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Aug. 9, 2012 /PRNewswire/ -- BioDelivery Sciences International, Inc. (Nasdaq: BDSI) announced that it has filed its Quarterly Report on Form 10-Q for the quarter ended
June 30, 2012 with the U.S. Securities and Exchange Commission. In connection therewith, BDSI is providing a review of its recent achievements in 2012, as well as an update on business operations and upcoming milestones for the balance of the year.
June 30, 2012, BDSI had
$43.0 million in cash compared to
$10.8 million at
June 30, 2011. Contributions to BDSI's cash balance during the second quarter included a milestone payment of
$15 million associated with the licensing and development agreement with Endo Health Solutions (Endo) for BEMA Buprenorphine. The milestone was triggered by the granting of a patent extending the exclusivity for BEMA Buprenorphine and BEMA Buprenorphine/Naloxone (BNX) by seven years to 2027.
BDSI also received a milestone payment from Meda in the amount of
$2.5 million following the first E.U. country registration and pricing approval for BREAKYL (trade name for ONSOLIS in the E.U.). Meda is BDSI's worldwide commercial partner for ONSOLIS/BREAKYL, outside of
South Korea, where the product is separately partnered.
Last week, BDSI and Endo announced initiation of enrollment in the Phase 3 clinical program for BEMA Buprenorphine for the treatment of moderate to severe chronic pain. Additionally, data is anticipated to be available by the end of September for the pivotal bioavailability study for BNX, which is currently ongoing.
"We are extremely pleased to have both of our key assets, BEMA Buprenorphine for chronic pain and BNX for opioid dependence, move into pivotal registration trials," said Dr.
Mark A. Sirgo, President and Chief Executive Officer of BDSI. "We announced a number of exciting achievements in the first quarter of this year, including the signing of the licensing and development agreement for BEMA Buprenorphine with Endo and a positive meeting with FDA on our BNX development program. Since the first quarter, we have built on these prior accomplishments by progressing both BEMA Buprenorphine and BNX into registration studies. These are significant achievements and have ushered in a very exciting period of time at BDSI. As it relates to the BNX clinical development program, we look forward to the availability of data from our pivotal pharmacokinetic study in late September."