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.
FOR FURTHER INFORMATION PLEASE CONTACT:
Steve Gannon
Senior Vice President, Chief Financial Officer and Treasurer
Aptalis Pharma
+1-450-467-5138
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.