BioDelivery Sciences soars on positive trial results
Shares of BioDelivery Sciences International Inc. (Nasdaq: BDSI) skyrocketed by 75% on heavy volume this morning after the Morrisville, N.C., drug delivery company announced positive trial results for cancer pain therapy Bema Fentanyl.
By 10:21 ET, the stock had shot up $3.48, or 75%, to a new 52-week-high of $8.12 on the news. Prior to today, shares had traded between $1.65 (on June 24, 2006) and $6.35 (on April 11) in the past year.
Volume was exceptionally heavy, with more than 4.6 million shares changing hands by 10:23 ET compared with an average three-month daily volume of 137,722 shares.
BioDelivery Sciences said that Bema Fentanyl showed a greater reduction in pain when compared to a placebo. Eighty patients participated in the placebo-controlled portion of the study.
According to Dr. Andrew Finn, BDSI’s executive vice president of product development, only five patients did not receive “adequate pain relief.”
He also said that Bema Fentanyl – a patch used to treat severe pain in cancer patients -- was well-tolerated by patients in the trial.
The company’s next step is to submit the data to a scientific conference for presentation. It has said that it expects to file a New Drug Application with the U.S. Food and Drug Administration for Bema Fentanyl, its lead drug candidate, during the second quarter of 2007.
BioDelivery Sciences believes that Bema Fentanyl’s efficacy and safety profile makes it “well-suited” to penetrate the 90% of the market that is not served by existing products. The firm projects it will reach annual peak sales of $250 million for the drug.
The road to approval hasn’t been entirely smooth so far. In August 2006, Clinical Development Capital IV, a fund managed by Elliott Associates that was a major financial backer of BEMA Fentanyl, terminated a contract to provide BDSI with up to $7 million in funding for phase III trials of the product.
In September, BDSI accused the fund of breaching a clinical development and license agreement and of trying to purchase the patents and/or rights underlying the Bema technology directly from BDSI's licensor.
