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Aptalis Pharmaceutical Technologies Announces European Commission Approval for a New Oral Granule Formulation of Viread®


12/13/2012 11:27:44 AM

Bridgewater, New Jersey, December 13, 2012 – Aptalis Pharmaceutical Technologies, formerly Eurand Pharmaceutical Technologies, focused on developing differentiated oral products utilizing its pharmaceutical technologies, today announced that the European Commission granted marketing authorization for a new pediatric indication of a new oral granule formulation of Gilead Sciences, Inc.'s Viread® (tenofovir disoproxil fumarate) for HIV-1 infected children aged 2 to less than 6 years, and for HIV-1 infected children above 6 years of age for whom a solid dosage form is not appropriate. This authorization, which covers all 27 countries of the European Union (EU), follows the January 2012 U.S. Food and Drug Administration’s (FDA) New Drug Application (NDA) approval of Viread® oral powder in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients ages 2-5. The oral powder, which utilizes Microcaps® taste-masking formulation technology, will be manufactured and supplied to Gilead by Aptalis Pharmatech, Inc. Gilead will be responsible for product commercialization.

"The FDA and European Commission approvals of the oral granule formulation of Gilead’s Viread® for use in the United States and Europe respectively, are examples of how our company’s turnkey business model differentiates our services in the drug development process. We leverage our breadth of capabilities, experience and expertise to provide a comprehensive resource for our partners to establish effective pathways to commercialization. To this end, we are pleased to have had the opportunity to co-develop the pediatric oral powder formulation of ! !Viread® with Gilead using our Microcaps® proprietary technology” said John Fraher, President of Aptalis Pharma.

About Microcaps®

The 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 company’s AdvaTab® technology to provide an orally disintegrating tablet with superior mouth-feel attributes.

About Aptalis Pharmaceutical Technologies

Aptalis Pharmaceutical Technologies, formerly known as Eurand Pharmaceutical Technologies, offers a broad portfolio of oral drug delivery technology platforms: Customized Drug Release, Bioavailability Enhancement, and Taste Masking for ODT’s (orally disintegrating tablets) and other dosage forms. Together, these technology platforms combined with licensing, manufacturing, and R&D capabilities enable Aptalis Pharmaceutical Technologies to produce customized drug formulation solutions for partners across a range of dosage forms and therapies. Aptalis Pharmaceutical Technologies develops and manufactures products for its partners, and supports the drug development process for the Aptalis pipeline and portfolio of products. For more information about Aptalis Pharmaceutical Technologies, visit www.AptalisPharmaTech.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. Formed from the recent combination of Axcan Pharma and Eurand, Aptalis 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 technologies, and taste-masking/orally disintegrating tablet (ODT) formulations. For more information, visit www.aptalispharma.com.

Media Contact:

Erin O’Brien, Director of Marketing

Aptalis Pharmaceutical Technologies

908-927-9600, Ext. 4084

eobrien@aptalispharma.com



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