HONG KONG Japan's Takeda Pharmaceutical Co. Ltd. and India's Biological E Ltd. are collaborating to develop and deliver affordable combination vaccines. Under two licensing agreements, Takeda will transfer its measles and acellular pertussis vaccine technologies to Biological E, which will commercialize them in other markets.
Takeda will provide 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.
"For more than 20 years, Takeda has provided effective measles and pertussis vaccines in the Japanese market and transformed the country's public health in the process," Tsuyoshi Tada, head of corporate communications at Takeda Pharmaceutical, told BioWorld Asia.
"We want to extend that legacy so that partners like Bio E that specialize in low-cost vaccine development can use our technology to create much-needed combination vaccines without compromising quality in countries like India, where populations are booming and large unmet patient needs exist.
"These agreements with Bio E will help extend the impact of Takeda's vaccine technology to countries like India to help address significant public health challenges," she said.
For its part, Biological E will be responsible for scaling up production technology. The company also holds the rights to fund and develop any combination MR and pertussis-containing combination vaccine using Takeda's vaccine technology.
Then, the company will bring the vaccines to markets such as India, China and other low- and middle-income countries where large, unmet public health needs exist.
With 25.7 million births in 2015, there is ample opportunity to provide vaccine protection to India's 1.3 billion strong population, nearly a fifth of the world's population.
Pertussis, popularly known as whooping cough, is a major contributor of infant death worldwide, and in India, according to data from the Indian Academy of Paediatrics, about 22,616 cases of pertussis were reported in 2006 though some estimate the number is even higher in reality, given the lack of vaccine coverage.
The World Health Organization estimates that global vaccination against pertussis averted about 687,000 deaths annually. But it continues to be a public health concern even in countries with high vaccination coverage.
Besides pertussis, India has been taking steps to launch vaccination campaigns in an effort to eliminate measles, which affects an estimated 2.5 million children every year, killing nearly 49,000.
"We would like to be a big force in contributing to measles elimination goals. We already service markets with whole cell pertussis-based combinations and with this deal will be able to service markets with acellular pertussis-based combinations, thus expanding our product franchise and geographical reach," Divya Bijlwan, vice president and head of business development at Biological E, told BioWorld Asia.
"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," said Mahima Datla, managing director at Biological E.
Japan and India have been talking of intensifying their joint cooperation. Government and industry representatives of both countries deliberated various ways of strengthening their partnership at the 2nd Japan-India Medical Products Regulation Symposium held in Tokyo in April. Going forward, the symposium will be held in each country alternately on a biannual basis to facilitate cooperation.
The Indian government has also been courting multinational companies to manufacture in the country under the "Make in India" initiative. Part of the efforts include a number of biotechnology parks that act as incubators for biotech companies, such as the Shapoorji Pallonji Biotech Park near Hyderabad, India.
Hyderabad-based Biological E has been in the pharmaceutical business since 1953, with a focus on vaccines and biologics.
On the other side, Takeda is Japan's largest drugmaker. The company focuses its research on oncology, gastroenterology and central nervous system therapeutic areas plus vaccines.
"We expect to commercialize the vaccine based on the licensed measles technology by 2019. The cellular pertussis vaccine would take longer," Bijlwan told BioWorld Asia.
Bijlwan also confirmed that the vaccines will be made available through both public and private health care facilities.
The financial details of the deals have not been disclosed.