Actelion Pharmaceuticals Ltd / Actelion to Present at the 28th Annual J.P. Morgan Healthcare Conference processed and transmitted by Hugin AS. The issuer is solely responsible for the content of this announcement.
* Chief Executive Officer Jean-Paul Clozel to increase previous fiscal year
2009 guidance - total net revenues and Cash EBIT growth to exceed 19 percent
in local currencies
* First patient enrolled inPhase III Morbidity / Mortality Study of novel PGI2
receptor agonist for the treatment of patients with pulmonary arterial
hypertension (PAH) at the end of 2009
* Phase III BUILD-3 with bosentan in idiopathic pulmonary fibrosis to read out
in Q1 2010
ALLSCHWIL/BASEL, SWITZERLAND - 11 January 2010 -Actelion Ltd (SIX: ATLN)
announced today that Jean-Paul Clozel, M.D., Chief Executive Officer of
Actelion, will present at the upcoming J.P. Morgan Healthcare Conference on
Monday, January 11, 2010 at 3:30 p.m. Pacific time / 6:30 p.m. Eastern time at
the Westin St. Francis Hotel in San Francisco, CA.
Actelion will provide an overview of the Company's products and development
programs during its presentation. The Company will also report that at year-end
2009, the first patient has been enrolled in the Phase III morbidity-mortality
study of its first-in-class, orally active non-prostanoid PGI2 receptor agonist
in pulmonary arterial hypertension (PAH). This has triggered a milestone payment
to its partner Nippon Shinyaku, which will be accounted for in the 2009
financial statement as a research and development expense.
During the presentation, Dr. Clozel will increase fiscal year 2009 guidance for
both total net revenues and Cash Earnings Before Tax and Interest (EBIT),
announcing that 2009 growth exceeded the previous guidance of 19 percent local
currency growth. This strong performance in 2009 is the result of all three
products - Tracleer, Ventavis and Zavesca - exceeding expectations. US GAAP
operating and net profit for 2009 are adversely affected by the USD 91 million
arbitration award payable by its subsidiary CoTherix, Inc. to Asahi Kasei Pharma
Corporation.
The company will also reiterate its positive outlook for 2010, with top-line
growth expected in the low-double digit range, as commercial leverage will allow
for both continued strong cash operating margins and above average investment in
innovative growth opportunities.
Jean-Paul Clozel commented: "We expect that Actelion products will perform very
well in the marketplace again in 2010 and are looking forward to important
clinical data announcements from several of our programs, including data from
the bosentan Phase III trial in idiopathic pulmonary fibrosis, which we expect
in the coming weeks."
To access the live and subsequently archived webcast of the presentation, visit
"Events" in the Investor Relations section of Actelion's Web site
atwww.actelion.com <http://www.actelion.com/>. An archived replay will be
available for 3 months beginning 24 hours after the live presentation.
###
Notes to the Editor:
About Pulmonary Arterial Hypertension (PAH)
Pulmonary arterial hypertension (PAH) is a chronic, life-threatening disorder
characterized by abnormally high blood pressure in the arteries between the
heart and lungs of an affected individual. The function of the heart and lungs
is severely compromised, manifested by a limited exercise capacity, and,
ultimately, a reduced life expectancy. Approximately 100,000 people in Europe
and the United States are afflicted with either primary or secondary forms of
the disease related to conditions or tissue disorders that affect the lungs,
such as scleroderma, lupus, HIV/AIDS or congenital heart disease.
PAH is associated with structural changes in both the pulmonary vasculature and
the right ventricle. Recent advances [1] in the understanding of the pathogenic
factors leading to the pulmonary vascular disease have led to the development of
new therapies targeting specific pathways (the prostacyclin pathway; the
endothelin pathway; and the nitric oxide pathway) [2]. The available therapies
have positive effects in PAH, but they do not provide a cure, and in many
patients the disease will progress. PAH remains a serious life-threatening
condition [2,3]. Early recognition and an understanding of the selection and
timing of therapeutic options remain critical elements in the optimal management
of patients with this disorder.
