Titan Pharmaceuticals (NSDQ:TTNP) and Braeburn Pharmaceuticals said today that they plan to end a 2012 licensing agreement that gave Braeburn exclusive rights to commercialize Probuphine in the U.S. and Canada.
Probuphine, which was developed using Titan’s ProNeura continuous drug-delivery tech, is an implant that can be placed in a patient’s upper arm in an outpatient office procedure. The FDA approved Probuphine in May 2016 to deliver buprenorphine as a long-term maintenance treatment for people suffering from opioid addiction.
According to the terms of the deal, Braeburn will fork over $1 million to Titan and Titan will regain all rights to commercialize and develop Probuphine in the U.S. and Canada. Braeburn plans to help Titan with the transition through December 28, the companies said.
“We believe that Probuphine is an important product in the face of a growing opioid addiction epidemic and we will continue to explore options with the potential to improve uptake of the product in the U.S., as well as expand global access through partnerships in Europe and other territories with Molteni & C. dei F.lli Alitti Società di Esercizio S.p.A. and Knight Therapeutics Inc. in Canada,” Titan president & CEO Sunil Bhonsle said in prepared remarks.
“As a result of this agreement, we will have greater focus on our flagship weekly and monthly depot products,” Braeburn president & CEO Mike Derkacz added.
In January, the FDA issued a complete response letter to Braeburn, denying an application for its weekly and monthly buprenorphine depot injections designed to treat adults with opioid use disorder.
The company reported that the dreaded CRL does not request additional clinical studies, but Braeburn did not elaborate as to what sort of additional information the FDA needs to move the application forward.
