Actelion announces presentation of positive Phase II results with selexipag in patients with pulmonary arterial hypertension at the American Thoracic Society 2010 International Conference
(Thomson Reuters ONE) -
Actelion Pharmaceuticals Ltd / Actelion announces presentation of positive Phase II results with selexipag in patients with pulmonary arterial hypertension at the American Thoracic Society 2010 International Conference processed and transmitted by Hugin AS. The issuer is solely responsible for the content of this announcement.
ALLSCHWIL, SWITZERLAND - 17 May 2010 - Actelion Ltd (SIX: ATLN) announced today
that full data from the Phase II study of selexipag (proposed INN), the
company's first-in-class, orally available, selective IP receptor agonist in
patients with pulmonary arterial hypertension (PAH) were presented by Gerald
Simonneau M.D., Ph.D, Chief of the Department of Pneumology, Hospital Antoine
Béclère, Clamart, France, and Lead investigator on the trial, during the
American Thoracic Society's (ATS) 2010 international conference taking place
this week in New Orleans.
Results of the 43-patient, placebo-controlled, double-blind study, where
patients were randomized in a 3:1 ratio receiving selexipag or placebo, showed a
statistically significant reduction in pulmonary vascular resistance (PVR;
primary parameter for the study). The treatment effect was shown to be 30.3
percent after 17 weeks of treatment (p=0.0045). Results also showed an
encouraging numerical improvement in 6-minute walk distance (6MWD), which was a
secondary endpoint of this trial. Selexipag was well tolerated and the safety
profile was in-line with the expected pharmacologic effect.
Prof. Simonneau M.D., Ph.D. commented: "These Phase II results are very
encouraging, particularly considering that the efficacy observed, is on top of
oral background therapy. They strongly support the study of this very promising
oral IP receptor agonist in the ongoing Phase III study."
Treatment with selexipag was initiated at 200 microgram (mcg) b.i.d., which, if
tolerated, was uptitrated to b.i.d. 400, 600 and 800 mcg on Days 3, 7 and 21,
respectively. All patients enrolled in the trial were on background therapy with
endothelin receptor antagonists and/or phosphodiesterase type 5 inhibitors
before and during the course of the study. The primary efficacy endpoint of the
trial was change from baseline to Week 17 in PVR. The secondary endpoints
included 6MWD and other hemodynamic parameters. Safety and tolerability were
evaluated in all enrolled patients.
Selexipag is currently being evaluated in the Phase III GRIPHON, (Prostacyclin
(PGI(2)) Receptor agonist in Pulmonary arterial Hypertension) trial, which is
enrolling patients around the world.
About GRIPHON
GRIPHON is a multicenter, double-blind, placebo-controlled morbidity/mortality
Phase III trial evaluating the efficacy and safety of oral selexipag in patients
with pulmonary arterial hypertension. The primary endpoint of the trial is to
demonstrate the effect of Selexipag on the time to first clinical event of
morbidity or mortality in patients with PAH. This trial is being conducted under
an agreed special protocol assessment (SPA) with the U.S. Food and Drug
Administration.
About Actelion's PAH Franchise
Actelion is dedicated to providing best-in-class therapies and industry leading
resources for people living with PAH. Actelion's commercial product portfolio
consists of market leading oral therapy Tracleer(®), a dual endothelin receptor
antagonist and in the US, inhaled prostacyclin Ventavis(®) as well as the
recently launched Epoprostenol for Injection which provides added convenience
for patients. In addition to its marketed products, Actelion leads the way in
cutting edge science to advance PAH care with a pipeline of clinical candidates.
Macitentan and selexipag are currently being evaluated in pivotal Phase III
trials, and have the potential to become the next generation of care for
patients. Further highlighting its commitment to patients, Actelion sponsors the
REVEAL registry, the world's largest PAH patient registry, which provides a
complete picture of the PAH treatment landscape and ultimately improves patient
care.
About Selexipag
Selexipag (proposed INN, previously known as ACT-293987 or NS-304), originally
discovered and synthesized by Nippon Shinyaku, is a first-in-class, orally
available, selective IP receptor agonist which exerts vasodilating effects.
[4,5] The selexipag ATS abstract can be found by clicking on following link:
https://cms.psav.com/cAbstract/itinerary/day.html
[Search ACT-293987].
###
Notes to Editor:
About the American Thoracic Society (ATS) International Conference 2010
The annual International Conference is being held in New Orleans and offers many
sessions and several speakers on important scientific and clinical advances in
pulmonary, critical care, and sleep medicine.
