Pharma

BDSI needs partner to finance round 2 of phase 3 trials in chronic pain

BioDelivery Sciences International (NASDAQ:BDSI) is running low on cash and running short on time as it works to find a drug partner before it runs out of both. The company has $15.1 million in cash — enough to last through the second quarter of 2012. But Raleigh, North Carolina-based BDSI is working on two clinical-stage […]

BioDelivery Sciences International (NASDAQ:BDSI) is running low on cash and running short on time as it works to find a drug partner before it runs out of both.

The company has $15.1 million in cash — enough to last through the second quarter of 2012. But Raleigh, North Carolina-based BDSI is working on two clinical-stage drug programs and it doesn’t have enough money to pay for both of them. One of them, BEMA Buprenorphine, indicated for treating chronic pain, needs another set of phase 3 trials after failing in trials in September.

CEO Mark Sirgo told analysts on a conference call that the company has studied those trial results and concluded that the failure was due to an exaggerated placebo effect in patients who have not been treated with opioids before. Sirgo said that BEMA Buprenorphine is the subject of active partnership discussions with pharmaceutical companies experienced in pain treatment and familiar with the nuances of opioid drugs. The drug buprenorphine works. BDSI’s drug delivery mechanism works. But even if BDSI can explain the clinical trial failure to a potential partner, that failure still hurts the company’s negotiating position.

“We haven’t lost any ground; what we’ve lost is time,” Sirgo said. “Of course, time is money. So we’ve lost some leverage.”

BDSI estimates a new phase 3 trial will take about seven months and cost up to $8 million. Those costs and further commercialization efforts could be covered by a partner interested in adding a new pain treatment to its drug pipeline. BDSI estimates its chronic pain treatment could generate as much as $500 million in annual sales.

In the meantime, the company has shifted attention to its other drug candidate. BEMA Buprenorphine/Naloxone is now BDSI’s lead drug program, Sirgo said. The treatment, indicated for treating opioid dependence, is the same drug combination provided by current market leader Suboxone, a $1 billion revenue product for Reckitt Benckiser (LON:RB). BDSI believes its proprietary drug delivery technology, which administers the drug via a small piece of film that dissolves when placed on the inside of the cheek, will offer it a competitive advantage and a $300 million chunk of the opioid dependence treatment market.

BEMA Buprenorphine/Naloxone has a faster path to commercialization than BEMA Buprenorphine for chronic pain. Showing bioequivalence to the already approved and commercialized Suboxone means BDSI won’t have to take its product through three phases of clinical trials. Bioequivalence studies, which will be funded from existing capital, are expected to begin in January.

BDSI’s most immediate prospect for improving its cash position will come from sales of Onsolis, which treats breakthrough pain in cancer patients by delivering the pain-killer fentanyl. Onsolis sees revenue in the form of royalties from drug partner Meda (STO:MEDA). But BDSI has had unfortunate luck cashing in on its first commercialized product. Onsolis, approved in 2009, is subject to the U.S. Food and Drug Administration’s “Risk Evaluation and Mitigation Strategies” plan, or REMS. The guidelines set rules on distribution of drugs that can have dangerous side effects. But older competitors have not been subject to REMS requirements, putting Onsolis at a disadvantage. That could soon change. Sirgo said that a group of fentanyl products providers have developed a single classwide REMS for all companies. Sirgo estimates those guidelines will be in place in the first quarter of 2012.

Right now, this is where BDSI stands: It has an approved product in Onsolis that is not generating enough revenue; a drug candidate targeting a slice of the $1 billion opioid dependence market still far from producing revenue; and a chronic pain treatment that needs a new set of phase 3 studies that the company can’t pay for.

BDSI is pushing hard to land a drug partner to commercialize BEMA Buprenorphine, which would add another product to a portfolio that for now only has Onsolis.

“We are not a one trick pony,” Sirgo said.

Coming months will be crucial for BDSI to prove it.