A new option for API

PARIS—Sanofi announced earlier this week that it intends to establish a leading European company dedicated to producing and marketing active pharmaceutical ingredients (API) to third parties. The standalone company would combine Sanofi's API commercial and development activities with six of its European API production sites: Brindisi in Italy, Frankfurt Chemistry in Germany, Haverhill in the U.K., St. Aubin les Elbeuf in France, Újpest in Hungary, and Vertolaye in France.

The standalone company would be able to increase sales to third parties and expand industry partnerships, and would have “significant competitive strengths, including a broad portfolio of both volume and niche products, high standards of quality, competitive pricing, state-of-the-art industrial capabilities and technologies across Europe (including France, Italy, Germany, Hungary, and the United Kingdom) as well as leveraging an extensive commercial network covering more than 80 countries,” per a Sanofi press release.

“Based on the expertise and experience built over decades within our industrial network, this new entity would help ensure a greater stability in supplying drugs to millions of patients in Europe and beyond. With this endeavor, this new entity would be agile as a standalone company, and able to unlock its growth potential, especially in capturing new third-party sales and all the opportunities of a market growing at a pace of 6 percent per year,” stated Philippe Luscan, executive vice president, Global Industrial Affairs at Sanofi.

Sanofi expects the new standalone company would employ 3,100 individuals and be headquartered in France. Per the company press release, “A planned IPO on Euronext Paris would be evaluated with a decision expected by 2022, subject to market conditions.” The new entity would be the world's second-largest API company, according to Sanofi, with a forecasted €1 billion in expected sales by 2022, and Sanofi would establish a long-term customer relationship with the new firm and hold a minority stake of roughly 30 percent.

In other recent news for the company, Sanofi Pasteur, Sanofi's vaccines global business unit, shared word of a collaboration with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (a U.S. Health and Human Services office). The partnership will focus on exploring Sanofi's previous work to develop a SARS vaccine and evaluating its potential as a possible COVID-19 vaccine for the recent coronavirus outbreak. Sanofi has an advanced preclinical SARS vaccine candidate that will be investigated to determine if it has any utility against the COVID-19 virus. Using Sanofi's recombinant DNA platform, an exact genetic match to proteins found on the surface of a virus can be produced, and the DNA sequence for such an antigen is then combined into the DNA of the baculovirus expression platform.

“Emerging global health threats like the 2019 novel coronavirus require a rapid response,” remarked BARDA Director Dr. Rick A. Bright. “By expanding our partnership with Sanofi Pasteur and leveraging a licensed recombinant vaccine platform, we hope to speed development of a vaccine candidate to protect against a new virus.”

“Addressing a global health threat such as this newest coronavirus is going to take a collaborative effort, which is why we are working with BARDA to quickly advance a potential vaccine candidate,” added David Loew, global head of Vaccines at Sanofi. “While we are lending our expertise where possible, we believe the collaboration with BARDA may provide the most meaningful results in protecting the public from this latest outbreak.”