Abbott Laboratories and Orion Corporation have expanded their licensing agreement for the injectable formulation of levosimendan (marketed as Simdax in most countries), Orion's proprietary drug for the treatment of acutely decompensated heart failure.
Abbott previously had marketing rights in many countries including the United States. Under the expanded terms, Abbott gains commercial rights for levosimendan in Germany, France, the United Kingdom, and other European countries which were previously included in Orion's marketing territory. Additionally, Abbott will assume responsibility for current research and development programs for the drug. Orion will continue to market levosimendan in Denmark, Finland, Norway and Sweden.
Levosimendan, a first-in-class calcium sensitizer, improves cardiac function and symptoms. Levosimendan is currently available in an intravenous formulation and is approved in approximately 30 countries. Levosimendan is currently in Phase III clinical studies in the United States and Europe and has been granted fast-track status by the FDA. Upon completion of clinical trials already in progress, Abbott will seek approval to market levosimendan in countries where it is not yet available.
"We are pleased that Abbott recognizes the clinical value of levosimendan and will put the necessary resources behind it to get this unique, effective treatment to patients who need it around the world," said Jukka Viinanen, president and chief executive officer of Orion. "This agreement also enables Orion to focus our resources on diversifying our research pipeline."
"We believe that levosimendan represents a significant advance in the treatment of congestive heart failure, and for patients in many parts of the world, it has already proven beneficial," said Jeffrey M. Leiden, M.D., Ph.D., president and chief operating officer, pharmaceutical products group, Abbott Laboratories. "Additionally, the expanded rights to levosimendan, a Phase III compound, gives us another near-term pipeline opportunity."
Under the terms of the new agreement, Orion retains the existing patent rights to levosimendan. Orion will manufacture the active substance and provide finished product according to Abbott's requirements. Orion also retains all rights to veterinary applications and non-injectable formulations, including orally administered levosimendan.