Braeburn, a subsidiary of Apple Tree Partners, has gained commercialization rights to Titan Pharmaceuticals' long-acting subdermal implant in the US and Canada, under the signed license agreement.
The investigational subcutaneous implant, Probuphine, is designed for delivering six months of the drug buprenorphine hydrochloride and treating patients with opioid dependence.
Under the terms of the agreement, Titan will be responsible for any expenses associated with the support of the current NDA review process while Braeburn Pharmaceuticals will be responsible for commercialization and further clinical development of Probuphine in the US and Canada, on completion of FDA review process.
Titan has received a non-refundable $15.75m up-front payment and will receive up to $50m, upon the approval of Probuphine by the FDA.
Titan will also be eligible to receive up to $130m, upon achievement of sales milestones, and up to $35m in regulatory milestones for additional contemplated indications including chronic pain.
In addition to the potential milestone payments, Apple Tree has allocated in excess of $75m to launch, commercialize and continue the development of Probuphine.
Titan filed an NDA for Probuphine for the treatment of opioid dependence in October 2012, including a request for Priority Review.