Orion comments on new ANDA by Sun Pharma Global, Inc. for generic entacapone (Orion's proprietary drug Comtan®) in the United States
Company states the realisation of generic competition is still neither certain nor imminent
Orion Corporation has been informed that Sun Pharma Global, Inc. has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking authorisation to produce and market a generic version of entacapone (200 mg tablets) in the United States. Entacapone is the active ingredient in Comtan®, a product originated by Orion Corporation for Parkinson's disease and marketed in the United States by its exclusive licensee, Novartis. Orion previously sued Sun Pharmaceutical Industries Ltd. for patent infringement when it challenged certain Orion U.S. patents as part of an earlier filed ANDA on a generic version of Orion's proprietary drug, Stalevo®. That action is pending in the District Court for the District of New Jersey.
The new ANDA by Sun Pharma Global is expected to neither alter the order of priority among existing generic applicants nor significantly change the overall status regarding the current U.S. patent litigations where Orion is a party. Wockhardt Limited (Wockhardt), another generic manufacturer, filed an ANDA on a generic version of Comtan in 2007, and would appear to have first-filer status for that product. Orion sued Wockhardt for patent infringement last year in the District Court for the District of Delaware. That litigation remains pending, with a trial not scheduled until November 2009. Sun Pharma Global's new ANDA challenges two of Orion's U.S. patents listed in the FDA's Orange Book, U.S. Patent Nos. 5,446,194 (already part of the New Jersey lawsuit) and 6,599,530. Regarding the two remaining U.S. patents covering Comtan, Sun Pharma Global did not challenge the U.S. patents No. 5,112,861 and No. 5,135,950, the latter of which expires 31 October 2010. As such, generic competition is still neither certain nor imminent.
Orion is, together with Novartis, currently evaluating its legal options to protect its rights. Under the U.S. system, if a patent owner brings a lawsuit against an ANDA applicant within a certain time limit, there will be a 30-month stay of final FDA approval. During that time, the FDA can give only a tentative approval to the ANDA applicant unless the applicant obtains a favorable decision on all challenged patents in the lawsuit.
Orion is dedicated to treating and preventing disease by discovery and developing innovative medicinal treatments. In 2007, Orion generated net sales of EUR 683.6 million, invested EUR 98.5 million in research and development and employed approximately 3,180 people. Orion corporate headquarters are in Espoo, Finland. For more information, please visit: http://www.orion.fi/english/.
Timo Lappalainen Olli Huotari
President and CEO Senior VP, Corporate Functions
Olli Huotari, Senior VP, Corporate Functions, phone +358 10 426 3054
Statements in this news release other than historical information are forward-looking statement subject to risks and uncertainties. Actual results could differ materially depending on factors such as the availability of resources, the timing and effects of regulatory actions, the strength of competition, the outcome of litigation and the effectiveness of patent protection. Additional information regarding risks and uncertainties is set forth in Annual Report for 2006.
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