About Professor G. Simonneau MD, PhD
Gérald Simonneau, MD, PhD is Chief of the Department of Pneumology, Hospital
Antoine Béclère, Clamart, France. Professir Simonneau is past-President of the
working Group on Pulmonary Circulation of the European Society of Cardiology. He
has published widely in the fields of pulmonary hypertension, pulmonary vascular
diseases, and pneumology. Professor Simonneau has been Director of the Unité
Propre de Recherche de l'Enseignement Supérieur on pulmonary vascular diseases
since 1998.
About the Phase II study with selexipag
The study was a multicenter, double-blind, randomized, placebo-controlled study
evaluating efficacy and safety of selexipag in PAH patients. The primary
endpoint was pulmonary vascular resistance. The study was completed in July
2009 with 43 patients randomized 3:1.
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.
About prostacyclin
Prostacyclin and prostaglandins are types of prostanoids. Endothelial cells
produce several vasoactive chemical factors, among them prostacyclin (PGI(2)),
which induce vasodilation 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.
About prostacyclin receptor agonism
The IP receptor (PGI(2) (prostacyclin) receptor) is one of 5 types of prostanoid
receptor available to prostanoid replacement therapies. Prostacyclin activates
the IP receptor inducing vasodilation and inhibiting proliferation of vascular
smooth muscle cells. With selective IP receptor agonism, the risk of side
effects mediated by activation of other prostanoid receptors is minimized.
Actelion is developing a first-in-class, orally available, selective IP receptor
agonist that mimics the actions of endogenous prostacyclin for the treatment of
PAH.
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.
4. Kuwano et al (2008). A long-acting and highly selective prostacyclin
receptor agonist prodrug,
2-{4-[(5,6-diphenylpyrazin-2-yl)(isopropyl)amino]butoxy}-N-(methylsulfonyl)
acetamide (NS-304), ameliorates rat pulmonary hypertension with unique
relaxant responses of its active form,
{4-[(5,6-diphenylpyrazin-2-yl)(isopropyl) amino]butoxy}acetic acid
(MRE-269), on rat pulmonary artery. J Pharmacol Exp Ther 326: 691-699
5. Kuwano et al (2007). 2-[4-[(5,6-diphenylpyrazin-2-yl) (isopropyl)
amino]butoxy]-N-(methylsulfonyl) acetamide (NS-304), an orally available and
long-acting prostacyclin receptor agonist prodrug. J Pharmacol Exp Ther
322: 1181-1188.
About the Actelion / Nippon Shinyaku alliance
Actelion and Nippon Shinyaku entered into an exclusive worldwide alliance in
April 2008 to collaborate on selexipag, a first-in-class orally-available,
selective IP receptor agonist for patients suffering from pulmonary arterial
hypertension (PAH). This compound was originally discovered and synthesized by
Nippon Shinyaku. Phase II evaluation has been completed, and a Phase III program
in PAH patients has been initiated. Actelion is responsible for global
development and commercialization of selexipag outside Japan, while the two
companies will co-develop and co-commercialize in Japan. Nippon Shinyaku will
receive milestone payments based on development stage and sales milestones as
well as royalties on any sales of selexipag.
Nippon Shinyaku
For further information on Nippon Shinyaku please visit:
http://www.nippon-shinyaku.co.jp/english/index.html
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 2,300 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) as part of the Swiss blue-chip index SMI (Swiss Market Index
SMI(®)).
For further information please contact:
Roland Haefeli
Vice President, Head of Investor Relations & Corporate Communications
Actelion Pharmaceuticals Ltd, Gewerbestrasse 16, CH-4123 Allschwil
+41 61 565 62 62
+1 650 624 69 36
http://www.actelion.com
[HUG#1416340]
--- End of Message ---
Actelion Pharmaceuticals Ltd
Gewerbestrasse 16 Allschwil Switzerland
ISIN: CH0010532478;
Media Release PDF: http://hugin.info/131801/R/1416340/366960.pdf
Unternehmensinformation / Kurzprofil:
Datum: 17.05.2010 - 17:35 Uhr
Sprache: Deutsch
News-ID 21005
Anzahl Zeichen: 0
contact information:
Town:
Allschwil
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 270 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"Actelion announces presentation of positive Phase II results with selexipag in patients with pulmonary arterial hypertension at the American Thoracic Society 2010 International Conference"
steht unter der journalistisch-redaktionellen Verantwortung von
Actelion Pharmaceuticals Ltd (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
