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Jill Wechsler is Pharm Exec's Washington Corespondent
Up until a few months ago, there was little industry interest or public support for developing vaccines and treatments to combat the Ebola virus.
Up until a few months ago, there was little industry interest or public support for developing vaccines and treatments to combat the Ebola virus. Now the rush is on to launch clinical trials of therapies with some potential effectiveness against the disease.
The situation has also encouraged FDA and regulatory authorities to facilitate these efforts by collaborating on testing and production requirements for experimental treatments. FDA recently approved initial trials in humans of two vaccine candidates and previously utilized its Emergency Use Authorization to allow broader use in Africa of a not-yet-approved Ebola diagnostic.
FDA also authorized initial human testing of the VSV-EBOV vaccine, developed by NewLink Genetics of Ames Iowa, using a platform licensed from the Public Health Agency of Canada. That set the stage for the Walter Reed Army Institute of Research to initiate Phase I trials. In addition, Johnson & Johnson hopes to launch clinical trials of an Ebola vaccine formulated by its Crucell vaccines unit (Netherlands) in collaboration with NIAID and Bavarian Nordic (Denmark). J&J says it could produce some 7,000 doses in six months if wider distribution is warranted.
Expanded production of experimental Ebola therapies could utilize three new BARDA Centers for Innovation in Advanced Development and Manufacturing, which were launched in 2012 to provide more flexible, modern vaccine manufacturing technologies able to produce 150 million doses in 12 weeks in the event of an influenza pandemic. BARDA’s fill-finish manufacturing network also could be tapped to support production of Ebola vaccines and injectibles. These programs and other medical countermeasure initiatives supported by HHS, DOD, and other federal agencies will be discussed at the annual BARDA Industry Day, Oct. 15-17, in Washington, D.C.?
While public and private organizations are rising to the challenge of developing treatments to subdue Ebola, the world is watching to see if these efforts translate into broader R&D on drugs and preventives for other neglected tropical diseases (NTDs). Government funding can offset the risks of developing therapies for conditions affecting less-developed countries, but so far, there has been scant investment in such research. What has occurred has been targeted to more widespread conditions such as malaria, TB, and AIDS. GlaxoSmithKline is readying a big campaign for a new malaria vaccine it hopes to market in the coming year.
A sign of change is the race to produce a vaccine for dengue fever, a disease spreading throughout Latin America and Asia. Sanofi currently leads the competition as its anticipates registration in 2015. Interest may rise in developing preventives for West Nile virus as that spreads through California.
There have been efforts over the years to provide economic incentives for industry investment in drugs for NTDs, such as guaranteed pricing and guaranteed supply models. Congress also authorized FDA to issue priority review vouchers to sponsors of new drugs to prevent and treat NTDs, but the program has been stymied by complex rules. Just this year, though, Canada’s Paladin Therapeutics was awarded a voucher for developing a new treatment for Leishmaniasis; if Paladin can sell the voucher for a good price, that could spur broader interest in NTD drug development.