Sanofi and Regeneron Pharmaceuticals said they will accelerate and expand investment for the clinical development of the PD-1 (programmed cell death protein 1) antibody cemiplimab in oncology and dupilumab in Type 2 allergic diseases. According to the companies, both of these breakthrough therapies have the potential to benefit a number of different patient populations and this strategic investment will enable the companies to evaluate cemiplimab and dupilumab in broad clinical development programs.
As revealed in the press release by the companies on Monday, the investment in cemiplimab will be increased to $1.64 billion, an increase of approximately $1 billion over the initial 2015 agreement and Sanofi and Regeneron will continue to equally fund cemiplimab development. The companies said that they will also continue their investment in other immuno-oncology programs under their existing Immuno-oncology Discovery Agreement.
Investigational cemiplimab is being studied as 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 said they expect to apply for the U.S. and EU regulations for cemiplimab in advanced cutaneous squamous cell carcinoma in the first quarter of 2018.
Additional investments for dermatitis, asthma and copd
The companies also said that the additional investment will enhance the development of REGN3500, an IL-33 antibody, with studies expected in atopic dermatitis, asthma and chronic obstructive pulmonary disease. The increased funding for dupilumab and REGN3500 will be pursuant to the existing Antibody License and Collaboration Agreement between the companies.
Elias Zerhouni, Global Head of R&D at Sanofi said that the expansion of the collaboration between the two companies and the clinical programs for both cempilimab and dupilumab should enable to quickly identify treatment opportunities in other disease areas.
According to the Monday press release, Regeneron has agreed to grant a limited waiver of the “lock-up” in the 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.
It is understood that 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, which is about 6 percent of the 23.9 million shares of Regeneron common stock Sanofi currently owns.
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.
Image: A logo is seen in front of the entrance at the headquarters French drugmaker Sanofi in Paris October 30, 2014. REUTERS/Christian Hartmann/File Photo