Company states generic competition is not imminent
Orion Corporation has filed a patent infringement lawsuit in the United States to enforce Orion's U.S. patent No. 5,446,194 covering Comtan® against Mylan Pharmaceuticals Inc. (Mylan).
Mylan seeks authorisation to produce and market a generic version of 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 by its exclusive licensee, Novartis, as an adjunct to levodopa/carbidopa therapy to treat patients with idiopathic Parkinson's Disease who experience the signs and symptoms of end-of-dose "wearing-off." At this point, the ANDA review process is just beginning and generic competition is not imminent.
As reported in December 2010, Orion Corporation was notified that Mylan submitted an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) that included a Paragraph IV challenge to the above mentioned patent.
By suing to enforce its patent 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 patent in the infringement lawsuit. As such, the realisation of generic competition is not imminent. Orion Corporation will defend the intellectual property rights covering Comtan.
Timo Lappalainen Olli Huotari
President and CEO Senior VP, Corporate Functions
Olli Huotari, Senior VP, Corporate Functions, phone +358 10 426 3054, gsm +358 50 966 3054
Orion is an innovative European R&D-based pharmaceutical and diagnostic company with a special emphasis on developing medicinal treatments and diagnostic tests for global markets. Orion develops, manufactures and markets human and veterinary pharmaceuticals, active pharmaceutical ingredients and diagnostic tests. Orion's pharmaceutical R&D focuses on the following core therapy areas: central nervous system drugs, cancer and critical care drugs, and Easyhaler® pulmonary drugs.
The Group's net sales in 2009 amounted to EUR 772 million. The Company invested EUR 95 million in research and development. At the end of 2009, the Group had a total of 3,100 employees, of whom 2,500 worked in Finland and 600 in other European countries. Orion's A and B shares are listed on NASDAQ OMX Helsinki.
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 the Annual Report for 2009.
Orionintie 1A, FI-02200 Espoo