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FDA Approves Gilead Sciences, Inc. (GILD) NDA for Viread in HIV-Infected Children


1/19/2012 8:29:27 AM

BRIDGEWATER, NJ--(Marketwire - January 18, 2012) - Aptalis Pharma, a global specialty pharmaceutical company focused on gastrointestinal diseases and cystic fibrosis, today announced that the U.S. Food and Drug Administration (FDA) has approved a New Drug Application (NDA) for Gilead Sciences, Inc.'s Viread® (tenofovir disoproxil fumarate) oral powder in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients ages 2-5. Co-developed by Aptalis and Gilead, the oral powder formulation of Viread® uses the Aptalis Microcaps® taste-masking technology. Gilead will be responsible for the product commercialization, while Aptalis will manufacture and supply the oral powder to Gilead.

John Fraher, President of Aptalis Pharma, stated, "We are delighted to have the opportunity to use our Microcaps® proprietary technology to co-develop the oral powder formulation of Viread® with Gilead, which was the result of an Aptalis program referred to as EUR-1030."

About Microcaps®
The Aptalis microencapsulation technology, known as Microcaps®, employs versatile and precise coating techniques to encapsulate individual drug particles using solvent- and aqueous-based coacervation. This includes taste and odor masking, customized release profiles, conversion of liquids to solids and the separation of incompatible materials. Microcaps® can also be combined with the Aptalis AdvaTab® technology to provide an orally disintegrating tablet with superior mouth-feel attributes.

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.

Forward-Looking Statements
This release contains forward-looking statements within the meaning of the U.S. federal securities laws, including statements regarding the transaction, its timing and terms and statements regarding the expectations for the commercialization and marketing of Viread. 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, the successful preparation and implementation of an effective marketing plan, and any other risks set forth in Aptalis' filings with the SEC, including Aptalis Pharma Inc.'s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, in each case together with all amendments thereto. 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.

Viread® is a registered trademark of Gilead Sciences, Inc.


FOR FURTHER INFORMATION PLEASE CONTACT:

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




   

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