ALLSCHWIL/BASEL, Switzerland, Oct. 29, 2003 (PRIMEZONE) -- Actelion Ltd (SWX:ATLN) today provided a comprehensive overview of its preclinical and clinical pipeline at its R&D Day in London (UK). The company believes that its substantial efforts in drug discovery and clinical development are providing a strong and broad base for potential future growth.
Actelion already has two orally available products on the market, Tracleer(R), approved for pulmonary arterial hypertension (PAH), and Zavesca(R), approved as the first oral treatment of type 1 Gaucher disease.
Jean-Paul Clozel, MD and Chief Executive Officer at Actelion, said: "Our pipeline is the basis of Actelion's strategy of industrial growth. We have set ourselves the target to develop first-in-class drugs. We have highly professional and experienced teams at work in both drug discovery and clinical development, all dedicated to innovation, the key feature of our corporate culture."
Commenting on the current pipeline, Jean-Paul Clozel concluded: "Actelion now has five different molecules in various states of clinical development. We have three compounds in full preclinical development and a fourth one most probably entering that stage by year-end. We are also pursuing another eight research projects. Indeed, I believe this R&D effort is one of the most productive and promising ones in the industry."
Actelion's clinical program Tracleer(R), an orally available dual endothelin receptor antagonist primarily focusing on chronic diseases, is currently being tested in digital ulcerations (phase III), pulmonary fibrosis (phase III) and metastatic melanoma (phase II). A new clinical trial, to be initiated soon, will test Tracleer(R) in patients suffering from mildly symptomatic (NYHA class II) pulmonary arterial hypertension (phase III).
Veletri(TM), the company's intravenous dual endothelin receptor antagonist, is currently being investigated in acute heart failure (phase III) and hepatorenal syndrome associated with liver cirrhosis (phase II).
Zavesca(R) is being tested in other lipid-storage disorders than type 1 Gaucher diseases, such as late-onset Tay-Sachs, Nieman-Pick type C and type 3 Gaucher disease.
Clazosentan, newly added to Actelion's pipeline through the recent Axovan acquisition, will be evaluated for the prevention of vasospasm following cerebral bleeding. The development program has to be agreed with regulatory authorities.
The first urotensin II receptor antagonist ever to enter clinical testing has successfully concluded phase I. It was shown to be orally active and well tolerated. It will now be evaluated in chronic renal failure in diabetic patients (phase II).
Actelion's research pipeline
The company currently has three projects in full preclinical development, of which two are not disclosed for competitive reasons. The third compound is an orexin receptor antagonist with oral activity in animal models of sleep and appetite disorders.
Potentially by year-end, Actelion expects to move a fourth compound into full-preclinical development, as substantial progress has been made regarding the bioavailability and activity of the company's renin inhibitor. Some renin inhibitors developed by Actelion achieved a high oral bioavailability, a real breakthrough in this field. In animal models of hypertension, the use of these renin inhibitors resulted in sustained decreases of high blood pressure without changing the heart rate.
Within Actelion's efforts to identify BACE inhibitors targeting the enzymatic process believed to be at the core of the Alzheimer disease, Actelion, through its structural biology group, has been able to crystallize this aspartyl protease. Studies like this will assist in further optimization studies for an orally available BACE inhibitor.
Actelion's research program is focusing on two molecular platforms; G-protein coupled receptors (GPCRs, such as Tracleer(R) and the urotension II antagonist) and aspartyl proteases (such as renin). In addition to the compounds mentioned above, Actelion is disclosing that it is currently pursuing an additional eight projects in these two areas.
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 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 R&D Day in London (UK) on Wednesday, 29 October 2003 at 10.30 a.m. CET / 09.30 a.m. GMT / 03.30 a.m. EST To access the webcast live, simply visit the link on our homepage http://www.actelion.com/ 5-10 minutes before the conference is due to start. The archived Investor Webcast will be available for replay through http://www.actelion.com/Apps/WebObjects/Actelion.woa/wa/dp?name=corp_pres approximately 60 minutes after the call has ended.