Anticipated 2012 MilestonesIn 2012, BDSI is focusing its resources on achievement of the following key milestones:
- Recruitment of two Phase 3 studies for BEMA Buprenorphine. BDSI and Endo expect to continue recruitment in two Phase 3 efficacy studies for BEMA Buprenorphine for chronic pain, one in opioid experienced and one in opioid naïve patient groups.
- Reporting of pivotal pharmacokinetic study results for BNX. BDSI will advance the development of BNX for the treatment of opioid dependence through completion of the pivotal pharmacokinetic study and full recruitment of the safety study, allowing for a potential NDA submission in the first half of 2013. The data from the pivotal pharmacokinetic study is anticipated by the end of September 2012.
- Launch of BREAKYL in the E.U. BDSI expects its commercial partner, Meda, to launch BREAKYL (brand name for ONSOLIS in the E.U.) in the E.U. during the fourth quarter of 2012. This launch would result in a milestone payment to BDSI of $2.5 million.
- Exploration of Potential New Products and Technologies. In addition to supporting its marketed product and advancing its lead products in development, BDSI is also, as in the past, exploring the application of its BEMA drug delivery technology to additional pharmaceuticals. Furthermore, BDSI has been investigating potential new products or technologies to compliment its existing portfolio.