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May 9, 2013 /PRNewswire/ -- BioDelivery Sciences International, Inc. (NASDAQ: BDSI) announced that it has filed its Quarterly Report on Form 10-Q for the quarter ended
March 31, 2013, with the U.S. Securities and Exchange Commission and, in connection therewith, is providing a review of BDSI's recent achievements and an update on business operations and upcoming milestones for 2013.
Continued progress was made in the development of BDSI's two buprenorphine-containing products with the completion in
January 2013 of the safety study for BUNAVAIL for the treatment of opioid dependence. The study, which included 249 patients who were switched from Suboxone to BUNAVAIL, demonstrated the ease of use and tolerability of BUNAVAIL.
In addition, recruitment continued toward a late 2013 or early 2014 completion of the two ongoing Phase 3 studies for BEMA Buprenorphine for the treatment of chronic pain, which are being conducted in conjunction with BDSI's partner, Endo Health Solutions.
March 31, 2013, BDSI had
$49.7 million in cash compared to
$63.2 million at
December 31, 2012 and
$32.1 million at
March 31, 2012. Cash used in operations for the first quarter of 2013 totaled
$13.5 million. Research and development costs were
$12.0 million in the first quarter of 2013, compared to a corresponding
$4.7 million in the first quarter of 2012. The current quarter increase over the prior year first quarter is due primarily to additional research and development costs associated with the concomitant running of the BUNAVAIL and BEMA Buprenorphine late stage development programs. Also contributing to the increase was the recording in
March 2013 of
$2.1 million of in-process R&D associated with the license discussed below for Clonidine Topical Gel from Arcion Therapeutics (Arcion).
In addition to clinical development activities, BDSI also made an important stride forward in building its pipeline of products for the treatment of pain with the acquisition of patented Clonidine Topical Gel for the treatment of painful diabetic neuropathy (PDN). BDSI entered into a worldwide licensing agreement with privately held Arcion, where BDSI will develop and commercialize Clonidine Topical Gel.