ORION CORPORATION STOCK EXCHANGE RELEASE 4 DECEMBER 2009 at 17.00 p.m.
Orion Corporation is clarifying information emanating from the Capital Markets Day on 1 December 2009 concerning the number of companies that have submitted Abbreviated New Drug Applications ("ANDAs") in the United States for generic versions of Orion's entacapone products. As previously announced, companies of two Groups have submitted ANDAs that challenge the US entacapone basic patent no 5,446,194, which expires on 19 October 2013. Lawsuits have been initiated against these companies, one of which has been settled, as announced by Orion on 29 April 2009. In addition, Orion is aware that a third applicant has submitted an ANDA that challenges only a patent that will expire after the expiry of the entacapone basic patent, and this application has not given Orion cause to file a lawsuit or take further action.
Orion is issuing this release because the number of companies that have submitted ANDAs could have been misunderstood from the discussions at the Capital Markets Day, and this misunderstanding has appeared in some analysts' reports following the Capital Markets Day.
Orion stresses that it does not regard as material to the Company's communication any application by an applicant for an ANDA to launch its generic products in the markets only after the expiry of the entacapone basic patent. More over, Orion does not regard information about the number of companies that have submitted ANDAs as in itself material to the Company. Orion will continue to announce in stock exchange releases all ANDAs known to the Company for generic versions of entacapone products submitted in the United States that it considers might have a material effect on the Company's share value. The Company does not generally publish information about other applications.
Timo Lappalainen Olli Huotari
President and CEO SVP, Corporate Functions
Olli Huotari, Senior Vice President, Corporate Functions, tel. +358 10 426 3054, mobile tel. +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 2008 amounted to EUR 711 million. The Company invested EUR 90 million in research and development. At the end of 2008, the Group had a total of 3,300 employees, of whom 2,700 worked in Finland and 600 in other European countries. Orion's A and B shares are listed on NASDAQ OMX Helsinki.