Company states the realisation of generic competition is neither certain nor imminent
Orion Corporation has filed a patent infringement lawsuit in the United States to enforce U.S. Patent No. 5,446,194 and U.S. Patent No. 5,135,950 against generic drug companies Wockhardt USA, Inc. and Wockhardt Limited, who seek to market generic entacapone (200 mg tablets) in the United States. Entacapone is the active ingredient in Comtan®, a product originated by Orion Corporation and marketed in the United States for the treatment of Parkinson's disease by its exclusive licensee, Novartis. Orion Corporation and Novartis will vigorously defend the intellectual property rights covering Comtan.
As previously reported, Orion Corporation was notified in August 2007 that a generic drug company had submitted an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) that included a Paragraph IV certification challenging three of Orion Corporation's patents. By suing to enforce its patents within 45 days from receipt of the Paragraph IV certification notice, Orion Corporation is entitled to an automatic stay prohibiting the FDA from approving the applicant's ANDA for 30 months, or until an earlier court decision adverse to Orion Corporation's patents in the patent infringement lawsuit. As such, the realisation of generic competition is neither certain nor imminent.
ABOUT ORION
Orion Corporation is dedicated to treating and preventing disease by discovery and developing innovative medicinal treatments. In 2006, Orion Corporation generated sales of EUR 641.1 million, invested EUR 84.1 million in research and development and employed approximately 3,060 people. Orion corporate headquarters are in Espoo, Finland. For more information, please visit: http://www.orion.fi/english/.
Orion Corporation
Jukka Viinanen Olli Huotari
President and CEO Senior VP, Corporate Functions
Contact persons:
Jukka Viinanen, President and CEO, phone +358 10 426 3710
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.
Publisher:
Orion Corporation
Communications
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Homepage: www.orion.fi