Positive CHMP recommendations for Sanofi and Novartis, but not for Celgene

There was a batch of good news for two pharma companies and a negative opinion for one last Friday coming from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) following its monthly meeting on human use marketing authorization applications.

The CHMP issued a positive opinion recommending the approval of once-daily Lyxumia (lixisenatide), under development at French drug major Sanofi (Euronext: SAN) for the treatment of adults with type 2 diabetes mellitus to achieve glycemic control in combination with oral glucose-lowering medicinal products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycemic control. The CHMP’s positive opinion will now be forwarded to the European Commission, which has the authority to approve medicines for the European Union. Following EC marketing authorization, which is typically granted two to three months after a positive opinion, Lyxumia will significantly expand the company’s diabetes franchise, said Sanofi.

In addition to the European Union, lixisenatide has been submitted for regulatory approval in 11 countries and a New Drug Application to the US Food and Drug Administration is planned for December 2012.Eric Le Berrigaud, an analyst at Bryan Garnier & Co in Paris, quoted by Bloomberg, believes Lyxumia could garner sales of $1.4 billion by 2020.