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Novavax, Inc. NVAX announced that it has signed a Heads of Terms (Term Sheet) with the Government of the United Kingdom, which is looking to purchase 60 million doses of its COVID-19 vaccine candidate, NVX-CoV2373. The company will also collaborate with the UK government for a phase III study, which will evaluate the efficacy of the vaccine in the country’s population. The study will commence in the third quarter of 2020.
The above study will assess the ability of NVX-CoV2373 to protect from the symptomatic COVID-19 infection as well as evaluate antibody and T-cell responses. Novavax is looking to supply 60 million doses of NVX-CoV2373 to the UK government as early as the first quarter of 2021.
Notably, Novavax will expand its collaboration with FUJIFILM Diosynth Biotechnologies, which will manufacture the antigen component of NVX-CoV2373. The FUJIFILM Diosynth Biotechnologies site in the UK is expected to produce up to 180 million doses annually.
We note that Novavax already has an agreement with the US government to deliver 100 million doses of NVX-CoV2373 as early as late 2020. In July, the company was selected for the U.S. government’s Operation Warp Speed (OWS) and was awarded $1.6 billion by the federal government to support the late-stage development of its coronavirus vaccine candidate.
Shares of Novavax have skyrocketed 3248.7% year to date compared with the industry’s increase of 3.9%.
In a separate press release, Novavax announced that it has entered into a development and supply agreement with the South Korean biopharmaceutical company SK bioscience to manufacture the antigen component of NVX-CoV2373, which will be used in the final vaccine product. Moreover, the companies signed a letter of intent with the Republic of Korea’s Ministry of Health and Welfare to provide access to the vaccine for the global market as well as in South Korea.
Per the agreement, SK bioscience will manufacture the vaccine antigen component, using its cell culture and recombinant protein capability in South Korea beginning this month.
Novavax also has a partnership pact with Takeda Pharmaceutical for the development, manufacturing and commercialization of NVX-CoV2373 in Japan. The company already has a deal with Emergent BioSolutions EBS to manufacture and supply its GMP vaccine product for use in its clinical studies.
We note that NVX-CoV2373 includes Novavax’s proprietary Matrix-M adjuvant to improve immune responses and stimulate high levels of neutralizing antibodies. The company initiated a phase I/II study on the candidate in May. In August, it released encouraging results on the first human trial of its COVID-19 vaccine candidate. The clinical trial data showed that the vaccine was generally well-tolerated and elicited robust antibody responses, numerically superior to what was seen in human convalescent sera (antibodies derived from blood donated by people who recovered from the illness).
Notably, Novavax received a total funding of $2 billion, roughly broken up into the U.S. Department of Defense’s$60 million, the CEPI’s $388 million and the U.S. government’s OWS grant of $1.6 billion for developing NVX-CoV2373.
Significantly, all the above entities are financing several biotechs and large pharma companies including AstraZeneca AZN, Sanofi, Moderna MRNA, Inovio Pharmaceuticals and many universities to accelerate the development of vaccines against COVID-19.
Novavax currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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