P5 Progress The very-low-profile Pox-Protein Public-Private Partnership (P5) recently announced progress in the continuing development of the only vaccine shown to have potential against HIV (NIH press release). The vaccine, known as RV144, combines two vaccines in a prime/boost approach (Sanofi’s ALVAC-HIV to prime and AIDSVAX B/E from VaxGen to boost immune response) and demonstrated a modest level of protection in a trial in Thailand in 2009 (FierceVaccines story). In the latest trial, run in South Africa, RV144 was found safe and generated a strong immune response; more trials are planned for 2015. P5 was established in 2010 includes the NIAID, the Bill & Melinda Gates Foundation, the HIV Vaccine Trials Network, the U.S. Military HIV Research Program, Sanofi Pasteur, and Global Solutions for Infectious Diseases, a CA not-for-profit that is a licensee of VaxGen and is “engaged in the development of vaccines and other product to help prevent the spread of infectious disease, especially in the developing world” (GSID).
TB Drug Tech Transfer The big pharma, Eli Lilly and Co., recently reported a review of its more than 10-year program to transfer manufacturing of its drugs to treat multi-drug-resistant tuberculosis (MDR-TB) (Lilly press release and FiercePharmaManufacturing story). Since 2003, Lilly spent about $160 million to transfer processes for making the drugs (capreomycin and cycloserine) to seven manufacturers in China, India, Russia, and South Africa (plus Greece and the US) at no- or low-cost to the companies, resulting in eight approved products (Lilly Whitepaper). Bottom line: the program, though costly and challenging, worked but improvements in market, supply chain, and public health infrastructure are needed to maximize the results.
Time to Negotiate a License As reported in a FiercePharma story , the Indian generic drug company, Cipla, has petitioned the Indian authorities to revoke Novartis’s patents on Indacterol, a drug to treat chronic obstructive pulmonary disease (COPD), and started selling its own version. Cipla stated that Novartis only imports enough of the drug to treat less than one percent of all patients and that it is selling its drug at 25% of the price of Indacterol. Maybe Cipla wants to get some leverage in negotiating a license with Novartis (note that Cipla is a licensee of Gilead’s anti-HIV drugs) but maybe Novartis is gearing up for another fight over its Indian patents (see my post, “Dueling Sitars”).
They Are Winners The Boston-based international business accelerator program, MassChallenge, recently announced the 2014 recipients of $1.5 million in grants and $10 million in in-kind services and two are based on ROW (rest-of-world) business models. Disease Diagnostic Group is developing a rapid diagnostics for malaria (MC profile and my BGH No. 5) and Drinkwell aims to sell a novel water filtration method through franchises to provide 20L of water daily to customers in rural areas of India and Bangladesh for a low monthly fee (MC profile).
Mr. Bill Speaks Earlier this month, Bill Gates spoke at the annual meeting of the American Society of Tropical Medicine and Hygiene in New Orleans and said the Gates Foundation will increase its malaria program budget by 30 percent to more than $200 million per year. Also, as was reported by CBSnews.com, the Foundation will continue its support of product development and public health programs for Ebola ($50 million committed), polio eradication (“my top priority”), dengue fever (trials of a vaccine), and chikungunya (R and D). Mr. Bill: “I really do believe malaria can be eradicated in my lifetime” and he provides details on how in his blog, Gates Notes.