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Aptalis Pharmaceutical Technologies Announces U.S. Commercial Availability of ULTRESA™ (Pancrelipase) Delayed-Release Capsules


12/10/2012 9:29:29 AM

BRIDGEWATER, NJ--(Marketwire - December 10, 2012) -

Aptalis Pharma U.S., Inc., a global specialty pharmaceutical company focused on gastrointestinal diseases and cystic fibrosis (CF), announced that ULTRESA™ (pancrelipase) delayed-release capsules are now commercially available in the U.S. ULTRESA is a combination of porcine-derived lipases, proteases, and amylases indicated for the treatment of exocrine pancreatic insufficiency (EPI) due to CF or other conditions.

Frank Verwiel, M.D., President and Chief Executive Officer of Aptalis Pharma, stated, "Aptalis is pleased to be able to make ULTRESA available in the U.S. With ULTRESA, patients and their healthcare providers will have another important treatment option for EPI due to CF or other conditions. ULTRESA gives us a new opportunity to support the CF and gastrointestinal disorder communities and represents another important step toward the mission that inspires us: to improve health and quality of care by providing specialty therapies for patients around the world."

ULTRESA helps treat malabsorption in patients with EPI due to CF or other conditions by significantly improving protein and fat absorption versus placebo.

In the pivotal, placebo-controlled study of 31 patients with EPI due to CF, ULTRESA-treated patients had a significantly higher coefficient of fat absorption (CFA, primary endpoint) and protein absorption (secondary endpoint) than placebo. Mean CFA was 89% with ULTRESA treatment compared to 56% with placebo treatment. The mean difference in CFA was 35 percentage points in favor of ULTRESA treatment (95% CI: (25, 45); p < .0001). The mean coefficient of nitrogen absorption (CNA) was 84% with ULTRESA compared to 59% with placebo treatment. The mean difference in CNA was 26 percentage points in favor of ULTRESA (95% CI: (18,33); p < .0001).*

ULTRESA is available in three capsule strengths (23,000, 20,700, and 13,800 USP units of lipase) containing enteric-coated mini tablets. The 23,000 unit high dosage strength capsule may allow patients to take fewer capsules to achieve the prescribed dose per meal.

The ULTRESA Patient Support Program will also be available to eligible patients at launch.

ULTRESA is well tolerated. The most common adverse reactions occurring in at least two patients treated with ULTRESA were headache, pharyngolaryngeal pain, and epistaxis.

Important Safety Information for ULTRESA

  • Fibrosing colonopathy is associated with high-dose use of pancreatic enzyme replacement. Exercise caution when doses of ULTRESA 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 ULTRESA or retain in mouth.
  • Exercise caution when prescribing ULTRESA to patients with gout, renal impairment, or hyperuricemia.
  • There is theoretical risk of viral transmission with all pancreatic enzyme products, including ULTRESA.
  • 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.
  • The most common adverse reactions ( ≥ 7% of patients treated with ULTRESA) were headache, pharyngolaryngeal pain, and epistaxis.
  • Use of ULTRESA in pediatric patients is limited by the available capsule dosage strengths and their ability to provide the recommended dose based on age and weight.
  • ULTRESA is not interchangeable with any other pancrelipase product.

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

*A multicenter, randomized, double-blind, placebo-controlled crossover study of 31 patients, aged 8 to 37, with EPI due to CF or other conditions. The final analysis population was comprised of 24 patients who completed both treatment periods and had stool results available for each treatment period. Patients were randomized to receive ULTRESA (at a dose not to exceed 2500 lipase units per kilogram per meal or snack) or matching placebo for six to seven days of treatment followed by crossover to the alternate treatment for an additional six to seven days. All patients consumed a high-fat diet during the treatment periods. The CFA and CNA were determined by a 72-hour stool collection during both treatment periods.

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™, ULTRESA™ 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 ULTRESA™. 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.


FOR FURTHER INFORMATION PLEASE CONTACT:

Steve Gannon
Senior Vice President
Chief Financial Officer
Treasurer
Aptalis Pharma
+1-450-467-5138

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