Orion Corporation ("Orion") and Mylan Pharmaceuticals Inc. ("Mylan") have executed a settlement agreement on lawsuit filed by Orion in the United States against Mylan regarding Mylan's submission of abbreviated new drug application ("ANDA") for generic version of Orion's Comtan® product (strength 200 mg). Comtan is used as an adjunct to levodopa/carbidopa therapy to treat patients with idiopathic Parkinson's Disease who experience the signs and symptoms of end-of-dose "wearing-off". Comtan contains entacapone, a COMT enzyme inhibiting agent originated and patented by Orion.
The lawsuit was filed by Orion in the U.S. in 2011. Under the terms of the settlement agreement, Mylan may launch generic version of Comtan 200 mg on 1 April 2013 at the earliest.
Subject to the Court's approval, the case will be dismissed and the U.S. Patent No. 5,446,194 remains in force.
In compliance with the applicable U.S. laws, Orion will file the above agreement with the United States Federal Trade Commission and the United States Department of Justice.
| Timo Lappalainen|
President and CEO
| Olli Huotari|
SVP, Corporate Functions
Olli Huotari, SVP, Corporate Functions
tel. +358 10 426 3054
Orionintie 1A, FI-02200 Espoo, Finland
Orion is a globally operating Finnish company developing pharmaceuticals and diagnostic tests - a builder of well-being. Orion develops, manufactures and markets human and veterinary pharmaceuticals, active pharmaceutical ingredients and diagnostic tests. The company is continuously developing new drugs and treatment methods. Pharmaceutical R&D focuses on central nervous system drugs, oncology and critical care drugs, and Easyhaler® pulmonary drugs.
Orion's net sales in 2011 amounted to EUR 918 million and the company had about 3,400 employees. Orion's A and B shares are listed on NASDAQ OMX Helsinki.