European Commission Approves Paediatric Indication of Oral Granule Formulation

Aptalis Pharmaceutical Technologies, formerly Eurand Pharmaceutical Technologies, focused on developing differentiated oral products utilising its pharmaceutical technologies, has announced that the European Commission granted marketing authorisation for a new paediatric indication of a new oral granule formulation of Gilead Sciences, Inc.’s Viread (tenofovir disoproxil fumarate) for HIV-1 infected children aged two to less than six years and for HIV-1 infected children above six years of age for whom a solid dosage form is not appropriate.

This authorisation, which covers all 27 countries of the EU, follows the January 2012 FDA’s NDA approval of Viread oral powder in combination with other antiretroviral agents for the treatment of HIV-1 infection in paediatric patients ages two to five. The oral powder, which utilises Microcaps taste-masking formulation technology, will be manufactured and supplied to Gilead by Aptalis Pharmatech, Inc. Gilead will be responsible for product commercialisation.

John Fraher, President of Aptalis Pharma, commented: “The FDA and European Commission approvals of the oral granule formulation of Gilead’s Viread for use in the US 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 commercialisation. To this end, we are pleased to have had the opportunity to co-develop the paediatric oral powder formulation of Viread with Gilead using our Microcaps proprietary technology.”

Aptalis Pharmaceutical Technologies, +1 908 927 9600, www.aptalispharmatech.com.