Sanofi (SAN) won European Union backing for new drugs against diabetes and colorectal cancer, helping the Paris-based drugmaker compete with products from Novo Nordisk A/S (NOVOB) and Roche Holding AG. (ROG)
The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended approval for Lyxumia as a treatment for diabetes, and Zaltrap for use with chemotherapy in adults with colorectal cancer that’s spread after initial treatment, it said in a statement today. The European Commission usually follows the committee’s recommendations.
Approval of Lyxumia would give Sanofi, maker of the world’s best-selling insulin Lantus, a product to compete with Novo’s Victoza and Bristol-Myers Squibb Co. (BMY)’s Byetta and Bydureon. European approval would also bode well for marketing authorization in the U.S., where Sanofi plans to apply for approval next month, said Eric Le Berrigaud, an analyst at Bryan Garnier & Co. in Paris. He rates the stock a buy.
“This is the first significant approval in a significant market, so that shows that there is nothing wrong or anything to be concerned about in the regulatory package,” Le Berrigaud said in a telephone interview today. “Where things really matter for Sanofi in diabetes is in the U.S.”
Lyxumia, also known as lixisenatide, belongs to a class of drugs known as GLP-1 analogues, which mimic the function of a digestive hormone that stimulates the pancreas to produce insulin after meals. Diabetics lack the insulin needed to convert blood sugar into energy.
’Validates Our Belief’
Patients are increasingly using a long-acting insulin in combination with a GLP-1, and having both products will prevent Sanofi’s customers having to use a competitor’s drug, Le Berrigaud said. Lyxumia may get sales of $1.4 billion by 2020, he said.
The committee’s recommendation “validates our belief” that Lyxumia can be used in combination with other drugs as a once-daily treatment, Pierre Chancel, the head of Sanofi’s diabetes business, said in an e-mailed statement today. The company defended the product at a diabetes conference last month after some scientists questioned its novelty. Bristol-Myers’s Byetta is given twice-daily.
The approval of Zaltrap is less significant because the drug will be used as a second or third-line treatment and profits are split with Regeneron Pharmaceuticals Inc. (REGN) The product may reach 250 million euros by 2019, Le Berrigaud said.
U.S. regulators approved Zaltrap in August. Sanofi effectively cut the price of the $11,000-a-month drug in half after Memorial Sloan-Kettering Cancer Center in New York decided not to use the medicine because it was more costly than Roche’s Avastin and no more effective, the New York Times reported Nov. 9.
“It is gratifying to see the years of effort that went into designing and developing the angiogenesis inhibitor Zaltrap translate into a clinical benefit for patients,” George Yancopoulos, chief scientific officer at Tarrytown, New York- based Regeneron, said in an e-mailed statement.
Sanofi fell 0.9 percent to 66.46 euros in Paris. Zealand Pharma A/S (ZEAL), the Glostrup, Denmark-based drugmaker that licensed Lyxumia to Sanofi, dropped 1.4 percent to 103 Danish kroner in Copenhagen. Regeneron climbed 11 percent to $157.69 at the close in New York, its biggest single-day gain in nine months.
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