Raleigh-based BioDelivery Sciences (Nasdaq: BDSI), whichrecently raised $60 million to help commercialize its proposed chronic pain reliever drug and hopes to win FDA approval for it in June, on Thursday said it had chosen Durham-based Quintiles (NYSE: Q), the world’s largest life science services firm, to help take the drug to market.
The deal includes formation of a sales force.
Financial terms of the agreement were not disclosed.
“We have been working with and have formed strong relationships with these two companies over the past year, and in conjunction with them have developed a commercial plan that will support what we believe will be a successful launch of Bunavail in the U.S. later this year,” said Dr. Mark Sirgo, BDSI’s CEO, in announcing the deal.
BDSI also selected the firm Ashfield Market Access to help it work with healthcare providers in payment strategies for the drug.
“Both Quintiles and Ashfield Market Access have an excellent history of supporting companies like BDSI in successfully launching and commercializing important new products,” Sirgo said. “We are very pleased to now formalize our collaborations. We will provide greater details around our plans for the launch of Bunavail as we approach our June 7th [FDA review] date and the product’s potential approval.”
The Capital Raiser
In February, capitalizing on news that the drug showed positive top-line phase III clinical trial results, BDSI raised $60 million through a stock offering.
The company said proceeds will be used for:
- “Execution of the sales, marketing and other commercialization and product supply chain activities to support the anticipated second half 2014 launch of BUNAVAI, BDSI’s treatment for opioid dependence which is currently under review by the FDA with a June 7, 2014 PDUFA date, and that BDSI is actively preparing to commercialize on its own
- “For the initiation this quarter of the Phase III clinical program for Clonidine Topical Gel for the treatment of painful diabetic neuropathy, along with the overall clinical and regulatory advancement of this product
- “For support of BDSI’s existing partnered products
- “For potential acquisition of clinical stage or marketed products in the therapeutic areas of central nervous system, addiction and pain medicine, to complement BDSI’s current product pipeline; and for general working capital purposes.”
On Jan. 24, BDSI and drug partner Endo Pharmaceuticals (NASDAQ: ENDP) said that Bunavail successfully met the primary clinical trial goal of significant chronic pain relief compared to a placebo. The companies said that secondary study targets also support BEMA buprenorphine’s case for efficacy when compared against a placebo.
In addition to the top-line phase III trial results, Sirgo said that trial data from patients who have not been previously treated with opioids is now ready for analysis, a milestone that triggers a $10 million payment to BDSI. BDSI could also see more payments.