The following are key events that occurred at BDSI since the start of the second quarter of 2012:
- BEMA Buprenorphine - Chronic Pain. BDSI and Endo announced the initiation of the Phase 3 clinical program for BEMA Buprenorphine for the treatment of moderate to severe chronic pain. The Phase 3 program will consist of two efficacy studies, one in opioid naïve and one in opioid experienced subjects. Both studies are anticipated to be completed by late 2013 or early 2014. Both are double-blind, randomized, placebo-controlled, enriched-enrollment studies in patients with chronic lower back pain.Based on the licensing agreement for BEMA Buprenorphine, BDSI will receive milestone payments from Endo at completion of study enrollment and database lock for each trial, and subsequently, for the acceptance of filing of the New Drug Application (NDA) by the FDA. These payments will total $30 million. In January 2012, BDSI signed a worldwide license and development agreement with Endo for the exclusive rights to develop and commercialize BEMA Buprenorphine for the treatment of chronic pain. The agreement, worth up to $180 million to BDSI if all milestones are met, included an upfront payment of $30 million at signing, the recently received $15 million triggered by the granting of a patent extending exclusivity of BEMA products containing buprenorphine and a tiered mid- to upper-teen royalty on net sales in the U.S.
- BNX - Opioid Dependence. Positive results were obtained from a pharmacokinetic study (BNX-106) examining the effects of multiple BNX films administered concurrently. The study confirmed that the buprenorphine pharmacokinetics were nearly identical following multiple BNX films applied at one time compared to an equivalent dose administered as a single film. Additionally, there was a linear relationship in buprenorphine pharmacokinetics across the dose range of BNX administered. Regarding the naloxone component of BNX, the study demonstrated that the exposure of naloxone is similar to the reference standard, Suboxone. Results of the aforementioned study allowed for initiation of both the pivotal pharmacokinetic study and the safety study, both of which are currently underway. Results of the pivotal pharmacokinetic study are anticipated by the end of September. The current study timeline supports the filing of an NDA for BNX in the first half of 2013.
- ONSOLIS/BREAKYL. BDSI announced receipt of a pre-launch milestone payment of $2.5 million from Meda in conjunction with the first country registration and pricing approval for BREAKYL. A last milestone payment related to the E.U. of $2.5 million, is payable at the time of commercial launch, which is anticipated in late 2012. In the U.S., as previously announced, the re-launch of ONSOLIS is delayed until the product formulation can be modified and agreement reached with FDA to address certain appearance issues noted by FDA. Reformulation work has been completed and final test results are being compiled for an expected August submission of a formal meeting request to FDA.