Aptalis Pharmaceutical Technologies Announces U.S. Commercial Availability of VIOKACE(TM) (Pancrelipase) Tablets

BRIDGEWATER, NJ--(Marketwire - August 14, 2012) -

Aptalis Pharma, a global specialty pharmaceutical company focused on gastrointestinal diseases and cystic fibrosis, announced that VIOKACE™ (pancrelipase) Tablets are now commercially available in the U.S. Approved by the U.S. Food and Drug Administration on March 1st, VIOKACE, in combination with a proton pump inhibitor, is indicated in adults for the treatment of exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatectomy.

Frank Verwiel, M.D., President and Chief Executive Officer of Aptalis Pharma, stated, “We are very pleased to be able to make VIOKACE available in the U.S. The launch of VIOKACE brings an uncoated pancreatic enzyme to market, providing another important treatment option for adult patients with exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatectomy. VIOKACE provides Aptalis an opportunity to support this patient population, as well as the healthcare professionals who treat them, in meeting the significant challenges posed by these conditions.”

VIOKACE, in combination with a proton pump inhibitor, produced significant improvement in fat absorption in the pivotal, placebo-controlled study* of patients with exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatectomy. The mean CFA was 86% with VIOKACE treatment compared to 58% with placebo. The mean difference in CFA at the end of the double-blind treatment period was 28 percentage points in favor of VIOKACE treatment with 95% Confidence Interval of (21, 37) and P≤.0001.

Important Safety Information for VIOKACE™

• Fibrosing colonopathy is associated with high-dose use of pancreatic enzyme replacement. Exercise caution when doses of VIOKACE 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 VIOKACE or retain in the mouth.
• Exercise caution when prescribing VIOKACE to patients with gout, renal impairment, or hyperuricemia.
• There is theoretical risk of viral transmission with all pancreatic enzyme products including VIOKACE.
• In rare cases, patients taking pancreatic enzyme products with different formulations of the same active ingredient (pancrelipase) have experienced severe allergic reactions including anaphylaxis, asthma, hives, and pruritus. Exercise caution when administering pancrelipase to a patient with a known allergy to proteins of porcine origin.
• VIOKACE tablets contain lactose monohydrate. Patients who have lactose intolerance may not be able to tolerate VIOKACE.
• Adverse reactions occurring in at least 2 chronic pancreatitis or pancreatectomy patients (greater than or equal to 7%) receiving VIOKACE are biliary tract stones and anal pruritus.
• The safety and effectiveness of VIOKACE in pediatric patients have not been established. VIOKACE use in pediatric patients may result in suboptimal growth due to tablet degradation in the gastric environment. In general, delayed release (enteric-coated) capsules should be used for pediatric patients.
• VIOKACE is not interchangeable with any other pancrelipase product.

For complete information about safety, warnings and precautions for VIOKACE™, please click here for the full Prescribing Information and Medication Guide.

*A multicenter, randomized, parallel-group, placebo-controlled, double-blind study of 50 patients, ages 24 to 70 years. After a wash-out period (6-7 days), patients were randomized to a fixed dose of VIOKACE, 22 tablets per day (6 tablets with 3 meals and 2 tablets with 2 or 3 snacks) or placebo, in combination with a proton pump inhibitor. Duration of exposure ranged from 6 to 7 days. All patients were maintained on a controlled high-fat diet of 100 grams of fat per day. Forty-nine patients completed the double-blind period. The CFA was determined by a 72-hour stool collection during both treatments, when both fat excretion and fat ingestion were measured.

About Aptalis
Aptalis Pharma is a privately held, leading specialty pharmaceutical company providing innovative, effective therapies for unmet medical needs including cystic fibrosis and gastrointestinal disorders. Aptalis has manufacturing and commercial operations in the United States, the European Union and Canada, and its products include ZENPEP®, CANASA®, CARAFATE®, PYLERA®, RECTIV™, VIOKACE™, 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.

Forward-Looking Statements
This release contains forward-looking statements within the meaning of the U.S. federal securities laws, including statements regarding the expectations for the commercialization and marketing of VIOKACE™. Forward-looking statements include those which express plan, anticipation, intent, contingency, goals, targets or future development and/or otherwise are not statements of historical fact. The words “expects,” “potentially,” “anticipates,” “could,” “calls for” and similar expressions also identify forward-looking statements. These statements are based upon Aptalis’ current expectations and are subject to risks and uncertainties which could cause actual results and developments to differ materially from those expressed or implied in such statements. Factors that could affect actual results and developments include the results, consequences, effects or timing of any inquiry or investigation by any regulatory authority or any legal or administrative proceedings, and the successful preparation and implementation of an effective marketing plan. Investors should evaluate any statement in light of these important factors. Forward-looking statements contained in this press release are made as of this date, and, other than as required by applicable law, Aptalis undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Actual events could differ materially from those anticipated in the forward-looking statements.

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