs of all age groups from 5 years and above.”

To date, Biological E. Limited has manufactured 30 crore doses of CORBEVAXTM and have already supplied nearly 10 crore doses to the Government of India. Currently, over 3 crore doses of CORBEVAXTM have been administered in children between 12-15 years of age. And now, with an approval for the 5-12-year age group, this move will not only reduce the risks children face from the infectious disease, but it will also enable them to concentrate on their education and social development, which were severely impacted by the pandemic. Getting their kids vaccinated will also help ease parents' concerns while sending them to school.

About Biological E. Limited

Biological E. Limited (BE), a Hyderabad-based Pharmaceuticals & Biologics Company founded in 1953, is the first private sector biological products company in India and the first pharmaceutical company in Southern India. BE develops, manufactures and supplies vaccines and therapeutics. BE supplies its vaccines to more than 130 countries and its therapeutic products are sold in India and the USA, Europe. BE currently has 8 WHO-prequalified vaccines in its portfolio and 5 USFDA approved Injectables.

In recent years, BE has embarked on new initiatives for organizational expansion such as developing specialty injectable products for global markets, exploring synthetic biology and metabolic engineering as a means to manufacture APIs sustainably and developing novel vaccines for the global market.

Please follow us on Facebook, LinkedIn and Twitter

Media Contacts
Biological E. Limited
K. Vijay Amruth Raj
Email : Vijay.Kammari@biologicale.com
Phone: +91 83740 77433
www.biologicale.com/news

BE to Get mRNA Tech from WHO to Produce COVID-19 Vaccines

WHO selects BE as a recipient of mRNA technology
Biological E. Limited produces a number of critical & life-saving vaccines, including CORBEVAXTM

Hyderabad, April 4, 2022: Biological E. Limited (BE), one of the world’s largest vaccine manufacturers, has today announced that it has been selected as a recipient of mRNA technology from the World Health Organisation (WHO) technology transfer hub.

After examining a number of proposals from India, the World Health Organisation's Advisory Committee on Vaccine Product Development (ACPDV) selected Biological E. Limited as a recipient of mRNA technology from the WHO technology transfer hub.

WHO and their partners will work with the Indian government and BE to develop a roadmap and put in place the necessary training and support for BE to start producing mRNA vaccines as soon as possible.

Primarily set up to address the COVID-19 emergency, the WHO mRNA technology transfer hub has the potential to expand manufacturing capacity for other products as well, including treatments, and target other priorities.

mRNA vaccines use a messenger RNA created in a laboratory to teach the human cells how to produce a protein that in turn initiates an immune response inside the body against a particular disease. The immune response will fight the actual virus as it gets into the body. At present, India has no COVID-19 vaccine made on mRNA platform.

Ms. Mahima Datla, Managing Director, Biological E. Limited, said "We are excited about this remarkable milestone in our efforts to produce affordable vaccines for the world. We are very pleased with the trust that WHO places in our organisation, which adheres to the standards set by the WHO. This is also a reflection of our world-class processes, scale and effectiveness. BE has been investing in mRNA technologies since last year. This new technology will definitely strengthen our resolve to develop and manufacture more vaccines in future. This partnership with WHO will enhance our ability to develop next generation mRNA vaccines that could be more suitable globally and expand the reach of vaccines availability worldwide.’’

About Biological E. Limited

Biological E. Limited (BE), a Hyderabad-based Pharmaceuticals & Biologics Company founded in 1953, is the first private sector biological products company in India and the first pharmaceutical company in Southern India. BE develops, manufactures and supplies vaccines and therapeutics. BE supplies its vaccines to over 100 countries and its therapeutic products are sold in India and the USA. BE currently has 8 WHO-prequalified vaccines in its portfolio.

In recent years, BE has embarked on new initiatives for organisational expansion such as developing generic injectable products for the regulated markets, exploring synthetic biology and metabolic engineering as a means to manufacture APIs sustainably and developing novel vaccines for the global market.

Please follow us on Facebook, LinkedIn and Twitter

Media Contacts
Biological E. Limited
K. Vijay Amruth Raj
Email : Vijay.Kammari@biologicale.com
Phone: +91 83740 77433
www.biologicale.com/news

Biological E. Limited Gears Up for new phase of India’s Vaccination Drive on National Immunisation Day!

Currently around 300 million doses of ready-to-use CORBEVAXTM doses
Biological E. Limited’s production capacity is up to 1 billion vaccines annually

Hyderabad, March 16, 2022: On the occasion of National Immunisation Day today and in an effort to support

the Government’s ongoing efforts to protect our country against COVID-19, Biological E. Limited is geared to facilitate the first phase of the vaccination drive for the 12 to 15 years’ Indian population through its vaccine CORBEVAXTM. Biological E. Limited collaborated with the Texas Children’s Hospital and the Baylor College to develop CORBEVAXTM vaccine.

Dynavax, Inc from USA supported CORBEVAXTM development by providing the adjuvant and THSTI Delhi conducted key immunogenicity testing as part of a comprehensive clinical trial development plan.

BIRAC, a division of Department of Biotechnology, Bill & Melinda Gates Foundation and Coalition for Epidemic Prevention and Innovation (CEPI) provided partial funding during clinical development. CORBEVAXTM is a recombinant protein subunit vaccine against the novel coronavirus and has been given emergency use authorisation (EUA) for children aged 12-18 years and adults from 18-80 yrs. CORBEVAXTM is administered through intramuscular route with two doses scheduled 28 days apart and is stored at 2 to 8 degrees Celsius.

Biological E limited had begun the manufacturing CORBEVAXTM for stockpiling after approval, based on the favourable clinical evidence and review by experts. Multiple Biological E. Limited facilities in Hyderabad are currently producing and will continue to produce the vaccine. The group will leverage its robust pan India presence and partner with the State Governments, hospitals and Medical institutions to leave no stone unturned in facilitating the uninterrupted supply of “CORBEVAXTM”: COVID-19 vaccine. To date, 30 crore vaccines have been produced as part of the commitment made to the Government of India.

On the occasion, Ms. Mahima Datla, Managing Director, Biological E. Limited said, “As the entire country awaits the new phase of immunisation drive for the 12 to 15 years, we at Biological E. Limited are privileged to support the Indian Government in this valiant exercise through our CORBEVAXTM vaccine. We are grateful to our Prime Minister, Shri Narendra Modi for giving us an opportunity to join the fight against the deadly coronavirus.

It’s been a significant development for us to extend our vaccine reach to children aged 12-15 years. Not only will this allow them to resume their daily lives, but it will also lower the parents’ concerns as they see their children resuming academic activities in person.

We are happy to share that, Biological E. Limited has been strengthening its production and supply chain facilities, to ensure the efficient and fast administration of vaccines with the highest safety standards. As one of the largest and most trusted pharmaceutical company in the country, we believe that it is our duty and responsibility to actively participate in the nation’s fight against COVID-19 and make India safe. Biological E Limited has achieved a capacity to produce 100+ million doses per month in order to ensure adequate supply and we are able to respond to any increasing demand too, should the need arise.

The SARS-CoV-2 virus has undergone a lot of mutations in a short duration. In clinical trials, CORBEVAXTM induced immune response demonstrated consistent neutralization of the Ancestral SARS-COV-2 strain as well as the Variants of Concern such as Beta, Delta and Omicron. In the efforts to bolster COVID-19 vaccines in India, I am grateful to our dedicated team, who have worked tirelessly to develop CORBEVAXTM and get it to this stage of readiness.”

Biological E. Limited’s is making continuous efforts to provide access to affordable healthcare by serving the community and society at large. We are proud that, CORBEVAXTM is the most affordable COVID-19 vaccine for the Government of India which is providing free vaccination to all eligible citizens. The pricing of CORBEVAXTM in the private market will be Rs. 990 inclusive of all taxes and vaccine administration charges.

Key Highlights of the CORBEVAXTM vaccine:
  • The first indigenous Indian vaccine to get EUA for vaccinating the Indian population between the age group of 12 to 80 Yrs
  • CORBEVAXTM is a recombinant protein subunit vaccine against the novel coronavirus
  • CORBEVAXTM induced immune response was indicative of over 90% effectiveness against the Ancestral strain; while >80% in the case of the Delta strain based on the level of neutralizing antibody titers.
  • CORBEVAXTM vaccination generates antibody response that is highly persistent for more than 6 months post vaccination.
  • Biological E. Limited’s CORBEVAXTM production capacity is up to 1 billion vaccines annually
  • CORBEVAXTM will be the most affordable COVID-19 vaccine in India as well as globally
About Biological E. Limited

Biological E. Limited (BE), a Hyderabad-based Pharmaceuticals & Biologics Company founded in 1953, is the first private sector biological products company in India and the first pharmaceutical company in Southern India. BE develops, manufactures and supplies vaccines and therapeutics. BE supplies its vaccines to over 100 countries and its therapeutic products are sold in India and the USA. BE currently has 8 WHO-prequalified vaccines in its portfolio.

In recent years, BE has embarked on new initiatives for organisational expansion such as developing generic injectable products for the regulated markets, exploring synthetic biology and metabolic engineering as a means to manufacture APIs sustainably and developing novel vaccines for the global market.

Media Contacts
Biological E. Limited
K. Vijay Amruth Raj
Email : Vijay.Kammari@biologicale.com
Phone: +91 83740 77433
www.biologicale.com/news

Ms. Mahima Datla Receives Dr. B. S. Bajaj Memorial Award

Hyderabad, India – February 25, 2022: Ms. Mahima Datla, Managing Director, Biological E. Limited, received Dr. B. S. Bajaj Memorial Award for introducing CORBEVAXTM vaccine in augmenting the global collective fight against COVID-19 today in Hyderabad.

The award was presented to Ms. Mahima Datla during the 19th edition of BioAsia, the largest annual global Biotechnology and Life Sciences summit of Asia, organised by the Government of Telangana and the Federation of Asian Biotech Associations (FABA).

The FABA presents this prestigious FABA Award, which was named after Dr. B. S. Bajaj last year, to individuals or organisations for their valuable contribution to the advancement in Biotechnology.

CORBEVAXTM Receives EUA for 12-18 Age Group

CORBEVAXTM is India’s 1st indigenously developed Receptor Binding Domain Protein sub-unit vaccine against COVID-19

Hyderabad, India – February 21, 2022: Biological E. Limited (BE), one of the world’s largest vaccine manufacturers, has today announced that its CORBEVAXTM vaccine, which is India's first indigenously developed Receptor Binding Domain (RBD) Protein sub-unit vaccine against COVID-19, has received emergency use authorisation (EUA) from India's drug regulator for the 12 to 18-year age group.

The Drugs Controller General of India (DCGI) has already approved CORBEVAXTM for restricted use in emergency situation among adults on December 28, 2021. BE received the approval for restricted use in an emergency situation in adolescents aged 12 to less than 18 years based on interim results (of the ongoing phase II/III clinical study).

Ms. Mahima Datla, Managing Director, Biological E. Limited, said, “We are pleased with this significant development, which helps extend the reach of our vaccine to the age group of 12 to 18 years in our country. We truly believe that with this approval, we are even more closer to finishing our global fight against the COVID-19 pandemic. Once fully vaccinated, children can resume their activities and educational pursuits in schools & colleges without any apprehension. We thank all the participants in the clinical trials, Biotechnology Industry Research Assistance Council (BIRAC) and Department of Biotechnology, Govt of India, Translational Health Science and Technology Institute (TSTHI) and the principal investigators and clinical site staff who have extended their support during the last several months.’’

Last September, BE received approval to conduct a Phase II/III clinical trial on CORBEVAXTM in children and adolescents aged 5 to 18 years. Based on the no-objection certificate, BE initiated the clinical study in October 2021 and evaluated the available safety and immunogenicity results of the ongoing phase II/III study, which indicated that the vaccine is safe and immunogenic.

The CORBEVAXTM vaccine is administered through intramuscular route with two doses scheduled 28 days apart and is stored at 2 to 8 degrees’ Celsius temperature and presented as 0.5 ml (single dose) and 5 ml (10 doses) vial and 10 mL (20 doses) vial pack

BE conducted phase I/II, II/III clinical trials of its CORBEVAXTM vaccine for adults in the country. In addition, it conducted a Phase III active comparison clinical trial to evaluate superiority over Covishield vaccine.

About Biological E. Limited

Biological E. Limited (BE), a Hyderabad-based Pharmaceuticals & Biologics Company founded in 1953, is the first private sector biological products company in India and the first pharmaceutical company in Southern India. BE develops, manufactures and supplies vaccines and therapeutics. BE supplies its vaccines to over 100 countries and its therapeutic products are sold in India and the USA. BE currently has 8 WHO-prequalified vaccines in its portfolio.

