SII May Do it Again The Serum Institute of India (SII) is a leading for-profit provider of vaccines to global public health programs and has a corporate policy of quality and low price. Already known for venturing where the big pharma vaccine companies fear to tread (e.g., making the Africa-specific meningitis vaccine, MenAfriVac, and developing a low-cost ten-valent pneumococcal vaccine), SII recently announced it was on track to launch a low-price human papilloma virus vaccine to compete against Merck’s Gardasil and Glaxo’s Cervarix. As reported in FierceVaccines, an SII exec said the price may be one-third the current UNICEF/GAVI price of Gardasil which is $4.50 per dose and thought to be a barrier to its use in public health programs.
Sanofi Invests in India The Paris-based multi-national drug company, Sanofi, announced significant investments in reaching diabetes patients in India, estimated to number 65 million. As reported in FiercePharmaManufacturing, the company will buy into a chain of 26 diabetes clinics run by India’s Apollo Hospitals for $14.5 million and build a $74 million facility to make its version of human insulin in Hyderabad, the only one outside Germany.
BMGF Ventures Again Although I have criticized the lackadaisical approach to investing in early-stage companies by the Bill and Melinda Gates Foundation (see my post, “Nothing Ventured”), I am glad to see its venture group continues to grind forward. Last week, , Sera Prognostics, Inc. said in a press release that the BMGF added $5 million to a recent B Series funding round, bringing the total to $25 million. The company is using proteomics to identify markers in blood associated with complications of pregnancy. The new funding will be used in part “to advance the development of a new tool that can be effectively and economically deployed in underserved developing countries to identify women’s risk of preterm birth,” the leading cause of newborn mortality.
Ebola Update While an acute public health failure, the Ebola outbreak in Western Africa continues to provide an example of how quickly public and private resources can be applied in global health, if there is the will. Here are updates on vaccines, a drug, and a diagnostic.
Jumping a step in standard product development, the NIH will soon initiate a Phase III trial of vaccine candidates from GlaxoSmithKline and Merck/NewLink. According to a story in FierceVaccines, either one of the candidates or a placebo will be administered to 30,000 people in Liberia.
As reported in FierceBiotech, researchers from the French Institute for Health and Medical Research (Inserm) will soon publish results of a Phase I study of favipiravir, an anti-viral drug developed by Toyama Chemical, a division of Fujifilm, on 80 Ebola patients in Guinea. The study found that the drug, which is marketed in Japan for treating influenza, decreased mortality by half for patients in early stages of the disease, but was not nearly as effective in treating those with high viral levels.
The German company, Stada Pharma, announced that it will begin selling a rapid diagnostic assay for Ebola developed by the German start-up, Senova (FierceMedicalDevices story). The test detects an antigen using a lateral-flow format and centrifuged body fluid samples, so requires battery power but otherwise is good for field use.
Running on Empty? From an article in the Boston Globe, I learned of a study that found the revenues of recently developed drugs have not exceeded their development costs. Berndt et al. 2015 analyzed the economic returns for four groups of new prescription drugs launched in the US in 1991–94, 1995–99, 2000–04, and 2005–09 and found lifetime net economic returns were positive and reached a peak with the 1995–99 and 2000–04 groups, but that “returns have fallen sharply since then, with those for the 2005–09 cohort being very slightly negative and, on average, failing to recoup research and development and other costs.” Perhaps pharmaceutical companies should try developing drugs that could be sold at low margins to billions of people outside the US.