From Frank Vinluan, MedCityNews
A month after licensing a clinical-stage chronic pain treatment to Endo Pharmaceuticals(NASDAQ:ENDP) in a deal worth up to $180 million, BioDelivery Sciences International (NASDAQ: BDSI) is now preparing an additional $40 million financial cushion.
The Raleigh, North Carolina specialty pharmaceutical company has filed a shelf registration that would allow BDSI to raise up to $40 million by selling stock if it needs the money. Not too long ago, it looked like such an offering would be likely. The pain treatment that BDSI was developing, BEMA Buprenorphine, failed in phase 3 clinical trials last September and the company faced the prospect of financing another phase 3 trial. But the company was also running out of cash; CEO Mark Sirgo had said that BDSI only had enough money to last the company through the second quarter of 2012.
The Endo deal, which gave BDSI $30 million up front, secures a partner responsible for the phase 3 trials and commercialization of BEMA Buprenorphine. That frees BDSI to devote its attention and its financial resources to the rest of its drug pipeline, which uses the same drug delivery technology as BEMA Buprenorphine. BDSI says in the shelf registration that proceeds from an offering would be used for “general corporate purposes, including the advancement of our product candidates, and to meet working capital needs.” BDSI’s next pipeline product is BEMA Buprenorphine/Naloxone, which the company is developing for the treatment of opioid dependence.
“BEMA” stands for or BioErodible MucoAdhesive. All of BDSI’s treatments employ the technology, which quickly delivers a drug to patients via a small piece of film that dissolves on the inside of a patient’s cheek. With BEMA Buprenorphine/Naloxone, BDSI is aiming to take on market leading product Suboxone, which generates more than $1 billion in revenue for Reckitt Benckiser (LON:RB). BDSI last year got the U.S. Food and Drug Administration’s blessing to puruse a 505(b)(2) regulatory pathway for the treatment.
BEMA Buprenorphine/Naloxone uses the same drug combination as Suboxone but delivers it with BDSI’s BEMA drug delivery technology. Rather than taking the treatment all the way through a phase 3 clinical trial, the 505(b)(2) pathway allows BDSI to show bioequivalence to the Reckitt Benckiser product. It’s a faster and less expensive pathway. BDSI expects these studies to occur this year and the company will have sufficient funds to finance them. In a months time, BDSI has gone from wondering whether it had enough resources to finance two pipeline candidates to having the capital in place to move forward on both. BDSI now has the flexibility to turn its attention to other applications for its BEMA technology. In the shelf filing, the company says that it will explore BEMA as a way to address other unmet medical needs such as nausea, vomiting and migraines.
