BIOCENTURY GUEST COMMENTARY (https://www.biocentury.com/article/632451)
RESTORING BARDA FUNDING AND EXTENDING MARKET EXCLUSIVITY FOR COVID-19 THERAPEUTICS WOULD DRAMATICALLY EXPAND PIPELINE
By Upendra Marathi, President and CEO, 7 Hills Pharma,
and Joseph Bailes, Adviser, 7 Hills Pharma
Dec 6, 2020
With excitement of the encouraging data on COVID-19 prophylactic vaccines, let’s not forget the infection rate and mortality are higher than ever, and treatment options are limited. One of the missed opportunities in the federal government’s response to the pandemic has been the failure to assess the potential of generic or proprietary drugs with limited patent life for the treatment of COVID-19. But it’s not too late.
Two incentives — restoration of Biomedical Advanced Research and Development Authority (BARDA) funding for therapeutics trials and establishment of a meaningful period of marketing exclusivity — would dramatically expand the pipeline of candidate therapies in testing for COVID-19.
FDA should take a cue from the U.K. Health Service System. The U.K. identified the potential merit of the generic drug dexamethasone, and then launched randomized clinical trials in more than 12,000 patients. In less than six months, findings from the studies established dexamethasone’s utility in reducing the destructive inflammation inflicted by SARS-CoV-2, the virus that causes COVID-19.
Thanks to the U.K.’s effort, dexamethasone, a low-cost corticosteroid that reduced risk of mortality by one-third, has become a standard of care in treating hospitalized COVID-19 patients.
There are a number of other generic drugs or agents with limited patent life that have been identified by researchers as potential treatments for COVID-19 based on clinical or preclinical evaluation.
These include fluvoxamine, an antidepressant with anti-inflammatory properties that showed promise in a small, investigator-led clinical study of COVID-19 outpatients; cyclosporine, an immunosuppressant that is known to inhibit replication of coronaviruses; camostat mesilate, a protease inhibitor that may prevent the coronavirus from entering cells; and GS-441524, an antiviral drug closely related to Veklury (remdesivir), which FDA recently approved as a COVID-19 treatment.
The federal government should immediately allocate funding and provide regulatory incentives to evaluate these drugs and others.
Incentives that can make a difference
BARDA initially invested billions in advancing diagnostics, treatments and vaccines for COVID-19. But in June, the agency ended funding for treatments in favor of accelerating development of vaccines under the Operation Warp Speed program. Both are needed investments.
Federal funding has led to a set of master protocol trials through NIH's Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) initiative, which has included repurposed therapies. But these trials are not enough to evaluate all of the most promising agents. And industry-led repurposing trials testing multiple agents, such as the COVID R&D alliance's master protocol testing agents from Takeda Pharmaceutical Co. Ltd. (Tokyo:4502; NYSE:TAK), Amgen Inc. (NASDAQ:AMGN) and UCB S.A. (Euronext:UCB), have been few.
Additional federal investment should be made in the development of therapeutics – with urgency.
We argue two initiatives could spur repurposing efforts for COVID-19. First, establish a regulatory incentive for drug companies to invest in repurposing. This could be achieved by extending market exclusivity for the treatment of COVID-19.
Currently, the only governmental incentive to develop a new indication for an approved drug is three years of market exclusivity as authorized under the Hatch-Waxman amendments to the U.S. Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 355(c)(3)(E).
Three years, however, is not sufficient incentive for companies to make the substantive financial investment in conducting the clinical trials and manufacturing and commercializing the drugs.
The incentive should be extended to seven years, the period of market exclusivity for drugs approved by the FDA under its orphan drug designation This program has been instrumental in the development of new treatments and cures for patients with rare diseases, indications that were largely ignored by drug developers before the pathway.
The second suggestion is to re-establish funding for COVID-19 treatments by BARDA.
The government could make significantly greater progress in battling COVID-19 by investing $1 billion to support clinical trials of the generic drugs already identified as potential treatments. We estimate that with an additional allocation of about $1 billion, more than 10 products could be made Phase III ready, and two to three products could receive authorization for management of COVID based on completion of Phase I/II studies.
Furthermore, to help ensure BARDA is well-placed to quickly marshal the nation’s resources in fighting future pandemics, it should be designated a strategic national defense asset and its management should be moved from the U.S. Health and Human Services Department to the Department of Homeland Security, a move that makes sense given viruses can be weaponized.
Signed commentaries do not necessarily reflect the views of BioCentury.