Aptalis Announces European Commission Approval for New Formulation of Viread®
Aptalis Pharmaceutical Technologies, formerly Eurand Pharmaceutical Technologies, focused on developing differentiated oral products utilising its pharmaceutical technologies, today announced that the European Commission has granted marketing authorisation for a new pediatric indication of a new oral granule formulation of Gilead Sciences’s Viread® (tenofovir disoproxil fumarate) for HIV-1 infected children aged two to six years of age, 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 in the European Union (EU), follows the January 2012 US 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 two to five.
The oral powder, which utilises Microcaps® taste-masking formulation technology, will be manufactured and supplied to Gilead by Aptalis Pharmatech. Gilead will be responsible for product commercialisation.
"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 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.