Sanofi (SAN) won the backing of a European Union advisory panel for its diabetes treatment Lyxumia, allowing the French drugmaker to expand its product offering for the disease.
The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended that Lyxumia, also known as lixisenatide, be granted marketing approval, the London-based agency said in a statement today. The European Commission usually follows the panel’s recommendations.
Sanofi, whose Lantus treatment is the world’s best-selling insulin, needs Lyxumia to counter increasing competition from drugmakers such as Novo Nordisk A/S. (NOVOB) Paris-based Sanofi wants to build upon the success of Lantus, which garnered 3.92 billion euros ($5 billion) in sales last year and will lose patent protection in 2015.
The recommendation “is positive because it comforts Sanofi’s strategy to build a product offer around Lantus,” Pierre Corby, an analyst at Aurel BGC in Paris, said in a telephone interview.
Sanofi rose 0.6 percent to 67.45 euros at 1:20 p.m. in Paris.
Lyxumia 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. Lyxumia will compete with Victoza, produced by Bagsvaerd, Denmark-based Novo, as well as with Bristol-Myers Squibb Co. (BMY:US)’s Byetta and Bydureon.
Chief Executive Officer Chris Viehbacher created a diabetes division in 2009, and two years later introduced blood-metering devices to Sanofi’s product offering, pushing for an approach to patients dubbed “360 degrees.” Sanofi is also testing a combination of Lyxumia with Lantus.
Late-stage tests of the medicine in combination with Lantus using a new pen-like device called “fix-flex” will start by the middle of 2013, David Solomon, chief executive officer of Zealand Pharma A/S (ZEAL), the Danish company from which Sanofi licensed Lyxumia, said in an interview last month. U.S. regulatory filing for the product is scheduled for December, Solomon said.
Sanofi will “aggressively” pursue a strategy of becoming “a major, if not the major, player in diabetes,” Elias Zerhouni, the French drugmaker’s global head of research and development, said during a Sept. 12 presentation.
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