Orion Corporation ("Orion") and Sun Pharmaceutical Industries Limited and certain other companies belonging to Sun group of companies (together "Sun") have executed a settlement agreement on lawsuits filed by Orion in the United States against Sun regarding Sun's submissions of abbreviated new drug applications ("ANDAs") for generic versions of Orion's Comtan® and Stalevo® products. Comtan (entacapone) is indicated as an adjunct to levodopa/carbidopa to treat patients with idiopathic Parkinson's disease who experience the signs and symptoms of end-of-dose "wearing-off". Stalevo is a combination of carbidopa, levodopa and entacapone for the treatment of Parkinson's disease. Both products contain entacapone, a COMT enzyme inhibiting agent originated and patented by Orion.
Litigations against Sun have been ongoing by Orion in the U.S. since 2007. The settlement agreement relates to all lawsuits. Under the terms of the settlement agreement, Sun will be able to launch generic versions of 25/100/200 mg and 37,5/150/200 mg strengths of Stalevo tablets in the US on 1 April 2012. In addition to these strengths, Sun will be able to launch generic versions of other strengths of Stalevo product on 2 October 2012 and generic versions of Comtan product on 1 April 2013, unless certain conditions relating to launch are fulfilled even earlier. The parties have agreed that Orion will supply said generic product versions to Sun. The other terms of the settlement are confidential.
As a consequence of this settlement, Wockhardt, with which Orion executed a patent dispute settlement on 29 April 2009, can launch other generic versions of Stalevo except the strengths of 25/100/200 mg and 37,5/150/200mg in the US already on 1 April 2012, and the strengths of 25/100/200 mg and 37,5/150/200 mg approximately six months after Sun is allowed to market pursuant to license from Orion, unless certain conditions relating to launch are fulfilled even earlier.
The settlement with Sun warrants no revision of the full-year 2010 outlook estimate for the Orion Group provided in the stock exchange release published on 14 June 2010.
Subject to the Court's approval, the cases will be dismissed and the challenged U.S. Patents No. 5,446,194 and No. 6,500,867 remain in force.
In compliance with the applicable U.S. laws, Orion will file all of the agreements related to the settlement with the United States Federal Trade Commission and the United States Department of Justice.
Timo Lappalainen Olli Huotari
President and CEO SVP, Corporate Functions
Timo Lappalainen, President and CEO, phone +358 10 426 3692
Orion is a European pharmaceuticals and diagnostics company dedicated to treating and preventing disease by discovering and developing innovative medicinal treatments and diagnostic tests for global markets. Orion is engaged in human and veterinary drugs, active pharmaceutical ingredients and diagnostic tests. In 2009, Orion's net sales were EUR 771.5 million. Operating profit was EUR 207.0 million, and the company invested EUR 95 million in pharmaceutical research and development. The number of employees is about 3,100. Orion corporate headquarters are in Espoo, Finland. Orion is listed on NASDAQ OMX Helsinki. For more information, please visit: http://www.orion.fi/en/.
Orionintie 1A, FI-02200 Espoo