Formosa Laboratories, Inc.

TAOYUAN, June 3, 2024 /PRNewswire/ -- Formosa Laboratories, Inc., a leading API supplier and CDMO headquartered in Taiwan, has successfully completed its acquisition of SynChem, Inc., a contract research laboratory located in suburban Chicago. SynChem will now operate under the new name SynChem-Formosa. As a now wholly-owned subsidiary of Formosa Laboratories, Dr. W. Paul Mar will continue as CEO of SynChem-Formosa, leading the company's operations and reporting directly to Dr. Cheng, Chairman and President of Formosa. Continue Reading Dr. Cheng commented on the acquisition, stating, "This acquisition represents a pivotal advancement in Formosa's ongoing growth within the CDMO sector. SynChem's track record of delivering high-quality organic synthesis and process development services to numerous pharmaceutical and biotech firms, especially in areas such as ADC payloads and linkers, positions us well for future growth. Backed by Formosa's extensive capabilities in scale-up, commercial GMP production, bio-conjugation, and injectable fill-finish operations, we are now poised to offer comprehensive, fully GMP-compliant CDMO services to our clients across the U.S. and internationally." Dr. Mar added, "Joining the Formosa family marks an exciting new chapter for us. We are enthusiastic about leveraging this merger to become a leading CDMO for small molecule APIs and ADCs in the United States." SOURCE Formosa Laboratories Inc.

Chinese biotech WestGene announced an FDA approval for its mRNA therapeutic cancer vaccine. Credit: aslysun via Shutterstock. The US Food and Drug Administration (FDA) has approved an mRNA therapeutic cancer vaccine developed by China-based biotech WestGene. This decision makes the vaccine the world’s first approved mRNA therapeutic vaccine to treat Epstein Barr (EB)-virus-related cancers. The approval was based on results from investigator-initiated trials that evaluated the vaccine in patients with nasopharyngeal carcinoma (NPC) and natural killer T cell lymphoma. EB virus is a part of the herpesvirus family and spreads primarily through bodily fluids. The illness infects more than 90% of the global adult population but does not always lead to cancer, as detailed by Cancer Research UK. The virus has been linked with NPC, gastric cancer, lung cancer and other diseases. In a 10 May press release, WestGene highlighted liver cancer, oesophageal cancer, breast cancer and the aforementioned diseases as potential future indications for the vaccine. The Chinese company has a pipeline that includes four infectious disease vaccines, seven anti-tumour immunotherapies, and three gene editing treatments amongst other therapies. See Also: Formosa and Tabuk sign deal for FDA-approved ophthalmic suspension Four ways the vaccine rush will define infectious disease trends for CROs in 2024 In 2010, the FDA approved Dendreon Pharmaceutical’s prostate cancer prophylactic Provenge (sipuleucel-T) as the first marketed therapeutic cancer vaccine. Since its approval, other therapeutic cancer vaccines have entered the US market, with eight being available in the US, according to GlobalData. GlobalData is the parent company of Pharmaceutical Technology. In 2021, Pfizer and BioNTech gained the first-ever FDA approval for an mRNA vaccine with Comirnaty (BNT162b2) as a preventative measure against Covid-19. Since this milestone, several preventive and therapeutic mRNA vaccines have been in development for a wide range of conditions. Some pharmaceutical companies are using the mRNA approach to develop vaccines for other infectious diseases such as respiratory syncytial virus (RSV), Influenza A, Influenza B and cytomegalovirus while companies, including Moderna , Curevac , and Cartesian Therapeutics, are developing therapeutic mRNA vaccines for treating different cancers.

The deal also sees Sanofi take an equity stake of less than 5% in Novavax. Credit: Viacheslav Lopatin / Shutterstock.com. Sanofi has signed a $1.2bn licensing agreement with Novavax to co-commercialise its stand-alone adjuvanted Covid-19 vaccine. Starting in 2025, the drugmaker will co-commercialise the vaccine worldwide, except for in countries such as India, South Korea, and Japan where Novavax already has existing partnerships in place. As per the “co-exclusive” agreement, Sanofi will also support certain R&D, regulatory, and commercial expenses. The American vaccine company has faced tough times in the post-Covid-19 landscape, going as far as to issue a “going concern” warning in 2023 about its ability to continue operating. At the time, Novavax said it was subject to “significant uncertainty” concerning future sales and funding from the US Government. Following the deal with Sanofi, the removal of this warning was noted in Novavax’s first quarter 2024 financial results and operational highlights released today. Novavax CEO John Jacobs told CNBC that the agreement with Sanofi would allow it to lift the “going concern” warning it first issued last year over doubts surrounding its ability to continue operations. See Also: WestGene wins FDA nod to study mRNA vaccine to treat certain cancers Formosa and Tabuk sign deal for FDA-approved ophthalmic suspension The Q1 financials show that Novavax achieved revenues of $94m in its first quarter, up from $81m in the same period in 2023. While Novavax’s adjuvanted Nuvaxovid (NVX-CoV2373) vaccine is not currently approved or licensed by the US Food and Drug Administration (FDA), it has been authorised by the agency under an emergency use authorisation (EUA) to prevent Covid-19 for use in individuals aged 12 and above. The EUA was amended late last year to incorporate the 2023-2024 version. Last year, Novavax received a full marketing authorisation from the European Medicines Agency (EMA) for Nuvaxovid. The vaccine has been authorised in more than 40 markets worldwide. The deal also gives Sanofi a sole licence to use the vaccine in combination with its flu vaccines, and non-exclusive licences to use it in combination with non-flu vaccines and Novavax’s Matrix-M adjuvant in vaccine products. The Matrix-M adjuvant comprises naturally occurring compounds found in the bark of the soap bark tree, which is commonly found in Chile. According to Novavax, the combination of ingredients has been shown to enhance the immune system response to its vaccines. Jean-Francois Toussaint, global head of vaccines R&D at Sanofi, commented: “With flu and Covid-19 hospital admission rates now closely mirroring each other, we have an opportunity to develop non-mRNA flu-Covid-19 combination vaccines offering patients both enhanced convenience and protection against two serious respiratory viruses.” Jacobs added: “Novavax is now in a stronger position to refocus our efforts on leveraging our technology platform and novel adjuvant in research and development and pipeline expansion to help advance our mission of developing life-saving vaccines to fight infectious diseases.” According to GlobalData analysts, Sanofi was the tenth top pharmaceutical company by R&D spend in 2023 . The company’s R&D expenditure totalled $7.18bn, making its R&D budget 15.6% of its revenue. GlobalData is the parent company of Pharmaceutical Technology.