January 27, 2015
By Alex Keown, BioSpace.com Breaking News Staff
MUMBAI, INDIA – Serum Institute of India, which makes 65 percent of children’s vaccines, is taking aim at a larger market share by offering new lower-priced vaccines that could undercut some of the industry’s biggest companies, including Merck & Co. .
India’s largest biotechnology company is developing a vaccine to battle Human papillomaviruses (HPV), which can lead to cervical cancer. Serum Institute’s vaccine could be on the market by 2018 and sell for about one-third the cost of Merck & Co.’s Gardasil, the top selling HPV vaccine, which sells for about $113 a dose, according to a report by a report by Bloomberg news.The vaccine would become a cheaper alternative for developing nations to purchase to fight cancers and sexually transmitted diseases caused by HPV.
Serum Institute will begin running clinical trials for its HPV vaccine beginning this year. In June 2006 Gardasil was approved by the U.S. Food and Drug Administration and was recommended by the U.S. Advisory Committee on Immunization Practices for girls and women ages nine to 26. The vaccine has also been approved for use in most foreign countries, according to the World Health Organization. Gardasil protects against genital warts and anal and oral cancer in both male and females. The vaccine also protects against cervical, vulvar and vaginal cancers in women.
Like Gardasil and GlaxoSmithKline ’s Cervarix, Serum Institute’s new vaccine would protect against four strains of HPV. Because of its lower cost, the Indian vaccine would be cheaper for developing nations to purchase for immunization programs – programs supported by organizations such as the World Health Organization.
According to Merck & Co. ’s third quarter reports for 2014, Gardasil recorded revenues of $590 million, down 11 percent year over year, reflecting lower purchases in the U.S. Merck earned $1.8 billion from sales of Gardasil in 2013.
Cervical cancer impacts about 500,000 women per year and about half of those cases are terminal, according to the U.S. Center for Disease Control. The World Health Organization has recommended universal use of vaccines against the virus. In a 2014 report, the World Health Organization projected worldwide cancer cases will increase by 57 percent over the next 20 years, from roughly 14 million diagnoses in 2012 to approximately 22 million.
Unicef, which purchases vaccines from companies at a reduced cost for use in developing countries, has called for increased funding and prioritization of vaccinating children in developing countries. According to a 2014 Unicef report, vaccination rates are slowing across the globe.
The U.S. Center for Disease Control recommends HPV vaccination for preteen boys and girls before becoming sexually active. A recent University of Texas Medical Branch study showed that only about half of U.S. preteen girls are receiving the recommended HPV vaccinations.
Serum Institute’s HPV vaccine program has been supported, at least verbally, by the Bill and Melinda Gates Foundation. During a 2012 visit to the Indian company, the Microsoft founder said there was “a need for cost-effective vaccines against various infectious diseases and the Foundation is interested in several new products developed at the Serum Institute.”
Serum Institute of India’s vaccines are being used in approximately 140 countries as part of national vaccination strategies. In addition to the HPV vaccine, Serum Institute also plans to manufacture vaccines to prevent meningococcal A, meningitis A, Y, C and bladder cancer.
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