In recent years, BE has embarked on new initiatives for organisational expansion such as developing generic injectable products for the regulated markets, exploring synthetic biology and metabolic engineering as a means to manufacture APIs sustainably and developing novel vaccines for the global market.

Please follow us on Facebook, LinkedIn and Twitter

Media Contacts
Biological E. Limited
K. Vijay Amruth Raj
Email : Vijay.Kammari@biologicale.com
Phone: +91 83740 77433
www.biologicale.com/news

CORBEVAXTM GETS DCGI APPROVAL

CORBEVAXTM is India’s 1st indigenously developed protein sub-unit COVID-19 Vaccine

  • CORBEVAXTM is a “recombinant protein sub-unit” vaccine, developed from a component of the spike protein on the virus’s surface, which helps the body build the immune response against the virus
  • The vaccine has the Receptor Binding Domain (RBD) protein as an antigen, and also an optimum adjuvant consisting of Dynavax (DVAX) CpG 1018 and alum

Hyderabad, India – December 28, 2021: Biological E. Limited (BE), one of the world’s largest vaccine manufacturers, has today announced that its CORBEVAXTM, India’s first indigenously developed protein sub-unit vaccine against COVID-19, received the approval from the Drugs Controller General of India (DGCI).

CORBEVAXTM is a “recombinant protein sub-unit” vaccine, developed from the receptor binding domain (RBD) of the spike protein on the virus’s surface combined with Dynavax’s CpG 1018 adjuvant with alum, which helps the body build the immune response against the virus. The vaccine has been developed by Biological E. Limited in collaboration with Texas Children’s Hospital Center for Vaccine Development (Texas Children’s CVD) and Baylor College of Medicine (Baylor) in Houston, Texas.

The vaccine will be effective both in scale and affordability, providing sustainable access to low-and middle-income countries.

Clinical Basis & Vaccine Characteristics

Biological E. Limited's CORBEVAXTM has completed two Phase III clinical trials involving more than 3000 subjects between the ages of 18 and 80 at 33 study sites across India. The vaccine was found to be safe, well tolerated and immunogenic.

  • In the pivotal Phase III study conducted with an endpoint of immunogenic superiority, CORBEVAXTM demonstrated superior immune response in comparison with COVISHIELDTM vaccine when assessed for Neutralizing Antibody (nAb) Geometric Mean Titers (GMT) against the Ancestral-Wuhan strain and the globally dominant Delta variant. CORBEVAXTM vaccination also generated significant Th1 skewed cellular immune response
  • CORBEVAXTM nAb GMT against Ancestral-Wuhan strain is indicative of vaccine effectiveness of >90% for prevention of symptomatic infections based on the Correlates of Protection assessment performed during Moderna and Astra-Zeneca vaccine Phase III studies.
  • CORBEVAXTM nAb GMT against the Delta strain indicates a vaccine effectiveness of >80 percent for the prevention of symptomatic infections based on published studies.
  • While none of the subjects who took CORBEVAXTM or COVISHIELDTM had serious adverse events, CORBEVAXTM had 50 percent fewer adverse events than COVISHIELDTM.

In the continuous monitoring of phase II studies, CORBEVAXTM showed high persistence of immune response as indicated by <30% drop in nAb GMT till 6 months second dose as compared to>80% drop observed with majority of the vaccines.

The Government of India, Ministry of Health & Family Welfare said, “We are glad that India has produced yet another COVID-19 vaccine. We believe that this vaccine will address the needs of the world and help the global population fighting against the spread of COVID-19.

Vaccine Rollout Timeline

Biological E. Limited plans to complete production at a rate of 75 Million doses per month, anticipating 100+ million doses per month from February 2022. These capacities will enable the Hyderabad-based company to deliver 300 Million doses as promised to the Government of India. Soon, the company plans to deliver more than one billion additional doses globally.

“Our scientists at Texas Children’s Hospital and Baylor College of Medicine are thrilled to help in the development of this vaccine, possibly the first covid vaccine specifically designed for global health,” said Dr. Peter Hotez, professor and dean of the National School of Tropical Medicine at Baylor and co-director of the Texas Children’s Hospital Centre for Vaccine Development.

Ms. Mahima Datla, Managing Director, Biological E. Limited, said, “Over the years, we have worked to make quality vaccines and pharmaceutical products accessible to families around the world. With this as our backdrop, we resolved to develop an affordable and effective COVID-19 vaccine. It has now become a reality.

Ms. Mahima further said that ``The journey of CORBEVAXTM has been eventful and any words will fall short to appreciate and acknowledge the contribution of all our collaborators and their continued support in this endeavour. We would like to take the opportunity to specially thank our Prime Minister Shri. Narendra Modi ji for making vaccination a national mission. His vision and the advance commitments we received towards CORBEVAXTM were instrumental in our ability to scale-up and manufacture at such huge capacities. While COVID Suraksha Program’s endeavour to accelerate vaccine development played a crucial role in the initial development, the mechanism that was setup with the support of Department of Biotechnology (DBT) and Biotechnology Industry Research Assistance Council (BIRAC) allowed us to scale up to a capacity of about 1.2 billion doses per annum making the dream of accessibility – affordability and supply – a reality.

We deeply appreciate CEPI, BCM, the Bill and Melinda Gates Foundation, DFC, Texas Children’s Hospital, Translational Health Science and Technology Institute (THSTI), and the Government of Telangana for their continuous support and cooperation during this journey. We also thank our volunteers and our funding institutions IFC and EXIM for the trust placed in us. The combined efforts & unceasing support demonstrate that we can collectively overcome any challenge.”

About Biological E. Limited

Biological E. Limited (BE), a Hyderabad-based Pharmaceuticals & Biologics Company founded in 1953, is the first private sector biological products company in India and the first pharmaceutical company in Southern India. BE develops, manufactures and supplies vaccines and therapeutics. BE supplies its vaccines to over 100 countries and its therapeutic products are sold in India and the USA. BE currently has 8 WHO-prequalified vaccines in its portfolio.

In recent years, BE has embarked on new initiatives for organisational expansion such as developing generic injectable products for the regulated markets, exploring synthetic biology and metabolic engineering as a means to manufacture APIs sustainably and developing novel vaccines for the global market.

For further details, please visit Biological E. Limited and follow us on Facebook, LinkedIn and Twitter

Media Contacts
Biological E. Limited
K. Vijay Amruth Raj
Email : Vijay.Kammari@biologicale.com
Phone: +91 83740 77433
www.biologicale.com/news

DFC and Biological E. Limited Finalize Financing Arrangement to
Expand COVID-19 Vaccine Manufacturing Capabilities in India

Hyderabad, India – October 25, 2021: U.S. International Development Finance Corporation (DFC) COO David Marchick and Biological E. Limited Managing Director Mahima Datla today unveiled the expansion of Biological E.’s vaccine manufacturing facility in Hyderabad and finalized a U.S. government financing arrangement formalizing $50 million to ex-pand the company’s capacity to produce COVID-19 vaccines.

The continued partnership will help bolster near-term COVID-19 response efforts and will also benefit long-term global health in India and throughout the Indo-Pacific region. This work is in support of the historic commitment set out by President Biden and his counterparts in the “Quad” – Australia, India, Japan, and the United States.

To underscore the significance of the agreement under the Quad Vaccine Partnership, U.S. Chargé d’Af-faires Patricia Lacina, U.S. Consul General Joel Reifman, Ministry of External Affairs Joint Secretary Vani Rao, Telangana Principal Secretary of IT & Industries Jayesh Ranjan, Japanese Consul General Taga Ma-sayuki, and Australian Consul General Sarah Kirlew participated in the event in Hyderabad.

“DFC’s partnership with Biological E will support capacity for production of more than one billion vaccine doses by the end of 2022 for India and for developing countries around the world,” said David Marchick, Chief Operating Officer, DFC. “Today’s agreement represents a model of the close collaboration among countries that will be essential to achieve President Biden’s goal of ending the pandemic in 2022. Scaling Biological E.’s new facility, which is already producing vaccines, will help close the vaccine gap and save lives in developing countries.”

"We are pleased with the financial support from the U.S. government, especially DFC, which was an-nounced at the Quad Summit in March 2021,” said Ms. Mahima Datla, Managing Director, Biological E. Limited. “This investment will not only help us augment our capacity to produce more COVID-19 vaccines, but also help the global community that has been relentlessly fighting against the spread of the COVID-19 pandemic,” further said Ms. Mahima.

"I'm delighted that DFC is supporting CEPI's vaccine development partner Bio E to increase their manufac-turing capacity. International collaborations such as this to expand and diversify global manufacturing ca-pacity are key to controlling COVID-19 and strengthening global health security for the benefit of the en-tire world,” said Dr. Richard Hatchett, CEPI Chief Executive Officer.

DFC’s investment in Biological E. Limited is part of the agency’s Global Health and Prosperity Initiative, which is focused on supporting the global response to the COVID-19 pandemic and strengthening health resilience in developing countries. Through the initiative, DFC is working to catalyze $5 billion in projects that bolster health systems, support infrastructure development, and expand access to clean water, sanita-tion, and nutrition.

Several U.S. government agencies, including DFC, the Department of Health and Human Services, the U.S. Agency for International Development, and the National Security Council, have worked together to sup-port Biological E.’s manufacturing, bolstering President Biden’s global effort to end the pandemic. DFC and Biological E. have also collaborated with the Coalition for Epidemic Preparedness (CEPI), which provided early research and technical support for the company’s COVID vaccine efforts.

Under President Biden’s leadership, DFC’s financial tools are driving growth in vaccine manufacturing ca-pacity in multiple regions, in large and small countries, and with different technologies. Already, DFC’s sup-port is projected to facilitate capacity expansion to produce nearly 2 billion COVID-19 vaccine doses across the globe, with more projects in the pipeline. The agency is also working on expanding access to critical therapeutics and introducing medical equipment designed for low-resource environments.

About DFC

U.S. International Development Finance Corporation (DFC) is America’s development bank. DFC partners with the private sector to finance solutions to the most critical challenges facing the developing world to-day. We invest across sectors including energy, healthcare, critical infrastructure, and technology. DFC also provides financing for small businesses and women entrepreneurs in order to create jobs in emerging mar-kets. DFC investments adhere to high standards and respect the environment, human rights, and worker rights.

About Biological E. Limited

Biological E. Limited (BE), a Hyderabad-based Pharmaceuticals & Biologics Company founded in 1953, is the first private sector biological products company in India and the first pharmaceutical company in Southern India. BE develops, manufactures and supplies vaccines and therapeutics. BE supplies its vaccines to over 100 countries and its therapeutic products are sold in India and the USA. BE currently has 8 WHO-prequalified vaccines in its portfolio.

In recent years, BE has embarked on new initiatives for organisational expansion such as developing generic injectable products for the regulated markets, exploring synthetic biology and metabolic engineering as a means to manufacture APIs sustainably and developing novel vaccines for the global market.

For further details, please visit Biological E. Limited and follow us on Facebook, LinkedIn and Twitter

Media Contacts
Amanda Burke (DFC)
Email : aburke@dfc.gov
Phone: +1 202-664-6945

Email : press@dfc.gov
Phone: +1 (202) 312-2188

Biological E. Limited
K. Vijay Amruth Raj
Email : Vijay.Kammari@biologicale.com
Phone: +91 83740 77433
www.biologicale.com/news

Dynavax and Biological E Announce Commercial Supply Agreement of Dynavax’s CpG 1018 Adjuvant for Biological E’s COVID-19 Vaccine Candidate

Biological E to purchase CpG 1018 adjuvant from Dynavax for use in the commercial production of Biological E’s COVID-19 vaccine candidate, CORBEVAXTM

Hyderabad (India), July 06, 2021: Dynavax Technologies Corporation (Dynavax, Nasdaq: DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines and Biological E. Limited (BE), a Hyderabad-based vaccine and pharmaceutical company, today announced the execution of a commercial supply agreement of Dynavax’s CpG 1018TM advanced adjuvant, for use in BE’s subunit COVID-19 vaccine candidate, CORBEVAX™. The commercial supply agreement extends through 2022. The agreement includes doses for delivery in 2021, which were manufactured under the previously announced funding agreement between the Coalition for Epidemic Preparedness Innovations (CEPI) and Dynavax. Pending conditional regulatory approvals in India, BE expects to commence product launch of CORBEVAXTMlater this year.

Last month, India’s Union Ministry of Health announced that it had finalized arrangements with BE to reserve 300 million doses of CORBEVAX™ to be manufactured later this year. The arrangement with BE is part of the wider endeavor from the Government of India to encourage indigenous vaccine manufacturers by providing financial support.

