Orion and Hospira,Inc. sue Sandoz companies in the U.S. to enforce
their U.S. Patents covering the p
(Thomson Reuters ONE) - Orion Corporation Stock Exchange Release Sep 4th 2009 at 21:50 p.m.EESTOrion and Hospira,Inc. sue Sandoz companies in the U.S. to enforcetheir U.S. Patents covering the proprietary drug Precedex®Orion states the realisation of generic competition is neithercertain nor imminentOrion Corporation and Hospira, Inc. filed together a patentinfringement 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 SandozInc.Sandoz Inc. seeks authorisation to produce and market a genericversion of Precedex® (dexmedetomidine hydrochloride 100 mcg base/ml)in the United States. Precedex®, originated by Orion Corporation andmarketed in the United States by Hospira, Inc., is approved forcontinuous intravenous sedation of initially intubated andmechanically ventilated patients in the intensive care setting for upto 24 hours and in non-intubated patients requiring sedation prior toand/or during surgical and other procedures.As reported in July 2009, Orion Corporation was notified that SandozInc. submitted an Abbreviated New Drug Application (ANDA) with theU.S. Food and Drug Administration (FDA) that included a Paragraph IVchallenge to above mentioned patents.By suing to enforce its patents within 45 days from receipt of theParagraph IV certification notice, Orion Corporation and Hospira,Inc. are entitled to an automatic stay prohibiting the FDA fromapproving the applicant's ANDA for 30 months, or until an earliercourt decision adverse to Orion Corporation's and Hospira's patentsin the infringement lawsuit. As such, the realisation of genericcompetition is neither certain nor imminent. Orion Corporation andHospira, Inc. will defend the intellectual property rights coveringPrecedex.Orion estimates that its costs of this patent litigation will besubstantially lower than those of the ongoing entacapone patentlitigations in the United States. The patent infringement lawsuitwarrants no revision of the full-year outlook estimate provided inthe Interim Report 1-6/2009 of the Orion Group, published on7 August 2009.About OrionOrion is an innovative European, R&D-based, pharmaceutical anddiagnostic company with a special emphasis on developing medicinaltreatments and diagnostic tests for global markets. Orion develops,manufactures and markets human and veterinary pharmaceuticals, activepharmaceutical ingredients as well as diagnostic tests. Orion'spharmaceutical R&D focuses on developing medicines for the centralnervous system diseases, critical care and oncology as well asinhaled products for the Easyhaler® platform.The Group's net sales in 2008 amounted to EUR 711 million and thecompany invested EUR 90.0 million in research and development. At theend of 2008, the Group had a total of 3,300 employees, of whom 2,700worked in Finland and the rest 600 in other European countries.Orion's Shares A and B are both listed on the NASDAQ OMX Helsinki.Orion CorporationTimo Lappalainen Olli HuotariPresident and CEO Senior VP, Corporate FunctionsContact person:Olli Huotari, Senior VP, Corporate Functions, phone +358 10 426 3054Statements in this news release other than historical information areforward-looking statements subject to risks and uncertainties. Actualresults could differ materially depending on factors such as theavailability of resources, the timing and effects of regulatoryactions, the strength of competition, the outcome of litigation andthe effectiveness of patent protection. Additional informationregarding risks and uncertainties is set forth in the Annual Reportfor 2008.Publisher:Orion CorporationCommunicationsOrionintie 1A, FI-02200 EspooHomepage: www.orion.fiThis announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.
Datum: 04.09.2009 - 20:50 Uhr
Sprache: Deutsch
News-ID 5519
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