BDSI takes on full ownership of BEMA drug delivery tech
rights to the BEMA oral adhesive disc drug delivery technology for
$3m, with a further $4m to be paid at a later date.
The North Carolina-based company had licensed the technology from QLT USA, but decided to buy it out in a strategic move, which now eliminates any payment of royalties to or sharing of milestone payments with QLT USA on any BEMA product. "We are pleased to have been able to take full ownership of this technology which plays such a significant strategic role to our company," BDSI president and chief executive Mark Sirgo said in a statement. "We are following through on our strategic plan, initiated last year, when we acquired the non-US BEMA assets." The full ownership also means BDSI does not have to share any financial payments with QLT USA following last week's license and supply agreement with Meda AB for the commercialization rights to BDSI's BEMA Fentanyl product in the US, Canada and Mexico. This includes the anticipated $30m non-refundable upfront milestone payment from Meda upon the approval of the required Hart Scott Rodino antitrust review. The BEMA (Bioerodible MucoAdhesive Disc) drug delivery technology involves a bilayer patch that binds to the inside of the cheek and delivers its payload directly across the mucosa lining, typically eroding away within 20-30 minutes. A backing layer prevents active drug being deposited in saliva and swallowed, helping to control the administration. BEMA Fentanyl is the top contender involving the technology, with filing for marketing approval expected within the next two months. Compared to orodispersible fentanyl tablets it is hard to extract the fentanyl from the BEMA patch, providing a safeguard against opioid abuse. BDSI has two other BEMA-based products in early stage clinical testing: a BEMA long-acting analgesic for moderate to severe pain, and BEMA Zolpidem for insomnia. BDSI paid QLT USA $3m at the closing of the acquisition and has issued a promissory note in the amount of $4m, which will be payable in the future in two $2m installments triggered by the occurrence of specific milestones. The initial $3m payment was financed by a short-term bank note and the company expects to pay back the bank note with a portion of the $30m milestone payment from Meda, which is anticipated next month. "We believe this transaction, coupled with the US licensing partnership with Meda, solidifies our financial position for the foreseeable future," Sirgo said. "With the Meda funds in hand and a vastly improved balance sheet, we expect, following the submission of our BEMA Fentanyl NDA (New Drug Application) filing in the next 30-45 days, to begin to aggressively address the rest of our rich and differentiating product pipeline, including proof of concept data on our follow on pain product BEMA LA and our Bioral Amphotericin B product in 2008."