Ryan Spencer, Chief Executive Officer of Dynavax commented, “Dynavax is proud to extend our collaboration with Biological E with a commercial supply agreement and deliver significant amounts of CpG 1018 in hopes that CORBEVAX™ will be an important COVID-19 vaccine protecting people globally regardless of income level.”

“We are pleased to collaborate with Dynavax and our collaboration will produce yet another vital vaccine against the spread of COVID-19. We believe CORBEVAX™ will play a critical role in eradicating the global pandemic,” said Ms. Mahima Datla, Managing Director, Biological E. Limited.

About CpG 1018 Adjuvant

CpG 1018 is the adjuvant used in HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted], an adult hepatitis B vaccine approved by the U.S. Food and Drug Administration (FDA) and the European Commission. Dynavax developed CpG 1018 adjuvant to provide an increased vaccine immune response, which has been demonstrated in HEPLISAV-B. CpG 1018 adjuvant provides a well-developed technology and a significant safety database, potentially accelerating the development and large-scale manufacturing of a COVID-19 vaccine.

About Dynavax

Dynavax is a commercial stage biopharmaceutical company developing and commercializing novel vaccines. The Company’s first commercial product, HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted], is approved in the U.S. and the European Union for prevention of infection caused by all

known subtypes of hepatitis B virus in adults age 18 years and older. Dynavax is also advancing CpG 1018 adjuvant as a premier vaccine adjuvant through research collaborations and partnerships. Current collaborations are focused on adjuvanted vaccines for COVID-19, pertussis and universal influenza. For more information, visit www.dynavax.com and follow the company on LinkedIn.

About Biological E. Limited

Biological E. Limited (BE), a Hyderabad-based Pharmaceuticals & Biologics Company founded in 1953, is the first private sector biological products company in India and the first pharmaceutical company in Southern India. BE develops, manufactures and supplies vaccines and therapeutics. BE supplies its vaccines to over 100 countries and its therapeutic products are sold in India and the USA. BE currently has 8 WHO-prequalified vaccines in its portfolio.

In recent years, BE has embarked on new initiatives for organisational expansion such as developing generic injectable products for the regulated markets, exploring synthetic biology and metabolic engineering as a means to manufacture APIs sustainably and developing novel vaccines for the global market.

For further details, please visit Biological E. Limited and follow us on Facebook, LinkedIn and Twitter

Forward-Looking Statements

This press release contains "forward-looking" statements, including statements regarding the potential to develop a COVID-19 vaccine containing CpG 1018 adjuvant, the timing and amount of potential sales to Biological E and timing of regulatory approvals. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in vaccine research and development, including the timing of completing development, whether CpG 1018 combined with the antigen in BE’s subunit vaccine candidate will prove to be beneficial in clinical trials, whether use of CpG 1018 will reduce the amount of antigen required per dose, whether and when the vaccine will be approved for use, protection rates realized and whether sufficient quantities of CpG 1018 and of vaccine will be able to be manufactured, as well as other risks detailed in the "Risk Factors" section of our Annual Report on Form 10-K for the fiscal year ended December 31, 2020, as well as discussions of potential risks, uncertainties and other important factors in our other filings with the U.S. Securities and Exchange Commission. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. Information on Dynavax's website at www.dynavax.com is not incorporated by reference in our current periodic reports with the SEC.

Media Contacts
Dynavax
Nicole Arndt, Senior Manager, Investor Relations
Email : narndt@dynavax.com
Phone: 510-665-7264


Derek Cole, President
Investor Relations Advisory Solutions
Email : derek.cole@IRadvisory.com

Biological E. Limited
K. Vijay Amruth Raj
Email : Vijay.Kammari@biologicale.com
Phone: +91 83740 77433
www.biologicale.com/news

Providence Therapeutics Holdings Inc. of Canada and Biological E. Limited of India announce the execution of a term sheet for the licensing and collaboration of mRNA vaccine

Hyderabad (India), June 1, 2021:Providence Therapeutics Holdings Inc. (“Providence”) and Biological E. Limited (“Biological E”) announce the execution of a term sheet (the “Term Sheet”), that sets forth the material terms for a definitive licensing and collaboration agreement (the “Definitive Agreement”) and also outlines the terms for sale by Providence of up to 30 million doses of Providence’s proprietary messenger RNA vaccine, PTX-COVID19-B, to Biological E and other End-buyers. This sale represents the sale of all the remaining 2021 Providence production, plus a portion of the early 2022 Providence production, after accounting for the first sale of Providence vaccines to the Province of Manitoba, Canada.

Providence will provide the necessary technology transfer for Biological E to manufacture mRNA vaccines in India, with a minimum production capacity of 600 million doses in 2022 and a target capacity of 1 billion doses. Biological E will be responsible for all clinical development and regulatory activities for the mRNA vaccine in India and other jurisdictions licensed by Biological E.

“This initiative is an important commitment by a Canada-based company to help India and other nations vaccinate their citizens against COVID19. Providence was founded to serve patients, and this commitment by Biological E allows us to achieve that essential goal,” indicated Brad Sorenson, CEO of Providence.

“The mRNA platform has emerged as the front runner in delivering the first vaccines for emergency use to combat the COVID-19 pandemic. Biological E. is very pleased to be able to work with Providence on its promising mRNA vaccine candidate. We hope to provide India and other countries yet another option to ramp up their efforts towards achieving herd immunity against COVID-19,” said Mahima Datla, Managing Director of Biological E Limited.

The financial terms of the transaction have not been disclosed.

About Biological E. Limited

Biological E. Limited (BE), a Hyderabad-based Pharmaceuticals & Biologics Company founded in 1953, is the first private sector biological products company in India and the first pharmaceutical company in Southern India. BE develops, manufactures and supplies vaccines and therapeutics. BE supplies its vaccines to over 100 countries and its therapeutic products are sold in India and the USA. BE currently has 8 WHO-prequalified vaccines in its portfolio.

In recent years, BE has embarked on new initiatives for organisational expansion such as developing generic injectable products for the regulated markets, exploring synthetic biology and metabolic engineering as a means to manufacture APIs sustainably and developing novel vaccines for the global market.

For further details, please visit Biological E. Limited and follow us on Facebook, LinkedIn and Twitter

About Providence Therapeutics

Providence is a leading Canadian clinical stage biotechnology company pioneering mRNA therapeutics and vaccines with operations in Calgary, Alberta and Toronto, Ontario. In response to a worldwide need for a COVID-19 vaccine, Providence expanded its focus beyond oncology therapies and devoted its energy and resources to develop a world-class mRNA vaccine for COVID-19. Providence is focused on serving the needs of Canada, and other countries that may be underserved by large pharmaceutical programs. For more information, please visit providencetherapeutics.com.

Media Contacts
Providence Therapeutics
Noy Wong
Investor Relations & Communications
Email : media.reach@providencetherapeutics.com
Phone: 1 (403) 800-3031 (Canada) OR Toll-Free number 1 (877) 324-0006

Biological E. Limited
K. Vijay Amruth Raj
Corporate Communications Lead
Email : Vijay.Kammari@biologicale.com
Phone: +91 83740 77433
www.biologicale.com/news

FORWARD LOOKING STATEMENTS

The forward-looking statements and information in this press release include but are not limited to statements with respect to the successful negotiation and entering into the Definitive Agreement described in this press release and the satisfaction of each party's obligations in accordance with the Definitive Agreement. Such statements and information reflect the current views of Providence and Biological E. with respect to risks and uncertainties that may cause actual results to differ materially from those contemplated in those forward-looking statements and information. Such statements are not historical facts. Readers are cautioned not to place undue reliance on forward-looking statements, as there can be no assurance that the plans, intentions or expectations upon which they are based will occur. By their nature, forward-looking statements involve numerous assumptions, known and unknown risks and uncertainties, both general and specific, that contribute to the possibility that the predictions, forecasts, projections in the forward-looking statements will not occur. Except as required by law, Providence and Biological E. Limited disclaim any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Providence's and Biological E. Limited’s current expectations and speak only as of the date hereof.

Biological E. Limited Gets CDSCO Nod to Start Phase III Clinical Trial of its COVID-19 Vaccine Candidate

Successfully Completes Phase I/II Clinical Trial
Results are Highly Positive and Promising

Hyderabad (India), April 24, 2021: Biological E. Limited (BE), a Hyderabad-based vaccine and pharmaceutical company, today announced that it has successfully completed the Phase I/II clinical trial of its COVID-19 subunit vaccine candidate in India and received the approval to start the Phase III clinical trial from the Central Drugs Standard Control Organization (CDSCO) - Subject Expert Committee (SEC).

BE started the Phase I/II Clinical Trial of its COVID-19 Vaccine Candidate in the second week of November 2020. Its candidate includes an antigen developed by Texas Children’s Hospital Center for Vaccine Development and in-licensed from BCM Ventures, Baylor College of Medicine’s integrated commercialization team, along with Dynavax Technologies Corporation’s (Nasdaq: DVAX) advanced adjuvant CpG 1018TM. The Coalition for Epidemic Preparedness Innovations (CEPI) and the Biotechnology Industry Research Assistance Council (BIRAC) have provided support for the Phase I/II Clinical Trials and also for the upcoming Phase III trial of this vaccine candidate.

BE's Phase I/II clinical trial evaluated the safety and immunogenicity of the vaccine candidate consisting of the Receptor Binding Domain of the Spike Protein of SARS-CoV-2 at three-dose level adjuvanted with CpG 1018 plus alum, in about 360 healthy subjects in the age range of 18 to 65 years. The vaccination schedule consisted of two doses for each study participant, administered via intramuscular injection 28 days apart. BE’s novel Covid-19 vaccine was found to be safe and well tolerated and immunogenic.

“We are delighted with the success of the Phase I/II clinical trials of our COVID-19 vaccine candidate. The results of these clinical trials are very positive and promising. We believe that our vaccine candidate will become another effective global COVID-19 vaccine as we move forward into Phase III clinical trials,” said Ms. Mahima Datla, Managing Director, Biological E. Limited.

“Having our Texas Children’s and Baylor vaccine construct advance into phase III clinical studies in India and globally highlights the importance of advancing traditional protein-based vaccine platforms, which now brings added hope for a people’s vaccine to be scaled and deployed in low- and middle-income settings,” said Dr. Maria Elena Bottazzi, associate dean of the National School of Tropical Medicine at Baylor College of Medicine and co-director of Texas Children’s Hospital Center for Vaccine Development.

“This vaccine could one day soon fill urgently needed gaps and vaccine supply shortages in Africa, Latin America, and in low-income Asian countries. It’s so exciting to partner with BE helping India to provide a vaccine to halt the COVID-19 pandemic globally,” said Dr. Peter Hotez, professor and dean of the National School of Tropical Medicine at Baylor and co-director of Texas Children’s Hospital Center for Vaccine Development.

The Phase III clinical study to be conducted in 15 sites across India will evaluate the Immunogenicity and Safety of Biological E’s SARS-CoV-2 COVID-19 vaccine for protection against COVID-19 disease in about 1268 healthy subjects in the age range of 18 to 80 years. It is intended to be part of a larger global Phase III study.

About Biological E. Limited

Biological E. Limited (BE), a Hyderabad-based Pharmaceuticals & Biologics Company founded in 1953, is the first private sector biological products company in India and the first pharmaceutical company in Southern India. BE develops, manufactures and supplies vaccines and therapeutics. BE supplies its vaccines to over 100 countries and its therapeutic products are sold in India and the USA. BE currently has 8 WHO-prequalified vaccines in its portfolio.

In recent years, BE has embarked on new initiatives for organisational expansion such as developing generic injectable products for the regulated markets, exploring synthetic biology and metabolic engineering as a means to manufacture APIs sustainably and developing novel vaccines for the global market.

For further details, please visit Biological E. Limited and follow us on Facebook, LinkedIn and Twitter

About Baylor College of Medicine

Baylor College of Medicine (www.bcm.edu) in Houston is recognized as a health sciences university and is known for excellence in education, research and patient care. It is the only private medical school in the greater southwest and is ranked 22nd among medical schools for research and 4th for primary care by U.S. News & World Report. Baylor is listed 21th among all U.S. medical schools for National Institutes of Health funding and No. 1 in Texas. The Baylor pediatrics program ranked 6th among all pediatric programs, reflecting the strong affiliation with Texas Children’s Hospital where our faculty care for pediatric patients and our students and residents train. Located in the Texas Medical Center, Baylor has affiliations with seven teaching hospitals and jointly owns and operates Baylor St. Luke’s Medical Center, part of CHI St. Luke’s Health. Currently, Baylor has more than 3,000 trainees in medical, graduate, nurse anesthesia, physician assistant, orthotics and genetic counseling as well as residents and postdoctoral fellows. Follow Baylor College of Medicine on Facebook, Twitter

About BCM Ventures

Baylor College of Medicine Ventures is the commercial engine of the health sciences university, created to support the translation of academic knowledge and intellectual assets for the benefit of society. We do this by engaging university innovators, entrepreneurs and industry to fully develop ideas along their best commercial path. We foster a culture of commercialization and engage with industry to identify market opportunities for collaborative ventures. To learn more about partnering with BCM Ventures and accessing our available technologies, contact bcmventures@bcm.edu.

