Pfizer has responded swiftly to a decision by a Canadian federal court to deny its request to prevent the launch of a generic form of its cholesterol-lowerer Lipitor and announced plans to appeal.
The court has ruled in favour of Canadian generic drugmaker Apotex and turned down Pfizer’s bid to stop the Toronto-headquartered firm from launching its own version of Lipitor (atorvastatin) prior to the expiry of the drug giant’s enantiomer, or calcium salt, patent in July 2010. An appeal will now be made and Pfizer added that the decision would have no immediate commercial impact because Lipitor is protected by other patents in Canada, which are also subject to pending legal challenges.
The ruling by the federal court has no impact on Lipitor patent litigation in other countries, Pfizer concluded. The company has been battling, mostly successfully, all over the world to defend its patents on Lipitor, sales of which declined 5% to $3.17 billion for the third quarter, as doctors switched patients to generic versions of Merck & Co’s similar drug Zocor (simvastatin).
Pfizer, NiCox glaucoma drug starts Phase II Japan study
Meantime, Pfizer’s French partner NiCox said that the New York-based group has begun a dose-ranging Phase II clinical study in Japan for the glaucoma treatment PF-03187207, the first drug to come out of a collaboration agreement originally signed by the firms in August 2004.
The trial, which follows a Phase II proof-of-concept study started in the USA last March, will involve approximately 120 Japanese patients in a 28-day trial that will compare PF-03187207 to Pfizer’s market leader Xalatan (latanoprost). Maarten Beekman, vice president of clinical development at NicOx, said the initiation of this separate Japanese study for PF-03187207 “highlights Pfizer’s determination to rapidly advance this clinical programme towards coordinated regulatory filing in the world’s major pharmaceutical markets”.
