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Regeneron, Roche to Distribute Antibody Cocktail for Coronavirus
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Regeneron Pharmaceuticals, Inc. (REGN - Free Report) announced that it has collaborated with Swiss pharma giant Roche Holding (RHHBY - Free Report) to develop, manufacture and distribute REGN-COV2, its experimental dual antibody cocktail, which is under mid-to-late-stage evaluation for the prevention and treatment of COVID-19.
Per the agreement, Regeneron will be responsible for distributing REGN-COV2 in the United States while Roche will lead the distribution in the ex-U.S. markets. The alliance is expected to increase the supply of REGN-COV2 by at least three-and-half times with the potential of a further expansion.
REGN-COV2 is currently being evaluated in two phase II/III studies for the treatment of COVID-19 and in a phase III study for the prevention of COVID-19 in household contacts of infected individuals. Both Regeneron and Roche will bear its own distribution expenses in their respective territories.
Notably, the antibody cocktail approach may have long-term some utility for the elderly and immuno-compromised patients who often do not respond well to vaccines.
Shares of Regeneron have soared 64.7% so far this year compared with the industry’s increase of 4.5%.
We note that Regeneron initiated studies on REGN-COV2, a novel investigational antibody cocktail treatment designed to prevent and treat the SARS-CoV-2 virus. A phase III study to evaluate REGN-COV2's ability to prevent infection among the uninfected people who have had close exposure to a COVID-19 patient (such as the patient's housemate) was initiated following the review of the REGN-COV2 phase I safety results by the Independent Data Monitoring Committee (IDMC). The study is being run jointly with the National Institute of Allergy and Infectious Diseases (NIAID). In addition, REGN-COV2 moved into the phase II/III portion of two adaptive phase I/II/III studies, testing the cocktail's ability to treat hospitalized and non-hospitalized patients with COVID-19. The company plans to report initial virology and biomarker data from the REGN-COV2 treatment trials in September 2020.
Meanwhile, Regeneron and partner Sanofi (SNY - Free Report) reported that the US phase III study of Kevzara 400 mg in COVID-19 patients requiring mechanical ventilation, led by the former, did not meet its primary and key secondary endpoints. Based on such unfavorable outcomes, this U.S.-based trial was discontinued.
Currently, there are no FDA-approved treatments for the severe illness caused by SARS-CoV-2. The pharma/biotech sector is racing against time to develop treatments and vaccines that will prevent or cure patients from the contagion. Given the alarming levels of the spread and severity of the pandemic, quite a few biotechs are developing antibodies or evaluating their approved drugs or pipeline candidates to determine if they are effective enough to treat the infected patients.
Earlier this month, Gilead Sciences, Inc. (GILD - Free Report) submitted a New Drug Application (NDA) for Veklury (remdesivir) to the FDA. The drug is an investigational antiviral for the treatment of patients with COVID-19. Veklury is currently available in the United States under an Emergency Use Authorization for the treatment of hospitalized patients with severe COVID-19. The filing is the final tier of the rolling NDA submission initiated on Apr 8, 2020. It is already approved by multiple regulatory authorities around the world including the European Union and Japan.
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Regeneron, Roche to Distribute Antibody Cocktail for Coronavirus
Regeneron Pharmaceuticals, Inc. (REGN - Free Report) announced that it has collaborated with Swiss pharma giant Roche Holding (RHHBY - Free Report) to develop, manufacture and distribute REGN-COV2, its experimental dual antibody cocktail, which is under mid-to-late-stage evaluation for the prevention and treatment of COVID-19.
Per the agreement, Regeneron will be responsible for distributing REGN-COV2 in the United States while Roche will lead the distribution in the ex-U.S. markets. The alliance is expected to increase the supply of REGN-COV2 by at least three-and-half times with the potential of a further expansion.
REGN-COV2 is currently being evaluated in two phase II/III studies for the treatment of COVID-19 and in a phase III study for the prevention of COVID-19 in household contacts of infected individuals. Both Regeneron and Roche will bear its own distribution expenses in their respective territories.
Notably, the antibody cocktail approach may have long-term some utility for the elderly and immuno-compromised patients who often do not respond well to vaccines.
Shares of Regeneron have soared 64.7% so far this year compared with the industry’s increase of 4.5%.
We note that Regeneron initiated studies on REGN-COV2, a novel investigational antibody cocktail treatment designed to prevent and treat the SARS-CoV-2 virus. A phase III study to evaluate REGN-COV2's ability to prevent infection among the uninfected people who have had close exposure to a COVID-19 patient (such as the patient's housemate) was initiated following the review of the REGN-COV2 phase I safety results by the Independent Data Monitoring Committee (IDMC). The study is being run jointly with the National Institute of Allergy and Infectious Diseases (NIAID). In addition, REGN-COV2 moved into the phase II/III portion of two adaptive phase I/II/III studies, testing the cocktail's ability to treat hospitalized and non-hospitalized patients with COVID-19. The company plans to report initial virology and biomarker data from the REGN-COV2 treatment trials in September 2020.
Meanwhile, Regeneron and partner Sanofi (SNY - Free Report) reported that the US phase III study of Kevzara 400 mg in COVID-19 patients requiring mechanical ventilation, led by the former, did not meet its primary and key secondary endpoints. Based on such unfavorable outcomes, this U.S.-based trial was discontinued.
Currently, there are no FDA-approved treatments for the severe illness caused by SARS-CoV-2. The pharma/biotech sector is racing against time to develop treatments and vaccines that will prevent or cure patients from the contagion. Given the alarming levels of the spread and severity of the pandemic, quite a few biotechs are developing antibodies or evaluating their approved drugs or pipeline candidates to determine if they are effective enough to treat the infected patients.
Earlier this month, Gilead Sciences, Inc. (GILD - Free Report) submitted a New Drug Application (NDA) for Veklury (remdesivir) to the FDA. The drug is an investigational antiviral for the treatment of patients with COVID-19. Veklury is currently available in the United States under an Emergency Use Authorization for the treatment of hospitalized patients with severe COVID-19. The filing is the final tier of the rolling NDA submission initiated on Apr 8, 2020. It is already approved by multiple regulatory authorities around the world including the European Union and Japan.
Regeneron currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Breakout Biotech Stocks with Triple-Digit Profit Potential
The biotech sector is projected to surge beyond $775 billion by 2024 as scientists develop treatments for thousands of diseases. They’re also finding ways to edit the human genome to literally erase our vulnerability to these diseases.
Zacks has just released Century of Biology: 7 Biotech Stocks to Buy Right Now to help investors profit from 7 stocks poised for outperformance. Our recent biotech recommendations have produced gains of +50%, +83% and +164% in as little as 2 months. The stocks in this report could perform even better.
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