The U.S. Patent and Trademark Office has issued BDSI a notice of allowance, which means that patent officials have reviewed the patent application and determined it meets the requirements for a patent. Once issued, BDSI’s patent protection on its BEMA Buprenorphine and BEMA Buprenorphine/Naloxone products will be extended from 2020 to 2027. BDSI should receive the patent in the coming months.
The milestone payment will be coming from drug partner Endo Pharmaceuticals (NASDAQ:ENDP). Raleigh, North Carolina-based BDSI and Endo last month entered a development and commercialization deal that could pay BDSI up to $180 million upon successful commercialization of the BEMA Buprenorphine chronic pain treatment, plus royalties.
BDSI has been searching for a drug partner for BEMA Buprenorphine for some time. BDSI CEO Mark Sirgo, speaking today at the CED Life Science conference in Raleigh, discussed some of the issues that come up in searching for a partner. He said that the large companies who could be potential partners are becoming more risk averse. They’re willing to take on commercial risk but less willing to take on development risk. That means smaller companies need to take their products further into development, which in turn means taking on more cost. But Sirgo said that if a small company can demonstrate to a potential partner that the product has a clear need, it strengthens the smaller party’s negotiating position.
BDSI had to redouble its efforts to make the case to drug partners about BEMA Buprenorphine. The pain treatment delivers buprenorphine through BDSI’s proprietary drug delivery system, which administers medication via a small piece of film placed on the inside of the cheek. Last September, BDSI announced that BEMA Buprenorphine failed in a phase 3 clinical trial. The company later said that the failure was due to an exaggerated placebo effect in people who had never been treated with opioids before. But BDSI still needed to redo the phase 3 studies. With the Endo partnership, Endo now takes responsibility for the phase 3 trials and subsequent regulatory filings.
BDSI also stands to get patent protection for BEMA Buprenorphine/Naloxone, a product that the company is developing to treat opioid dependence. While BDSI has worked with drug partners on two products so far, Sirgo said that BEMA Buprenorphine/Naloxone will be the first product BDSI commercializes on its own.