BioMerieux-Pierre Fabre licenses pitavastatin

France's BioMerieux-Pierre Fabre has licensed certain marketing rightsto Sankyo of Japan's new-generation statin drug, pitavastatin. The French company has acquired rights to the drug formerly held by Sankyo's partner Kowa, in France, Spain, Portugal, Greece, Tunisia and other French-speaking African countries. An application to market the drug in Europe is expected towards the end of 2003, said BioMerieux-Pierre Fabre.

Novartis holds Sankyo's share of the European marketing rights, and may pursue a US (co-marketing) license as well if its clinical profile is favorable. It is currently in Phase III trials, and at present appears to have a profile similar to Pfizer's market-leading Lipitor (atorvastatin). Much will depend on the findings of ongoing higher-dose studies (8mg-16mg), as equivalence to Lipitor may not be enough to win it a significant market share in this highly-competitive sector.

Also crucial will be its profile with regard to myopathy, the side effect that led to the withdrawal from the market of Bayer's cerivastatin (Marketletters passim), particularly at higher doses. Analysts at Banc of America Securities noted recently that, given the safety concerns with statins, commercial success for new entrants will probably require class-leading efficacy.