Actelion receives marketing approval for Opsumit (macitentan) in pulmonary arterial hypertension in Japan
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Actelion Pharmaceuticals Ltd /
Actelion receives marketing approval for Opsumit (macitentan) in pulmonary
arterial hypertension in Japan
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ALLSCHWIL, SWITZERLAND - 26 March 2015 - Actelion (SIX: ATLN) announced today
that Japan's Ministry of Health, Labor and Welfare granted marketing approval
for Opsumit(®) (macitentan) for the treatment of pulmonary arterial hypertension
(PAH).
The approval was based on data from a local study conducted in Japan and the
landmark global Phase III SERAPHIN study. In both studies, improvements in
pulmonary vascular resistance, 6MWD, and WHO function class were observed. In
the SERAPHIN study, treatment with macitentan 10 mg per day resulted in a 45%
risk reduction (p <0.0001) of the composite morbidity-mortality endpoint when
compared to placebo.
Satoshi Tanaka, Dr. med Sci. President of Actelion Japan commented: "Opsumit
represents a major step forward for the management of PAH as the first and only
approved PAH treatment with proven long-term outcome efficacy. We are delighted
to be able to add Opsumit to our PAH portfolio alongside epoprostenol 'ACT' and
Tracleer as another crucial element in successful PAH management for physicians
across Japan."
Jean-Paul Clozel, M.D. and Chief Executive Officer of Actelion commented: "This
is a great achievement for Actelion Japan. This approval is based on the
SERAPHIN data and the local Japanese study performed by Actelion Japan. I am
very happy that the Japanese PAH patients can soon benefit from Opsumit, an
innovative product discovered in our laboratories."
The most common adverse events that were reported in the SERAPHIN study at a
frequency at least 3% greater on macitentan than on placebo were
nasopharyngitis, headache, anemia, bronchitis, urinary tract infection,
pharyngitis and influenza.
Opsumit was approved by the US FDA in October 2013 and by the EU Commission in
December 2013. Launch activities are progressing rapidly, with market
introductions in the US, EU, Australia, Canada and Switzerland.
Actelion Pharmaceuticals Japan will co-promote Opsumit with Nippon Shinyaku in
Japan and the companies will jointly ensure that Opsumit is made available to
patients as soon as possible.
###
NOTES TO THE EDITOR
ABOUT OPSUMIT(®) (MACITENTAN)
Opsumit (macitentan) is a novel dual endothelin receptor antagonist (ERA) that
resulted from a tailored drug discovery process with the target of developing an
ERA to address efficacy and safety [2,3].
ABOUT THE SERAPHIN STUDY
SERAPHIN (Study with an Endothelin Receptor Antagonist in Pulmonary arterial
Hypertension to Improve cliNical outcome) was the largest and longest
randomized, controlled study in PAH patients to include a clearly defined
morbidity/mortality primary endpoint [1]. The pivotal Phase III study was
designed to evaluate the efficacy and safety of Opsumit (macitentan) - a novel
dual endothelin receptor antagonist that resulted from a tailored drug discovery
process - through the primary endpoint of time to first morbidity and all-cause
mortality event in patients with symptomatic PAH.
Global enrolment was completed in December 2009 with a total of 742 patients.
Patients were randomized 1:1:1 to receive two different doses of macitentan (3
mg and 10 mg once daily) or placebo. Patients were allowed to receive PAH
background therapy throughout the study, either PDE-5 inhibitors or oral/inhaled
prostanoids. This event-driven study was conducted in 151 centers from almost
40 countries in North America, Latin America, Europe, Asia-Pacific and Africa,
and was completed in the first half of 2012, with 287 patients having an
adjudicated event.
