Actelion Ltd./Merck & Co., Inc. Renin Alliance Achieves Fourth Milestone -- Dosing in Phase II Initiated -- Actelion Receives USD10 Million
Jean-Paul Clozel, MD and Chief Executive Officer commented: "I am very pleased about today's progress. Over the last four years, Actelion and Merck have worked closely to advance our common understanding about what is needed to realize the full potential of renin inhibition in cardiovascular disease."
Merck Actelion global renin alliance organization
Actelion and Merck formed an exclusive worldwide alliance in December 2003 to discover, develop and market new classes of orally available renin inhibitors for patients suffering from cardio-renal diseases.
The parties are collaborating on the development of products via a joint committee. Research and development funding will initially be the responsibility of Actelion. The two companies will jointly fund Phase II development, with Merck responsible for funding all Phase III and outcome studies. Merck will lead and fund commercialization. Actelion retains a worldwide option to co-promote any product resulting from this alliance as a paid-for sales force.
Upon signing, Actelion received USD10 million. Actelion is also eligible to receive significant research, development and approval milestone payments of up to USD262 million for the successful commercialization of the first collaboration product. A first milestone of USD15 million was achieved in March 2004 with the completion of the technology transfer, which provided Merck with unrestricted access to Actelion's multiple renin inhibitor classes. A second milestone of USD5 million was achieved in March 2005 when the first compound was selected for full preclinical development. A third milestone of USD7 million was achieved in July 2006 when the first compound -- which demonstrated good bioavailability in animal models -- started full clinical development in man.
Actelion will also be eligible to receive certain milestone payments for the successful commercialization of additional products and Merck will pay Actelion substantial royalties on the sale of all products resulting from this renin inhibitor alliance.
Scientific background on renin inhibition
Renin plays a key role in the regulation of blood volume, arterial pressure as well as cardiac and vascular function by serving as an early component of the renin-angiotensin system. Renin is an enzyme that catalyzes the formation of the hormone angiotensin I, which is transformed to angiotensin II by the angiotensin converting enzyme (ACE). Angiotensin II acts on specific receptors to increase blood pressure and modulate long-term processes such as arteriosclerosis and remodeling of heart and kidney. Therapeutic manipulation of the renin-angiotensin pathway has become very important in treating hypertension and heart failure. In 2007, a first renin inhibitor was introduced into the cardiovascular market.
Renin inhibition is the most recent pharmacological approach for the treatment of hypertension and, potentially, renal failure and vascular diseases.
Actelion Ltd.
Actelion Ltd is a biopharmaceutical company with its corporate headquarters in Allschwil/Basel, Switzerland. Actelion's first drug Tracleer(r), an orally available dual endothelin receptor antagonist, has been approved as a therapy for pulmonary arterial hypertension. Actelion markets Tracleer(r) through its own subsidiaries in key markets worldwide, including the United States (based in South San Francisco), the European Union, Japan, Canada, Australia and Switzerland. At the end of September 2006, Tracleer(r) was commercially available in 35 countries worldwide. Actelion, founded in late 1997, is a leading player in innovative science related to the endothelium - the single layer of cells separating every blood vessel from the blood stream. Actelion's over 1,500 employees focus on the discovery, development and marketing of innovative drugs for significant unmet medical needs. Actelion shares are traded on the SWX Swiss Exchange (ticker symbol: ATLN).
CONTACT: Actelion Pharmaceuticals Ltd. Roland Haefeli, Vice President, Head of Investor Relations and Public Affairs +41 61 565 62 62 +1 650 624 69 36 http://www.actelion.com Gewerbestrasse 16 CH-4123 Allschwil