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 supply Abbott's requirements of the finished product. Orion also retains all rights to veterinary applications and non-injectable formulations, including orally administered levosimendan, as well as the rights to market injectable Simdax in Finland, Sweden, Norway and Denmark, and co-promotion rights in Hungary, Russia and Ukraine.
Abbott gains worldwide rights to further develop and commercialize the product and will assume clinical and financial responsibility for in-process research and development programs. Abbott will make an upfront payment to Orion of EUR 10 million. Additionally, Orion will receive considerable milestone payments upon meeting specified development and commercial milestones and will receive a percentage of Abbott's net sales of levosimendan. Additional financial terms were not disclosed.
New opportunities for Orion
to intensify early phase research and development
to intensify early phase research and development
Simdax has been a major research project for Orion. The solution with Abbott means an opportunity for Orion to diversify its R&D portfolio emphasising the focus of research activity on the discovery of new chemical entities and the earlier clinical phases. Orion Pharma continues to invest in the three core therapeutic areas both in discovery and development: central nervous system diseases, cardiology and critical care, and hormonal therapies and urology, which are the company's traditionally very strong competence areas having led to several successful commercialisations of proprietary products.
Jukka Viinanen Timo Lappalainen
President and CEO, Senior Vice President,
President, Orion Pharma Orion Pharma
Jukka Viinanen, President and CEO, phone +358 10 429 3710, or +358 50 429 3710
Timo Lappalainen, Senior VP, Orion Pharma, phone +358 10 429 3692, or +358 50 500 8755
Helpful additional information
- about levosimendan
- about heart failure
- about Orion
- about Abbott
Levosimendan is indicated for the short-term treatment of acutely decompensated severe chronic heart failure. Levosimendan should only be used as add-on therapy in situations where conventional therapy with, for example, diuretics, ACE-inhibitors and digitalis is not sufficient and where there is a need for inotropic support.
Levosimendan 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.
The most common adverse reactions in clinical trials were headache and hypotension (both 5 percent). In levosimendan treated patients extrasystoles were reported in 1.3 percent of patients, atrial fibrillation in 1.4 percent, tachycardia in 2.4 percent, ventricular tachycardia in 1 percent, palpitations in 0.9 percent and myocardial ischaemia in 2 percent. Of all reported reactions, 83 percent occurred during levosimendan therapy and 17 percent after end of therapy. The majority of adverse reactions (98.6 percent) were seen within three days after start of the infusion.
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 (HEX: ORNAS, ORNBS) is one of the leading companies in the healthcare sector in the Nordic area of Europe. At the heart of the Group is Orion Pharma, a research and development-orientated pharmaceutical division. Orion Pharma focuses on three therapy areas: CNS therapies, cardiology and critical care, and hormonal therapies. For a closer look at Orion, please visit www.orion.fi.
About Abbott Laboratories
Abbott Laboratories is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs more than 70,000 people and markets it products in more than 130 countries. Web site www.abbott.com.
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