EU Gives Green Light to Two New Sanofi Drugs

Sanofi won the backing of European regulators for two new drugs against diabetes and cancer on Friday, a shot in the arm for the French company's drive to bring new products to market.

New diabetes drug Lyxumia was recommended for treating type 2 diabetes and Zaltrap was endorsed for the treatment of advanced colorectal cancer, the European Medicines Agency (EMA) said.

Recommendations from the EMA are normally endorsed by the European Commission within two or three months and Sanofi said it expected to hear from the Commission in the first quarter of 2013.

Lyxumia, which Sanofi licensed from Denmark's Zealand Pharma, is part of a new class of diabetes treatments called GLP-1 analogues which prompt the body to release insulin when a diabetic's blood sugar level climbs too high.

It is one of several new medicines Sanofi is banking on to drive growth after patent losses on former top-selling drugs.

Pierre Chancel, Sanofi's global head of diabetes, said the positive opinion for Lyxumia was "an important milestone" and would help expand the company's already strong diabetes franchise, which is dominated by the long-acting insulin Lantus.

Sanofi plans to submit Lyxumia for approval with the U.S. Food and Drug Administration by the end of the year.

Rival GLP-1 treatments include Novo Nordisk's Victoza, and Byetta and Bydureon, from Amylin, the U.S. drugmaker acquired earlier this year by Bristol-Myers Squibb and AstraZeneca.

Zaltrap, developed with Regeneron Pharmaceuticals, is a so-called anti-angiogenic agent, designed to starve tumors of blood. It was approved in the United States in August.

Although the drug failed to live up to its promise as a treatment for prostate cancer in late-stage tests, it has shown significant improvement in overall survival in patients with colon cancer.

Shares in Sanofi were 0.6 percent by 1340 GMT. The stock is up close to a fifth this year, making it France's largest company by market capitalization, reflecting growing confidence that new drugs will help it offset patent losses on older ones.