Shares of BioDelivery Sciences International Inc. (BDSI) are up more than 500% year-to-date and trade over $4. As the company moves closer towards reporting the study results of its late-stage product candidate, BNX for the treatment of opioid dependence, it will be interesting to see how the stock price plays out in the coming days.
For readers who are new to BioDelivery Sciences, here's a brief overview of the company's pipeline and the upcoming catalysts to watch out for...
BioDelivery Sciences is a specialty pharmaceutical company focused on developing effective opioid analgesics with a low propensity for abuse and addiction. The company's patented and proprietary drug delivery technologies are BEMA (BioErodible MucoAdhesive) and Bioral.
There are two products under phase III testing - BEMA Buprenorphine for the management of moderate to severe chronic pain, and BEMA Buprenorphine/Naloxone, or BNX, for the treatment of opioid dependence.
The company is scheduled to report results of its pivotal pharmacokinetic study of BNX for the treatment of opioid dependence, dubbed BNX-103, before the end of this month (September, 2012). The BNX-103 study completed enrollment in August of this year.
According to BioDelivery Sciences, BNX contains the same drug components as Suboxone, the only currently marketed formulation of buprenorphine and naloxone, developed by UK-based consumer health firm Reckitt Benckiser plc. Buprenorphine reduces the craving and withdrawal effects from the dependent opioid, and the opioid antagonist, naloxone, is present to deter abuse.
Suboxone was approved for the treatment of opioid dependence in 2002, and according to market research firm Wolters Kluwer, sales of the drug in the U.S. exceeded $1.2 billion in 2011 and continue to steadily grow.
A positive outcome of BNX-103 will show that BEMA Buprenorphine/Naloxone is bioequivalent to Suboxone.
A safety study for BNX, which is the last clinical requirement for this program, is scheduled for completion by this year-end. If all goes well as planned, the product stability data for BNX is anticipated in the first quarter of 2013, followed by submission of the NDA in the second quarter.
BEMA Buprenorphine, for the management of moderate to severe chronic pain, is yet another compound which is under phase III testing. BioDelivery Sciences has a definitive license and development agreement with Endo Health Solutions Inc. (ENDP), formerly Endo Pharmaceuticals Holdings Inc., to develop and market BEMA Buprenorphine product candidate on a worldwide basis.
Last month, a phase III clinical program for BEMA Buprenorphine for the treatment of moderate to severe chronic pain was initiated with input from the FDA. The phase III program of BEMA Buprenorphine consists of two efficacy studies, one in opioid naïve and one in opioid experienced subjects. The studies are anticipated to be completed by late 2013 or early 2014.
A previous phase III study of BEMA Buprenorphine for the treatment of moderate to severe chronic pain in a mixed opioid naive and opioid experienced population, the results of which were which were reported last September, failed to meet the primary endpoint of overall pain intensity difference between BEMA Buprenorphine and placebo. However, there was significant pain control in the opioid "experienced" group of patients when treated with BEMA Buprenorphine in that phase III study, according to the company.
BioDelivery Sciences has one approved product - ONSOLIS for the management of breakthrough pain in cancer patients 18 years of age and older. The company has licensed the commercialization rights to ONSOLIS to Meda globally, with the exception of Taiwan and South Korea. In Europe, the drug is marketed as Breakyl.
A quick look at the company's balance sheet...
In the second quarter ended June 30, 2012, the company reported a net income of $2.53 million or $0.08 per share compared to a net loss of $5.09 million or $0.18 per share in the year-ago quarter. BioDelivery Sciences' total revenue, which included, contract revenue from the Endo license agreement and contract revenue under the Meda agreements, rose to $15 million in Q2, 2012, up from $38 thousand in the year-ago quarter. The company ended Q2, 2012 with cash and cash equivalents of approximately $43 million.
BDSI has thus far hit a low of $0.77 and a high of $5.19. The stock closed Friday's trading at $4.93, up 1.44%.
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