BioDelivery Sciences Provides Business Review and Update in Conjunction with Filing of its Ann... (cStyle type disc Quality Financing .&...)

BioDelivery Sciences Provides Business Review and Update in Conjunction with Filing of its Annual Report

Date:3/19/2012

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Quality Financing. Secured a financing in March 2011 yielding gross proceeds of $15 million with fundamental health care investors at market terms and without warrant coverage.

BEMA Buprenorphine - Chronic Pain. Completed and announced results of the Phase 3, randomized, placebo-controlled clinical study of BEMA Buprenorphine for the treatment of moderate to severe chronic low back pain in a mixed population of opioid naive and experienced patients. While the primary endpoint, overall pain intensity difference between BEMA Buprenorphine and placebo, was not achieved, a near statistically significant difference between BEMA Buprenorphine and placebo was seen in the opioid experienced group of patients in the trial (p=0.067), and further, when eliminating the group of patients that did not titrate beyond the starting dose, a statistically significant difference between BEMA Buprenorphine and placebo (p=0.025) was identified. The knowledge gained in the study is being directly applied in partnership with Endo to the design of two additional Phase 3 trials anticipated to start in the third quarter of 2012. BDSI believes such knowledge will enhance the probability of such trials meeting their primary endpoints.

BNX - Opioid Dependence. Obtained positive results from two studies assessing the pharmacokinetics of BNX. Results of the studies demonstrated the ability of the BEMA formulation to meet the key pharmacokinetic goal of delivering plasma concentrations of buprenorphine in the range needed to treat opioid dependence while minimizing the exposure to the abuse deterrent, naloxone. Results of the studies were shared with FDA and an agreement was reached on the development program for BNX that is anticipated to result in a New Drug Application (NDA) for the treatment of opioid dependence in the first half of 2013. Key data results from the pivotal phar

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