Aptalis Pharma

Aptalis Pharma

17 juin 2011 11h55 HE

Aptalis Pharma Announces FDA Approval of 3,000 Lipase-Unit Strength of ZENPEP®

New Strength Specifically Formulated for Infants

BRIDGEWATER, NEW JERSEY--(Marketwire - June 17, 2011) - Aptalis Pharma, a global specialty pharmaceutical company focused on gastrointestinal diseases and cystic fibrosis (CF), today announced that the U.S. Food and Drug Administration (FDA) has approved a new low strength of ZENPEP® (pancrelipase) Delayed-Release Capsules that is specifically formulated for infants with exocrine pancreatic insufficiency (EPI) due to cystic fibrosis.

The new formulation will be offered in 3,000 units of lipase, the lowest strength of pancreatic enzyme replacement therapy currently approved by the FDA. The 3,000-lipase unit will allow caregivers to provide a full dose of ZENPEP, thereby eliminating the uncertainty about giving part of a larger capsule per serving.

"Proper nutrition is extremely important for patients with CF, and particularly for infants," said Frank Verwiel, M.D., President and Chief Executive Officer, Aptalis Pharma. "We are pleased to offer this new strength, which reflects our commitment to the CF community by providing another treatment option for physicians who treat infants with EPI due to CF, as well as more convenient and more precise dosing for caregivers."

With the addition of the 3,000-unit capsule, ZENPEP is now available in five strengths – including 5,000, 10,000, 15,000 and 20,000 units of lipase – to allow for dosing flexibility and potentially reduced pill burden to meet the varied needs of infants, toddlers, adolescents and adults with EPI. "Bringing this full range of ZENPEP strengths to physicians and patients is a result of our ongoing commitment to research and development," Verwiel noted.

Providing five even strengths of ZENPEP, along with award-winning patient-support programs such as ZPoints (www.zenpep.com/site/cfpatient.aspx) and CareFirst for Life (http://www.carefirstforlife.com), also will allow CF physicians and patients to continue to benefit from the products and programs offered by Aptalis. The ZPoints program, which provides vitamins, supplements and other support for patients with CF, will be extended to include this new dosage strength.

About Exocrine Pancreatic Insufficiency

Exocrine Pancreatic Insufficiency (EPI) is the inability to properly digest food due to a lack of digestive enzymes made by the pancreas. EPI can result from a number of diseases, including cystic fibrosis, pancreatic cancer, gastrointestinal surgery, and chronic pancreatitis. The FDA estimates that more than 200,000 Americans suffer from EPI. If left untreated, EPI causes malnutrition and, especially in CF patients, impaired growth in children, compromised immune response and shortened life expectancy.


Aptalis, through its Eurand Pharmaceuticals, Inc. subsidiary, manufactures and markets ZENPEP® (pancrelipase) Delayed-Release Capsules, an FDA-approved pancreatic enzyme product (PEP) indicated for the treatment of exocrine pancreatic insufficiency (EPI) due to cystic fibrosis or other conditions. This condition affects approximately 90% of patients with CF. ZENPEP is currently marketed only in the U.S.

Important Prescribing Information

Fibrosing colonopathy is associated with high-dose use of pancreatic enzyme replacement. Exercise caution when doses of ZENPEP exceed 2,500 lipase units/kg of body weight per meal (or greater than 10,000 lipase units/kg of body weight per day).

To avoid irritation of oral mucosa, do not chew ZENPEP or retain in the mouth.

Exercise caution when prescribing ZENPEP to patients with gout, renal impairment, or hyperuricemia.

There is theoretical risk of viral transmission with all pancreatic enzyme products, including ZENPEP.

Exercise caution when administering pancrelipase to a patient with a known allergy to proteins of porcine origin.

The most common adverse events (>6% of patients treated with ZENPEP) are abdominal pain, flatulence, headache, cough, decreased weight, early satiety, and contusion.

The safety and effectiveness of ZENPEP were assessed in pediatric patients, ages 1 to 17 years. The safety and efficacy of pancreatic enzyme products with different formulations of pancrelipase in pediatric patients have been described in the medical literature and through clinical experience.

For complete information about safety, warnings and precautions for ZENPEP, please see full Prescribing Information and Medication Guide at www.zenpep.com.

About Aptalis

Aptalis Pharma Inc. is a privately held, leading specialty pharmaceutical company providing innovative, effective therapies for unmet medical needs including cystic fibrosis and gastrointestinal disorders. Aptalis, formed from the recent combination of Axcan Pharma and Eurand, has manufacturing and commercial operations in the United States, the European Union and Canada, and its products include ZENPEP®, CANASA®, CARAFATE®, PYLERA®, LACTEOL®, DELURSAN®, PANZYTRAT® and SALOFALK®. Aptalis also formulates and clinically develops enhanced pharmaceutical and biopharmaceutical products for itself and others using its proprietary technology platforms including bioavailability enhancement of poorly soluble drugs, custom release profiles, and taste-masking/orally disintegrating tablet (ODT) formulations. For more information, visit www.aptalispharma.com.