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Cornerstone Therapeutics Initiates PERTZYE(R) (pancrelipase) Sales and Marketing Efforts for the Treatment of Exocrine Pancreatic Insufficiency in Patients With Cystic Fibrosis
CARY, NC--(Marketwired - Jul 29, 2013) - Cornerstone Therapeutics Inc. (NASDAQ: CRTX) announced today it is now actively marketing PERTZYE® (pancrelipase) in the U.S. for the treatment of Exocrine Pancreatic Insufficiency (EPI) due to cystic fibrosis. PERTZYE is the only U.S. Food and Drug Administration (FDA) approved pancreatic enzyme replacement therapy (PERT) containing bicarbonate-buffered, enteric-coated microspheres.1 It is estimated that about 90% of patients with cystic fibrosis require PERT.2

In healthy individuals, the pancreas produces bicarbonate that helps regulate the pH of the small intestine to hydrolyze fat, support sufficient lipase bioactivity, and optimize nutrient absorption.3-5 Patients with CF who have EPI may have a more acidic duodenal pH environment because the pancreas does not produce the bicarbonate-rich secretion required to neutralize gastric acid.3,5 PERTZYE's unique formulation, containing pancreatic enzymes buffered with bicarbonate, is designed to simulate normal pancreatic function in CF patients with EPI. 1,3-5

"We are pleased to now be able to provide patients a unique PERT formulation to help manage this complex condition," said Craig A. Collard, Cornerstone's Chief Executive Officer. "PERTZYE is the first of two FDA approved cystic fibrosis therapies that Cornerstone plans to offer this year. PERTZYE, together with BETHKIS® (tobramycin inhalation solution) when it launches this fall, will deliver on our goal to build a portfolio of cystic fibrosis treatments and educational support for people living with this disease."

Cornerstone Therapeutics licensed exclusive U.S. marketing rights to PERTZYE for the treatment of EPI in patients with cystic fibrosis from Digestive Care, Inc. (DCI) in May 2013. DCI's sales and marketing efforts for PERTZYE will continue to focus on meeting the needs of patients with EPI due to conditions other than cystic fibrosis in the U.S. market.

ABOUT PERTZYE (pancrelipase) DELAYED-RELEASE CAPSULES

PERTZYE is approved by the U.S. Food and Drug Administration (FDA) for the treatment of Exocrine Pancreatic Insufficiency due to cystic fibrosis or other conditions. PERTZYE is not interchangeable with other pancrelipase products. PERTZYE is the only FDA approved PERT containing bicarbonate-buffered, enteric-coated microspheres. This unique formulation was designed to optimize the pH environment for enzyme activity and nutrient absorption.1 PERTZYE is currently available in two strengths: 8,000 and 16,000 USP units of lipase/capsule.

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