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Braeburn Pharmaceuticals Names Mike Derkacz as President and CEO

Braeburn Pharmaceuticals Names Mike Derkacz as President and CEO, former Head of CNS and Pain Therapeutics for Teva Pharmaceuticals

Braeburn President and CEO, Behshad Sheldon, steps down from Company and Board of Directors – Princeton, New Jersey — June 5, 2017

Braeburn Pharmaceuticals, Inc. (Braeburn) announced today that Mike Derkacz has been named as President and Chief Executive Officer, and joins Braeburn’s Board of Directors. A biopharmaceutical executive with 25 years of commercial experience and proven success, most recently he was Senior Vice President and Head of Global Central Nervous System (CNS) and Pain Therapeutic Areas for Teva Pharmaceuticals (Teva). “Mike is an accomplished and highly successful commercial leader, with deep expertise in launching new products, creating highly effective teams and focused organizational leadership,” said Seth L. Harrison, M.D., Chairman of Braeburn. “We welcome Mike to Braeburn at this important moment in the Company’s growth, as we drive commercial efforts for our first approved product and finalize regulatory filings seeking approval of our flagship opportunity, CAM2038.”

During the past six years at Teva, Mike led the strategic development of the CNS and Pain Therapeutic Areas, advancing several clinical candidates, building market-leading brands, and directing important corporate acquisitions to expand the CNS pipeline and sustain leadership in the market. Mike led the launch of Copaxone 40 mg, considered one of the most successful product introductions in the multiple sclerosis category and within the industry. He joined Teva through the acquisition of Cephalon, where he served as Vice President of the CNS Business unit. Previously at Cephalon, he was Vice President, Marketing for CNS responsible for the award-winning launch of Nuvigil, as well as managing the commercial development and lifecycle strategy for Provigil.

“Braeburn represents a compelling and unique opportunity to make an important difference for patients suffering serious neurological and psychiatric disorders, including opioid addiction, pain, and schizophrenia,” noted Mike Derkacz. “With a broad portfolio of products, utilizing innovative technologies, Braeburn is poised to lead the way at a time when there is universal alignment among physicians, patients, payers, and the U.S. Government around the high sense of urgency to provide novel and effective treatments for those suffering from addiction. I look forward to working with the talented team at Braeburn to build upon the impressive track record of success they have achieved to date.”

Previously, Mike worked for more than 15 years at GlaxoSmithKline in positions of increasing leadership and commercial responsibility for major brands including Levitra, Paxil, Coreg, and its adult vaccine portfolio. He has been recognized for excellence in building award-winning strategic campaigns and leading pharmaceutical brands.

Behshad Sheldon, who joined Braeburn as a founding member in 2012, has announced that she is stepping down from Braeburn as President and CEO and from the Board of Directors, effective immediately, but will continue to serve as a consultant to Braeburn. “We are grateful for the leadership and resolve Behshad has demonstrated, guiding Braeburn through clinical and regulatory challenges, resulting in the U.S. Food and Drug Administration (FDA) approval for our first product, as well as NDA readiness for CAM2038 and the creation of a strong clinical pipeline,” noted Dr. Harrison. “Braeburn has been built on the mission to develop and deliver individualized, long-acting medicines to patients that suffer from serious, stigmatized neuropsychiatric disorders, such as opioid addiction, chronic pain, and schizophrenia,” said Ms. Sheldon. “I am proud of all we have accomplished and have great confidence that the team can build on the foundation set and attain the exciting clinical and commercial milestones anticipated in the years ahead.”

About Braeburn Pharmaceuticals

Braeburn Pharmaceuticals, an Apple Tree Partners company, is a commercial-stage pharmaceutical company delivering individualized medicine in neuroscience. Long-acting therapeutic treatment options can be essential to improving patient outcomes and facilitating recovery in neurological and psychiatric disorders, which are often complicated by stigma and present significant public health challenges. Braeburn’s commercial product, Probuphine® (buprenorphine) implant was approved by the FDA in May 2016. Braeburn’s investigational product pipeline consists of long-acting implantable and injectable therapies for serious neurological and psychiatric disorders, including opioid addiction, pain, and schizophrenia. Braeburn’s pipeline products are at various stages of clinical development and include weekly and monthly CAM2038, subcutaneous injection depot formulations of buprenorphine, being investigated in opioid addiction and pain, BB0417 buprenorphine/granisetron injectable for acute pain, and BB0817, six-month risperidone implant being investigated in schizophrenia. More information on Braeburn can be found at www.braeburnpharmaceuticals.com.

Contact: Sherry Feldberg for Braeburn Pharmaceuticals
MSLGROUP Phone 781-684-0770
braeburnpharma@mslgroup.com


 
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About CAM2038

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.

For additional information, please contact:

Media Relations:
Nancy Leone: nleone@braeburnpharma.com

Investor Relations:
Chris Taylor: ctaylor@braeburnpharma.com