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Cystic Fibrosis Canada Welcomes Health Canada's Approval Of KALYDECO™

Calling for the manufacturer and drug insurance plans to ensure CF patients receive equitable and affordable access to KALYDECO

TORONTO, Dec. 3, 2012 /CNW/ - Health Canada has issued a Notice of Compliance (NOC) for KALYDECO™, approving the drug for use in Canada. This gives Canadian cystic fibrosis (CF) patients with the G551D mutation (ages six and older) a chance to gain access to this new, breakthrough treatment. Cystic Fibrosis Canada calls on Vertex Pharmaceuticals Inc. and drug plan administrators to work together to resolve the high price of KALYDECO™ so that CF patients can access this drug in an equitable and affordable way.

"The approval of KALYDECO™ is just the first step in bringing this new, breakthrough therapy to CF patients," said Ken Chan, Vice President, Advocacy, Research and Healthcare. "As one of the most expensive drugs in the world, CF patients simply cannot afford to pay for this much-needed medicine. Cystic Fibrosis Canada is calling for a compassionate approach from manufacturers and drug plan administrators when it comes to making new, life-changing medicines accessible to CF patients."

KALYDECO™ is the first therapy that targets the underlying cause of cystic fibrosis. This drug helps to improve the function of the defective protein, leading to better lung function, weight gain and lower sweat chloride levels. For a CF patient with the specific G551D mutation, access to KALYDECO™ could lead to a healthier, longer life. Canada now joins the United States and the European Union in making KALYDECO™ available for use for CF patients. The G551D mutation is present in roughly 100 Canadians with cystic fibrosis.

"When the gene responsible for cystic fibrosis was discovered in Canada back in 1989, one could only imagine the moment when that discovery would lead to a drug like KALYDECO™, said Cystic Fibrosis Canada President and CEO Maureen Adamson. "This is the beginning of good news for Canadian CF patients, and I look forward to even better news when this drug will be affordable and accessible to the patients who will benefit from it." Cystic Fibrosis Canada helped fund the international team that discovered the CF gene under the leadership of Dr. Lap- Chee Tsui at the Hospital for Sick Children in Toronto.

Key opinion leaders throughout the Canadian CF clinical community also strongly support giving patients access to this drug.

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