Biopharma Industry News for March 23: Update on the Novel Coronavirus

CV Update_March 23



FDA Actions

Patient Access to Certain REMS Drugs:  The FDA issues new guidance for drugs subject to REMS laboratory testing or imaging requirements. Regarding REMS drugs, healthcare providers should consider whether there are compelling reasons not to complete tests or studies during this time.

"Under these circumstances, undergoing testing or imaging studies in order to obtain a drug that is subject to a REMS can put patients and others at risk for transmission of the coronavirus. We will continue to work with sponsors to ensure that patients have appropriate access to the medications they need,” said FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D.

Access to Crucial Medical Products: The FDA took action to help increase the availability of respiratory devices to support patients. 

“The FDA’s new actions will mean America can make more ventilators during this crisis,” said Health and Human Services Secretary Alex Azar. “Today’s actions are another step by the FDA and HHS to eliminate every possible barrier to the all-of-America approach that President Trump has called for."



Unauthorized At-Home Coronavirus Tests: The FDA is warning the public that at this time, the FDA has not authorized any test that is available to purchase for testing at home for COVID-19. 

Oxford University researchers developed a 30-minute COVID-19 test that costs $25 for the raw materials. They have been working on it for about eight weeks with Chinese authorities. They expect it to pass clinical trials within a few days.


Testing Therapies, Antivirals and Vaccines

French researchers have published an article in the International Journal of Antimicrobial Agents describing the potential use of a combination of hydroxychloroquine and the antibiotic azithromycin, which is better known as Z-Pak to treat COVID-19. The U.S. Food and Drug Administration (FDA) is also evaluating the drugs but have not yet made recommendations.

Gilead Sciences: Gilead Sciences has been overwhelmed with requests for remdesivir to treat cases of COVID-19, the disease caused by the novel coronavirus. As a result of that increased demand, the company has been forced to put compassionate use requests on a temporary hold until it can process previously approved requests. Gilead said it would make exceptions for pregnant women and children under 18 with severe COVID-19.

Pharnext SA: Pharnext SA announced that through artificial intelligence, they have identified 97 frequently prescribed drugs as potential candidates to be repurposed for treating COVID-19. 

Researchers ran a trial of 55 people in China with mild cases of COVID-19 and 13 severe cases. The goal was to determine if the cytotoxic lymphocytes in patients with the disease were exhausted—these cytotoxic lymphocytes are necessary to control viral infections, and functional exhaustion of them is linked to disease progression. The short answer is: yes, “the function of NK and CD8+ cells was exhausted with the increased expression of NKG2A in COVID-19 patients. Importantly, in patients convalescing after therapy, the number of NK and CD8+ cells were restored with reduced expression of NKG2A.” Patients were administered AbbVie’s Kaletra in about 94.12% of patients, and chloroquine phosphate was used in 7.35%, with 64.71% receiving interferon (IFN). About half also received antibiotic treatment. The researchers believe that by targeting NKG2A with various therapies, which might include checkpoint inhibitors and other drugs, they may be able to prevent the functional exhaustion of the cytotoxic lymphocytes. Innate Pharma's monalizumab is being evaluated in Phase II trials in certain cancers because it binds with NKG2A and activates NK and T-cell responses.

CNS Pharmaceuticals: CNS announced it has entered into an agreement with WPD Pharmaceuticals to develop several preclinical drugs including WP1122. WP1122 is currently being tested on many viruses including the coronavirus SARS-CoV-2. 

Hoth Therapeutics: Hoth Therapeutics and Voltron Therapeutics have reached an agreement to form a joint venture, HaloVax. The joint venture will start preclinical studies for the development of potential vaccines to prevent COVID-19.

Parallax Health Sciences signed a contract with a medical distribution company in China for point-of-care testing.

Masimo is offering rainbow licenses at no additional charge to hospitals currently using rainbow-ready devices. The rainbow platform allows noninvasive and continuous patient monitoring of 12 parameters.

The World Health Organization (WHO) is organizing the SOLIDARITY clinical trial to create data that can be leveraged to decide which treatments are most effective, if they decrease mortality and hospital stays. It will have 5 arms, one standard of care, one Gilead’s remdesivir, one a combination of lopinavir/ritonavir, another a combination of lopinavir/ritonavir/interferon beta, and the fifth of chloroquine. Ten countries are participating.

Adaptive Biotechnologies and Microsoft are leveraging their existing partnership mapping population-wide adaptive immune responses to diseases at scale to study COVID-19. Discovering the relevant immune response signature may advance solutions to treat the disease, the companies said. The data from this mapping project will be available to other researchers and health officials through an open data access panel. To generate immune response data, Adaptive will open enrollment in April to collect de-identified blood samples, using a LabCorp-enabled mobile phlebotomy service, from individuals diagnosed with or recovered from COVID-19 in a virtual clinical trial managed by Covance.

eTheRNA immunotherapies NV announced the formation of a consortium with North American and European partners to develop a novel mRNA vaccine against CoV-2. Preclinical development has launched and Chinese partners may be added. It will include partners EpiVax, Nexelis, REPROCELL and CEV.

Company Actions

Bristol-Myers Squibb: Due to the novel coronavirus pandemic, Bristol-Myers Squibb announced that they will reschedule their April 2, 2020 Investor Day for a later date. 

Thermo Fisher Scientific: Thermo Fisher Scientific is investing more than $475 million in 2020 for new capabilities and capacity. "We've invested strategically to ensure that lack of capabilities, capacity or supply is never a reason medicines are delayed in reaching patients," said Mike Shafer, president, Thermo Fisher's pharma services business. "Our offering can provide solutions at all points along the pathway to commercialization, whether it's an emerging biotech working on a vaccine for a novel virus or a high-volume pharmaceutical manufacturer delivering necessary drugs at scale."

Thermo Fisher Scientific also filed a regulatory Form 8-K, to warn of the risks associated with the novel coronavirus pandemic. COVID-19 has been noted to have an adverse impact on their operations, supply chains and disruption systems. 

Eli Lilly and Company, Galapagos NV and Provention Bio have all announced the pause in some clinical trials due to concerns over the coronavirus pandemic. Lilly said it will delay the start of new trials and pause enrollment of others in order to ease the burden on an overtaxed healthcare system scrambling to treat COVID-19. Galapagos is pausing enrollment of some Phase II and Phase III filgotinib trials, while Provention is pausing a diabetes trial out of an abundance of caution.


Other Industry News

Insys: Insys founder John Kapoor is using the coronavirus pandemic as part of his legal defense to remain out of prison while he appeals his January racketeering conviction for kickback schemes to boost prescriptions of his company’s powerful opioid, Subsys.

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