Takeda has been eyeing India’s vaccine market since at least 2015, even looking at possible M&A targets. Its plan is now coming to fruition with two production technology licensing deals with Biological E.
Having sold measles and pertussis vaccines in Japan for more than two decades, Takeda is transferring its knowledge in low-cost bulk production for those vaccines to the Indian company.
The deals will allow Biological E to apply Takeda’s technologies to a measles-rubella vaccine candidate currently in development and to any pertussis combination vaccines for marketing in India and China and among other low- and middle-income countries.
Through the arrangement, the Japanese drugmaker will transfer its proprietary pertussis bacteria and measles virus seed strains to the Indian vaccine maker, as well as provide technical assistance such as infrastructure reviews and training for production and quality control. Takeda will also help with process development and preclinical study design, a spokesperson told FiercePharma.
Biological E has been selling DTwP-based products since the 1960s, and currently has three such vaccines, including a DTwP-HepB-Hib vaccine competing with Shantha’s and Serum’s products in the same field; all of them are on UNICEF’s procurement list. Divya Bijlwan, Biological E's head of business development, told FiercePharma that the Takeda deal will allow the company to offer DTaP-based combinations.
Diptheria, tetanus and pertussis vaccines can be either whole cell (DTwP) or acellular (DTaP) depending on whether they contain the whole pertussis organism or a portion. With the licensing deals, Biological E will scale up the bulk production technology and manufacture the vaccines for clinical trials and eventually commercialization. The new technology will allow the Indian company to offer its products in additional markets, Bijlwan said.
When Takeda opened an emerging markets headquarters in Singapore back in February 2015, its Global Vaccine Business Unit President Rajeev Venkayya confirmed to FiercePharma that the company was looking at Indian vaccine makers for possible M&A or other deal structures. Some of the rumored targets included three major Indian vaccine players—Bharat Biotech, Serum Institute of India and Biological E.
Exactly why did Takeda choose to proceed with licensing agreements instead of going through the M&A path? According to Takeda's spokesperson, given that Biological E specializes in low-cost vaccine development, “these two licensing agreements are an appropriate way to extend the legacy of effective measles and pertussis vaccines.”
The company representative also pointed out that Takeda’s vaccine effort is currently focused on its pipeline. That includes a tetravalent dengue vaccine candidate, which just wrapped up phase 3 enrollment, and one early-phase candidate against Zika, which has nabbed up to $312 million in funding from U.S. governmental agency BARDA.