Serum Institute of India is planning to launch four vaccines in the coming years for pneumococcal disease, HPV, meningococcal disease and dengue virus. Ring any bells? Some of the world's bestselling vaccines target those same diseases.
Even though Serum Institute is the world’s largest vaccine manufacturer by number of doses—the company provides about 1.3 billion doses each year to over 140 countries—it has never sold vaccines in the Western market. The firm intends to change that, with a Tdap vaccine launch expected in Europe in three years, CEO Adar Poonawalla told local news agency PTI.
According to PTI and the company’s product pipeline webpage, the meningococcal vaccine in development is a pentavalent shot against meningococcus types A, C, W-135, X and Y, so it won’t be a competitor with GSK’s big-selling Bexsero, which targets the most difficult serotype B. Pfizer markets older MenACWY vaccines called Nimenrix and Mencevax that it purchased from GSK back in 2015.
Serum Institute's PATH-partnered pneumococcal conjugate vaccine is intended to protect against 10 serotypes seen in 70% of affected population, fewer than Pfizer’s 13-valent shot, the megablockbuster Prevnar 13.
Poonawalla told PTI that his company is working with the Indian government to secure fast track approvals for these new vaccines, with the plan to launch the pneumonia candidate by end of 2019 and the meningitis vaccine in less than two years. He also told PTI for an earlier story that the company has commenced human studies on the dengue shot in Singapore with the hope to launch in 2020.
Sanofi markets the troubled dengue vaccine Dengvaxia, and Takeda is also working on a late-stage candidate.
When FierceVaccines reached out to Serum Institute for comments, Poonawalla, citing competition considerations, declined to go into details about those launches or whether the company will seek additional approvals in the U.S. and EU.
Serum Institute currently has a large, diverse portfolio with many vaccines prequalified by the WHO for procurement, but it has historically focused on low- and middle-income countries, offering vaccines at affordable prices in exchange for accessibility and large volume. Its meningococcal A vaccine, MenAfriVac, for example, is provided to UNICEF in 2017 at only $0.67 per 10 mcg dose.
Médecins Sans Frontières, which is currently challenging Pfizer’s Prevnar 13 patent in India, said Serum has agreed to offer its up-and-coming three-dose pneumococcal regimen at $2 per dose to Gavi-approved countries, lower than the $3.05 per dose that Pfizer charges for Prevnar 13.
The low-price, high-volume strategy is working for the company, according to the helmsman. In a recent interview with PTI, Poonawalla said Serum is growing at 30% CAGR and achieved revenues of Rs 4,000 crore ($620 million) last year. “We are hoping to be Rs 10,000 crore company in the next five years period,” he added, which would be $1.55 billion.
The Indian company currently has facilities in Europe for polio vaccine manufacturing, one in the Netherlands it acquired 5 years ago and one in Czech Republic it just picked up from Nanotherapeutics for €72 million. Poonawalla said Serum Institute's new facility in Pune, which will be ready in a year and half, will make vaccines for Europe and the U.S.