About Dynavax

Dynavax is a commercial stage biopharmaceutical company developing and commercializing novel vaccines. The Company’s first commercial product, HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted], is approved in the U.S. and the European Union for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older. Dynavax is also advancing CpG 1018 as a premier vaccine adjuvant through global research collaborations and partnerships. Current collaborations are focused on adjuvanted vaccines for COVID-19, pertussis and universal influenza. For more information, visit www.dynavax.com and follow the company on LinkedIn.

Media Contacts
Baylor College of Medicine
Molly Chiu
Email : Molly.chiu2@bcm.edu
Phone: 713-798-4710
www.bcm.edu/news

Biological E. Limited
K. Vijay Amruth Raj
Email : Vijay.Kammari@biologicale.com
Phone: +91 83740 77433
www.biologicale.com/news

CEPI Partners with Biological E. Limited to advance Development and
Manufacture of COVID-19 Vaccine candidate

Hyderabad (India), December 29, 2020: CEPI, the Coalition for Epidemic Preparedness Innovations and Biological E Limited, India (Bio E), a Hyderabad-based vaccines and pharmaceutical company, today announced a collaboration to advance the development and manufacture of Bio E’s COVID-19 subunit vaccine candidate. CEPI will initially contribute up to $5m toward the cost of scaling up the process for manufacturing the vaccine, and will explore providing additional funding to Bio E with the goal of potentially enabling the production of 100 million doses in 2021. The candidate has also received seed funding from the Department of Biotechnology, Government of India.

Bio E initiated a Phase 1/2 clinical trial to evaluate the safety and immunogenicity of the vaccine candidate in India in November 2020, and expects interim data from the trial to be available in Q1 of 2021.

CEPI and Bio E are committed to global equitable access of COVID-19 vaccines and have agreed that vaccine output funded by CEPI’s investment will be made available for procurement and allocation, if proven to be safe and effective, through the COVID-19 Vaccine Global Access (COVAX) Facility. The COVAX Facility aims to ensure equitable access to COVID-19 vaccines for all countries, at all levels of development, that wish to participate.

The Bio E COVID-19 vaccine candidate

Bio E’s COVID-19 vaccine candidate is based on classical vaccine technology of a protein antigen, SARS-CoV-2 Spike RBD, adsorbed to the adjuvant Alhydrogel (Alum), in combination with another approved adjuvant, CpG 1018. The RBD of S1 subunit binds to the Angiotensin Converting Enzyme-2 (ACE2) receptor on host cell membrane and facilitates virus entry.

RBD protein is expressed in yeast Pichia pastoris, and is similar to technology Bio E is employing for large-scale commercial production of Hep B vaccines. The Baylor College of Medicine construct “RBD N1C1” was selected as the final vaccine antigen candidate on the basis of its manufacturability, due to the yields of protein antigen achieved, ease of process steps and favourable formulation aspects.

The combination of Alum with CpG with N1C1 antigen elicited a highly synergistic, balanced immune response in preclinical models. Four formulations with these components are currently being evaluated in a Phase I/ II clinical study in India to select the final vaccine candidate to be tested in subsequent Phase III trials.

Potential advantages of this vaccine candidate include scalability and thermostability, which could make it suitable for deployment at scale in low-resource settings.

Dr Richard Hatchett, CEO of CEPI said:

“The world has made huge strides in developing vaccines against COVID-19, but there is still much work ahead of us and it is absolutely critical that vaccine R&D continues at pace. To end the acute phase of the pandemic, and control the virus in the longer term, we will need a range of safe and effective vaccines that can be manufactured at scale to meet global demand for billions of doses, and deployed to a wide range of populations and settings so that nobody is left behind.

“Bio E’s vaccine candidate has the potential to be produced at scale, and characteristics which could make it suitable for broad distribution in developing countries. I’m pleased to partner with Bio E to progress the development of this promising vaccine.”

Ms. Mahima Datla, Managing Director, Biological E. Limited said:

“We are very happy to have partnered with CEPI on this endeavour. This collaboration with CEPI validates the technology platform BioE is working on for developing an effective COVID-19 vaccine candidate. The initial investment from CEPI comes on the heels of investments from the Bill & Melinda Gates Foundation and Government of India’s Biotechnology Industry Research Assistance Council (BIRAC) under the National Biopharma Mission of Department of Biotechnology, Government of India, and provides the impetus for accelerated efforts towards a successful and scalable outcome for global access.

“Over the past 10 months, the world has witnessed an unprecedented health emergency and is eagerly awaiting a COVID-19 vaccine. We are working tirelessly to produce a safe and effective vaccine against COVID-19 at an unprecedented pace’’ she further added.

About CEPI’s COVID-19 vaccine programmes

Built on the principles of speed, scale and equitable access, CEPI is supporting the research and development of a diverse portfolio of vaccine candidates based on a range of vaccine approaches. Including Bio E, CEPI has invested in 11 vaccine candidates, nine of which are still in development, and seven of which are in clinical trials.

CEPI has raised US$1.3bn in support of COVID-19 vaccine research and development, but urgently needs $800m in additional funds to achieve its aim of developing three safe and effective vaccines which can be made globally available through COVAX. These funds are vital for CEPI to progress the most promising vaccine candidates in the portfolio through crucial late-stage clinical trials to prove their safety and efficacy, and ultimately to licensure.

About CEPI

CEPI is an innovative partnership between public, private, philanthropic, and civil organisations, launched at Davos in 2017, to develop vaccines to stop future epidemics. CEPI has moved with great urgency and in coordination with WHO in response to the emergence of COVID-19. CEPI has initiated 11 partnerships to develop vaccines against the novel coronavirus. The programmes will leverage rapid response platforms already supported by CEPI as well as new partnerships. The aim is to advance COVID-19 vaccine candidates into clinical testing as quickly as possible. 

Before the emergence of COVID-19 CEPI’s priority diseases included Ebola virus, Lassa virus, Middle East Respiratory Syndrome coronavirus, Nipah virus, Rift Valley Fever and Chikungunya virus. CEPI also invested in platform technologies that can be used for rapid vaccine and immunoprophylactic development against unknown pathogens (Disease X).

Follow our news page for the latest updates.

About Biological E. Limited

Biological E. Limited (BE), a Hyderabad-based Pharmaceuticals & Biologics Company founded in 1953, is the first private sector biological products company in India and the first pharmaceutical company in Southern India. BE develops, manufactures and supplies vaccines and therapeutics. BE supplies its vaccines to over 130 countries and its therapeutic products are sold in India and the USA. BE currently has 8 WHO-prequalified vaccines in its portfolio.

In recent years, BE has embarked on new initiatives for organisational expansion such as developing generic injectable products for the regulated markets, exploring synthetic biology and metabolic engineering as a means to manufacture APIs sustainably and developing novel vaccines for the global market.

Follow us on Facebook, LinkedIn and Twitter

About COVAX

COVAX is the vaccines pillar of the ACT-Accelerator. It is co-led by CEPI, Gavi, the Vaccine Alliance, and the World Health Organization (WHO) – working in partnership with developed and developing country vaccine manufacturers, UNICEF, the World Bank, Civil Society Organisations and others. COVAX is the only global initiative that is working with governments and manufacturers to ensure COVID-19 vaccines are available worldwide to economies of all financial means. 

Media Contacts
CEPI
Email : press@cepi.net
Phone: +44 7387 055214

Biological E. Limited
K. Vijay Amruth Raj
Email : Vijay.Kammari@biologicale.com
Phone: +91 83740 77433

WHO Pre-Qualifies BE’s Typhoid Conjugate Vaccine

BE is one of the two Pre-Qualified Suppliers of TCV to UN Agencies

Hyderabad (India), December 11, 2020: Biological E. Limited (BE), a Hyderabad-based vaccines and pharmaceutical company, today announced that its Typhoid Conjugate Vaccine (TCV) has been pre-qualified by the World Health Organisation (WHO). With this pre-qualification, BE became one of two pre-qualified suppliers of TCV to the UN agencies.

BE’s TCV is a single-dose injectable vaccine, which can be administered to children from 6 months of age to adults up to the age of 45 and it is formulated with Vi polysaccharide conjugated to a carrier protein (CRM197). The Vi polysaccharide antigen used in BE’s TCV is derived from C. freundii, which is a non-pathogenic source (BSL 1 organism), compared to virulent Salmonella Typhi used by other manufacturers, and the carrier protein used for conjugation is a non-toxic CRM197 protein locally developed by BE through in-house R&D effort. Clinical studies conducted in India have shown that the safety and immunogenicity profiles of this vaccine are comparable with those of the other WHO pre-qualified TCV. BE offers this vaccine as single-dose and multi-dose vials for ease of administration.

The vaccine was developed in collaboration with the GSK Vaccines Institute for Global Health (GVGH), based in Siena, Italy, which first developed the vaccine strain and transferred the technology to BE in 2013. BE has further developed the vaccine, including manufacturing process optimization and scale up, pre-clinical studies and comprehensive clinical trials for Phase I, II/III in India. Today, this vaccine is being manufactured in BE’s GMP manufacturing facilities in Hyderabad, India.

“This is a remarkable accomplishment and a significant milestone in the journey of our vaccines. I am delighted that we have been able to produce a new WHO pre-qualified vaccine. We believe that every year this vaccine would save about 1.5 Lakh people worldwide,” said Ms. Mahima Datla, Managing Director, Biological E. Limited.

“GSK, through its R&D efforts at GVGH, is proud to have played an essential role in providing technologies to Biological E for their Typhoid Conjugate Vaccine (TCV),” said Francesco Berlanda-Scorza, GVGH Director. For more than a decade, GVGH has been advancing vaccines for under-recognised diseases, and as a result of an innovative partnership with Biological E to develop this vaccine, and TCV prequalification by WHO, many more children will have access to a much needed intervention for prevention of typhoid fever.”

In March 2020, BE received approval from India's health regulators to authorise and market a new TCV (BE’s product TYPHIBEV) for infants, children and adults from 6 months.

This pre-qualification from WHO allows BE to make a significant contribution to unmet public health needs in developing countries by helping to protect children against typhoid and helping to secure the supply of vaccines against typhoid.

About Biological E. Limited

Biological E. Limited (BE), a Hyderabad-based Pharmaceuticals & Biologics Company founded in 1953, is the first private sector biological products company in India and the first pharmaceutical company in Southern India. BE develops, manufactures and supplies vaccines and therapeutics. BE supplies its vaccines to over 130 countries and its therapeutic products are sold in India and the USA. BE currently has 8 WHO-prequalified vaccines in its portfolio.

In recent years, BE has embarked on new initiatives for organisational expansion such as developing generic injectable products for the regulated markets, exploring synthetic biology and metabolic engineering as a means to manufacture APIs sustainably and developing novel vaccines for the global market.

For further details, please visit www.biologicale.com and follow us on Facebook, LinkedIn and Twitter

Biological E. Limited Media Enquiries:
K. Vijay Amruth Raj
TEL: +91 8374077433
Vijay.Kammari@biologicale.com

Ohio State Innovation Foundation Exclusively Licenses COVID-19 Vaccine Technology to
Biological E. Limited

OSIF Licenses SARS-CoV-2 Vaccine Candidates Using Live Attenuated Measles Virus Vector Exclusively to BE

Hyderabad (India), December 8, 2020: Biological E. Limited (BE), a Hyderabad-based vaccine & pharmaceutical company, and the Ohio State Innovation Foundation (OSIF), USA, today announced the execution of an exclusive license agreement for a COVID-19 vaccine technology. OSIF has licensed novel live attenuated measles virus vectored vaccine candidates against SARS-CoV-2, which were developed by the Ohio State University College of Veterinary Medicine, exclusively to Biological E. Limited (BE).

BE will be responsible for the evaluation and further development, including the commercialization of the vaccine candidate(s).

