Marietta, Ga., May 1, 2009 –  Solvay Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) approved CREON® (pancrelipase) Delayed-Release Capsules for the treatment of exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF) or other conditions. CREON® is the first and only pancreatic enzyme product (PEP) to receive FDA approval under new guidelines for the class.

"Left untreated, EPI causes maldigestion, malabsorption and malnutrition and can ultimately be life-threatening," said Virginia Stallings, M.D., Director, Nutrition Center at the Children's Hospital of Philadelphia, PA and Professor of Pediatrics, University of Pennsylvania School of Medicine. "The goals of treating EPI are to optimize digestion and absorption of food and nutrients, improve outcomes for patients and prevent malnutrition and growth faltering in children and weight loss in adults. Pancreatic enzymes serve as an important component in the effective management of EPI throughout a patient's lifetime."

The efficacy of FDA-approved CREON® was demonstrated in a randomized, double-blind, placebo-controlled crossover study which enrolled 32 patients with CF.1B The primary efficacy endpoint was the coefficient of fat absorption (CFA), which measures the percentage of fat absorption relative to dietary fat intake.1B CREON® produced significantly greater mean CFA values compared to placebo in this study. The mean CFA during treatment with CREON® was 89% versus 49% during treatment with placebo, representing a mean difference in CFA of 41%. CREON® showed statistically-significant increases in CFA for both adults (age >18 years) and adolescents (age 12-18 years). There was no relevant difference in the magnitude of response between the age groups. The incidence of adverse events (regardless of causality) was higher during placebo treatment (71%) than during CREON treatment (50%).Treatment-emergent adverse events occurring in at least two patients (greater than or equal to 6%) receiving CREON® or placebo were abdominal pain, abdominal pain upper, abnormal feces, cough, dizziness, flatulence, headache and weight decreased.

"As the first and only product in the pancreatic enzyme class to be FDA-approved under the new guidelines, CREON® helps meet a critical need for thousands of patients with EPI," said Dr. Stephen Hill, President, Solvay Pharmaceuticals, Inc. "For more than 20 years, Solvay Pharmaceuticals has been committed to the pancreatic enzyme market in the United States and is proud to bring FDA-approved CREON® to patients suffering from EPI."

The FDA-approved formulation of CREON® is targeted to become commercially available in the third quarter of 2009. The currently-marketed formulation of CREON® will continue to be commercially available until the launch of the FDA-approved product. Solvay Pharmaceuticals is committed to helping healthcare professionals, patients and their caregivers transition to the FDA-approved formulation of CREON®. Solvay Pharmaceuticals has ongoing partnerships with leading professional organizations to educate healthcare professionals and to encourage proper prescribing of CREON®.

Solvay Pharmaceuticals, Inc., of Marietta, Georgia, is the U.S. subsidiary of Solvay Pharmaceuticals. For more information, visit www.solvaypharmaceuticals-us.com.