Orion comments on ANDA filed by Sandoz Inc. for a generic version of Orion's proprietary drug Precedex® (dexmedetomidine hydrochloride 100 mcg base/ml ) in the United States
Orion Corporation Stock Exchange Release Jul 31st 2009 at 2.30 p.m.
Company states the realisation of generic competition is neither certain nor imminent
Orion Corporation has been informed that an Abbreviated New Drug Application (ANDA) has been filed by Sandoz Inc. with the U.S. Food and Drug Administration (FDA) seeking authorisation to produce and market generic versions 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 IV 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.
At this point, the ANDA review process is just beginning and the realisation of generic competition is neither certain nor imminent.
Sandoz's ANDA for dexmedetomidine contains so-called Paragraph IV certifications challenging Orion's U.S. Patent No.4,910,214 and Orion's and Hospira's commonly owned patent U.S. Patent No. 6,716,867. Both patents cover Precedex and are listed in the Orange Book, the FDA's official listing of approved drug products.
Paragraph IV certifications are not uncommon in the U.S. Orion is 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 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 Annual Report for 2008.
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