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2015-03-26

Actelion Pharmaceuticals Ltd: Actelion receives marketing approval for Opsumit (macitentan) in pulmonary arterial hypertension in Japan

Actelion Pharmaceuticals Ltd / Actelion receives marketing approval for
Opsumit (macitentan) in pulmonaryarterial hypertension in Japan . Processed
and transmitted by NASDAQ OMX Corporate Solutions.The issuer is solely
responsible for the content of this announcement.
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 anEndothelinReceptorAntagonist inPulmonary
arterialHypertension toImprove 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 terminology such as "estimates", "believes", "expects",
"may", "are expected 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 and research and development
programs and anticipated expenditures in connection therewith, descriptions
of new products expected to be introduced by the company and anticipated
customer demand for such products and products in the company's existing
portfolio. Such statements reflect the current views of the company with
respect to future events and are subject to certain risks, uncertainties and
assumptions. Many factors could cause the actual results, performance or
achievements of the company to be materially different from any future
results, performances or achievements that may be expressed or implied by
such forward-looking statements. Should one or more of these risks or
uncertainties materialize, or should underlying assumptions prove incorrect,
actual results may vary materially from those described herein as
anticipated, believed, estimated or expected.

Press Release PDF
http://hugin.info/131801/R/1906191/678549.pdf

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The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Actelion Pharmaceuticals Ltd via Globenewswire

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