There is an urgent need to protect the global population with SARS-CoV-2 vaccines that are safe and efficacious, can be manufactured with efficient, scalable processes and have reasonable costs to store and distribute. The licensed intellectual assets were developed in the laboratories of Jianrong Li, DVM, PhD, and Stefan Niewiesk, DVM, PhD, as a response to the global pandemic. The vaccine candidates are live attenuated recombinant viral vectored vaccines based on measles vaccine strains.

“Translating this vaccine platform into the hands of a global vaccine company for further evaluation and development is a critical step and we are excited that Biological E has taken on this role,” said Dr. Patrick Green, Associate Dean for Research and Graduate Studies, Ohio State University College of Veterinary Medicine.

The Ohio State University College of Veterinary Medicine (CVM) team’s approach utilizes the SARS-CoV-2 spike (S) protein as a target protein for SARS-CoV-2 vaccine candidates, generating a series of attenuated recombinant measles viruses (rMeVs) expressing SARS-CoV-2 antigens. All resultant rMeVs, the basis for the vaccine candidates, grow to high virus titer in Vero cells, a WHO-approved cell line for vaccine production. They were also shown to express the recombinant S antigens, a critical step in developing a SARS-CoV-2 vaccine. The rMeV-based SARs-CoV-2 vaccine candidates have proceeded through proof-of-concept trials in multiple animal models – demonstrating successful production of SARS-CoV-2 antibodies.

“BE has been working to develop a safe and effective vaccine for the COVID-19. BE is very happy to help further this innovation and expand that effort,’’ said Ms. Mahima Datla, Managing Director, Biological. E. Limited.

“With this licensing transaction, we have expanded the repertoire of the candidate vaccine(s) that we are evaluating, both in terms of the antigen and the platform technology,” said Mr. Narender Dev Mantena, Director, BioE Holdings Inc., who heads BE’s novel vaccine initiative.

About College of Veterinary Medicine (CVM), Ohio State University

Founded in 1885, The Ohio State University College of Veterinary Medicine is ranked fourth in the nation by U.S. News & World Report. The College is home to Ohio State’s Center for Retrovirus Research comprised of internationally recognized leaders in the field who work to facilitate interdisciplinary investigations for prevention and treatment of retrovirus diseases of humans and animals. In addition, the College’s Infectious Disease Signature Program is an integral part of the Ohio State University Infectious Disease Institute, focused on controlling the spread and severity of infectious diseases through the creation and dissemination of knowledge, practices and solutions. Multidisciplinary active networks in high impact programmatic areas implement this mission.  The college includes degree programs in Veterinary Medicine, Comparative Biomedical Sciences and a unique Master’s degree in Veterinary Public Health, in partnership with the College of Public Health and operates a large referral Veterinary Health System. Learn more at vet.osu.edu.

About Ohio State Innovation Foundation (OSIF)

The Ohio State Innovation Foundation, is a 501(c)(3) organization formed by The Ohio State University in 2012 to hold, manage and facilitate commercialization of the university's intellectual property.

About Biological E. Limited

Biological E. Limited (BE), a Hyderabad-based Pharmaceuticals & Biologics Company founded in 1953, is the first private sector biological products company in India and the first pharmaceutical company in Southern India. BE develops, manufactures and supplies vaccines and therapeutics. BE supplies its vaccines to over 100 countries and its therapeutic products are sold in India and the USA. BE currently has 8 WHO-prequalified vaccines in its portfolio.

In recent years, BE has embarked on new initiatives for organisational expansion such as developing generic injectable products for the regulated markets, exploring synthetic biology and metabolic engineering as a means to manufacture APIs sustainably and developing novel vaccines for the global market.

Follow us on Facebook, LinkedIn and Twitter

Media Contacts
Ohio State’s CVM
Toni Hare
Director, Strategic Communications and Marketing
College of Veterinary Medicine
Hare.48@osu.edu

Biological E. Limited
K. Vijay Amruth Raj
Lead, Corporate Communications
Biological E. Limited, Hyderabad, India
Vijay.Kammari@biologicale.com

Biological E. Limited Starts Phase I/II Clinical Trial of its COVID-19 Vaccine Candidate

Hyderabad (India), November 16, 2020: Biological E. Limited (BE), a Hyderabad-based vaccines and pharmaceutical company, Dynavax Technologies Corporation (Dynavax), a US-based vaccine focused biopharmaceutical company, and Baylor College of Medicine, a health sciences university in Houston, TX, today announced that BE has initiated a Phase I/II clinical trial of its COVID-19 subunit vaccine candidate in India following approval from the Drugs Controller General of India (DGCI).

The vaccine candidate includes an antigen in-licensed from BCM Ventures, Baylor College of Medicine’s integrated commercialization team, along with Dynavax’s advanced adjuvant CpG 1018.

BE's Phase I/II clinical trial will evaluate the safety and immunogenicity of the vaccine candidate consisting of the Receptor Binding Domain of the Spike Protein of SARS-CoV-2 at three dose levels adjuvanted with CpG 1018 plus alum, in about 360 healthy subjects in the age range of 18 to 65 years. The vaccination schedule consists of two doses for each study participant, administered via intramuscular injection 28 days apart.

The results of this clinical trial are expected to be available by February 2021.

“The transition of our vaccine candidate into human trials is an important milestone, and exemplifies a successful transfer of technology with BE, that could lead to a safe, effective and affordable vaccine,” said Dr. Maria Elena Bottazzi, associate dean of the National School of Tropical Medicine at Baylor College of Medicine and co-director of Texas Children’s Hospital Center for Vaccine Development.

“This vaccine represents an urgent biotechnology innovation for ensuring health equity and combating the COVID-19 pandemic,” said Dr. Peter Hotez, professor and dean of the National School of Tropical Medicine at Baylor and co-director of Texas Children’s Hospital Center for Vaccine Development.

“We are very happy indeed to transition our potential vaccine candidate to clinical trials and offer one more potential option for the prophylaxis of COVID-19,” said Ms. Mahima Datla, Managing Director, Biological E. Limited.

“We are proud to contribute CpG 1018 to support development of an adjuvanted vaccine to prevent COVID-19. CpG 1018’s potential to boost the immune response to produce more antibodies and longer lasting immunity may also minimize the dose of antigen needed, enabling vaccination of a greater number of people,” commented Ryan Spencer, Chief Executive Officer of Dynavax.

About Biological E. Limited

Biological E. Limited (BE), a Hyderabad-based Pharmaceuticals & Biologics Company founded in 1953, is the first private sector biological products company in India and the first pharmaceutical company in Southern India. BE develops, manufactures and supplies vaccines and therapeutics. BE supplies its vaccines to over 100 countries and its therapeutic products are sold in India and the USA. BE currently has 8 WHO-prequalified vaccines in its portfolio.

In recent years, BE has embarked on new initiatives for organisational expansion such as developing generic injectable products for the regulated markets, exploring synthetic biology and metabolic engineering as a means to manufacture APIs sustainably and developing novel vaccines for the global market.

Follow us on Facebook, LinkedIn and Twitter

About Baylor College of Medicine

Baylor College of Medicine (www.bcm.edu) in Houston is recognized as a health sciences university and is known for excellence in education, research and patient care. It is the only private medical school in the greater southwest and is ranked 22nd among medical schools for research and 4th for primary care by U.S. News & World Report. Baylor is listed 21th among all U.S. medical schools for National Institutes of Health funding and No. 1 in Texas. The Baylor pediatrics program ranked 6th among all pediatric programs, reflecting the strong affiliation with Texas Children’s Hospital where our faculty care for pediatric patients and our students and residents train. Located in the Texas Medical Center, Baylor has affiliations with seven teaching hospitals and jointly owns and operates Baylor St. Luke’s Medical Center, part of CHI St. Luke’s Health. Currently, Baylor has more than 3,000 trainees in medical, graduate, nurse anesthesia, physician assistant, orthotics and genetic counseling as well as residents and postdoctoral fellows. Follow Baylor College of Medicine on Facebook and Twitter.

About Dynavax

Dynavax is a commercial stage biopharmaceutical company developing and commercializing novel vaccines. The Company’s first commercial product, HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted], is approved in the U.S. for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older. Dynavax is also advancing CpG 1018 as a premier vaccine adjuvant through global research collaborations and partnerships. Current collaborations are focused on adjuvanted vaccines for COVID-19, pertussis and universal influenza. For more information, visit www.dynavax.com and follow the company on LinkedIn.

Dynavax Forward-Looking Statements

This press release contains "forward-looking" statements, including statements regarding the potential to develop a COVID-19 vaccine containing CpG 1018. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in vaccine research and development, including the timing of completing development, whether CpG 1018 combined with the antigen in BE’s subunit vaccine candidate will prove to be beneficial in clinical trials, whether use of CpG 1018 will reduce the amount of antigen required per dose, whether and when the vaccine will be approved for use, and whether sufficient quantities of CpG 1018 and of vaccine will be able to be manufactured, as well as other risks detailed in the "Risk Factors" section of our Annual Report on Form 10-K for the fiscal year ended December 31, 2019, as well as discussions of potential risks, uncertainties and other important factors in our other filings with the U.S. Securities and Exchange Commission. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. Information on Dynavax's website at www.dynavax.com is not incorporated by reference in our current periodic reports with the SEC.

Media Contacts
Baylor College of Medicine
Molly Chiu
Molly.chiu2@bcm.edu
TEL: 713-798-4710
www.bcm.edu/news

Dynavax
Nicole Arndt
narndt@dynavax.com
Derek Cole
derek.cole@IRadvisory.com

Biological E. Limited
K. Vijay Amruth Raj
Vijay.Kammari@biologicale.com
TEL: +91 8374077433
www.biologicale.com/news

Biological E. Limited Acquires Akorn India

This Acquisition Will Enhance BE’s Capabilities in Vaccines & Generic Injectables

Hyderabad (India), August 17, 2020: Biological E. Limited (BE), a Hyderabad-based pharmaceuticals & Biologics company, today announced the acquisition of Akorn India Limited, a subsidiary of Akorn Inc., USA.

By this strategic acquisition, BE, which manufactures specialty generic injectable medicines and also vaccines, will be able to enhance its manufacturing capabilities and capacities to produce & supply its vaccines and injectable medicines. BE is in the process of developing a COVID-19 vaccine and may be able to use the facilities at Akorn India Paonta Sahib Plant in Himachal Pradesh for commercial scale manufacture of the vaccine at the appropriate time.

The Akorn India plant in Paonta Sahib, Himachal Pradesh has a fully staffed sterile injectable manufacturing facility with a 39,000 sq. mtrs of built up area spread over a 14-acre campus with an annual capacity for about 135 Million Units with the potential for immediate expansion of a further 30 Million Units.

Ms. Mahima Datla, Managing Director, Biological E. Limited, said: “We are happy to have made a strategic investment in acquiring Akorn India. We would leverage BE’s and Akorn India’s capabilities to enhance our supply capacities both in Vaccines and in Generic Injectables. The timing of this acquisition is fortuitous as it will immediately allow us to expand our capacity to manufacture our investigational COVID-19 vaccine. With these capacities, we would be in a position to offer over 1 billion doses per annum.”

Commenting on the acquisition, Mr. Narender Dev Mantena, Director, BioE Holdings Inc., who heads BE’s novel vaccines initiative, said “We are glad to have acquired Akorn India, which is known for its injectables and specialty sterile pharmaceuticals capabilities. This acquisition will allow us to expand our capacities to meet the increasing demands of our Specialty Generic Injectables for the US and EU customers. This acquisition will pave a new way for BE and add a significant value for our business operations and global supply of our products

About BioE Holdings Inc

BioE Holdings Inc. is a subsidiary of Biological E. Limited.

.
K. Vijay Amruth Raj
TEL: +91 8374077433
Vijay.Kammari@biologicale.com

Baylor College of Medicine collaborates with Biological E. Limited to develop a COVID-19 vaccine for global access

Hyderabad (India), August 13, 2020: Baylor College of Medicine and Biological E. Limited (BE) today announced a licensing agreement for the development of a safe, effective and affordable COVID-19 vaccine.

BE, an India-based company, has licensed the recombinant protein COVID-19 vaccine candidate developed at Baylor. The company engaged in license negotiations with the BCM Ventures team, part of Baylor College of Medicine, after initial discussions on Baylor’s technology and how it could possibly inform a vaccine to address the current global pandemic. The company will leverage its past experience for the further development and commercialization of the vaccine candidate, which currently is produced using a proven yeast-based expression technology.

“This week’s information that India has become the third-leading nation in terms of COVID-19 cases has sparked concern that COVID-19 will become widespread and a serious and deadly infection across the crowded urban areas of South Asia,” said Dr. Peter Hotez, professor and dean of the National School of Tropical Medicine at Baylor and co-director of Texas Children’s Center for Vaccine Development. “This is why this agreement is timely.”

