Although we don't believe in timing the market or panicking over market movements, we do like to keep an eye on big changes -- just in case they're material to our investing thesis.
What: Shares of BioDelivery Sciences (BDSI +0.00%), a specialty pharmaceutical company focused on developing therapies to manage pain care and oncologic support, surged higher by as much as 20% after it announced positive top-line phase 3 results involving BEMA buprenorphine for chronic pain patients that had previously been treated with an opioid-based therapy.
So what: According to the company's early morning press release, it and development part Endo Pharmaceuticals, a subsidiary of Endo Health Solutions (ENDP +0.00%), reported that BEMA buprenorphine met its primary endpoint of a statistically significant reduction in pain as measured by the mean change in the daily average pain numerical rating scale versus the placebo over a 12-week period. In addition, BEMA buprenorphine also met a number of key secondary endpoints. BioDelivery and Endo are both expected to meet with the Food and Drug Administration to discuss and subsequently file a new drug application as soon as possible. In lieu of the successful phase 3 results BioDelivery Sciences notes that it triggered a $10 million milestone payment from Endo.
Now what: Chronic pain management is a huge market opportunity for BioDelivery Sciences, but it's also a very crowded field, so even having Endo in its corner won't necessarily guarantee BEMA buprenorphine success. A lot will depend on drug pricing, insurance coverage, and physicians' willingness to prescribe the product. Although the company is being projected to turn the corner to profitability next year by Wall Street, I'm a bit concerned about its huge run-up into today's results. Given the crowded treatment field behind chronic pain patients, I'd suggest observing BioDelivery Sciences from the sidelines until we've witnessed a substantial pullback.
