BioDelivery Sciences International Inc.
) 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.
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
We note that in January 2012,
) 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'
BIODELIVERY SCI (BDSI): Free Stock Analysis
ENDO PHARMACEUT (ENDP): Free Stock Analysis
(RBGPY): ETF Research Reports
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