Sanofi SA (ADR) (NYSE:SNY) and Regeneron Pharmaceuticals Inc (NASDAQ:REGN) announced on Friday that their Cemiplimab skin cancer treatment was awarded Breakthrough Therapy designation by the Food and Drug Administration.
The two firms were pleased to make the announcement which marks a significant milestone for the Cemiplimab treatment. The latter is a checkpoint inhibitor targeting PD-1 (programmed death 1). Sanofi and Regeneron are pursuing an approval for the treatment so that it can be used to combat advanced metastatic cutaneous squamous cell carcinoma (CSCC) type of skin cancer in adults.
A Breakthrough Therapy designation serves to accelerate the development and review of drugs that target serious or life-threatening conditions,” pointed out Sanofi and Regeneron in a joint statement.
The Breakthrough Therapy destination was courtesy of previous review applications that the company made to the FDA. They also plan to submit a biologics license application (BLA) for the pipeline skin cancer treatment within the first quarter of 2018. The FDA’s ruling on the treatment is not only good news for the company but also for patients suffering from CSCC. The latter is said to be the most common type of skin cancer in the U.S. and thus a viable treatment might offer much-needed relief.
Despite the good news, Regeneron has been experiencing a decline in the value of its stock. This is because rival pharmaceutical company AbbVie Inc (NYSE:ABBV) also announced recently that its skin cancer treatment candidate called upadacitinib met its primary endpoints in its phase IIb clinical trials. This means Cemiplimab will have strong competition in the segment if upadacitinib makes a successful entry into the market.
The recent breakthrough destination issued by the FDA for Cemiplimab raises expectations for the financial outlook of both companies as well as an accelerated timeline. Sanofi and Regeneron entered the joint venture for the development of the skin cancer treatment in 2015. Regeneron also has also struck collaboration deals with other major companies such as Inovio Pharmaceuticals Inc (NASDAQ:INO).
Sanofi stock closed the latest trading session on Friday at $49.37 after a 0.14 percent gain compared to the value of the stock during the previous close.