Thursday, June 17, 2010

AstraZeneca Considers Options After Canadian Court Ruling On Generic Nexium - Update

AstraZeneca PLC (AZN, AZN.L) Thursday said the Federal Court of Canada dismissed its request to stop the Canadian Minister of Health from approving the regulatory applications for a generic copy of its ulcer drug, Nexium, submitted by Apotex Inc. The British-Swedish pharmaceutical giant said it would review and evaluate its options including a lawsuit to defend its intellectual property for the drug. Looking ahead, the company reiterated its earnings estimate for 2010 even if the generic version is launched shortly.
The ruling enables the Canadian health ministry to approve Apotex’ generic esomeprazole magnesium. Consequent to the court decision, Apotex must obtain a Notice of Compliance or NOC from the Minister of Health before being able to launch a generic esomeprazole magnesium product in Canada.
AstraZeneca said that any generic launch prior to patent expiration would be ‘at-risk’ and subject to a patent infringement action. The company has many patents protecting Nexium in Canada expiring between 2013 and 2019. Sales of Nexium in Canada during 2009 aggregated US$217 million.
In Canadian proceeding seeking prohibition of an NOC, the presiding court does not rule on the validity of patents, and the decision has no bearing on cases in other jurisdictions. The proceedings, under the Patented Medicines Notice of Compliance Regulations, are summary in nature and involve no discovery process or witness testimony in court.
The company said that it does not expect to alter its 2010 core earnings guidance range of $6.05-$6.35 per share in the event of a near term ‘at risk’ launch of generic esomeprazole magnesium.
On average, five analysts polled by Thomson Reuters currently expect earnings of $6.28 per share for fiscal year 2010. Analysts’ estimates typically exclude special items.
AZN is currently trading at $45.68, down $0.10 or 0.22%, on a volume of 670 thousand shares on the NYSE.
AZN.L is currently trading at GBX 3,082.00, down GBX 1.00 or 0.03%, on a volume of 2.81 million shares on the LSE.

Posted by suprastock at 6/17/2010 08:49:00 PM

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