Novavax, partnering with Morrisville firm, lands Covid-19 vaccine deal with U.K.

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Novavax Inc. has locked in a deal to provide 60 million doses of its Covid-19 vaccine to the United Kingdom, the latest of multiple agreements the Maryland biotech has inked in the past week.

Deal terms were not disclosed.

Novavax (Nasdaq: NVAX) said it will expand its partnership with Tokyo-based Fujifilm Diosynth Biotechnologies to make the antigen for its candidate, NVX-CoV2373, including 180 million doses at the latter’s U.K. site each year. That expanded supply would serve additional markets, Novavax said Friday. The company plans to start supplying doses to the U.K. as early as the first quarter of 2021.

Fujifilm has a major manufacturing operation in Morrisville with around 500 employees. President Donald Trump toured the facility last month to see the vaccine effort in person.

Novavax said it will also run a phase 3 clinical trial to assess the vaccine’s efficacy just in the U.K. That study, slated to start in the third quarter of this year, would involve about 9,000 adults ages 18 to 85. And it would assess the vaccine’s ability to prevent Covid-19 symptoms and evaluate antibody and T-cell responses to the disease.

The vaccine candidate, which plans to start the second phase of clinical trials in the U.S. soon, will need to perform well in those trials to be considered for final approval by the Food and Drug Administration. Results from its first phase of trials were released earlier this month, when Novavax said the vaccine was generally well-tolerated and showed a “robust” response with no “severe” side effects.

tolerated and showed a “robust” response with no “severe” side effects.

The latest U.K. deal has bolstered Novavax’s rising stock price, which closed Friday at $146, after starting 2020 at around $4. It also comes on top of a handful of other deals for the biotech’s coronavirus program, including a few within the last week outside of the U.S.

Novavax formed a development and supply agreement with SK Group vaccine business subsidiary SK Bioscience for the antigen component of its vaccine candidate, with production set to begin this month. The local company also signed a letter of intent with the Republic of Korea’s Ministry of Health and Welfare to promote access to its candidate in South Korea and for the global market.

That followed a partnership with Takeda Pharmaceutical Co. Ltd. (NYSE: TAK) for the development, manufacturing and commercialization of NVX‑CoV2373 in Japan, to make more than 250 million doses in the first year. The deal will receive funding from the Government of Japan’s Ministry of Health, Labour and Welfare — for tech transfer, infrastructure and scaling of manufacturing. That agreement also entitles Novavax to payments based on certain milestones and some proceeds from vaccine sales.

Novavax has also inked a license agreement with Serum Institute of India Private Ltd. to develop and commercialize its Covid-19 vaccine in low- and middle-income countries as well as India, while Novavax would retain rights to upper-middle and high-income countries.

These recent deals build upon the staff and funding Novavax, led by CEO Stanley Erck, has assembled amid the pandemic – namely, $2 billion for development and commercialization of NVX-CoV2373. That includes $1.6 billion from the federal government’s Operation Warp Speed program; $388 million from the Norway-based Coalition for Epidemic Preparedness Innovations (CEPI); $60 million from the Department of Defense; $200 million from selling its own stock.

The company also secured agreements with Fujifilm, Emergent BioSolutions Inc. (NYSE: EBS), AGC Biologics and PolyPetide Group; acquired Praha Vaccines and its Czech manufacturing facility for $167 million; and made several executive hires, including appointing David Mott to its board of directors.

Novavax separately came out with successful pivotal data for seasonal flu vaccine NanoFlu in March. But it needs additional capacity and, in prioritizing its Covid-19 work, has had to put additional progress for that product on the back burner for now.

Despite the agreements for the Covid vaccine, it’s still too early to know whether Novavax’s candidate, like so many others now in development, will ultimately succeed. Regulators, government and industry are working on expedited timelines and collaborating like never before, as the pandemic puts pressure on the world to end it. So these players, including Novavax, are committing to manufacturing and production well before an official approval – to ensure they’re ready to go if they do, in fact, find they have a safe and effective vaccine.

The company which does not yet have a product to market, reported a net loss of $43.4 million for the first six months of 2020, down from its net loss of $82.8 million for the same period of 2019. The company also generated $35.5 million in second-quarter revenue, up from $3.4 million in Q2 last year, because of development activities under its agreement with CEPI, it reported in earnings Monday. Novavax closed June with $609.5 million in cash, cash equivalents, marketable securities and restricted cash – a jump from the $82.2 million it had at the end of 2019.

Original Article Source: Triangle Business Journal