“For the past two decades, our vaccine center has been advancing global health vaccines to prevent neglected and emerging diseases,” said Dr. Maria Elena Bottazzi, associate dean of the National School of Tropical Medicine at Baylor and co-director of Texas Children’s Center for Vaccine Development. “We are therefore well suited to embark on this important collaboration with BE and look forward to facilitating the technology transfer for the COVID-19 vaccine to India and for the world.”

The current focus is on transfer of the technology for BE to initiate scale-up of the manufacturing process and undertake further development of the vaccine candidate.

“BE is pleased to be a part of the global scientific effort aimed at exploring ways to respond to the COVID-19 pandemic. The partnership with Baylor would help accelerate the development of an affordable vaccine, especially for India and other low- and middle-income nations,” said Mahima Datla, managing director of BE.

“We look forward to leveraging our capabilities for the development and manufacturing of this much needed vaccine. If the vaccine development is successful, we expect to make several hundred million doses of the vaccine available annually,” said Narender Dev Mantena, director of BioE Holdings Inc., who heads BE’s novel vaccine initiative.

About Baylor College of Medicine

Baylor College of Medicine in Houston is recognized as health sciences university and is known for excellence in education, research and patient care. It is the only private medical school in the greater southwest and is ranked 22nd among medical schools for research and 4th for primary care by U.S. News & World Report. Baylor is listed 20th among all U.S. medical schools for National Institutes of Health funding and No. 1 in Texas. The Baylor pediatrics program ranked 8th among all pediatric programs, reflecting the strong affiliation with Texas Children’s Hospital where our faculty care for pediatric patients and our students and residents train. Located in the Texas Medical Center, Baylor has affiliations with seven teaching hospitals and jointly owns and operates Baylor St. Luke’s Medical Center, part of CHI St. Luke’s Health. Currently, Baylor has more than 3,000 trainees in medical, graduate, nurse anesthesia, physician assistant, orthotics and genetic counseling as well as residents and postdoctoral fellows. Follow Baylor College of Medicine on Facebook and Twitter.

About BCM Ventures

Baylor College of Medicine Ventures is the commercial engine of the health sciences university, created to support the translation of academic knowledge and intellectual assets for the benefit of society. We do this by engaging university innovators, entrepreneurs and industry to fully develop ideas along their best commercial path. We foster a culture of commercialization and engage with industry to identify market opportunities for collaborative ventures. To learn more about partnering with BCM Ventures and accessing our available technologies, contact bcmventures@bcm.edu.

About Biological E. Limited

Biological E. Limited (BE), a Hyderabad-based Pharmaceuticals & Biologics Company founded in 1953, is the first private sector biological products company in India and the first pharmaceutical company in Southern India. BE develops, manufactures and supplies vaccines and therapeutics. BE supplies its vaccines to over 100 countries and its therapeutic products are sold in India and the USA. BE currently has 8 WHO-prequalified vaccines in its portfolio.

In recent years, BE has embarked on new initiatives for organisational expansion such as developing generic injectable products for the regulated markets, exploring synthetic biology and metabolic engineering as a means to manufacture APIs sustainably and developing novel vaccines for the global market.

Follow us on Facebook, LinkedIn and Twitter

About BioE Holdings Inc

BioE Holdings Inc. is a subsidiary of Biological E. Limited.

Media Contact:
Molly Chiu
TEL: 713-798-4710
molly.chiu2@bcm.edu
www.bcm.edu/news

.
K. Vijay Amruth Raj
TEL: +91 8374077433
Vijay.Kammari@biologicale.com

Biological E. Limited Signs an Agreement with Johnson & Johnson for Technology Transfer of their COVID-19 Vaccine Candidate

Hyderabad (India), August 13, 2020: Biological E. Limited (“BE”) has entered into an agreement with Janssen Pharmaceutica NV (“Janssen”), one of the Janssen Pharmaceutical companies of Johnson & Johnson, for the creation / enhancement of manufacturing capacities for drug substance and drug product for Johnson & Johnson’s COVID-19 vaccine candidate, Ad26.COV2.S. Johnson & Johnson’s COVID-19 vaccine candidate is currently in Phase 1/2a clinical trials.

“We are very pleased indeed to collaborate with an organisation like Johnson & Johnson. Given the magnitude of the COVID-19 pandemic, our ability to mount an effective response will be predicated on the ability to supply the vaccine globally and in significant quantities. This is best achieved through collaboration,” said Mahima Datla, Managing Director of BE.

“We look forward to deploying our manufacturing infrastructure to support Johnson & Johnson’s commitment to global access for its COVID-19 vaccine,” said Narender Dev Mantena, Director of BioE Holdings Inc., who heads BE’s novel vaccine initiative.

The WHO has declared COVID-19, caused by the novel coronavirus SARS-CoV-2, a pandemic. Globally; over 17 million confirmed cases of COVID-19, including over 686,000 deaths have been reported to the WHO. Currently, there is no approved vaccine for COVID-19.

About Biological E. Limited

Biological E. Limited (BE), a Hyderabad-based Pharmaceuticals & Biologics Company founded in 1953, is the first private sector biological products company in India and the first pharmaceutical company in Southern India. BE develops, manufactures and supplies vaccines and therapeutics. BE supplies its vaccines to over 100 countries and its therapeutic products are sold in India and the USA. BE currently has 8 WHO-prequalified vaccines in its portfolio.

In recent years, BE has embarked on new initiatives for organisational expansion such as developing generic injectable products for regulated markets, exploring synthetic biology and metabolic engineering as a means to manufacture APIs sustainably and developing novel vaccines for global use.

Follow us on Facebook, LinkedIn and Twitter

About BioE Holdings Inc

BioE Holdings Inc. is a subsidiary of Biological E. Limited.

Media Contact:
K. Vijay Amruth Raj
TEL: +91 8374077433
Vijay.Kammari@biologicale.com

K T Rama Rao Inaugurates BE’s Plant at Genome Valley & Unveils Typhoid Conjugate Vaccine

BE invested Rs.300 Cr. to build this Plant, which will generate employment for about 1000 people
TCV protects children against typhoid fever: one-step closer to the use of a new vaccine

Hyderabad (India) February 17, 2020: Mr. K T Rama Rao, Honourable Minister for Information Technology, Industries & Commerce, Municipal Administration and Urban Development, Government of Telangana, inaugurated Biological E. Limited’s (BE) Plant and unveiled its new Typhoid Conjugate Vaccine (TCV) today in the Special Economic Zone at Genome Valley in Kolthur Village on the outskirts of Hyderabad.

Addressing the gathering, IT and Industries Minister Mr. K T Rama Rao appreciated the expansion initiatives of Biological E. Limited and said: “We are committed to making the State of Telangana number one State in terms of industrial growth and employment generation with a special focus on life sciences. In fact, these growth engines will not only boost the economy of the State but also improve the livelihood of people, who depend directly or indirectly on these industries. We are happy to see that this massive state-of-the-art plant, the foundation stone for which was laid during BioAsia 2017, is getting inaugurated during this 17th edition of BioAsia today.’’

Welcoming the gathering, Ms. Mahima Datla, Managing Director, Biological E. Limited, thanked the honourable Minister for inaugurating the plant and unveiling the vaccine. Ms. Mahima said: ``BE has invested around Rs.300 crore for building this plant, which is now ready for commercial production, on about 29 acres of land. This Plant would generate employment opportunities for around 1000 people. This new facility will help our existing Vaccines Plant enhance the production and manufacture new products, which are in the pipeline.’’

Recently, BE received the authorisation from the health regulatory authorities of India to license and market a new Typhoid Conjugate Vaccine. The approval from the Central Drugs Standard Control Organisation (CDSCO) is based on a thorough assessment of the vaccine’s efficacy and safety profile.. TCV is an injectable single-dose vaccine to be administered to children from 6 months old as well as adults and it contains Vi Polysaccharide derived from C. Freundii conjugated to CRM197 protein. The clinical studies conducted in India demonstrated that the safety and immunogenicity profiles of this vaccine are comparable to the other licensed and WHO Pre-qualified Typhoid conjugate vaccine.

This vaccine was developed in partnership with the GSK Vaccines Institute for Global Health, based in Siena (Italy), which first developed the asset and transferred it to BE in 2013. Subsequent developmental work on the vaccine was done by BE, including manufacturing process optimization and scale up, pre-clinical studies and full clinical trials in India. This vaccine will be manufactured in BE’s GMP manufacturing facilities in Hyderabad, India and could be commercially available within 3 months.

With this authorization from CDSCO the vaccine is now approved to be marketed in India, and it also allows BE to submit the vaccine for WHO pre-qualification (PQ) and registration in several other countries. This will help to expand its current portfolio of seven WHO PQ vaccines.

Ms. Mahima Datla, Managing Director, Biological E. Limited, commented on the development: “We are happy that our joint efforts have successfully produced a promising Typhoid vaccine. This is a remarkable milestone in our collaborative journey with the GSK Vaccine Institute for Global Health to save the maximum number of people, particularly children, around the world from Typhoid, which is a deadly, yet vaccine preventable disease.”

Dr Thomas Breuer, Chief Medical Officer of GSK Vaccines, commented: “Having this new vaccine approved is an important milestone for Global Health. It shows that GSK’s innovative and sustainable partnership model works to deliver vaccines based on GSK latest science to help protect people in developing countries against major health threats. We are very pleased with the excellent and close collaboration with BE.”

Upon pre-qualification by WHO, which is anticipated in 2020, this new vaccine is anticipated to significantly contribute to the unmet public health need in developing countries by helping protect children against typhoid fever and by contributing to securing the supply typhoid vaccines.

About typhoid fever

It is estimated that in 2017, typhoid fever caused more than 116,000 deaths worldwide – more than a billion people are at risk globally with the highest morbidity and mortality in Asia (nearly 9 million cases and over 90,000 deaths). It is estimated that vaccination against Salmonella enterica serovar Typhi (S. Typhi) could help save thousands of lives.

About Biological E. Limited

Biological E. Limited (BE), a Hyderabad-based Pharmaceutical Company founded in 1953, is the first private sector biological products company in India and the first pharmaceutical company in Southern India. BE develops, manufactures and supplies vaccines and therapeutics. BE has a current portfolio of 7 WHO Pre-qualified vaccines and supplies to over 100 countries globally. For further details, please visit www.biologicale.com

About the GSK Vaccines Institute for Global Health

The GSK Vaccines Institute for Global Health (GVGH) in Siena Italy has a vision to develop effective and affordable vaccines for neglected infectious diseases with high health burden in developing countries. Its 40 scientists focus on translating laboratory concepts into high quality vaccines by demonstrating their proof of concept and building partnerships with local and global organisations to further develop and bring those assets to patients. Current areas of work are Shigella, invasive nontyphoidal Salmonella, typhoid and paratyphoid A fevers, and Group A streptococcus.

About the GSK

GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit www.gsk.com

GSK Media Enquiries:
Simon Moore
TEL: +44 (0)2080475502
(London)

Biological E. Limited Media Enquiries:
K. Vijay Amruth Raj
TEL: +91 8374077433
Vijay.Kammari@biologicale.com

BioE Holdings Inks an Exclusive License Agreement with NCI for BK and JC Polyomavirus Vaccines

Hyderabad (India), October 25, 2019: BioE Holdings Inc., a subsidiary of Biological E. Limited, has entered into an exclusive license agreement with the National Cancer Institute (NCI), part of the National Institutes of Health, in the United States for Virus-like Particle (VLP) Polyomavirus Vaccine(s) for the prevention / treatment of BK Polyomavirus (BKV) and/or JCV associated diseases in organ/kidney transplantation, bone marrow transplantation, and Progressive Multifocal Leukoencephalopathy (PML).

The technology was developed in the laboratory of Dr. Christopher B. Buck at NCI, which is engaged in Polyomavirus research, which includes evaluation of mechanisms of viral entry into cells to the development of vaccine candidates that elicit virus-neutralizing antibodies.

Biological E. Limited (BE) has embarked on several initiatives for business expansion in recent years, including development of generic injectables with a focus on the regulated markets and exploring synthetic biology and metabolic engineering as a means to manufacture active pharmaceutical ingredients sustainably. In this context, Ms. Mahima Datla, Managing Director of Biological E. Limited said “the recent years have heralded a period of transformation for BE, both in terms of its pipeline of product offerings as well as its geographical footprint. Transitioning from being a generic vaccines manufacturer to a novel vaccines developer is indeed a momentous milestone for the company as it continues to evolve.”

