Orion Corporation Stock Exchange Release Sep 4th 2009 at 21:50 p.m. EEST
Orion and Hospira,Inc. sue Sandoz companies in the U.S. to enforce their U.S. Patents covering the proprietary drug Precedex®
Orion states the realisation of generic competition is neither certain nor imminent
Orion Corporation and Hospira, Inc. filed together a patent infringement lawsuit in the United States to enforce Orion's U.S. Patent No.4,910,214 and Orion's and Hospira's commonly owned U.S. Patent No. 6,716,867 against Sandoz International Gmbh and Sandoz Inc.
Sandoz Inc. seeks authorisation to produce and market a generic version of Precedex® (dexmedetomidine hydrochloride 100 mcg base/ml) in the United States. Precedex®, originated by Orion Corporation and marketed in the United States by Hospira, Inc., is approved for continuous intravenous sedation of initially intubated and mechanically ventilated patients in the intensive care setting for up to 24 hours and in non-intubated patients requiring sedation prior to and/or during surgical and other procedures.
As reported in July 2009, Orion Corporation was notified that Sandoz Inc. submitted an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) that included a Paragraph IV challenge to above mentioned patents.
By suing to enforce its patents within 45 days from receipt of the Paragraph IV certification notice, Orion Corporation and Hospira, Inc. are 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 and Hospira's patents in the infringement lawsuit. As such, the realisation of generic competition is neither certain nor imminent. Orion Corporation and Hospira, Inc. will defend the intellectual property rights covering Precedex.
Orion estimates that its costs of this patent litigation will be substantially lower than those of the ongoing entacapone patent litigations in the United States. The patent infringement lawsuit warrants no revision of the full-year outlook estimate provided in the Interim Report 1-6/2009 of the Orion Group, published on
7 August 2009.
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 as well as diagnostic tests. Orion's pharmaceutical R&D focuses on developing medicines for the central nervous system diseases, critical care and oncology as well as inhaled products for the Easyhaler® platform.
The Group's net sales in 2008 amounted to EUR 711 million and the company invested EUR 90.0 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 the rest 600 in other European countries. Orion's Shares A and B are both listed on the NASDAQ OMX Helsinki.
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 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 2008.
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