Company states the realisation of generic competition is neither certain nor imminent
Orion Corporation filed a patent infringement lawsuit in the United States to enforce its U.S. Patent No. 5,446,194 ("the '194 patent") against Sun Pharma Global, Inc., who seeks to market a generic version of Orion Corporation's proprietary drug, Comtan® in the United States. Comtan contains entacapone and is a product originated by Orion Corporation and marketed in the United States for the treatment of Parkinson's disease by its exclusive licensee, Novartis.
As reported in October 2008, Orion Corporation was notified that Sun Pharma Global had submitted an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) that included a Paragraph IV challenge of Orion Corporation's '194 patent. By suing to enforce its patent within 45 days from receipt of the Paragraph IV certification notice, Orion Corporation is entitled to an automatic stay prohibiting the FDA from approving Sun Pharma Global's ANDA for 30 months, or until an earlier court decision adverse to Orion Corporation's patent in the patent infringement lawsuit. As such, the realisation of generic competition is neither certain nor imminent. Orion Corporation and Novartis will vigorously defend the intellectual property rights covering Comtan.
ABOUT ORION
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 and invested EUR 98.5 million in research and development. The number of employees is approximately 3,300. Orion corporate headquarters are in Espoo, Finland. For more information, please visit: http://www.orion.fi/english/.
Orion Corporation
Timo Lappalainen Olli Huotari
President and CEO Senior VP, Corporate Functions
Contact person:
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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Orion Corporation
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Homepage: www.orion.fi