FDA Approves Creon

Creon (pancrelipase) Delayed-Release Capsules First and Only Pancreatic Enzyme Product to Receive FDA Approval Under New Guidelines

– Therapy is medically-necessary for thousands of patients with exocrine pancreatic insufficiency due to cystic fibrosis or other conditions –

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. The primary efficacy endpoint was the coefficient of fat absorption (CFA), which measures the percentage of fat absorption relative to dietary fat intake. 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.

About Exocrine Pancreatic Insufficiency and Pancreatic Enzyme Products

Exocrine Pancreatic Insufficiency (EPI) is a condition resulting from a deficiency in the production and/or secretion of pancreatic enzymes that are necessary to digest nutrients in food. For patients with EPI, pancreatic enzymes are essential to ensure adequate nutrition and health. Pancreatic enzyme products work in patients with EPI by delivering pancreatic enzymes to the small intestine to help break down fats, proteins and carbohydrates in food, thereby acting as a replacement for digestive enzymes physiologically secreted by patients. EPI can occur as a complication of a variety of diseases or conditions, including CF, pancreatic cancer, gastrointestinal surgery and chronic pancreatitis. Statistics show that more than 80% of CF patients have EPI, which usually develops during the first year of life.

The original products in the pancreatic enzyme drug class pre-date modern FDA regulatory requirements. Over the past two decades, products in this class have been allowed to be marketed as prescription drugs without formal NDA approval. In 2004, the FDA required manufacturers to submit NDAs for all pancreatic enzyme products in order to remain on the market. By April 2010, all pancreatic enzymes are required to have approved NDAs and must be manufactured under the new guidelines.

Important Safety Information about FDA-Approved Creon

In the clinical study used to demonstrate the efficacy and safety of FDA-approved Creon, 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.

Warnings and precautions include fibrosing colonopathy, a rare, serious adverse reaction that has been described in association with high-dose use of pancreatic enzyme replacement therapy in the treatment of cystic fibrosis patients. Caution should be exercised when doses of Creon exceed 2,500 lipase units/kg of body weight per meal (or greater than 10,000 lipase units/kg of body weight per day). Care should be taken to ensure that Creon is not chewed or retained in the mouth to avoid irritation of oral mucosa. Caution should be exercised when prescribing Creon to patients with gout, renal impairment, or hyperuricemia. There is theoretical risk of viral transmission with all pancreatic enzyme products including Creon. Caution should be exercised when administering pancrelipase to a patient with a known allergy to proteins of porcine origin.

Creon has been approved with a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of the drug outweigh its risks. As part of the REMS, a Medication Guide with important dosing and safety information applicable to this class of products, including Creon, is provided for patients and caregivers, with an emphasis on understanding the risk of fibrosing colonopathy as well as the importance of not over- or under-dosing. The FDA requires that the Medication Guide be handed out with every prescription for the drug dispensed.

Full prescribing information for FDA-approved Creon will be distributed when the product becomes commercially available, targeted for the third quarter of 2009. For full safety and prescribing information about the current and FDA-approved formulations of Creon, visit www.CREON-US.com.

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

Solvay Pharmaceuticals is a research driven group of companies that constitutes the global pharmaceutical business of the Solvay Group. These companies seek to fulfill carefully selected, unmet medical needs in the therapeutic areas of neuroscience, cardiometabolic, influenza vaccines, gastroenterology and men's and women's health. Its 2008 sales were EUR 2.7 billion and it employs more than 9,000 people worldwide. For more information, visit www.solvaypharmaceuticals.com.

Solvay is an international Chemicals and Pharmaceuticals Group with headquarters in Brussels. It employs some 28,300 people in 50 countries. In 2008, its sales amounted to EUR 9.5 billion generated by its three activity sectors: Chemicals, Plastics and Pharmaceuticals. Solvay (NYSE-Euronext: SOLB.BE - Bloomberg: SOLB.BB - Reuters: SOLBt.BR) is listed on NYSE-Euronext at Brussels. Details are available at www.solvay.com.

# # #

CONTACT:

Neil Hirsch Trina Chiara

Manager, U.S. Corporate Communications Senior Vice President

Solvay Pharmaceuticals, Inc. Ruder Finn

(770) 578- (646) 244-1379

chiarat@ruderfinn.com

Posted: May 2009

Related Articles:

Creon (pancrelipase) FDA Approval History

View comments

Hide
(web3)