Orion Corporation has been informed that an Abbreviated New Drug Application (ANDA) has been filed with the U.S. Food and Drug Administration (FDA) by a generic drug company seeking authorisation to produce and market generic versions of Stalevo® tablets (25/100/200 and 37.5/150/200 mg strengths of carbidopa/levodopa/entacapone) 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.
The application contains so-called Paragraph IV certifications challenging two of six Orion U.S. patents covering Stalevo and listed in the Orange Book, the FDA's official listing of approved drug products. The patents receiving Paragraph IV certifications are the formulation patents, U.S. Patent No. 6,500,867 and U.S. Patent No. 6,797,732. According to the information received by Orion, the remaining four U.S. patents (U.S. Patent Nos. 4,963,590, 5,112,861, 5,135,950 and 5,446,194), the latest of which expires on 19 October 2013, have not received Paragraph IV certifications in the application.
Paragraph IV certifications are not uncommon in the USA.
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 2006, Orion 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/.
Jukka Viinanen Olli Huotari
President and CEO Senior VP, Corporate Functions
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.
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