Regeneron, Sanofi Win Approval for First Immuno-Oncology Drug

(Bloomberg) -- Regeneron Pharmaceuticals Inc. and Sanofi won U.S. Food and Drug Administration approval for their first immuno-oncology drug, a therapy that the companies hope will jump-start their cancer joint venture.

Libtayo, also known as cemiplimab, treats a deadly form of skin cancer. It’s the first drug to come out of the companies’ 2015 partnership to research therapies that use the body’s immune system to fight various malignancies. Since the companies struck their deal, Merck & Co.’s blockbuster cancer treatment, Keytruda, has edged out rivals to become the dominant product among a new class of cancer drugs.

Despite the competitive landscape, the two companies are confident about their newest therapy. It’s the only approved drug that targets advanced cutaneous squamous cell carcinoma, a common form of skin cancer that’s usually easily treated but can turn deadly in some patients. Like the immuno-oncology blockbusters that had won approval in recent years, cemiplimab works by targeting PD-1, a protein present on immune cells that, when activated, helps some patients more effectively fight off cancers.

“It’s an entry into this field,” said Israel Lowy, vice president of global clinical development and head of translational science and oncology at Regeneron, whose largest shareholder is Sanofi. “It’s a good start for us, but it’s a start.”

The companies said in a statement that before discounts a three-week treatment course would cost $9,100.

The approval marks a new chapter for the Tarrytown, New York-based biotechnology company, whose drug for macular degeneration, Eylea, remains its top seller. It plans to also study cemiplimab’s effectiveness in lung, cervical, and other forms of cancer.

Earlier this year, Regeneron announced a partnership with Bluebird Bio Inc. to research another type of cutting-edge cancer therapy that extracts immune-system cells from patients, modifies them to attack malignant cells, and then reinserts them back into the body.

Libtayo is also the first cancer therapy approved in seven years for Sanofi. It’s one of nine cancer drugs the company is currently researching in a bid to build its cancer business.

To contact the reporter on this story: Rebecca Spalding in Boston at rspalding@bloomberg.net

To contact the editors responsible for this story: Drew Armstrong at darmstrong17@bloomberg.net, Mark Schoifet

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