Shares of Endo International plc ENDP gained 8.44% after it announced that its subsidiary, Par Sterile Products, has entered into a non-exclusive manufacturing agreement with Novavax, Inc. NVAX for the latter’s COVID-19 vaccine candidate, NVX-CoV2373.
Per the agreement, Par Sterlite’s Rochester facility will provide fill-finish manufacturing services for NVX-CoV2373. The facility has begun the production of NVX-CoV2373 final drug product, with initial batches to be used in Novavax's phase III study in the United States. Par Sterile will also fill-finish the NVX-CoV2373 vaccine intended for commercial distribution in the United States.
The financial terms of the agreement were not disclosed.
The partnership with Endo in the United States will enable rapid delivery of the vaccine for pivotal clinical testing, which is expected to get underway soon.
We note that NVX-CoV2373 is currently in multiple phase II studies. A phase II study to evaluate the safety and immunogenicity of NVX-CoV2373 began in August 2020 in the United States and Australia building on positive phase I results and expanding to include older adults. A phase IIb study to assess efficacy began in South Africa in August. Interim data from these studies are expected before the end of 2020.
Novavax’s shares gained 10.8% on the news. Shares also gained last week after the company announced that it has initiated the first phase III study in the United Kingdom evaluating the safety, efficacy and immunogenicity of NVX-CoV2373. Data from this study are likely to support the regulatory submissions for licensure of the vaccine in the United Kingdom, the EU and other countries.
Shares of Endo have lost 32.8% in the year so far compared with the industry’s 8.5% decline.
The race for the development of a vaccine for COVID-19 has intensified in the last couple of months, as a second wave of the pandemic is likely to grip the western countries. The pharma and biotech companies are running a race against time to develop a vaccine and combat the contagion.
Last week, shares of pharma giant Johnson & Johnson JNJ surged after it announced the launch of its large-scale, multi-country phase III study (ENSEMBLE) for its COVID-19 vaccine candidate, JNJ-78436735.
Among other companies, Moderna MRNA is developing an mRNA-based vaccine, mRNA-1273, in collaboration with the National Institutes of Health (NIH) for COVID-19. A phase III study of 30,000 volunteers in the United States began in July 2020.
While Endo currently carries a Zacks Rank #4 (Sell), Novavax has a Zacks Rank #3 (Hold).
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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