Print“This unique collaboration between academia and industry holds the promise of trimming years from the long and expensive process of drug development.”
The National Institutes of Health is awarding $12.7 million to nine academic research teams exploring new applications for experimental compounds that have cleared human safety testing but were later shelved by Big Pharma.
Nine teams participating in the program will explore disease areas including Alzheimer’s disease, Duchenne muscular dystrophy, and schizophrenia. The projects will be supported for up to three years.
Other disease areas that will be explored include alcohol dependence, calcific aortic valve stenosis (a condition in which the heart valve hardens and makes it difficult to pump blood out of the heart), nicotine dependence, peripheral artery disease, and the progressive lung disease.
“This unique collaboration between academia and industry holds the promise of trimming years from the long and expensive process of drug development,” says NIH Director Francis Collins.
The Discovering New Therapeutic Uses for Existing Molecules initiative expands on a pilot program launched by the NIH's National Center for Advancing Translational Sciences. The program launched in May 2012 with initial contributions from Pfizer, AstraZeneca, and Eli Lilly. The new phase, launched June 18, adds compounds from AbbVie, Bristol-Myers Squibb, GlaxoSmithKline, Janssen Research & Development, and Sanofi. The eight companies have provided a total of 58 molecules for program so far.
The NIH hopes that by starting with partially developed compounds, scientists participating in the pilot will have a leg up in putting promising compounds to good use, moving them from testing against selected diseases to clinical trials in a fraction of the average 13 years it normally takes for drugs to advance from target discovery to approval.
The program also tested newly created template agreements between researchers and contributing pharmaceutical companies. The agreements streamlined negotiations, helping companies and academic researchers reach agreements in fewer than 11 weeks, versus a typical timeline of a year or more.
The templates provide the pharmaceutical company that provided a molecule with the first option to license any new intellectual property arising from an academic research partner’s research. In cases where the pharmaceutical company owns active patents on a molecule, it can decide whether to advance the molecule through further clinical studies to commercialize the new indication or allow another company to do so. In cases where the molecule is off-patent, if the pharmaceutical company passes on its commercialization option, participating researchers are free to find another commercial collaborator, according to the NIH.
So far, the program has received “a tremendous amount of positive feedback,” says the NIH. The agency is evaluating the pilot program in preparation for the next funding opportunity, scheduled for fiscal year 2015.
“With thousands of diseases remaining untreatable,” say U.S. Health and Human Services Secretary Kathleen Sebelius, “there is a sense of urgency to accelerate the pace at which discoveries are transformed into therapies for patients.”
June 18, 2013
http://www.burrillreport.com/article-nih_expands_repurposing_efforts_with_new_grants.html
.gif)
