The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), representing the world’s leading biopharmaceutical companies, have mobilized on an unprecedented scale to respond to the COVID-19 pandemic. The biopharmaceutical industry commits to accelerating its effort to use its skills, technology, and resources to bring safe, effective diagnostics, treatments and vaccines to patients around the world.
Biopharmaceutical companies began screening their libraries of medicines to identify potential treatments once the novel coronavirus (SARS-CoV-2) genome sequence was shared, building on the knowledge gained from experience with new viruses such as SARS, MERS, Zika, and Ebola. The industry has devoted significant resources and worked with partners in public health to develop technologies that have dramatically shortened the time it takes to decode viruses and develop a potential vaccine. As a result, platforms are available to facilitate the development of vaccines that enter clinical trials quickly.
FibroGenesis Announces Provisional Patent for a Fibroblast Therapy for COVID-19 Treatment
FibroGenesis, a regenerative medicine company located in Houston, TX, announced on April 1, 2020 that it has filed a provisional patent for peptides and adjuvants for augmentation of fibroblast therapy for COVID-19 treatment.
According to a company press release, the patent includes the use of fibroblast cells and adjuvants such as peptides and hydroxychloroquine, which fuel the assembly of natural interferon to overpower the virus. The patent also features methods for preventing infection, propagation, and pathology as a result of COVID-19. “We are working to expand our discoveries in the lab and accelerate the clinical development into a cure for COVID-19 using our advanced fibroblast cell therapy,” added Pete O’Heeron, CEO, FibroGenesis.
Biopharma Update on the Novel Coronavirus
Coronavirus Treatment Acceleration Program (CTAP): The FDA announced a new public-private approach to bring coronavirus treatments to the market as fast as possible, as stated by HHS Secretary Alex Azar. The CTAP program will use every means the agency has access to bring new therapies to sick patients.
Shortages of Hydroxychloroquine and Chloroquine: The FDA is working with manufacturers of this drug to ensure it can be meet market demand for those patients with malaria, lupus and rheumatoid arthritis as well as the possible use in treating COVID-19 patients or for use in clinical trials.
Warning Letters to Three Companies: The FDA and FTC issued warning letters to Halosense Inc, Bioactive C60/FullerLifeC60 LLC and JRB Enterprise Group Inc. DBA Anti-Aging Bed for using misleading claims that their products are safe and/or effective in the prevention or treatment of COVID-19.
Diagnostics Update: The FDA has worked with more than 220 test developers who plan to submit EUA requests to detect COVID-19. Also, 22 EUAs have been issued.
Roche’s Actemra (tocilizumab) may be approved as early as this summer to treat COVID-19, according to the FDA. The drug is already approved in the U.S. for rheumatoid arthritis. The company began a Phase III trial of the drug plus standard-of-care in hospitalized patients with COVID-19 pneumonia about two weeks ago.
Biopharma companies face regulatory, deal delays due to COVID-19
COVID-19 is already taking a toll on biopharma, with companies putting off clinical development and canceling meetings and other plans in order to slow the spread of the SARS-CoV-2 virus and free up space at hospitals that are quickly becoming overburdened. On Thursday, two companies announced that they had hit regulatory snags at the Food and Drug Administration, while two others have had to put off completion of a planned deal.
New York-based Intercept Pharmaceuticals said the FDA had notified it that an advisory committee meeting to discuss the drug obeticholic acid as a treatment for liver fibrosis due to nonalcoholic steatohepatitis, originally scheduled for April 22, had been rescheduled for June 9. However, the company said the FDA remained on track to decide whether or not to approve the drug by June 26. If approved, obeticholic acid, also known as OCA, would be the first-ever drug approved for NASH. The company noted that its NASH trials are fully enrolled, while it is pausing screening and randomization of patients in some of its primary biliary cholangitis trials of OCA. “The COVID-19 pandemic has created new challenges for bluebird, the broader biotech community and society as a whole,” bluebird CEO Nick Leschly said in a statement.
In a note to investors, Baird analyst Brian Skorney wrote that while COVID-19 has caused several delays in clinical development, Intercept’s NASH trials being fully enrolled may help it avoid any such issues. Furthermore, he wrote, the company has significant financial resources to weather the pandemic, with $650 million in cash and equivalents at the end of fiscal year 2019.
FDA launches push to speed up COVID-19 drug development efforts
The Food and Drug Administration hopes to expedite the development of treatments for COVID-19 under a new program that the agency announced Tuesday. The FDA said that under the Coronavirus Treatment Acceleration Program, or CTAP, it is redeploying staff and streamlining processes with the goal of speeding up reviews of clinical trial protocols and single-patient expanded-access requests.
The agency said it is organizing requests from developers and scientists seeking to develop new drugs to treat COVID-19, the disease caused by the SARS-CoV-2 virus, according to their urgency, helping relevant FDA staff in touch with them and providing input to expedite the initiation of studies. It said that in doing so, it has managed to review some clinical trial protocols within 24 hours and reviewed expanded-access requests generally within three hours. It has also created protocols that can be used across institutions and platforms.
To accomplish this, the FDA said it has redeployed medical and regulatory staff to serve on teams dedicated to reviewing COVID-19 therapies and streamlined the ways that requests and inquiries can be submitted to the agency.
Some clinical trials of COVID-19 therapies and vaccines have gotten up and running very quickly, such as Moderna’s Phase I study of the vaccine mRNA-1273 and the Regeneron-Sanofi trial.