Mike Derkacz

A biopharmaceutical executive with 25 years of commercial experience, Mike is an accomplished and highly successful leader, with deep expertise in launching new products, creating highly effective teams and focused organizational leadership. Prior to Braeburn, he was Senior Vice President and Head of Global CNS and Pain Therapeutic Areas for Teva Pharmaceuticals.

During his tenure 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. He led the launch of Copaxone 40mg, 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, 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.

Mike began his career working 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. A graduate of University of Texas Arlington, Mike has received numerous industry awards for excellence in building strategic campaigns and leading pharmaceutical brands.

Seth Harrison, MD

Seth Harrison is the managing partner of Apple Tree Partners and serves as Executive Chairman of Braeburn Pharmaceuticals. He has invested in life sciences since 1991. Seth has served as founding investor, acting CEO or chairman of numerous portfolio companies. He is currently also Chairman of Tokai Pharmaceuticals, Chairman of Aileron Therapeutics and Deputy Chairman of Heartware International, all companies he founded. Prior to founding ATP, Seth was a general partner at Oak Investment Partners and earlier was a venture partner at Sevin Rosen Funds. His prior investments include: ArQule, Coelacanth, Cyrano Sciences, Gloucester Pharmaceuticals, Informed Access, SGX Pharmaceuticals, Ultracision and ViroPharma. Seth received an A.B. from Princeton University, an MD and MBA both from Columbia University and completed a surgery internship at the Presbyterian Hospital in the City of New York. From 2002 – 2010 he served on the board of the International Partnership for Microbicides, a Rockefeller Foundation/Gates Foundation sponsored public-private partnership engaged in the development of anti-HIV microbicides.

Mike Derkacz

A biopharmaceutical executive with 25 years of commercial experience, Mike is an accomplished and highly successful leader, with deep expertise in launching new products, creating highly effective teams and focused organizational leadership. Prior to Braeburn, he was Senior Vice President and Head of Global CNS and Pain Therapeutic Areas for Teva Pharmaceuticals.

During his tenure 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. He led the launch of Copaxone 40mg, 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, 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.

Mike began his career working 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. A graduate of University of Texas Arlington, Mike has received numerous industry awards for excellence in building strategic campaigns and leading pharmaceutical brands.

Braeburn Pharmaceuticals’ Probuphine® Study Hits Enrollment Milestone

FOR IMMEDIATE RELEASE

Braeburn Pharmaceuticals’ Probuphine® Study Hits Enrollment Milestone

95 of 180 Patients Enrolled; Additional Patients Screened, Awaiting Randomization

Princeton, N.J. – Sept. 24, 2014 – Braeburn Pharmaceuticals today announced that it has surpassed the midway point for patient enrollment in its Phase 3 study of Probuphine®, which began in July of 2014. Probuphine is a buprenorphine subdermal implant being studied for the maintenance treatment of opioid dependence. Completion of the study is on track for the middle of 2015, with submission of the New Drug Application (NDA) to the U. S. Food and Drug Administration (FDA) expected to follow later in the year.

“We are encouraged by the speed with which stable opioid-dependent patients are enrolling in this trial,” said Behshad Sheldon, president and CEO of Braeburn Pharmaceuticals. “We believe the pace of enrollment reflects the great need for new long-term maintenance treatment options for those suffering from opioid dependence. We will continue working with our clinical investigators to complete this study expeditiously, and if ultimately approved by the FDA, look forward to the opportunity to provide physicians and their patients a unique treatment alternative.”

There are currently 21 clinical research sites with IRB approval to participate in the six-month, randomized, double-blind, double-dummy study. All sites are actively recruiting and screening patients. As of today 95 of 180 anticipated patients have been enrolled in the study. An additional 10 patients are awaiting scheduling for randomization, and 23 patients are in the middle of the screening process. More information on primary endpoints as well as inclusion and exclusion criteria for the study can be found here.

“It is fitting for Braeburn to share progress on patient participation in its Probuphine study during National Recovery Month, a time when the addiction community is encouraged to spread the positive message that treatment is effective and people can and do recover,” said Frank Young, M.D., Ph.D., executive vice president, Clinical and Regulatory Affairs. “It is our hope that, one day, Probuphine will be an approved long-term maintenance treatment option to assist the overwhelming number of people with opioid dependence struggling to get their lives back.”

