Allschwil, Switzerland - September 26, 2000 -- Actelion Ltd. (SWX New Market: ATLN) announced today that it has submitted the initial sections of its New Drug Application (NDA) for bosentan for the treatment of pulmonary hypertension. As agreed with the FDA, Actelion expects to submit the final sections beginning of November. "The work of the development team has allowed a submission of this NDA nine months ahead of schedule. Actelion is committed to working in close collaboration with American and European authorities to make bosentan available as soon as possible to patients suffering from this severe and debilitating disease," said Jean-Paul Clozel, Actelion's Chief Executive Officer. "We believe bosentan could become the first oral treatment of pulmonary hypertension, which would represent a major therapeutic breakthrough," he added.
Bosentan is the first orally active endothelin receptor antagonist. The results of a placebo-controlled, double-blind study of bosentan in pulmonary hypertension will be presented at the American Heart Association Meeting by the Principal Investigator of the trial, Dr. Lewis Rubin, on November 13th, 2000 in New Orleans. In addition, Actelion has initiated a trial called BREATHE-1 (Bosentan: Randomized trial of Endothelin Antagonist THErapy for pulmonary hypertension) to confirm and expand upon the excellent results observed in this first study. Approximately one fourth out of 150 patients have already been enrolled.
Pulmonary hypertension is a disease in which blood pressure in the arteries between the heart and lungs is abnormally increased. Pulmonary hypertension causes shortness of breath and fainting and reduces life expectancy. About 100'000 patients in Europe and the US suffer from pulmonary hypertension, either primary or secondary to other diseases, such as scleroderma.
Endothelin is the most potent vasoconstrictor known to date and appears to play a fundamental mechanistic role in the development of pulmonary hypertension. Bosentan, the first orally active endothelin receptor antagonist, blocks the action of endothelin at both ETA and ETB receptors and could offer significant advantages over currently available pulmonary hypertension therapy. The only currently approved agent is epoprostenol which needs to be given by continuous IV infusion through a surgically implanted central line.
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. Bosentan (chronic heart failure and pulmonary hypertension) and tezosentan (acute heart failure), the two flagship drugs, are in late stage development. In addition, Actelion runs drug discovery programs in cardiovascular diseases, malaria, Alzheimer's disease and cancer. Actelion is quoted at the Swiss Stock Exchange (SWX New Market: ATLN).