Global Briefs: Sanofi, AbbVie & More
A roundup of news from Sanofi, the FDA, AbbVie and Neomorph. Highlights below.
Mfg News
* Sanofi Receives FDA Warning Letter for API Mfg Facility
Partnering News
* AbbVie, Neomorph in $1.6-Bn Molecular Glue Degrader Pact
Mfg News
Sanofi Receives FDA Warning Letter for API Mfg Facility
The US Food and Drug Administration (FDA) has issued a Warning Letter to Sanofi, following an inspection of the company’s active pharmaceutical ingredients (API) manufacturing facility in Framingham, Massachusetts, for quality issues at the facility.
The FDA cited that approximately 20% of bioreactor runs attempted between January 2022 and July 2024 were rejected for contamination or other quality failures. The agency stated that the company failed to conduct adequate investigations into critical deviations, including multiple microbiological contamination events recorded in this timeframe. The FDA also noted that the company deviated from its validated manufacturing process and that it used equipment unsuitable for its intended use in microbiologically controlled manufacturing environments. Additionally, the FDA noted that its inspection documented approximately 84 open and past due deviation investigations as of June 21, 2024, and in certain instances, multiple production deviations went unaddressed until FDA investigators informed facility personnel of the issues. In response to the letter, the FDA requested a comprehensive response and review of the issues cited.
Source: US Food and Drug Administration
Partnering News
AbbVie, Neomorph in $1.6-Bn Molecular Glue Degrader Pact
AbbVie and Neomorph, a San Diego, California-based bio/pharmaceutical company, have entered an agreement to develop molecular glue degraders for multiple targets across oncology and immunology, in a deal worth up to $1.64 billion.
Molecular glue degraders are a class of small molecules that are designed to selectively target and trigger degradation of proteins that drive cancer growth or immune system dysregulation, according to the companies.
Under the agreement, Neomorph will receive an upfront payment from AbbVie, and is eligible to receive up to $1.64 billion in aggregate option fees and milestones as well as tiered royalties on net sales.
Source: AbbVie