Canadian court reversal for Astra

17th Jun 2010 07:26

The Federal Court of Canada has blocked drugs giant AstraZeneca's attempt to delay the launch of a generic version of Astra's gastrointestinal disease treatment, Nexium.The court dismissed the drug company's request to prohibit the Canadian Minister of Health from issuing a Notice of Compliance (NOC) for the regulatory applications for generic esomeprazole magnesium submitted by Canadian pharmaceuticals company Apotex. The decision has no bearing on the validity of patents in other jurisdictions but does mean the minister is free to issue an NOC to Apotex, assuming their regulatory submissions are in order, prior to the expiration of the Canadian patents for Nexium, Astra's gastrointestinal disease treatment.Astra is currently reviewing the ruling and evaluating its options, which include initiating a comprehensive patent infringement action. The company will continue to vigorously defend its intellectual property for Nexium, it said.Nexium sales in Canada totalled US$217m. Should Apotex launch a generic esomeprazole magnesium product in Canada prior to the expiration of the Nexium patent it would be on an "at risk" basis. Astra does not expect such a launch would require it to adjust its guidance for core earnings per share for 2010 which ranges from $6.05 to $6.35.