Actelion Pharmaceuticals Canada Introduces CARIPUL® (epoprostenol) For Injection, A Treatment for Pulmonary Arterial

Actelion Pharmaceuticals Canada Introduces CARIPUL® (epoprostenol) For 
Injection, A Treatment for Pulmonary Arterial Hypertension 
LAVAL, QC, Sept. 16, 2013 /CNW/ - Actelion Pharmaceuticals Canada Inc. 
announced today that CARIPUL®( )(epoprostenol) for Injection is now available 
in Canada. CARIPUL® is a prescription medication indicated for the long-term 
intravenous treatment of primary pulmonary hypertension (or idiopathic 
pulmonary arterial hypertension), and secondary pulmonary hypertension due to 
scleroderma spectrum of diseases in NYHA functional Class III and Class IV 
patients who did not respond adequately to conventional therapy.(1) 
Pulmonary arterial hypertension (PAH) is a condition that is estimated to 
affect between 2,000 and 10,000 Canadians.(2) PAH affects the small blood 
vessels in the lungs, and is associated with increased pressure in the blood 
vessels leading to the right side of the heart.(3) An early symptom of 
pulmonary arterial hypertension, dyspnea (or breathlessness), presents in a 
wide range of health conditions; this can lead to delays in early diagnosis 
and treatment of PAH.(3) When PAH is suspected , the diagnostic gold 
standard is a right heart catheterization for assessment of hemodynamics, an 
in-hospital procedure performed by specialist physicians in respirology or 
Pulmonary arterial hypertension, if untreated, is usually progressive, with a 
high historical mortality rate in those who are untreated.(3) 
CARIPUL® Offers Key Benefits of Expanded Stability for IV Epoprostenol Therapy 
CARIPUL® offers patients an expanded stability profile and the convenience of 
prolonged refrigerated storage - something not available with other 
epoprostenol medications currently approved in Canada. "This is one example of 
our continued and long-term commitment to patients with pulmonary arterial 
hypertension," said Jacques Archambault, President of Actelion Pharmaceuticals 
Canada Inc. "Patients who are treated with continuously-infused IV 
epoprostenol now have an option that delivers greater flexibility in their 
daily lives. We are delighted to bring this product to market." 
CARIPUL® offers two preparation and storage options to patients: 
administered for up to 48 hours at room temperature (25°C) at concentrations 
≥3,000 ng/mL.(*,1) 
Fully diluted CARIPUL® can be stored in the refrigerator (i.e., 2°C to 8°C) 
for up to 8 days, and then administered at room temperature (25°C) for up to 
24 hours at concentrations between 3,000 ng/mL and 15,000 ng/mL and up to 48 
hours at concentrations ≥15,000 ng/mL.(*,1) 
Actelion is offering CARIPUL® in 2 vial strengths, 0.5 mg and 1.5 mg. The 0.5 
mg vial is recommended for patients using final concentrations of CARIPUL® 
between 3,000 ng/ml and 15,000 ng/mL, and the 1.5mg vial is recommended for 
final concentrations greater than 15,000 ng/mL. 
CARIPUL® is available, by prescription only, exclusively from Shoppers Drug 
Mart Specialty Health Network Inc., a specialty pharmacy providing home 
delivery and patient support through the CARIPUL® Patient Support Program 
(CARIPUL® PSP). The CARIPUL® PSP offers an enhanced level of personalized 
service to patients with pulmonary hypertension, and will provide call centre, 
nursing and reimbursement support services for patients using CARIPUL® and 
their healthcare providers. Patients and physicians can call the CARIPUL® PSP 
hotline at 1-877-CARIPUL (227-4785). 
Dr. David Langleben, Director of the Center for Pulmonary Vascular Disease at 
the Jewish General Hospital in Montreal and a Canadian clinical trial 
investigator for CARIPUL®, remarked, "The clinical profile of CARIPUL® 
represents a welcome improvement for patients with severe pulmonary arterial 
hypertension. For years, patients treated with IV epoprostenol had to concern 
themselves with daily preparation of their medication as well as the use ice 
of packs to keep the medication cold while being administered. CARIPUL® 
eliminates those requirements, which is of great benefit to PH patients." 
Added Dr. John Granton, head of the PH Centre at the Toronto General Hospital 
and an investigator in the CARIPUL® clinical program, "IV epoprostenol is a 
life-prolonging medication for patients with severe pulmonary arterial 
hypertension. A more stable formulation will provide greater flexibility for 
use and storage and will make life easier for many of our patients.'' 
"The improved stability and convenience of CARIPUL® offers patients with 
severe pulmonary arterial hypertension a better quality of life" said Frank 
Poon, President of PHA Canada, a national disease association representing 
patients with pulmonary hypertension. 
About Actelion Pharmaceuticals Canada Inc. 
Actelion Pharmaceuticals Canada Inc. is the Canadian operation of 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. 
Founded in late 1997 Actelion 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 
To learn more about Actelion Pharmaceuticals, visit 
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.(3) 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.(3) 
PAH is one group within the classification of pulmonary hypertension (PH).(3) 
This group includes idiopathic PAH, heritable PAH and PAH caused by factors 
which include connective tissue disease, HIV infection and congenital heart 
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.(3) 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 clinical trial data have highlighted the need for early 
intervention, goal-oriented treatment and combination therapy.(3) 
1. Product Monograph - CARIPUL® (epoprostenol) for Injection.  
 November 2012; Actelion Pharmaceuticals Canada Inc.
  2. Sourced from:
  3. Galiè N, Hoeper MM, Humbert M et al. Guidelines for the diagnosis 
 and treatment of pulmonary hypertension. Eur Respir J. 2009 Dec;34 

SOURCE  Actelion Pharmaceuticals Canada Inc. 
Actelion Canada Marie-Claude Lefebvre 
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CO: Actelion Pharmaceuticals Canada Inc.
ST: Quebec
-0- Sep/16/2013 16:31 GMT
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