Orion Corporation ("Orion") and Mylan Pharmaceuticals Inc. ("Mylan") have executed a settlement and license agreement to settle the lawsuit filed by Orion in the United States against Mylan regarding Mylan's submission of an abbreviated new drug application ("ANDA") for generic versions of Orion's Stalevo® (carbidopa/levodopa/entacapone) product.
The lawsuit was filed by Orion in the U.S. in April 2012. Under the terms of the settlement and license agreement, Mylan shall be authorized to launch generic versions of the Stalevo product (strengths 12.5/50/200 mg; 18.75/75/200 mg; 25/100/200 mg; 31.25/125/200 mg; 37.5/150/200 mg and 50/200/200 mg) immediately after entry of the agreement.
Subject to the Court's approval, the lawsuit against Mylan will be dismissed and the U.S. Patents Nos. 5,446,194, 6,500,867 and 6,797,732 shall remain 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 2012 amounted to EUR 980 million and the company had about 3,500 employees. Orion's A and B shares are listed on NASDAQ OMX Helsinki.