Braeburn Pharmaceuticals, Inc. (Braeburn) today announced that the Company has completed a $110 million mezzanine round of financing led by Wellington Capital Management. Other new investors participating in the financing include Avista Capital Partners, RA Capital Management, New Leaf Venture Partners, Deerfield Management, and Rock Springs Capital. Apple Tree Partners, the sole investor in Braeburn to date, also participated. Braeburn will use the proceeds to continue to advance the FDA approval process, and commercialize CAM2038, an investigational buprenorphine weekly and monthly depot injection for the treatment of adults with OUD.
"We are extremely pleased that this group of leading healthcare investors recognizes the potential of CAM2038, once approved, for which the FDA has granted priority review," said Mike Derkacz, President and CEO of Braeburn. "With opioid overdose now the leading cause of death among Americans under the age of 50, at Braeburn we are committed to playing our part by advancing new weekly and monthly medication-assisted treatments (MAT) to help support the recovery of people and their families devastated by opioid use disorder."
In 2016, roughly 11.6 million adults misused opioids in the U.S. yet only 1.1 million received MAT, according to the Substance Abuse and Mental Health Services Administration. According to the chair of the American Medical Association's Opioid Task Force, only 20 percent of those who need treatment are receiving it.
"Consistent with FDA Commissioner Gottlieb's recent statement encouraging wider, appropriate use of MAT for opioid addiction treatment, this financing further supports our efforts to expand treatment options by advancing CAM2038," said Derkacz.
In conjunction with the closing of the financing, Brian A. Markison will join the company's Board of Directors, together with an additional nomination to be confirmed shortly. Mr. Markison is Chief Executive Officer and Chairman of Osmotica Holdings, S.C.Sp. and an Avista Operating Executive. He is a seasoned executive with more than 30 years of operational, marketing, and commercial experience with international pharmaceutical companies.
On November 1, 2017, the FDA's Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee jointly voted 17-3 recommending approval of CAM2038 for the treatment of adults with OUD. The Advisory Committee's recommendation was based on a review of results from a clinical trial program that included seven Phase 1-3 clinical trials in patients with OUD, including a pivotal Phase 3 efficacy and a long-term safety study. CAM2038 was accepted under Priority Review designation by the FDA in September 2017 and previously granted Fast Track designation. The FDA has set a Prescription Drug User Fee Act (PDUFA) target date of January 19, 2018.
CAM2038 is an investigational buprenorphine weekly and monthly depot subcutaneous injection for the treatment of opioid use disorder, as a part of a comprehensive treatment plan to include counseling and psychosocial support. The product is designed for flexible and individualized treatment from initiation and stabilization to longer-term maintenance therapy, providing sustained buprenorphine release in once weekly and once monthly formulations. Administration by healthcare professionals ensures delivery and medication adherence, while potentially minimizing risks of diversion, misuse, and accidental pediatric exposure. CAM2038 has been successfully evaluated in seven Phase 1-3 clinical trials, including a pivotal Phase 3 efficacy and a long-term safety study. The safety profile of CAM2038 was generally consistent with the known safety profile of buprenorphine, with the exception of mild-to-moderate injection-site adverse events.
CAM2038 is presented ready for use in prefilled syringes for weekly or monthly administration by a healthcare professional. If approved, CAM2038 will be offered in dosage strengths for once weekly (8 mg to 32 mg) and once monthly (64 mg to 160 mg) subcutaneous injections.
About Braeburn Pharmaceuticals
Braeburn is a pharmaceutical company dedicated to delivering solutions for people living with the serious, often fatal consequences of opioid addiction. The company's mission is to advance a portfolio of next-generation therapies, with individualized dosing regimens and delivery options, to address the escalating disease burden of addiction faced by patients, healthcare professionals, payers and society. For more information about Braeburn, please visit www.braeburnpharmaceuticals.com.