Tuesday, Dec 12, 2000
South San Francisco, Calif. and Allschwil, Switzerland -- December 12, 2000 --Actelion Ltd. (SWX New Market: ATLN) and Genentech, Inc. (NYSE: DNA) today announced the signing of an agreement for the development and co-promotion of Actelion's endothelin receptor antagonist TracleerTM(Bosentan) in the United States. The companies anticipate co-promoting Tracleer upon receiving marketing approval from the U.S. Food and Drug Administration (FDA).
Under the terms of the agreement, both Actelion and Genentech will be involved in the marketing and promotion of Tracleer in the United States, with Actelion taking the lead in the development efforts and commercialization of Tracleer. Payments from Genentech include an up-front fee of $35 million (US dollars) this year plus additional payments contingent on the achievement of future milestones.
Tracleer is in development as the first oral dual endothelin receptor antagonist (ERA). Endothelin is the most potent vasoconstrictor known and endothelin levels appear to be abnormally elevated in pulmonary hypertension (PHT) and acute and chronic heart failure (AHF and CHF). In PHT, the pivotal clinical trial of Tracleer showed encouraging results when compared to placebo, with adverse events being similar in type and frequency between the two groups. These results are currently being verified by a larger Phase III study, BREATHE-1, involving over 150 patients. Recruitment into BREATHE-1 has been completed and the New Drug Application (NDA) has been filed with the FDA. Tracleer is also being evaluated in two pivotal Phase III trials in patients with CHF -- ENABLE-1 and ENABLE-2 -- involving over 1,600 patients.
Earlier this year Actelion and Genentech signed an agreement to co-promote Actelion's drug tezosentan in the treatment of acute heart failure as well as Genentech's new single bolus thrombolytic TNKaseTM (Tenecteplase), which was launched in June 2000.
"With our first two clinical compounds -- tezosentan and Tracleer;-- we potentially have the first-to-market intravenous and oral endothelin receptor antagonists to address both acute and chronic cardiovascular diseases," said Jean-Paul Clozel, CEO of Actelion. "We are excited to be extending our relationship with Genentech and are convinced of the great synergy we can bring to bear in ERA marketing. Together we are very committed to establishing this new class of agents, as well as the brands themselves."
"We are extremely pleased about this collaboration because the addition of Tracleer strongly builds upon our existing portfolio of cardiovascular products," said Myrtle Potter, executive vice president of Commercial Operations and chief operating officer. "The potential market opportunities that exist between Tracleer, tezosentan and our other cardiovascular products allow us to broaden the spectrum of treatment provided to patients."
In patients with CHF, the heart is unable to pump adequate amounts of blood for the body's needs. CHF has become one of the most common illnesses accounting for hospital admissions and physician visits in people over the age of 65 years with a mortality rate of approximately 50 percent over five years. There are approximately 10 million patients with CHF worldwide. PHT is a life-threatening disease; a disorder in which blood pressure in the arteries between the heart and lungs is abnormally increased. PHT causes shortness of breath, fainting, and reduces life expectancy. Some studies estimate that approximately 100,000 people in the U.S. and Europe are afflicted with PHT. PHT can occur either alone (primary PHT) or secondary to other diseases, such as scleroderma (secondary PHT); other causes of PHT include the use of appetite suppressants, portal hypertension and HIV/AIDS.
Actelion Ltd., is a biopharmaceutical company headquartered in Allschwil (Basel), Switzerland. Actelion is the global leader in creative science related to the endothelium -- the single layer of cells separating every blood vessel from the blood stream. Actelion concentrates on developing and bringing innovative drugs to patients. Tracleer (Bosentan) and tezosentan, the two flagship drugs, are in late stage development for several cardiovascular disorders including chronic and acute heart failure as well as pulmonary arterial hypertension. In addition, Actelion is conducting drug discovery programs in cardiovascular diseases, malaria, Alzheimer's disease and cancer. Actelion is quoted on the Swiss Stock Exchange (SWX New Market: ATLN).
Genentech, Inc. is a leading biotechnology company that discovers, develops, manufactures and markets human pharmaceutical for significant unmet medical needs. Fourteen of the currently approved biotechnology products stem from Genentech science. Genentech markets nine biotechnology products directly in the United States. The company has headquarters in South San Francisco, California and is traded on the New York Stock Exchange under the symbol DNA.
Disclaimer refers to Actelion Ltd. only: This information does not constitute an offer to sell or a solicitation to buy any securities in the United States of America. In addition, the securities of Actelion Ltd. have not been registered under the United States securities laws and therefore the shares may not be offered, sold or delivered, directly or indirectly, to or for the account of any U.S. Person (as defined in Regulation S under the Securities Act), in or into the United States, or by use of the United States mails or by any means or instrumentality of United States interstate commerce, absent registration or an exemption from registration under the Securities Act.
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