A new peer-reviewed publication from the Alzheimer's Drug Discovery Foundation (ADDF) and The Michael J. Fox Foundation for Parkinson's Research (MJFF) offers strategic insight on how philanthropy, industry and government organizations can advance repurposing of U.S. Food and Drug Administration (FDA)-approved drugs for the treatment of neurodegenerative diseases. The paper, published in the Annals of Clinical and Translational Neurology, was produced in collaboration with experts from these sectors and highlights the unique challenges and lack of commercial incentives for testing approved drugs in new disease indications, like Alzheimer's or Parkinson's disease, where they might be beneficial.
"Approved drugs generally have limited to no patent life remaining, which limits commercial interest in investing in the necessary trials that could prove efficacy for a new indication," said the paper's lead author,Diana Shineman, PhD, director of scientific affairs, ADDF. "Our paper addresses these challenges by outlining how foundations and government can work together to accelerate promising repurposed drugs to patients."
These ideas include increasing targeted funding from government and foundations; building innovative public-private partnerships; instituting changes in patent law related to repurposed drugs with new indications; addressing roadblocks in the FDA review and approval process; and creating innovative royalty structures to provide financial incentives to justify the cost of testing old drugs for new diseases.
"While it is important to continue developing new drugs, repurposing offers an opportunity to tap into drugs that have already gone through the lengthy and expensive approval process," said MJFF CEO Todd Sherer, PhD. "We have an obligation to our patient populations to ensure we are using all means possible to accelerate treatment development for neurodegenerative diseases."
Repurposing can rapidly expedite drug development timelines; drugs under investigation in repurposed studies have already gone through safety testing, formulation development and manufacturing. Repurposing can also eliminate many of the major challenges associated with bringing new compounds to market, including lengthy clinical trials, extremely high costs and large clinical trial patient populations.
The full paper can be accessed by visiting the Annals of Clinical and Translational Neurology webpage. http://onlinelibrary.wiley.com/doi/10.1002/acn3.76/full