Orion Corporation: Orion reacquires rights for i.v. levosimendan (Simdax®)
Orion Corporation Stock Exchange Release 6.5.2009 at 9.30 a.m.
Under an agreement signed today with Abbott, Orion Corporation reacquired rights and certain related assets to the intravenously administered formulation of levosimendan, marketed as Simdax®, Orion's proprietary drug for the treatment of acutely decompensated heart failure. After the transaction, Orion has rights for Simdax in all regions of the world except Latin America, where Abbott retains marketing rights for the product. The product fits well into the portfolio of Orion's products for critical care.
With the reacquired rights, Orion and its partners will continue selling Simdax in close to 40 countries where the product is approved for marketing. Abbott acquired the rights for Simdax in 1998 and expanded its licensing agreement in 2004, excluding the Nordic countries. The transaction is consistent with Orion's European-focused growth strategy. The global in-market sales of Simdax in 2008 came to a level of approximately EUR 40 million, and approximately 80 percent of the total was generated in regions now included in Orion's marketing area. The transaction warrants no revision of Orion's full-year 2009 outlook estimate provided on 27 April 2009 in the Interim Report 1-3/2009 of the Orion Group.
Orion will pay USD 18 million in payments upon signing the agreement. In 2009-2013, a 30 percent annual royalty will be payable by Orion to Abbott on the annual net sales of Simdax. Furthermore, a milestone payment of USD 15 million will become payable by Orion to Abbott when the cumulative net sales of the product have reached USD 12.5 million after the transaction has been closed.
Prior to this agreement, Orion had marketing rights for Simdax in Finland, Sweden, Denmark, Iceland and Norway. After the transaction, Orion's own organization will undertake marketing of Simdax Europe-wide.
About Simdax and levosimendan
Simdax (levosimendan) is a broadly studied intravenously (i.v.) administered cardiovascular and critical care product with cumulative treatment exposure on over 170,000 patients since its launch in 2000. The i.v. formulation of levosimendan, trade name Simdax, is indicated for the short-term treatment of acutely decompensated severe chronic heart failure in situations where conventional therapy is not sufficient, and in cases where inotropic support is considered appropriate.
Levosimendan, the active substance, is a calcium sensitizer that works through a dual mechanism of action. By binding to troponin C, a critical protein that affects heart muscle contraction, levosimendan increases the contractile force of the heart and avoids the buildup of excessive calcium, which can cause arrhythmia. Levosimendan also enhances vasodilation by opening potassium channels in vascular smooth muscle that eases the burden of delivering oxygen-rich blood and nutrients to the body and to the heart itself.
Levosimendan i.v. enjoys compound patent protection until 2015 in major European markets where Simdax is sold. Orion has no existing plans for further pivotal or large-scale clinical development of Simdax for severe heart failure, in view of additional marketing authorisations.
About heart failure
Heart failure is a condition in which the quantity of blood pumped by the heart is insufficient to meet the body's normal requirements for oxygen and nutrients. Acutely decompensated heart failure is the most severe form, occurring when sudden and severe damage of the heart muscle immediately decreases the pumping ability of the heart. In severe low output heart failure, patients suffer from a shortness of breath and poor blood flow to various organs, such as the brains, kidneys, intestines and liver, causing serious consequences. Some 15 million people worldwide suffer from heart failure. Half of the patients with a diagnosis of heart failure die within five years, and approximately 40 percent of patients who experience an episode of acutely decompensated heart failure die within one year.
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 2008, Orion's net sales were EUR 710.7 million. Operating profit was EUR 184 million, and the company invested EUR 90 million in research and development. The current 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/english.
Timo Lappalainen Olli Huotari
President and CEO Senior Vice President, Corporate Functions
A teleconference on this news release will be held for analysts and media today, Wednesday, 6 May 2009 starting at 11:00 EET.
The phone numbers to the conference call are:
when calling from the USA: +1 877 491 0064
when calling from other countries: +44 (0)20 7162 0025
The event can be followed live via Orion's website at www.orion.fi/english.
Contact persons after the teleconference:
Liisa Hurme, Senior Vice President, Proprietary Products, phone +358 10 426 2874, +358 50 966 2874
Jari Karlson, CFO, Orion Corporation, phone +358 10 426 2883, +358 50 966 2883
Orionintie 1A, FI-02200 Espoo, Finland