Orion comments on ANDA filed by Wockhardt Limited for a generic version of Orion's proprietary drug Stalevo® in the United States
Company states the realisation of generic competition is still neither certain nor imminent
Orion Corporation has been informed that an Abbreviated New Drug Application (ANDA) has been filed by Wockhardt Limited (Wockhardt) with the U.S. Food and Drug Administration (FDA) seeking authorisation to produce and market a generic version of Stalevo® (specifically 12.5/200/50 mg strength 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. At this point, the ANDA review process is just beginning and the realisation of generic competition is neither certain nor imminent.
Orion previously sued Wockhardt 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, Comtan® (entacapone). That action is pending in the District Court for the District of Delaware. Wockhardt's ANDA for Stalevo contains so-called Paragraph IV certifications challenging Orion U.S. patents Nos. 5,135,950; 5,446,194; 6,500,867; and 6,797,732 covering Stalevo and listed in the Orange Book, the FDA's official listing of approved drug products.
Paragraph IV certifications are not uncommon in the U.S. 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 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/.
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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