Sanofi ($SNY) made progress today on the product-replacement front. The French drug giant snagged endorsements from European Union regulators that pave the way to potential approvals of new drugs for diabetes and cancer, coming at a time when the company needs new products as older meds lose patent protection.
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) is advising the European Commission to stamp approvals on Sanofi's new GLP-1 drug Lyxumia for patients with Type 2 diabetes and Zaltrap or aflibercept for certain cases of colon cancer. Sanofi expects the EC to decide whether to green-light Zaltrap, which is from the Paris-based drugmaker's productive Regeneron ($REGN) partnership, in the first quarter of 2013. The FDA allowed tumor-starving therapy onto the U.S. market in August.
Licensed from Zealand Pharma, Sanofi's Lyxumia gives the drug giant its first product in the growing GLP-1 class of diabetes drugs that target biology that enables the body to generate insulin and keep blood sugar under control. And Sanofi has highlighted that the drug could offer safety advantages such as lower risk of hypoglycemia than existing GLP-1 contenders. The dominant players in the class include Novo Nordisk's ($NVO) Victoza and Bristol-Myers Squibb's ($BMY) exenatide.
Sanofi's diabetes business has been a bright spot in its pharmaceutical business that lost patent exclusivity to the blood-thinner Plavix. Last year the company's long-acting insulin brought in more than $5 billion in sales, anchoring a franchise that is now expanding as the diabetes epidemic grows fast across the world and new therapies become important to help patients avoid complications.
Still, Sanofi faces fierce competition in the diabetes arena. Novo could snag an approval to a longer-lasting rival to Lantus from U.S. regulators next year. And analysts have questioned how well Sanofi's Lyxumia stands out from other GLP-1 agents. The company plans to file for U.S. approval of the drug next month.
- here's Sanofi's Lyxumia release
- and the Zaltrap announcement
- see Reuters' article
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