Week of November 19, 2012: German Court Finds AstraZeneca's Seroquel XR Formulation Patent Invalid; FDA Advisory Committee to Recommend Approval of GSK's H5N1 Influenza Vaccine Candidate; and More

Nov 21, 2012
By Pharmaceutical Technology Editors

The Federal Patent Court in Germany has found the formulation patent protecting AstraZeneca’s Seroquel XR (quetiapine fumarate) prolonged-release tablets–marketed as Seroquel Prolong in Germany–to be invalid. The patent was challenged by Accord Healthcare, Hexal, and Teva Deutschland. The Federal Patent Court decision is limited to Germany and is not binding in other countries. AstraZeneca is engaged in numerous other proceedings regarding Seroquel XR-related patents and regulatory exclusivity for Seroquel XR. Further updates will be provided on a quarterly basis as part of the company’s earnings report. Total sales of Seroquel XR in Germany for the ten months, ending on Oct., 31 2012, were $82 million. Read More

GlaxoSmithKline (GSK) announced FDA’s Vaccines and Related Biological Products Advisory Committee voted unanimously 14–0 that the safety and immunogenicity data of the H5N1 adjuvanted influenza vaccine candidate supports its licensure for the active immunization for the prevention of disease in persons 18 years of age and older who are at increased risk of exposure to the influenza A virus H5N1 subtype contained in the vaccine. Read More

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