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Regeneron's REGEN-COV2 Antibody Cocktail for COVID-19 Receives FDA Emergency Use Authorization (EUA) for Recently Diagnosed, Mild to Moderate COVID-19 In High-Risk Patients

On November 21, 2020, Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced that the antibody cocktail casirivimab and imdevimab administered together (also known as REGN-COV2 or REGEN-COV2), a therapy currently being investigated for use in COVID-19, has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). Casirivimab and imdevimab administered together are authorized for the treatment of mild to moderate COVID-19 in adults, as well as in pediatric patients at least 12 years of age and weighing at least 40 kg, who have received positive results of direct SARS-CoV-2 viral testing and are at high risk for progressing to severe COVID-19 and/or hospitalization. The clinical evidence from Regeneron's outpatient trial suggests that monoclonal antibodies such as REGEN-COV2 have the greatest benefit when given early after diagnosis and in patients who have not yet mounted their own immune response or who have high viral load. The criteria for “high-risk” patients are described in the Fact Sheet for Health Care Providers (https://www.regeneron.com/sites/default/files/treatment-covid19-eua-fda-...). Casirivimab and imdevimab are not authorized for use in patients who are hospitalized or require oxygen therapy due to COVID-19, or for people currently using chronic oxygen therapy because of an underlying comorbidity who require an increase in baseline oxygen flow rate due to COVID-19. "This FDA Emergency Use Authorization is an important step in the fight against COVID-19, as high-risk patients in the United States will have access to a promising therapy early in the course of their infection," said Leonard S. Schleifer, MD, PhD, President and Chief Executive Officer of Regeneron. "The science and technology investments Regeneron has made over three decades positioned us to move rapidly to invent, study, and maximize production of REGEN-COV2. Even with these incredible efforts, demand may exceed supply initially, making it even more critical that federal and state governments ensure REGEN-COV2 is distributed fairly and equitably to the patients most in need. In the first quarter of 2021, we expect to increase available REGEN-COV2 global supply as we continue our collaboration with Roche."

CSO COMMENTS

"REGEN-COV2 is designed to mimic what a well-functioning immune system does by using very potent antibodies to neutralize the virus," said George D. Yancopoulos, MD, PhD, President and Chief Scientific Officer of Regeneron. "Data from approximately 800 non-hospitalized patients showed significant reductions in virus levels within days of receiving REGEN-COV2, which were associated with significantly fewer medical visits. This benefit was greatest in patients most at risk for poor outcomes due to high viral load, ineffective immune response at baseline, or pre-existing risk factors. We are encouraged that no variants resistant to the cocktail were identified in the clinical trial analyses to date, which is consistent with our preclinical findings.”

“We are also very encouraged by recently announced promising vaccine results; however, there remains a need to treat patients who develop COVID-19, especially as some may not have had access to or were not protected by vaccination. Importantly, we continue to advance our rigorous clinical trial program evaluating the safety and efficacy of REGEN-COV2 for both the treatment and prevention of COVID-19, and we will share new results as available."

80,000 DOSES AVAILABLE BY END OF NOVEMBER; 300,000 DOSES AVAILABLE END OF JANUARY 2021

Production of monoclonal antibodies is a complex, time- and labor-intensive process that requires deep expertise. Utilizing production and manufacturing platforms developed over decades, Regeneron rapidly scaled up REGEN-COV2, beginning in the early days of the pandemic with support from the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services. Regeneron now expects to have REGEN-COV2 treatment doses ready for approximately 80,000 patients by the end of November, approximately 200,000 patients by the first week of January, and approximately 300,000 patients in total by the end of January 2021.

DISTRIBUTION

As part of Operation Warp Speed, in July the U.S. government and Regeneron signed an agreement for this initial supply of REGEN-COV2. The U.S. government will coordinate with state authorities to allocate REGEN-COV2 on a weekly basis based on the number of COVID-19 cases in each state. The government has committed to providing these 300,000 doses at no cost to patients, although healthcare facilities may charge fees related to administration. Regeneron will immediately begin shipping REGEN-COV2 to Amerisource Bergen, a national distributor, which will distribute the therapy as directed by the government.