BE has historically developed and manufactured generic vaccines for the emerging markets. To ensure optimal emphasis on the new initiative, the company plans to focus on developing novel vaccines to address unmet medical needs for the global markets.

Mr. Narender Dev Mantena,: Director of BioE Holdings Inc., who is heading this new initiative, said “We are very excited at the prospect of developing the Polyomavirus vaccine candidates from the NCI. These augment our development pipeline of novel vaccines that currently includes a next generation Pneumococcal Conjugate Vaccine (in-house) that covers over 20 serotypes and a Staphylococcus aureus vaccine (partnered).”

About Biological E. Limited

Biological E. Limited (BE), a Hyderabad-based Pharmaceutical Company founded in 1953, is the first private sector biological products company in India and the first pharmaceutical company in Southern India. BE develops, manufactures and supplies generic vaccines and therapeutics. BE supplies its vaccines to over 100 countries while its therapeutic products are sold in India.

In recent years, BE has embarked on new initiatives for organisational expansion such as developing generic injectable products for the regulated markets, exploring synthetic biology and metabolic engineering as a means to manufacture APIs sustainably and developing novel vaccines for the global market.

BioE Holdings Inc. is a subsidiary of Biological E. Limited.

Media Contact:
K. Vijay Amruth Raj
TEL: +91 8374077433
Vijay.Kammari@biologicale.com

BE Pharmaceuticals AG Receives ANDA Approval for Fosaprepitant for Injection

Hyderabad (India), September 6, 2019: Biological E. Limited (BE) is pleased to announce that its subsidiary, BE Pharmaceuticals AG, received an Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (USFDA) for Fosaprepitant for Injection, 150-mg Single-Dose Vial.

Fosaprepitant for Injection, a substance P/neurokinin-1 (NK) receptor antagonist, is indicated for adults in combination with other antiemetic agents for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy / moderately emetogenic cancer chemotherapy.

USFDA Approves BE Pharmaceuticals AG’s Daptomycin for Injection

Hyderabad (India), July 9, 2019: Biological E. Limited is pleased to announce that its subsidiary, BE Pharmaceuticals AG, received an Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (USFDA) for Daptomycin Injection 500 mg/Vial.

Daptomycin for injection is a Lipopeptide antibacterial indicated for the treatment of complicated skin and skin structure infections (cSSSI) and Staphylococcus aureus bloodstream infections in adults.

BE Pharmaceuticals AG Gets ANDA Approval for Neostigmine Methylsulfate Injection

Hyderabad (India), May 14, 2019: Biological E. Limited is pleased to announce that its subsidiary, BE Pharmaceuticals AG, received the Abbreviated New Drug Application (ANDA) approval from the United States Food and Drug Administration (USFDA) for Neostigmine Methylsulfate Injection USP, 5 mg/10 mL (0.5 mg/mL) and 10 mg/10 mL (1 mg/mL).

Neostigmine Methylsulfate injection, a cholinesterase inhibitor, is indicated for the reversal of the effects of non-depolarizing neuromuscular blocking agents (NMBAs) after surgery.

Takeda and BE Collaborate to Develop Low-Cost Vaccines for Low and Middle-Income Countries

Two recently-signed agreements will transfer Takeda’s measles and acellular pertussis vaccine technologies to India-based multi-national company Biological E. Limited (BE) to develop low-cost combination vaccines including diphtheria, tetanus and acellular pertussis (DTaP) and measles-rubella (MR) vaccines

Hyderabad, India – June 26, 2017: Takeda Pharmaceutical Company Limited [TSE: 4502], (“Takeda”) and Biological E. Limited (BE) today announced that they have entered into a collaboration whereby two licensing agreements to expedite the development and delivery of affordable combination vaccines have been executed. BE will commercialize the vaccine in India, China and low-and middle-income countries where large, unmet public health needs exist.

Takeda has sold both the measles and pertussis vaccines in the Japanese market for more than 20 years.In heavily populated countries like India, where 25.7 million births occurred in 2015,substantial opportunities remain to deliver critical vaccines to those who need them. In the absence of access to vaccines in many parts of the world, this partnership illustrates Takeda’s desire to forge the kind of collaborations needed to overcome this public health challenge in low-and middle-income countries.

“Access to medicines is one of Takeda’s core values, and these agreements align with Takeda’s strategic goals to make high-impact contributions to global public health, either alone or through partners,” said Rahul Singhvi, Chief Operating Officer, Takeda Vaccine Business Unit.“These two agreements along with our current vaccine pipeline underscore our global commitment to address important infectious diseases across the globe.”

Under these agreements, Takeda will conduct a transfer from Japan to BE its existing measles and acellular pertussis vaccine bulk production technology, including the provision of technical services such as support in infrastructure review, training for production and quality control, technical assistance in process development, preclinical study design, and production of clinical batch and the first commercial batches.

BE will scale up the bulk production technology transferred from Takeda and will be solely responsible for conducting and funding development activities for the combination vaccines. BE has rights to use Takeda’s measles vaccine technology for a combination MR vaccine and the right to use Takeda’s pertussis vaccine technology for any pertussis-containing combination vaccine. BE will have commercialization rights for the MR and pertussis vaccines in India, China and selected public markets worldwide as defined in the agreements.

According to Mahima Datla, Managing Director,Biological E. Limited, “At the core of our mission is to develop and commercialize affordable vaccines. We have successfully demonstrated this through our DTwP franchise in developing countries, and this collaboration allows us to serve additional markets and diversify our geographic presence. In the context of MR, we look forward to contributing to the measles elimination goals and protection against rubella.”

Takeda’s Commitment to Vaccines

Vaccines prevent more than two million deaths each year and have transformed global public health. For 70 years, Takeda has supplied vaccines to protect the health of people in Japan. Today, Takeda’s global vaccine business is applying innovation to tackle some of the world’s most challenging infectious diseases, such as dengue, Zika, norovirus, and polio. Our team brings an outstanding track record and a wealth of knowledge in vaccine development, manufacturing and global access to advance a pipeline of vaccines to address some of the world’s most pressing public health needs.

About Takeda Pharmaceutical Company Limited

Takeda Pharmaceutical Company Limited (TSE: 4502) is a global, research and development-driven pharmaceutical company committed to bringing better health and a brighter future to patients by translating science into life-changing medicines. Takeda focuses its research efforts on oncology, gastroenterology and central nervous system therapeutic areas plus vaccines. Takeda conducts R&D both internally and with partners to stay at the leading edge of innovation. New innovative products, especially in oncology and gastroenterology, as well as its presence in emerging markets, fuel the growth of Takeda. More than 30,000 Takeda employees are committed to improving quality of life for patients, working with our partners in health care in more than 70 countries. For more information, visit www.takeda.com/news

About Biological E. Limited

Biological E. Limited (BE) is a privately held company established in 1953. BE is a globally focused biopharmaceutical company, which develops, manufactures and markets innovative vaccines and biologics that respond to healthcare needs worldwide. The company’s product development efforts are driven by an internationally experienced management team and the company has several strategic partnerships with leading biotechnology and pharmaceutical companies and research institutes around the world.

Takeda Contacts:
For media outside of Japan:
Elissa J. Johnsen
TEL: +1 224-554-3185
elissa.johnsen@takeda.com

Biological E. Limited Contacts:
K. Vijay Amruth Raj
TEL: +91 8374077433
Vijay.Kammari@biologicale.com

Takeda Contacts:
For Japanese media:
Tsuyoshi Tada
TEL: +81-3-3278-2417
tsuyoshi.tada@takeda.com

The Netherlands Delegation Visits BE

Hyderabad, India – June 22, 2017: A delegation from the Netherlands comprising of His Excellency, Mr. Marten Van Den Berg, Vice Minister and Director General, Ministry of Economic and Foreign Affairs, the Netherlands, and His Excellency, Mr. Alphonsus Stoelinga, the Netherlands Ambassador in India, visited Biological E. Limited (BE) here today.

The delegation met with Ms. Mahima Datla, Managing Director, BE, and other senior executives of the organisation.

BE has a great history of collaborating with various industry partners and a cademia around the world. The Netherlands-based Intravacc (erstwhile NVI)had transferred the technology of Hib Vaccine to BE in 2005. BE uses Hib as one of the components in its Liquid Pentavalent Vaccine.Ms. Mahima Datla said that the technology transfer from Intravacc to BE is a testament of a successful alliance between academia and industry and the impact such partnerships can have in the field of global health.

Mr. Thijs Veerman, CEO, Intravaac, and Mr. Ajay Justin Odethakal, Chief Representative, the Netherlands Business Support Office in Hyderabad, were also part of the delegation.

About Biological E. Limited

Biological E. Limited (BE), founded in 1953, the first private sector biological products company in India and the first pharmaceutical company in South India. Originally incorporated as Biological Products Private Limited, BE is a globally recognized vaccine manufacturer and has supplied over two billion doses of vaccines till date all over the world.

BE supplies several essential and lifesaving Vaccines and Pharmaceuticals to UN Agencies viz. UNICEF, PAHO and several global markets, and in India to the National Immunization Programme, various State Governments, PSUs, Indian Armed Forces and the domestic retail market. With a mission to improve health & survival of people, BE serves by providing equitable access to quality vaccines and therapeutics. BE has a long and richly textured history of supporting public health programmes in India for over five decades. BE’s portfolio of WHO pre-qualified vaccines include the 5-in-1 Pentavalent and a Japanese Encephalitis vaccine and its future offerings promise to be even more exciting.

Mr. K. T. Rama Rao Lays Foundation for BE’s Vaccine SEZ Plant

Hyderabad, India – February 6, 2017: Mr. K. T. Rama Rao, Honourable Minister for Industries & Commerce, IT, Municipal Administration & Urban Development, unveiled the foundation for a new vaccines plant being constructed by Biological E. Limited (BE) in the Special Economic Zone (SEZ) at Genome Valley in Kolthur Village, located on the outskirts of Hyderabad. The Minister was accompanied by Dr. Paul Stoffels, Worldwide Chairman, Pharmaceuticals, Johnson & Johnson (J&J), Ms. Mahima Datla, Managing Director, BE, Mr. Jayesh Ranjan, Principal Secretary, IT, Ms. Soumya Swaminathan, Director-general, Indian Council of Medical Research, and Mr. M. Sudheer Reddy, Medchal MLA, at the inaugural event of laying the foundation.

Addressing the gathering on this occasion, the Minister appreciated the expansion efforts of Biological E. Limited in being aligned with the State Government’s vision of industrial expansion, creation of employment and the commitment to make Hyderabad an industrial hub in India and thus realise the dream of the honourable Chief Minister, K. Chandrashekar Rao – the creation of Bangaru (/Golden) Telangana. He fondly recalled that BE, as one of the foremost Pharmaceutical & Biologics Companies in India, being based out of the State of Telangana, in addition to substantial exports of vaccines, contributes significantly to the Universal Immunization Programme launched by the Government of India.

Welcoming the gathering, Ms. Mahima Datla, Managing Director, BE, thanked the Honourable Minister and Dr. Stoffels, for laying the foundation for the new vaccines plant at the recently approved SEZ. The MD also appreciated the efforts of the Government of Telangana in general and Mr. K T Rama Rao in particular for helping the investors and entrepreneurs in setting up new ventures and industries and creating a conducive environment for smooth execution of business operations.

Elaborating further about the plant, Ms. Mahima said that BE is planning an initial investment of up to Rs.300 crore in this new plant, which would help the existing vaccines plant augment the production and manufacture new products that are in the pipeline. This investment is in line with and part of the already earmarked overall outlay of Rs.1000 crore in the Genome Valley across BE’s Vaccines & Pharma businesses that are underway. The construction of this new SEZ vaccines plant on about 29 acres of land would be completed by April 2018 and commercial production is expected to begin by December 2019. Ms. Mahima also said that by the time BE’s expansion initiatives in the Genome Valley are completed, an additional employment opportunity for around 1000 people would be generated.

About Biological E. Limited

Biological E. Limited (BE), founded in 1953, the first private sector biological products company in India and the first pharmaceutical company in South India. Originally incorporated as Biological Products Private Limited, BE is a globally recognized vaccine manufacturer and has supplied over two billion doses of vaccines till date all over the world.

BE supplies several essential and lifesaving Vaccines and Pharmaceuticals to UN Agencies viz. UNICEF, PAHO and several global markets, and in India to the National Immunization Programme, various State Governments, PSUs, Indian Armed Forces and the domestic retail market. With a mission to improve health & survival of people, BE serves by providing equitable access to quality vaccines and therapeutics. BE has a long and richly textured history of supporting public health programmes in India for over five decades. BE’s portfolio of WHO pre-qualified vaccines include the 5-in-1 Pentavalent and a Japanese Encephalitis vaccine and its future offerings promise to be even more exciting.

