Titan Pharmaceuticals (NASDAQ:TTNP) is in discussions with Braeburn Pharmaceuticals about their partnership for the development and commercialization of Probuphine, the first six-month maintenance treatment of opioid dependence.
In a statement, Titan said that Braeburn’s receipt of a complete response letter (CRL) from the FDA about the NDA for its CAM2038 injectable buprenorphine product is “likely to negatively impact Braeburn’s Probuphine marketing activities as it focuses on addressing the CRL.”
Braeburn said in a statement that the FDA has requested additional information in order to progress the NDA forward. CAM2038 is an investigational buprenorphine weekly and monthly depot injection for the treatment of adults with opioid use disorder.
Titan said it has been in preliminary discussions with Braeburn for the “return of U.S. commercialization rights to Probuphine and believes it is now appropriate to seek a new partner that can better focus on a successful commercialization strategy for Probuphine.”
Titan has retained Canaccord Genuity to assist in the evaluation of strategic and financial alternatives.
“While we are appreciative of Braeburn’s support in the development and initial U.S. commercial launch of Probuphine, the fact remains we have been disappointed with the product’s uptake to date,” said Titan president and CEO, Sunil Bhonsle.
Executive chairman, Dr. Marc Rubin, said Titan continues to believe that Probuphine has an important role to play in combatting the national epidemic of opioid addiction.
“To that end, our goal is to make certain that Probuphine is positioned for commercial success, and we will explore all available opportunities to achieve that,” he added. “We look forward to working with Canaccord Genuity to assist us in this endeavor.”
