Paper Addresses Challenges and Explores Opportunities to Stimulate Repurposing of FDA-Approved Drugs for Alzheimer’s, Parkinson’s and Related Diseases
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
About the Alzheimer’s Drug Discovery Foundation (ADDF)
The mission of the Alzheimer’s Drug Discovery Foundation (ADDF) is to accelerate the discovery of drugs to prevent, treat and cure Alzheimer’s diseases and related dementias. The ADDF has granted more than $65 million to fund nearly 450 Alzheimer’s drug discovery programs in academic centers and biotechnology companies in 18 countries. In 2013, 100 percent of funds raised by the ADDF went directly to Alzheimer’s drug research and other related programs. For more information, visit our website and follow us on Facebook and Twitter.
About The Michael J. Fox Foundation for Parkinson’s Research
As the world’s largest nonprofit funder of Parkinson’s research, The Michael J. Fox Foundation is dedicated to accelerating a cure for Parkinson’s disease and improved therapies for those living with the condition today. The Foundation pursues its goals through an aggressively funded, highly targeted research program coupled with active global engagement of scientists, Parkinson’s patients, business leaders, clinical trial participants, donors and volunteers. In addition to funding more than $450 million in research to date, the Foundation has fundamentally altered the trajectory of progress toward a cure. Operating at the hub of worldwide Parkinson’s research, the Foundation forges groundbreaking collaborations with industry leaders, academic scientists and government research funders; increases the flow of participants into Parkinson’s disease clinical trials with its online tool, Fox Trial Finder; promotes Parkinson’s awareness through high-profile advocacy, events and outreach; and coordinates the grassroots involvement of thousands of Team Fox members around the world. For more information, visit us on Facebook, Twitter, Web and LinkedIn.