ALLSCHWIL/BASEL, Switzerland, March 4, 2003 (PRIMEZONE) -- Actelion Ltd. (SWX:ATLN) (Other OTC:ALIOF) today provided a complete overview of its clinical pipeline at its annual Analyst and Media Day. The company expects that this clinical effort, currently involving four different compounds, could further accelerate the current and continuing growth Actelion realizes through the successful marketing of Tracleer(R) in its first approved indication, pulmonary arterial hypertension (PAH).
The clinical trials involve four compounds in numerous indications. These are two dual endothelin receptor antagonists (oral Tracleer(R) and intravenous Veletri(TM)), one agent targeting lipid storage diseases (Zavesca(R)) as well as the first, orally available urotensin II receptor antagonist ever to enter human testing.
Jean-Paul Clozel, MD and Chief Executive Officer at Actelion, commented: "Actelion today is the recognized world-leader in endothelin science. We have the unique opportunity to maximize the potential of this new therapeutic approach, while also addressing other areas of high market potential with Zavesca(R) and our urotensin program."
Dr. Clozel added: "Our first drug on the market, Tracleer(R), is generating substantial revenues, which, in turn, is propelling the company towards profitability in the near term. At the same time, the success of Tracleer(R) allows us to pursue a major effort in clinical development which targets additional, above industry-average growth."
Isaac Kobrin, MD and Head of Development at Actelion, said: "With our experienced group of clinical scientists, we have designed and implemented very comprehensive programs to address areas of high unmet medical need. Following the urotensin II receptor antagonist, we look forward to receive other compounds from our discovery effort, for example in the areas of orexin antagonism, renin inhibition and beta-secretase inhibition."
Strong near-term growth and strong financial outlook
In the year 2002, driven by strong Tracleer(R) sales of more than CHF 121 million (2001: 3.8 million), the company limited its net loss for 2002 to CHF 40.8 million (2001: 69.5 million). In the fourth quarter of 2002, the company moved very close toward profitability, with a net loss of CHF 0.6 million (Q3: 10.7 million).
Andrew J. Oakley, Chief Financial Officer commented: "Actelion has had a good start in 2003, with revenues well on track to reach the forecasted CHF 270 to 310 million by year-end. With costs well under control and despite major investments in R&D, Actelion may be profitable in 2003 on a full-year basis, one year ahead of schedule."
A full pipeline to fuel further growth
Tracleer(R) (bosentan) is already approved in most parts of the world for the treatment of pulmonary arterial hypertension. Tracleer(R) is currently being evaluated in scleroderma patients suffering from digital ulcers (Phase III), pulmonary fibrosis (Phase II/III) and metastatic melanoma (pilot study phase II).
Zavesca(R) (miglustat) is approved in the European Union for the treatment of type 1 Gaucher disease and is currently being evaluated -- together with Oxford Glycoscience -- in other lipid-storage disorders such as type 3 Gaucher disease, Nieman-Pick and Tay-Sachs (all phase II/III).
The investigational compound Veletri(TM) (tezosentan) is being evaluated in Acute Heart Failure AHF (phase III). Also with Veletri(TM), the company has initiated a pilot program evaluating the potential in hepatorenal syndrome HRS, a deadly complication of liver cirrhosis.
In January 2003, Actelion has also initiated clinical trials with the first orally available urotensin II receptor antagonist ever to be tested in man.
NOTE TO THE EDITOR: Full details about Actelion's performance in the past year and its clinical program going forward can be found in Actelion's Annual Report 2002, accessible through the internet at www.actelion.com as of 12:30 p.m. on March 4, 2003.
NOTE TO THE SHAREHOLDERS:
The annual general meeting of shareholders approving the Business Report of the year ending December 31, 2002 will be held on April 23, 2003. Shareholders holding more than 1 million CHF worth of shares (i.e. 400,000 shares), being entitled to add items to the agenda of the general meeting of shareholders, are invited to send in proposals, if any, for the annual general meeting of April 23, 2003 to Actelion Ltd., att. General Counsel, Gewerbestrasse 16, CH-4123 Allschwil, to arrive no later than March 17, 2003. Any proposal received after such deadline will be disregarded. In order to attend and vote at the annual general meeting of shareholders, shareholders must be registered in the company's shareholders register by March 27, 2003 at latest.
Actelion Ltd.
Actelion Ltd. is a biopharmaceutical company; with its corporate headquarter 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 as well as Canada 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).
Webcast -- Live and replay on demand
Actelion webcasts its Analyst Day on Tuesday, March 4, 2003, at 12:45 CET/6:45 a.m. EST. You may either follow the webcast live or have it replayed later on demand. To access the webcast, simply visit the link on our homepage http://www.actelion.com for further information.