New treatment option for PAH now available in Canada

05.01.2014

Media Release

  • For the first time, an oral treatment for pulmonary arterial hypertension has shown long term reduction in morbidity events.

LAVAL, QC – May 1, 2014 – Actelion Pharmaceuticals Canada Inc. announced today that OPSUMIT® (macitentan) is now commercially available to Canadians affected by pulmonary arterial hypertension (PAH). This new 10 mg once-daily oral tablet is a dual endothelin receptor antagonist (ERA), and was approved by Health Canada for the long-term treatment of PAH to reduce morbidity.

“Whenever a new treatment for PAH becomes available in Canada, our community can’t help but feel hopeful for improved potential health outcomes for patients. Since the effectiveness of treatments for PAH often varies from patient to patient, this availability marks another crucial option in the fight against PAH,” said Ruth Dolan, director of the Pulmonary Hypertension Association of Canada, and mother of a PAH patient.

OPSUMIT is indicated for the long-term treatment of pulmonary arterial hypertension (PAH, WHO Group I) to reduce morbidity in patients of WHO Functional Class II or III whose PAH is either of unknown origin or inherited, or associated with connective tissue disease or congenital heart disease. Opsumit is effective when used as a monotherapy or in combination with phosphodiesterase-5 inhibitors.

“The strength and quality of evidence supporting OPSUMIT’s efficacy is impressive from both pre-clinical and clinical standpoints. This medication was designed to penetrate tissues more effectively and bind to receptors longer than current therapies,” said Dr. Sanjay Mehta, MD, FRCPC, FCCP, Professor of Medicine at Western University, Director of the Southwest Ontario Pulmonary Hypertension Clinic at the London Health Sciences Center in London, Ontario and Chair of the Pulmonary Hypertension Association of Canada.

“This means better safety for our patients, fewer drug-drug interactions, and, as a result, easier, less frequent monitoring. Furthermore, macitentan’s long-term clinical study, SERAPHIN, for the first time demonstrated long-term positive results in reducing morbidity-mortality as measured

by a composite endpoint, in addition to improving short-term physical functioning. To date, other medications were only studied in the short-term, so Canadians affected by PAH can now be optimistic at the potential of a better quality of life and the long-term management of this devastating condition.

The efficacy of OPSUMIT was established in the SERAPHIN study, a long-term study of 742

PAH patients with predominantly WHO Functional Class II-III symptoms treated for an average of two years. Patients were treated with OPSUMIT monotherapy or in combination with phosphodiesterase-5 inhibitors or inhaled prostanoids.

The SERAPHIN study has shown that OPSUMIT reduces the risk of morbidity-mortality as measured by a composite endpoint by 45% and the risk of an event in the composite endpoint of PAH related death or hospitalization by 50%. OPSUMIT is the only oral PAH treatment that has proven efficacy on long-term PAH outcomes. [1]

OPSUMIT is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container; women who are or may become pregnant and nursing women (see Warnings and Precautions, Special Populations, Pregnant and Nursing Women sections of the product monograph).

The most common adverse reactions (more frequent than placebo by 3% or more) observed in patients treated with OPSUMIT were anemia, nasopharyngitis/pharyngitis, bronchitis, headache, influenza, and urinary tract infection.

Physicians are advised to measure hemoglobin prior to initiation of treatment, again after one month, and periodically thereafter as clinically indicated. Liver enzyme blood tests should be obtained prior to initiation of OPSUMIT, and monthly testing during the first year of treatment is recommended and then less frequently thereafter as clinically indicated.

“The availability of OPSUMIT in Canada marks a significant milestone for PAH physicians and patients, and our goal is to work closely with the provinces and insurance companies to ensure patients who will benefit from this innovative treatment can access it. I am pleased to confirm that many private insurers have already decided to reimburse Opsumit.” said Jacques Archambault, President of Actelion Pharmaceuticals Canada Inc.

About Pulmonary Arterial Hypertension [2,3]

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.

About 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 in patients with cutaneous T-cell lymphoma.

Founded in late 1997, with now over 2,400 dedicated professionals covering all key markets around the world including 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.

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

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