ABOUT SERAPHIN STUDY DATA
Patients were randomized to placebo (n=250), macitentan 3 mg (n=250), or
macitentan 10 mg (n=242). The primary end point occurred in 46.4%, 38.0%, and
31.4% of the patients in these groups, respectively. The hazard ratio for
macitentan 3 mg versus placebo was 0.70 (97.5% CI, 0.52 to 0.96; p=0.0108) and
the hazard ratio for macitentan 10 mg versus placebo was 0.55 (97.5% CI, 0.39 to
0.76; p<0.0001). Worsening of pulmonary arterial hypertension was the most
frequent primary end point event. The effect of macitentan on this end point was
observed irrespective of background therapy for pulmonary arterial hypertension.
[3]
ABOUT THE SAFETY AND TOLERABILITY PROFILE
The most common adverse events that were reported in the SERAPHIN study at a
frequency at least 3% greater on macitentan than on placebo were
nasopharyngitis, headache, anemia, bronchitis, urinary tract infection,
pharyngitis and influenza.
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 symptoms of PAH are non-specific
and can range from mild breathlessness and fatigue during normal daily activity
to symptoms of right heart failure and severe restrictions on exercise capacity
and ultimately reduced life expectancy.
PAH is one group within the classification of pulmonary hypertension (PH). This
group includes idiopathic PAH, heritable PAH and PAH caused by factors which
include connective tissue disease, HIV infection and congenital heart disease.
The last decade has seen significant advances in the understanding of the
pathophysiology of PAH, which has been paralleled with developments of treatment
guidelines and new therapies. Drugs targeting the three pathways that have been
established in the pathogenesis of PAH are endothelin receptor antagonists
(ERAs), prostacyclin analogs and phosphodiesterase-5 inhibitors. PAH treatments
have transformed the prognosis for PAH patients from symptomatic improvements in
exercise tolerance 10 years ago to delayed disease progression today. Improved
disease awareness and evidence-based guidelines developed from randomized
controlled clinical trial data have highlighted the need for early intervention,
goal-oriented treatment and combination therapy.
REFERENCES
1. Pulido T et al. Macitentan and Morbidity and Mortality in Pulmonary Arterial
Hypertension. N Engl J Med 2013;369:809-18.
2. Bolli MH et al. The Discovery of N-[5-(4-Bromophenyl)-6-[2-[(5-bromo-2-
pyrimidinyl)oxy]ethoxy]-4-pyrimidinyl]-N'-propylsulfamide (Macitentan), an
Orally Active, Potent Dual Endothelin Receptor Antagonist. J Med Chem.
2012; 55:7849-61.
3. Iglarz M. et al. Pharmacology of macitentan, an orally active tissue
targeting dual endothelin receptor antagonist. J Pharmacol Exp Ther.
2008;327(3):736-745.
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 leading biopharmaceutical company focused on the discovery,
development and commercialization of innovative drugs for diseases with
significant unmet medical needs.
Actelion is a leader in the field of pulmonary arterial hypertension (PAH). Our
portfolio of PAH treatments covers the spectrum of disease, from WHO Functional
Class (FC) II through to FC IV, with oral, inhaled and intravenous medications.
Although not available in all countries, Actelion has treatments approved by
health authorities for a number of specialist diseases including Type 1 Gaucher
disease, Niemann-Pick type C disease, Digital Ulcers in patients suffering from
systemic sclerosis, and mycosis fungoides type cutaneous T-cell lymphoma.
Founded in late 1997, with now over 2,400 dedicated professionals covering all
key markets around the world including Europe, the US, Japan, China, Russia and
Mexico, Actelion has its corporate headquarters in Allschwil / Basel,
Switzerland.
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®). All trademarks
are legally protected.
For further information please contact:
Andrew C. Weiss
Senior Vice President, Head of Investor Relations & Corporate Communications
Actelion Pharmaceuticals Ltd, Gewerbestrasse 16, CH-4123 Allschwi
+41 61 565 62 62
http://www.actelion.com
The above information contains certain "forward-looking statements", relating
to the company's business, which can be identified by the use of forward-looking
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to", "will", "will continue", "should", "would be", "seeks", "pending" or
"anticipates" or similar expressions, or by discussions of strategy, plans or
intentions. Such statements include descriptions of the company's investment
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