BioDelivery Sciences International Inc. (BDSI - Analyst Report) recently announced that it has finished enrolling patients in a pivotal pharmacokinetic study (BNX 103) being conducted with BEMA buprenorphine/naloxone (BNX). The company also announced the completion of the clinical portion of the study. BNX is being evaluated for the treatment of opioid dependence.
Study participants have already been dosed and a plasma sample analysis is being conducted. BioDelivery intends to present results from the study before the end of September 2012.
According to an agreement with the US Food and Drug Administration (FDA), in February 2012, BNX-103 was designed to compare the relative bioavailability of buprenorphine and naloxone with the reference drug of Reckitt Benckiser Pharmaceuticals Inc.’s Suboxone.
BioDelivery expects the open-label safety study for the program BNX-103, to be completed by the end of 2012. Necessary product stability data from the study are expected to be available by the first quarter of 2013. The company is also planning for submission of the New Drug Application (NDA) in the second quarter of 2013.
We note that in January 2012, Endo Pharmaceuticals (ENDP - Analyst Report) inked a global license and development agreement with BioDelivery Sciences regarding the latter’s pain candidate BEMA buprenorphine. As per the terms of the deal, Endo Pharma is responsible for the manufacturing, distribution and commercialization of the candidate on a worldwide basis.
Following the deal, BioDelivery Sciences has received $30 million as an upfront payment. The $15 million payable by Endo Pharma, on the extension of BEMA buprenorphine’s patent protection period will result in Endo Pharma making payments worth $45 million under the deal. BioDelivery Sciences is eligible to receive a further $135 million in milestone payments in addition to royalties from Endo Pharma.
Currently, we have a Neutral recommendation on BioDelivery Sciences, which carries a Zacks #3 Rank (short-term ‘Hold’ rating).