Orion comments on new challenge by Sun Pharmaceutical Industries Ltd., India, of Orion's U.S. Patent No. 5,446,194 covering its proprietary drug Stalevo® in the United States
Company states the realisation of generic competition is neither certain nor imminent
Orion Corporation has been informed that Sun Pharmaceutical Industries Ltd., India (Sun), has amended its Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) 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. Sun's amendment to its ANDA involves a Paragraph IV challenge to Orion's U.S. Patent No. 5,446,194. The ANDA review process has recently just begun and the realisation of generic competition is neither certain nor imminent. 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.
Sun previously filed Paragraph IV certifications against Orion's U.S. Patents 6,500,867 and 6,797,732, and Orion subsequently sued Sun (November 2007) in the United States for patent infringement. Of the six Orion patents listed in the FDA's Orange Book, three have not received Paragraph IV certifications from Sun (U.S. Patent Nos. 4,963,590, 5,112,861, and 5,135,950), and the latest of these expires 31 October 2010.
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/.
Timo Lappalainen Olli Huotari
President and CEO Senior VP, Corporate Functions
Timo Lappalainen, President and CEO, phone +358 10 426 2138
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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