Orion: Mylan Seeks Generic Version Of Parkinson's Drug In US

DOW JONES NEWSWIRES

Finnish pharmaceutical company Orion Corp. (ORNBV.HE) said Monday it has been informed that an Abbreviated New Drug Application (ANDA) has been filed by Mylan Pharmaceuticals Inc. (MYL) with the U.S. Food and Drug Administration (FDA) seeking authorisation to produce and market a generic version of Orion's proprietary drug Stalevo in the United States.

MAIN FACTS:

-The product is an enhanced levodopa treatment originated by Orion Corporation and marketed in the United States by its exclusive licensee, Novartis AG (NVS), for the treatment of Parkinson's disease.

-At this point, the ANDA review process of Mylan is just beginning in the United States and generic competition is not imminent based on this application.

-Orion is currently evaluating together with Novartis 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.

-Shares closed Friday at EUR14.77.

-By Dominic Chopping; Dow Jones Newswires; +46-8-5451-3093; dominic.chopping@ dowjones.com

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Orion: Mylan Seeks Generic Version Of Parkinson's Drug In US