The U.S. Government Accountability Office (GAO) reported on May 26 that a top-down analysis of the vaccine development and manufacturing process. The report notes that a vaccine development process can take on 10 to 15 years. However, steps are taken to accelerate the measures and move forward with vaccines.
The GAO report and biotechs like Novavax moving forward
While the report merely provides a descriptive explanation of the process and only deals with only a few COVID-19 vaccine candidates directly funded by the federal government, it highlights the importance of information dissemination for patients and investors.
Companies like Novavax (NVAX 3.27%), Regeneron Pharmaceuticals (REGN 0.41%) are showing collective promise amid the release of the GAO report and a non-stop circulation of news related to clinical test phases and the over 100 COVID-19 vaccine candidates worldwide.
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Novavax has enrolled human subjects for new clinical trials for the company's experimental COVID-19 vaccine candidate, NVX-CoV2373. This candidate is a stable perfusion protein made nanoparticle vaccine formats. The trial is a phase 1/2 trial starting in Australia and a phase 2 trial conducted across multiple countries following a phase 1 top-line trial. After, the development has permitted to scale-up production to potentially allow for the manufacturing of up to 100 million vaccine doses by the end of this year. Novavax says facilities across the world could offer a goal of producing over 1 billion prescriptions during 2021. The company is also fresh from $388 million from the Coalition for Epidemic Preparedness Innovations to develop its vaccine.
Regeneron's moves
Despite the developments coming out of Novavax, Regeneron has a lot to offer in regards to COVID-19 opportunities and movements across the market. The monoclonal antibody sarilumab rheumatoid arthritis drug is being tested in the treatment of COVID-19 caused pneumonia. Sarilumab was initially designed by Regeneron and Sanofi S.A. (SNY -0.08%) and approved in the U.S. and European in 2017 against interleukin-6 receptors.
Sarilumab was tested to evaluate the effectiveness of the drug concerning improving conditions on lung functions and the prevention of intensive care unit admissions linked to severe pneumonia related to SARS-CoV-2 between March 23 and April 4.
A preprint of the study shows that the primary outcomes and measures include clinical outcomes of 53 patients with SARS-CoV-2 severe pneumonia treated with the Sarilumab in an intravenous format and an intensive care unit admission rate in medical wards setting of live discharge rare in the ICU.
Regeneron's application of Sarilumab, if final clinical trials are complementary, could be a move that augments vaccine development across the board.
Sanofi exiting Regeneron
The news regarding the Sarilumab trials also comes at a time when Sanofi announced an exit from Regeneron. Both Sanofi and Regeneron expressed their intent to widely restructure their partnership as the Paris, France-based drug maker will sell off most of its stake in Regeneron.
According to a preliminary understanding of the registered purchase, Sanofi will share approximately 23.2 million shares of Regeneron's common stock, representing a 20.6 percent ownership stake. Regeneron agreed to repurchase shares of its stock from Sanofi as a conditional completion of the proposed public offering. That's about $5 billion. Sanofi will gain over $11 billion in cash from the sale of which owns approximately 400,000 shares of Regeneron's common stock.
Considering Novavax and Regeneron’s movements, the companies should be buys when we look into the importance of the work these firms are doing and the findings of the GAO report.