About Opioid Dependence

According to recent estimates, there are 2.2 million people with opioid dependence in the U.S. Approximately 20 percent of this population is addicted to illicit opioids, such as heroin, and the other 80 percent to prescription opioids, such as oxycodone, hydrocodone, methadone, hydromorphone and codeine. Before the year 2000, medication-assisted therapies for opioid dependence had been sanctioned to a limited number of facilities in the U.S. The Drug Addiction Treatment Act of 2000 (DATA 2000) allowed medical office-based treatment of opioid dependence and greatly expanded patient access to medication-assisted treatments. As a result, an estimated 1.2 million people in the U.S. sought treatment for opioid dependence in 2011.

About Probuphine

Probuphine is an investigational subdermal implant designed to deliver continuous, around the clock blood levels of buprenorphine for six months following a single treatment, and to simplify patient compliance and retention. Buprenorphine, an approved agent for the treatment of opioid dependence, is currently available in the form of daily dosed sublingual tablets and film formulations, with reported 2012 sales of $1.5 billion in the United States.

Probuphine was developed using ProNeura™, Titan’s continuous drug delivery system that consists of a small, solid implant made from a mixture of ethylene-vinyl acetate (EVA) and a drug substance. The resulting construct is a solid matrix that is placed subdermally, normally in the upper arm in a simple office procedure, and removed in a similar manner at the end of the treatment period. The drug substance is released slowly and continuously through the process of dissolution resulting in a steady rate of release.

The efficacy and safety of Probuphine has been studied in several clinical trials, including a 163-patient, placebo-controlled study over a 24-week period (published in the Journal of the American Medical Association (JAMA)), and a follow on study of 287 patients (published in the journal Addiction).

About Braeburn Pharmaceuticals

Braeburn Pharmaceuticals, an Apple Tree Partners company, is focused on developing and commercializing new treatment options for serious neuropsychiatric disorders, including addiction, in order to help those whose suffering is compounded by the stigma associated with their disease, and for whom long-acting medicines are particularly beneficial. In December 2012 Braeburn licensed the U.S. and Canadian development and commercialization rights for its first product, Probuphine®, a buprenorphine subdermal implant for the maintenance treatment of opioid dependence. Probuphine is currently the subject of a Phase 3 clinical study designed to address questions the FDA posed in its complete response letter last year, after review of the original NDA. Completion of the study is expected by the middle of 2015, to be followed by resubmission of the NDA later in the year.

Braeburn’s executive team has decades of experience successfully bringing medically significant pharmaceutical brands to market in several therapeutic areas including psychiatry, cardiovascular, metabolics, oncology, and dermatology. To learn more, please visit www.braeburnpharma.com.

Media Contacts:
MSLGROUP
Sherry Feldberg/Helen Shik
(781) 684-0770
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helen.shik@mslgroup.com

David McIntyre

David has over 20 years of experience as a senior executive and corporate advisor with multinational and growth companies in a wide variety of industries, including life sciences. With professional qualifications in finance and law, David has held senior financial, legal and operational roles in public and private organizations.

David has been a Partner in Apple Tree Partners since 2012 where his responsibilities includes a focus on medical device and healthcare technology investments. Previously David was Executive Vice President, Chief Financial Officer of HeartWare International, Inc. (NASDAQ: HTWR) from 2005 through 2011, and assumed the additional responsibilities of Chief Operating Officer during HeartWare’s global commercialization phase for the period from 2008 through 2011. HeartWare was acquired by Medtronic in 2016 in a transaction valued at approximately $1.1 billion.

Prior to HeartWare, David practiced as a senior attorney in private practice specializing in corporate, mergers and acquisitions and equity capital markets with Baker & McKenzie and KPMG as well as holding various senior financial roles in multi-national companies including Coal & Allied Limited, a publicly traded subsidiary of the Rio Tinto Group of companies.

David holds a Bachelor of Economics (Accounting) from the University of Sydney (Australia), a Bachelor of Law from the University of Technology, Sydney (Australia) and a Masters of Business Administration (Fuqua Scholar) from Duke University. He is also a Certified Practicing Accountant (CPA) and is admitted as a Legal Practitioner of the Supreme Court of New South Wales (in Australia).