ALLSCHWIL, Switzerland, Sept. 8, 2005 (PRIMEZONE) -- Actelion Ltd. (SWX:ATLN) (Other OTC:ALIOF) today provided a comprehensive overview of its preclinical and clinical pipeline at its 3rd R&D Day, held in Allschwil near Basel/Switzerland.
Jean-Paul Clozel, MD and Chief Executive Officer at Actelion, said: "Actelion is ready for accelerated growth. Line-extension studies for our two marketed products Tracleer(R) (bosentan) and Zavesca(R) (miglustat) will report data in short order until year-end. Over the coming 18 months, Actelion also expects important clinical results from several pipeline projects with the potential to radically improve treatment of various diseases."
Actelion has two products on the market, Tracleer(R) for pulmonary arterial hypertension (PAH Class III and IV in the United States, Class III in Europe), and Zavesca(R) for the oral treatment of type 1 Gaucher disease patients not willing or able to receive enzyme replacement therapy as their first therapy. Currently, the company has six compounds in various stages of clinical development and two compounds in full pre-clinical development. In mid-2005, the company had close to 1000 employees, thereof 420 researchers and developers located in Allschwil and more than 400 marketing and sales professionals in 19 affiliates worldwide.
Jean-Paul Clozel concluded: "Actelion's R&D staff has performed above and beyond the even most ambitious expectations. I am very grateful for all their efforts. I expect that the soon-to-be operational additional R&D facilities here in the Basel area will provide us with an outstanding environment in which we will turn even more innovative ideas into breakthrough drugs."
Key highlights of the Actelion R&D Day - Clinical Development
-- Before the end of the year 2005, the company expects the results
from the BUILD program evaluating the safety and efficacy of
bosentan in two forms of Pulmonary Fibrosis, idiopathic pulmonary
fibrosis (BUILD-1) and pulmonary fibrosis related to systemic
sclerosis (BUILD-2)
-- Before the end of the year 2005, the company also expects the
results from three clinical studies evaluating the safety and
efficacy of miglustat in rare lysosomal storage disorders
characterized by neurological deficiencies (type 3 Gaucher
disease, Nieman-Pick disease and late-onset Tay Sachs)
-- The company announced that it is finalizing preparations to
commence the evaluation of safety and efficacy of bosentan in PAH
patients in combination with sildenafil. The large-scale COMPASS
program will evaluate both hemodynamic benefits as well as effects
on disease of the combination.
-- The company provided detailed background on the CONSCIOUS
program, evaluating the safety and efficacy of clazosentan, an
intravenous endothelin receptor antagonist in development for the
prevention of vasospasm following sub-arachnoid hemorrhage (SAH).
-- The company described the early clinical development of Actelion's
Orexin Receptor antagonist. Preliminary analysis of the ongoing
Phase I program indicated that the compound has the pharmacokinetic
profile necessary for a drug to be evaluated as a sleep quality
improver.
Key highlights of the Actelion R&D Day - Drug Discovery
-- Actelion announced that it has commenced full pre-clinical
development of a novel, orally available immunomodulator. The
Actelion S1P1 agonist was well tolerated and efficacious in
pre-clinical models of autoimmune diseases, and demonstrated
appropriate modulation of the immune system.
-- The company provided background on the progress made in the
ongoing Global Actelion Merck Renin Inhibitor Alliance that had
selected a first highly bioavailable renin inhibitor for full
pre-clinical development in the spring of 2005.
-- Actelion disclosed that it has a broad research program in the
field of antibacterials focusing on fighting resistant bacterial
pathogens through novel mechanisms of action.
Note to the editor:
The Actelion R&D Day is being webcasted and the slide kit can be downloaded on the same page from which the webcast can be accessed, either live or archived.
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 as well as Canada, Australia and Switzerland. 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 focuses 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).