Sanofi and Regeneron Pharmaceuticals, a Tarrytown, New York-based biopharmaceutical company, have agreed to expand their investment for the clinical development of cemiplimab, a programmed cell death protein 1 antibody for oncology, and dupilumab, for treating Type II allergic diseases.

In July 2015, the two companies agreed to discover, develop, and commercialize new antibody cancer treatments. Under the 2018 expansion, the investment in cemiplimab will be increased to $1.64 billion, an increase of approximately $1 billion over the initial 2015 agreement. Sanofi and Regeneron will continue to equally fund cemiplimab development.

The companies will also continue their investment in other immuno-oncology programs under their existing discovery agreement. Cemiplimab is being studied as a monotherapy and in combination with other therapies in a wide range of cancers, including advanced skin cancers, non-small cell lung cancer, cervical cancer, and lymphomas, with more studies in other indications planned to begin in 2018. The companies expect to submit US and European Union (EU) regulatory applications for cemiplimab in advanced cutaneous squamous cell carcinoma in the first quarter of 2018.

The additional investment in the dupilumab development program is expected to help accelerate planned new studies in chronic obstructive pulmonary disease, peanut allergy, and grass allergy as well as in patients who have multiple allergic conditions. These areas are in addition to ongoing clinical development for dupilumab in pediatric atopic dermatitis, pediatric asthma, eosinophilic esophagitis, and nasal polyposis. Dupixent (dupilumab) is approved for treating adults with moderate-to-severe atopic dermatitis in the US and EU and a US supplemental biologics license application was submitted for uncontrolled, persistent asthma for patients aged 12 and over in the fourth quarter of 2017.

Regeneron has been granted a limited waiver of the “lock-up” in an amended and restated Investor agreement between the companies, so that Sanofi may sell a small percentage of the Regeneron common stock it owns to fund a portion of the cemiplimab and dupilumab development expansion. This waiver will allow Sanofi to sell in private transactions to Regeneron up to an aggregate of 1.4 million shares of Regeneron common stock through the end of 2020, representing approximately 6% of the 23.9 million shares of Regeneron common stock Sanofi currently owns. As of October 20, 2017, there were 107.4 million shares of Regeneron capital stock outstanding. If Regeneron decides not to purchase the shares, Sanofi will be allowed to sell those shares on the open market, subject to certain volume and timing limitations.

Source: Sanofi