Prostacyclin
Endothelial cells produce several vasoactive chemical factors, among them
prostacyclin (PGI2), which induce vasodilatation of blood vessels and inhibit
smooth muscle cell proliferation and platelet aggregation. The peptide
endothelin is also produced by the endothelium, and is a potent constrictor of
blood vessels and promotes cell proliferation. In a normal healthy state,
prostacyclin helps counter-balance the actions of endothelin. In certain disease
conditions, however, production of prostacyclin by the endothelium is impaired,
allowing the deleterious effects of excessive levels of endothelin to
predominate.
Prostacyclin receptor
Prostacyclin binds the prostacyclin receptor located on the surface of platelets
and vascular smooth muscle cells. The receptor is a G-protein coupled receptor
that, upon activation by prostacyclin, stimulates the formation of cyclic
adenosine monophosphate (cAMP). Dysfunction of the prostacyclin system occurs in
several cardiovascular disorders, including thrombosis, myocardial infarction,
stroke, myocardial ischemia, atherosclerosis and pulmonary arterial hypertension
(PAH). Restoration of prostacyclin function using prostacyclin analogues that
activate IP receptors improves prognosis for patients with PAH. Prostacyclin
counteracts the vasoconstrictor and pro-thrombotic activity of endothelin.
Actelion is developing an orally available and long-acting non-prostanoid PGI2
receptor agonist that mimics the actions of endogenous prostacyclin for the
treatment of PAH.
About Actelion's orally active non-prostanoid PGI2 receptor agonist
ACT-293987, originally discovered and synthesized by Nippon Shinyaku, is a
long-lasting orally-available drug that is converted to the active metabolite, a
potent non-prostanoid PGI2 receptor agonist which exerts vasodilating effects.
ACT-293987 has major potential as a novel treatment of pulmonary arterial
hypertension.
Positive data have been obtained in a Phase IIa, placebo-controlled study to
assess efficacy, safety and tolerability of this compound in 43 patients
suffering from PAH and already receiving standard care with oral PAH
medications. The primary endpoint of pulmonary vascular resistance (PVR) change
from baseline was met with high statistical significance (p < 0.01). The
compound was well tolerated.
Actelion has submitted several abstracts covering this study for presentation at
upcoming scientific congresses taking place throughout 2010.
References
1. Farber HW; Loscalzo J. Mechanisms of disease: pulmonary arterial
hypertension. N. Eng. J. Med. 2004; 351:1655-65.
2. Humbert M; Sitbon O; Simonneau G. Treatment of pulmonary arterial
hypertension. N. Eng. J. Med. 2004;351:1425-36.
3. Humbert M; Morrell NW; Archer SL; et al. Cellular and molecular pathobiology
of pulmonary arterial hypertension. J. Am. Coll. Cardiol. 2004; 43: Suppl.
12: 13S-24S.
About the Actelion / Nippon Shinyaku alliance
Actelion and Nippon Shinyaku entered into an exclusive worldwide alliance in
April 2008 to collaborate on an orally-available long-acting prostaglandin I2
(PGI2) receptor agonist for patients suffering from pulmonary arterial
hypertension (PAH). This compound was originally discovered and synthesized by
Nippon Shinyaku. Actelion will be responsible for global development and
commercialization of the PGI2 receptor agonist outside Japan, while the two
companies will co-develop and co-commercialize in Japan.
Actelion Ltd
Actelion Ltd is a biopharmaceutical company with its corporate headquarters in
Allschwil/Basel, Switzerland. Actelion's first drug Tracleer®, an orally
available dual endothelin receptor antagonist, has been approved as a therapy
for pulmonary arterial hypertension. Actelion markets Tracleer® through its own
subsidiaries in key markets worldwide, including the United States (based in
South San Francisco), the European Union, Japan, 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's over 2, 200 employees focus on
the discovery, development and marketing of innovative drugs for significant
unmet medical needs. Actelion shares are traded on the SIX Swiss Exchange
(ticker symbol: ATLN).
For further information please contact:
Roland Haefeli
Vice President, Head of Investor Relations & Public Affairs
Actelion Pharmaceuticals Ltd, Gewerbestrasse 16, CH-4123 Allschwil
+41 61 565 62 62
+1 650 624 69 36
http://www.actelion.com< http://www.actelion.com/>
[HUG#1372270]
--- End of Message ---
Actelion Pharmaceuticals Ltd
Gewerbestrasse 16 Allschwil Switzerland
WKN: 936767;ISIN: CH0010532478;
Press Release PDF: http://hugin.info/131801/R/1372270/336056.pdf