DOSES AND ADMINISTRATION

Under the EUA, the recommended dose is 1,200 mg of casirivimab and 1,200 mg of imdevimab (2,400 mg total) administered as a single intravenous infusion. The authorization is based on positive Phase 2 data announced in September (https://investor.regeneron.com/news-releases/news-release-details/regene...) and October (https://investor.regeneron.com/news-releases/news-release-details/regene...) from the first 799 adults in an ongoing randomized, double-blind, placebo-controlled trial of non-hospitalized patients ("outpatients") with COVID-19.

EMERGENCY USE AUTHORIZATION

The FDA grants Emergency Use Authorization to medicines that may help diagnose, treat, or prevent a life-threatening disease when adequate and approved alternatives are not available. The EUA is temporary and does not take the place of a formal biologics license application (BLA) submission review and approval process. This use is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use, unless terminated or revoked sooner. Casirivimab and imdevimab have not been approved by FDA and remain investigational. Evaluation of the cocktail’s safety and efficacy is ongoing in multiple clinical trials. Data from these trials will be used to support a future BLA submission. Health care providers should review the Fact Sheet for detailed information on the authorized use and requirements of the EUA and may call 844-734-6643 for more information. Please see the Fact Sheet and FDA Letter of Authorization at http://www.regencov2.com/.

ONGOING CLINICAL TRIALS

REGEN-COV2 continues to be evaluated in Phase 2/3 clinical trials for the treatment of COVID-19 in certain hospitalized and non-hospitalized patients, the Phase 3 open-label RECOVERY trial of hospitalized patients in the UK, and a Phase 3 trial for the prevention of COVID-19 in household contacts of infected individuals. To date, more than 7,000 people have participated in REGEN-COV2 clinical trials.
REGEN-COV2

REGEN-COV2 is a cocktail of two monoclonal antibodies (casirivimab and imdevimab, also known as REGN10933 and REGN10987, respectively) and was designed specifically to block infectivity of SARS-CoV-2, the virus that causes COVID-19.

To develop REGEN-COV2, Regeneron scientists evaluated thousands of fully-human antibodies produced by the company's VelocImmune® mice, which have been genetically modified to have a human immune system, as well as antibodies identified from humans who had recovered from COVID-19. The two potent, virus-neutralizing antibodies that form REGEN-COV2 bind non-competitively to the critical receptor binding domain (RBD) of the virus's spike protein, which diminishes the ability of mutant viruses to escape treatment and protects against spike variants that have arisen in the human population, as detailed in Science (https://investor.regeneron.com/news-releases/news-release-details/two-sc...).

DEVELOPMENT AND DISTRIBUTION

REGEN-COV2's development and manufacturing has been funded in part with federal funds from BARDA under OT number: HHSO100201700020C. Regeneron continues to increase in-house production of REGEN-COV2, and the company has partnered with Roche to increase the global supply of REGEN-COV2 beginning in 2021. If REGEN-COV2 proves safe and effective in clinical trials and regulatory approvals are granted, Regeneron will manufacture and distribute it in the U.S. and Roche will develop, manufacture, and distribute it outside the U.S. Once both companies are at full manufacturing capacity in 2021, there are expected to be at least 2 million treatment doses available annually.

REGENERON

Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, the compan’s unique ability to repeatedly and consistently translate science into medicine has led to eight FDA-approved treatments and numerous product candidates in development, all of which were homegrown in Regeneron laboratories. The company’s medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, infectious diseases, and rare diseases.

Regeneron is accelerating and improving the traditional drug development process through its proprietary VelociSuite® technologies, such as VelocImmune, which uses unique genetically-humanized mice to produce optimized fully-human antibodies and bi-specific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.

For additional information about the company, please visit http://www.regeneron.com.

[Regeneron news release]

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