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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.

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.

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
AGM, Corpcom
TEL: +91 8374077433
Vijay.Kammari@biologicale.co.in

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.

B E 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 Offer ing 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.

Biological E wins Outstanding Export Award - GOLD

Mumbai: 21st May 2014

Biological E 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.