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Actelion Pharmaceuticals Ltd : Actelion obtains marketing approval for Epoprostenol "ACT" in Japan



    Actelion Pharmaceuticals Ltd : Actelion obtains marketing approval for
                         Epoprostenol "ACT" in Japan

Actelion Pharmaceuticals Ltd / Actelion obtains marketing approval for
Epoprostenol "ACT" in Japan . Processed and transmitted by Thomson Reuters
ONE. The issuer is solely responsible for the content of this announcement.

ALLSCHWIL/BASEL, SWITZERLAND  -  18  February  2013  -  Actelion  (SIX:  ATLN) 
announced today that  Japan's Ministry  of Health, Labor  and Welfare  granted 
approval for  Epoprostenol "ACT"  (0.5 mg  and 1.5  mg) for  the treatment  of 
pulmonary arterial hypertension (PAH).

Satoshi Tanaka,  Dr.med  Sci. President  of  Actelion Japan  and  Chairman  of 
Actelion  South  Korea  commented:  "Unlike  other  epoprostenol  formulations 
approved for  PAH, Epoprostenol  "ACT" has  greater stability.  This  provides 
unique benefits, such  as a more  flexible preparation of  the medication  and 
infusion of the product within 24hrs at room temperature."

Satoshi Tanaka  concluded:  "By  adding Epoprostenol  "ACT"  to  our  Japanese 
product portfolio  we will  be able  to  offer PAH  physicians an  option  for 
intravenous  therapy  on  top  of  our  oral  endothelin  receptor  antagonist 
Tracleer^®, the leading oral treatment option in Japan."

Actelion Pharmaceuticals Japan will now ensure that Epoprostenol "ACT" is made
available to patients as soon as possible.

Actelion already markets this  product as Veletri^® in  the United States  and 
during 2012 Actelion received approval  to market as Veletri^® in  Switzerland 
and in  Canada under  the trade  name Caripul^®.  Regulatory review  for  this 
epoprostenol formulation is ongoing in the European Union.

 

                                     ###

 
Notes to the Editor

About Pulmonary Arterial Hypertension

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 3 pathways  that 
have been  established in  the  pathogenesis of  PAH are  endothelin  receptor 
antagonists (ERAs),  prostacyclins  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.

Despite these advances  in PAH, survival  rates are unacceptably  low and  PAH 
remains incurable.

About Actelion Pharmaceuticals Japan

Actelion Pharmaceuticals Japan  was established  in 2001 to  meet the  medical 
needs of patients  with pulmonary  arterial hypertension in  Japan. Since  its 
foundation  the  company  has  established  a  significant  presence  in   the 
pharmaceutical market and also provides clinical development for the  specific 
needs of the Japanese Health Authorities. The organization also has a  central 
role for East Asian cross-border  clinical development activities, such as  in 
South Korea.  In  2012  Actelion  Pharmaceuticals  Japan  contributed  12%  of 
Actelion's total product sales.

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 2,400  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
Senior 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
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.

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Source: Actelion Pharmaceuticals Ltd via Thomson Reuters ONE
HUG#1678832

--- End of Message ---

Actelion Pharmaceuticals Ltd
Gewerbestrasse 16 Allschwil Switzerland

ISIN: CH0010532478;
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