Braeburn Pharmaceuticals has licensed exclusive rights to Camurus’ weekly and monthly subcutaneous buprenorphine injection products (CAM2038) to treat opioid addiction and pain in North America, as well as option rights in Japan, Korea, Taiwan, and China, the companies said today.
The deal could be worth as much as $151 million to Camurus, which will retain all rights to the products in the rest of the world.
CAM2038 is based on Camurus' nanoscale FluidCrystal® delivery system, which is designed to allow easy drug administration as subcutaneous, low-volume injections providing stable therapeutic plasma levels of buprenorphine over one week or one month. Buprenorphine FluidCrystal injection depot products are intended to be administered by health care professionals, thus minimizing risks of abuse, diversion, and exposure to children.
Camurus has successfully completed Phase I and Phase II studies for CAM2038, and is working with Braeburn to prepare for Phase III trials assessing the compound for opioid dependence. Camurus’ subcutaneous, low-volume buprenorphine treatments are designed to relieve the burden of daily medication.
The companies said they expect to begin registration trials for CAM2038 in opioid dependence in 2015, following talks with regulators, and submit applications for marketing approval in both the U.S. and the EU in 2016.
Braeburn and Camurus also said they will seek to develop CAM2038 for pain, since buprenorphine drug products have been shown to be safe and effective in pain management.
In return for the rights and option rights, Braeburn agreed to pay Camurus a $20 million upfront license fee, as well as $35 million in payments tied to development milestones for opioid dependence, and $21 million in development milestones for pain. Camurus is also eligible to receive “mid-teen”-percentage royalties from Braeburn on products sales, as well as up to an additional $75 million in sales milestones, the companies said.
“Our combined efforts will expedite development of important treatment alternatives in opioid dependence and pain management that could minimize risks of misuse and diversion,” Camurus president and CEO Fredrik Tiberg said in a statement.
Behshad Sheldon, Braeburn’s president and CEO, added that CAM2038 broadens his company’s pipeline focus beyond addiction medicine into pain management. Since December 2012, the company has licensed from Titan Pharmaceuticals U.S. and Canadian development and commercialization rights for Probuphine®, a buprenorphine subdermal implant for maintenance treatment of opioid dependence. Braeburn and Titan say Probuphine is capable of delivering a stable dose of buprenorphine for six months following a single treatment.
Braeburn has completed enrollment in a Phase III trial of Probuphine in which 178 patients were randomized. Braeburn and Titan, which announce the enrollment completion separately, said they expect the study to be completed by mid-2015, to be followed by resubmission of an NDA later in the year.
The Phase III trial was designed after Titan and Braeburn received a Complete Response Letter from the FDA in April 2013. In the letter, the FDA requested additional efficacy data, including the ability of Probuphine to provide opioid blockade of relevant doses of agonists; the effect of higher doses of Probuphine, and human factors testing of the training associated with Probuphine’s insertion and removal.
Braeburn's pipeline includes several long-acting implantable and injectable buprenorphine alternatives to oral formulations, ranging from one week to six months.