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 cardiology.³

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:

1-     PREPARE AND USE IMMEDIATELY: Fully diluted CARIPUL® can be administered for up to 48 hours at room temperature (25°C) at concentrations ≥3,000 ng/mL.^*,1

2-     PREPARE AND STORE FOR UP TO 8 DAYS IN REFRIGERATOR BEFORE USE: 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 SMI®).

To learn more about Actelion Pharmaceuticals, visit www.actelion.com.

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 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.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

References:

1. Product Monograph - CARIPUL® (epoprostenol) for Injection.  November 2012; Actelion Pharmaceuticals Canada Inc.
2. Sourced from: http://www.livingwithph.ca/disease_3.htm
3. Galiè N, Hoeper MM, Humbert M et al. Guidelines for the diagnosis and treatment of pulmonary hypertension. Eur Respir J. 2009 Dec;34(6):1219-63.

SOURCE: Actelion Pharmaceuticals Canada Inc.

Actelion Canada
Marie-Claude Lefebvre
[email protected]

www.actelion.com