ALS Advocates, US Rep. Leonard Lance Urge Passage of ‘Dormant Therapies Act’

The ALS Association, ALS advocates, and representatives from the National Health Council joined Rep. Leonard Lance (R-NJ) in a Capitol Hill press conference to urge Congress to enact the Dormant Therapies Act, which Lance helped sponsor.

“We need a new way. Right now, there is no treatment available that significantly slows or stops the progression of the disease. That needs to change. We need to do all that we can to speed the development of new treatments for ALS and other diseases and we need to do it now,” said Lance, who has met with constituents with ALS to discuss their challenges and how they cope with the disease. “It is for that reason I championed the Dormant Therapies Act, to break down barriers that exist to ALS drug development.”

The legislation is one of a series of strategic recommendations from an upcoming Lewin Group Report, titled “New Therapies for Amyotrophic Lateral Sclerosis: Challenges and Next Steps,” as it would facilitate and incentivize the development of treatments for amyotrophic lateral sclerosis (ALS)-like diseases, for which there are currently no cures.

The Lewin Group Report’s initial recommendations include the creation of a patient-led guidance for ALS drug development, which is underway due to the funding made from the 2014 ALS Ice Bucket Challenge. It will be shared with the U.S. FDA in June.

“Today, there are thousands of potential treatments for ALS that are sitting on lab shelves collecting dust simply because they have lost patent protection. The Dormant Therapies Act would take those treatments off the shelf, bring more treatments into the drug development pipeline, and ultimately deliver them to patients,” explained Chris Brussalis, chair of the Public Policy Committee for the ALS Association’s Board of Trustees, emphasizing the critical need for the Dormant Therapies Act.

The current challenge is that losing patent protection, or having weak patents, is inhibiting the development of a series of potential treatments for ALS. Pharmaceutical companies don’t have enough incentive to develop a treatment without patent protection, regardless of how promising it might be.

The Dormant Therapies Act would tackle this problem by creating a new class of drugs — “dormant therapies” — which would be used to classify treatments that show promising evidence for treating diseases with unmet medical needs but that do not have patent protection or that have weak patents. The legislation would give dormant therapies 15 years of data exclusivity, and sponsors pursuing dormant therapies would have to waive all patent rights.

“In short, the Dormant Therapies Act would help us put more shots on goal. And the more shots we take, the better chance we have of scoring and finding a treatment for ALS,” Brussalis said.

The press conference was at the ALS Association’s National ALS Advocacy Day and Public Policy Conference, where nearly 1,000 ALS advocates from across the U.S. met with their elected officials in Congress. Speakers at the event included ALS advocate Nirali Shah, from Basking Ridge, N.J. Shah lost her mother, Sonal Shah, to ALS in November 2015.

“Although our loved ones may not be physically with us, their legacies and dreams live within each one of us. We can take our time to mourn, cry, and celebrate their lives, but I am sure they would want us to take action. We must keep their momentum and legacy alive,” Shah said.