BE Receives an Order from Govt. of India to Supply Liquid Pentavalent Vaccines

Hyderabad, India – March 21, 2016: Biological E. Limited (BE), a Hyderabad, Telangana-based pharmaceutical and vaccine company, has bagged a prestigious tender award for supplying ‘ComBE Five’, a 5-in-1 Liquid Pentavalent Vaccine (LPV), to the Ministry of Health & Family Welfare, Government of India. This vaccine would be inducted into the Government of India’s Universal Immunization Program (UIP) and give a boost to Mission Indradhanush, an initiative to empower the UIP and extend full immunization coverage to at least 90 percent of all children of the country.

The over Rs.895 crore order placed on BE to be supplier of ‘ComBE Five’ over a period of two years is a testimony to BE's commitment to preserving health and well-being while adhering to high standards of quality and safety.

Lauding the employees on receiving the award, Ms. Mahima Datla, Managing Director, Biological E Limited, said that “It is a momentous occasion for entire BE family! We are proud to be at the forefront of the Universal Immunization Programme of India since it aims at saving millions of precious lives of children. In fact, it signals the start of the much awaited countrywide rollout of LPV as part of Mission Indradhanush.”

She also added that, “It is also a historical moment because the ‘Hib’ vaccine is being rolled out all over India. BE has supported the UIP right from its inception as a major vaccine manufacturer. For BE, India is the most significant market and this contract will further contribute to BE’s growth. We are very proud to contribute to the Make in India initiative by becoming one of the world’s largest vaccine manufacturers of Liquid Pentavalent Vaccine.” As part of its expansion in Telangana, BE is investing more than Rs.500 crores in building new facilities over a period of 3 years to augment its production capacity for vaccines as well as complex generics. This is expected to generate additional employment for over 600 people.

BE's ComBE Five has received World Health Organization’s pre-qualification approval. The vaccine consists of Diphtheria, Tetanus, Pertussis, Hib (Haemophilus Influenza Type b) and Hepatitis B. More than 200 million doses of this 5-in-1 vaccine from BE have been administered to children around the world till date. ComBE Five is a 5-in-1, convenient and safe Vaccine that provides effective protection for children from six weeks of age against five deadly diseases: Diphtheria, Tetanus, Pertussis, Hepatitis B and Meningitis and Pneumonia caused by Hib. This vaccine is expected to make a significant contribution to reducing ‘Under 5 Yrs. Mortality’ rates in India.

About Biological E. Limited

Biological E. Limited (BE), founded in 1953, the first private sector biological products company in India and the first pharmaceutical company in South India. Originally incorporated as Biological Products Private Limited, BE is a globally recognized vaccine manufacturer and has supplied over two billion doses of vaccines till date all over the world.

BE supplies several essential and lifesaving Vaccines and Pharmaceuticals to UN Agencies viz. UNICEF, PAHO and several global markets, and in India to the National Immunization Programme, various State Governments, PSUs, Indian Armed Forces and the domestic retail market. With a mission to improve health & survival of people and contribute to the societies BE serves by providing equitable access to quality vaccines and therapeutics. BE has a long and richly textured history of supporting public health programmes in India for over five decades. Their portfolio of WHO pre-qualified vaccines include the 5-in-1 Pentavalent and a Japanese Encephalitis vaccine and their future offerings promise to be even more exciting.

BE Receives Pharmexcil Award for 3rd Year in a Row

Hyderabad, India – September 23, 2015: Biological E. Limited (BE), Hyderabad-based Vaccines major, received the 'Outstanding Export Performance Award-Gold' in the Category of Women Entrepreneur from the Pharmaceutical Export Promotion Council of India (Pharmexcil) set up by the Ministry of Commerce and Industry, Government of India, on September 23, 2015 at a ceremony held in Hyderabad.

BE is a proud recipient of the Award from the Pharmexcil for the third consecutive year (2012- 2013, 2013-2014 and 2014-2015).

About Biological E. Limited

Biological E. Limited (BE), founded in 1953, the first private sector biological products company in India and the first pharmaceuticals company in South India. Originally incorporated as Biological Products Private Limited, and launched by Dr. Vijay Kumar Datla, today, BE is a globally recognized vaccine manufacturer and has supplied over 2 Billion Doses of Vaccines till date all over the world. BE supplies several essential and lifesaving Vaccines and Pharmaceuticals to UN Agencies viz. UNICEF, PAHO, Many Global markets, and in India to the National Immunization program, various State Governments, PSUs, Indian Armed Forces and the domestic retail market. With a mission to improve health & survival of people and contribute to the societies, BE provides equitable access to quality vaccines and therapeutics. BE has a long and richly textured history of supporting public health programs in India for over five decades. BE’s portfolio of World Health Organisation pre-qualified vaccines include the 5-in-1 Pentavalent and Japanese Encephalitis vaccine and its future offerings promise to be even more exciting!

BE Pledges Its Offering of 5 Year Price Commitment to GAVI Graduated Countries

Hyderabad, India – January 27, 2015: Biological E. Limited (BE), the Hyderabad based Vaccines major has pledged its offering of a five year price commitment to GAVI (formerly Global Alliance for Vaccines and Immunization) graduated countries.

Ms. Mahima Datla, Managing Director, Biological E Limited, addressing the GAVI Pledging Conference in Berlin, Germany, on January 26, 2015 said that: ``As a company, we are deeply committed to improving the quality of human life and make immunization our biggest health priority. However, it’s also true that access to immunisation still continues to be a challenge. We at Biological E. will strive to ensure affordability of vaccines is NOT one of the contributing factors, so that countries can focus on sustainability and on overcoming other obstacles that are coming in the way of reaching that last child. So, today, to further our support to GAVI’s mission, I am pleased to announce Biological E.’s offer of a 5-year price commitment to GAVI graduated countries. This commitment aims to ensure that graduated countries will have access to affordable prices that are comparable to GAVI - eligible ones.”

Addressing the conference Dr. Seth Berkley, CEO, GAVI said that : “It is encouraging to see vaccine manufacturers increasingly recognizing the importance of sustainable vaccine markets for developing countries. The commitments made today will help us make more vaccine doses available at a lower cost and will support countries as they move towards financing and sustaining their own immunisation programmes. This will lead to more children being protected and more deaths being averted.”

Biological E. Limited had earlier reduced the price of their Pentavalent vaccine by 30% in order to increase access as an example of a key market shaping collaborative outcome. Biological E. Limited together with the GATES Foundation, GAVI and UNICEF took the decision to reduce the price of Pentavalent vaccine. Ms. Mahima Datla had mentioned that it was contextual For Biological E. Limited to make this reduction in order to improve access of immunization because of the company’s late Chairman Mr. Vijay Kumar Datla’s vision of building a successful business that is also socially responsible and delivers value to shareholders and to the broader communities we live in

Ms. Mahima Datla reiterated Biological E.’s commitment at the conference further by saying, “We are proud to support GAVIs replenishment effort and with this pledge, we commit to working with GAVI to give donors, country governments and ourselves the opportunity to save more lives. In our own humble capacity, we will continue to play our part in reducing inequities in access to vaccines, particularly in the countries that we together serve.” Ms. Angela Merkel, the Chancellor of Germany, hosted the pledging conference, which was attended by the several Heads of the States of European Union, GAVI members, CEOs of various vaccine manufacturing companies and other delegates.

About Biological E. Limited

Biological E. Limited, the first private sector biological products company in India and the first pharmaceuticals company in South India was established in 1953. Originally incorporated as Biological Products Private Limited, and launched by Dr. Vijay Kumar Datla , today, BE is a globally recognized vaccine manufacturer and has supplied over 2 Billion Doses of Vaccines till date all over the world. BE supplies several essential and lifesaving Vaccines and Pharmaceuticals to UN Agencies viz.UNICEF, PAHO, Many Global markets, and in India to the National Immunization program, various State Governments, PSUs, Indian Armed Forces and the domestic retail market. With a mission to improve health & survival of people and contribute to the societies BE serves by providing equitable access to quality vaccines and therapeutics. Biological E. Limited has a long and richly textured history of supporting public health programs in India for over five decades. Their portfolio of WHO prequalified vaccines include the 5-in-1 Pentavalent and a Japanese Encephalitis vaccine and their future offerings promise to be even more exciting.

Biological E. Limited’s Pentavalent Vaccine as a part of Government Immunization Program

Hyderabad, India – November 14, 2014: Biological E. Limited (BE), the first Indian Vaccine company and the first Pharma company based in South India has announced on Children’s day, that its 5-in-1 Pentavalent Vaccine is being launched for introduction in the Immunization program in Telangana, in the presence of the Honorable Chief Minister of State of Telangana, Sri K Chandrashekar Rao.

PentavalentBE’s Pentavalent vaccine has received Pre-Qualification from the World Health Organization (WHO). More than 100 Million doses of this 5-in-1 vaccine have been administered to children around the world till date. Pentavalent vaccine has been adopted for immunization by most countries in the world and is now being inducted into the National immunization program and in Telangana. With this Pentavalent vaccine, the children in India will be immunized not only against Diphtheria, Tetanus (also known as Lockjaw), Pertussis (also known as Whooping Cough), Hepatitis-B (also known as White Jaundice or silent killer) but also Bacterial Meningitis and pneumonia caused by Haemophilus influenzae type b Bacteria (Hib).The Pentavalent vaccine has been supplied by UNICEF to India and is supported by GAVI. BE, a Hyderabad Based company, is immensely proud to support the initiation of the Pentavalent vaccine in the immunization program in Telangana.

Adding to this, Ms. Mahima Datla, Managing Director BE Limited said, “Thousands of children in Telangana are exposed to the risk of deadly vaccine preventable diseases. Availability of this vaccine in Telangana will protect children from 5 deadly Diseases Diphtheria, Tetanus, Pertussis, Hepatitis B and Meningitis and Pneumonia caused by Hib. The Telangana Government’s endeavor is to increase health access to underprivileged children, and this vaccine will be available free of cost to all children through the Immunization program. This combination vaccine will improve Vaccine compliance and coverage. This vaccine has already been used to protect millions of children all over the world and the inclusion of this Pentavalent Vaccine into our National Immunization Program, and particularly in our home state is a proud moment for us. Our vision is to ensure protection to every single child against vaccine-preventable diseases.”

About Pentavalent Vaccine

Pentavalent Vaccine is a 5-in-1, convenient and safe, Liquid Vaccine that provides effective protection for children from 6 weeks of age against five diseases: Diphtheria, Tetanus, Pertussis, Hepatitis B and Meningitis and Pneumonia caused by Hib. Pentavalent Vaccine has been developed and produced by Biological E. Limited in Hyderabad, Telangana.

About Biological E. Limited

Biological E. Limited, the first private sector biological products company in India and the first pharmaceuticals company in South India was established in 1953. Originally incorporated as Biological Products Private Limited, and launched by Dr. Vijay Kumar Datla, today, BE is a globally recognized vaccine manufacturer and has supplied over 2 Billion Doses of Vaccines till date all over the world. BE supplies several essential and lifesaving Vaccines and Pharmaceuticals to UN Agencies viz. UNICEF, PAHO, Many Global markets, and in India to the National Immunization program, various State Governments, PSUs, Indian Armed Forces and the domestic retail market. With a mission to improve health & survival of people and contribute to the societies BE serves by providing equitable access to quality vaccines and therapeutics, BE Limited has had a long and richly textured history and the future promises to be even more exciting.

BE Wins Outstanding Export Award - GOLD

Hyderabad, India – May 21, 2014: Biological E. Limited (BE) won the “Outstanding Exports Award - GOLD” in recognition of commendable contribution to India’s pharma exports to Asia, Africa and Middle East during the year 2012-13.

This award was conferred by Pharmaceutical Export Promotion Council of India, Ministry of Commerce & Industry, Govt. of India. The Award was conferred on 21st May 2014 at 5.30 p.m. on the occasion of IPHEX 2014, Mumbai amidst eminent personalities from Indian Pharma industry, over 500 overseas delegates and senior Government officials.

For media inquiries please contact Communications

×

Left to Right: Ms. Mahima Datla, Managing Director, Biological E Limited, Ms. Kiran Mazumdar-Shaw, Chairperson & Managing Director, Mr. KT Rama Rao, Minister for IT, MA & UD, Govt. of Telangana, Prof. Baron Peter Piot, Director, London School of Hygiene & Tropical Medicine, and Mr. Jayesh Ranjan, Principal Secretary, Industries & Commerce (I&C) & Information Technology (IT), Govt. of Telangana.

×
×
×
×
×
×
×
×
×