Orion sues Wockhardt USA LLC and Wockhardt Limited in the U.S. to enforce Orion's U.S. Patents covering its proprietary drug Stalevo®
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 U.S. Patent Nos. 5,135,950; 5,446,194; and 6,500,867 against Wockhardt USA LLC and Wockhardt Limited, who seek to market generic versions of Orion Corporation's proprietary drug, Stalevo® (specifically 25/200/100 mg, 37.5/200/150 mg, and 50/200/200 mg strengths of carbidopa/entacapone/levodopa) in the United States. Stalevo is an enhanced levodopa treatment originated by Orion Corporation and marketed in the United States by its exclusive licensee, Novartis, for the treatment of Parkinson's disease.
As reported in December 2008, Orion Corporation was notified that Wockhardt Limited submitted an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) that included a Paragraph IV challenge to several 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 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 Stalevo.
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. In the end of 2008, the number of employees in the Orion Group was approximately 3,300, of which 2,700 persons were working in Finland. Orion corporate headquarters are in Espoo, Finland. For more information, please visit http://www.orion.fi/english/. The financial statements of the Orion Group for 2008 will be published on 6 February 2009.
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 statements 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 2007.
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