PRINCETON, NJ – February 13, 2017 – Braeburn Pharmaceuticals was named today by Fast Company as a Top 10 Most Innovative Company in Biotech in conjunction with its annual ranking of the world’s 50 Most Innovative Companies for 2017. Previous honorees in the top 10 most innovative biotech companies include Bristol-Myers Squibb, Amgen, and 23andMe. Continue reading “Fast Company Honors Braeburn Pharmaceuticals as Innovative”
PRINCETON, N.J. – November 21, 2016 – On Friday, November 18, 2016, Probuphine® was named a gold award winner at the 13th annual Stevie® Awards for Women in Business in the category of “Best New Product or Service of the Year.” Braeburn Pharmaceuticals’ President and CEO, Behshad Sheldon, was also selected as a bronze award winner in the category of “Best Female Executive of the Year.” Both awards were in the Consumer Products category.
Sheldon is committed to bringing innovative, new treatment options to treat chronic diseases shrouded in stigma, such as opioid dependence, pain and schizophrenia. Braeburn is focused on serving patients suffering from health conditions where there has been little innovation in recent years.
Gold award winner Probuphine is a six-month buprenorphine implant for the maintenance treatment of opioid addiction. Under Sheldon’s leadership, this product advanced through clinical development and received FDA approval for commercialization in May 2016. Braeburn is also developing six late-stage product candidates and two earlier-stage product candidates, all of which are either injectables or implants.
“Braeburn’s mission is to bring innovative and transformative treatments to underserved patients as quickly as possible,” said Sheldon. “Our company has a robust pipeline of treatments for patients who are often neglected and stigmatized by society, yet who deserve the same level of innovation that is dedicated to other chronic diseases. We are honored to be recognized as we work tirelessly to fulfill our vision.”
The awards were presented Friday, November 18 at the Annual Stevie Awards dinner in New York City. The event featured nominees from the U.S. and around the world, including leaders, entrepreneurs, employees and their companies.
“Judges were impressed with the quality of each nomination that qualified as a Stevie Finalist. The competition has grown each year because there are so many high-achieving women all over the world, who serve as an inspiration to those who would like to start, grow or lead a business,” said Michael Gallagher, founder and president of the Stevie Awards. “It is always a privilege to recognize such outstanding women.”For more information about Braeburn Pharmaceuticals, please visit us online at BraeburnPharmaceuticals.com.
About Stevie Awards
The Stevie Awards are conferred in seven programs: the Asia-Pacific Stevie Awards, the German Stevie Awards, The American Business Awards, The International Business Awards, the Stevie Awards for Great Employers, the Stevie Awards for Women in Business and the Stevie Awards for Sales & Customer Service. Stevie Awards competitions receive more than 10,000 entries each year from organizations in more than 60 nations. Honoring organizations of all types and sizes and the people behind them, the Stevies recognize outstanding performances in the workplace worldwide. To learn more about the fellow nominees in the “Female Executive of the Year – Consumer Products” category, please visit https://stevieawards.com/women/2016-stevie-award-winners.
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 .
Probuphine is the only six-month treatment for opioid dependence that delivers buprenorphine continuously using Titan Pharmaceuticals’ (NASDAQ: TTNP) ProNeura™ technology. Probuphine is placed under the skin of the upper arm during an outpatient office procedure and is removed in a similar manner. Probuphine is available through a closed distribution system. To learn more about how to obtain visit: www.braeburnaccessprogram.com. Qualified healthcare providers can register for Probuphine training at www.probuphineREMS.com or by calling 1-866-397-8939. Probuphine is available in all 50 U.S. States; people interested in finding a provider in their area can visit www.probuphinerems.com/probuphine-locator.
Probuphine Indication and Important Safety Information
PROBUPHINE is indicated for the maintenance treatment of opioid dependence in patients who have achieved and sustained prolonged clinical stability on low-to-moderate doses of a transmucosal buprenorphine-containing product (i.e., doses of no more than 8 mg per day of Subutex or Suboxone sublingual tablet or generic equivalent).
PROBUPHINE should be used as part of a complete treatment program to include counseling and psychosocial support.
PROBUPHINE is not appropriate for new entrants to treatment and patients who have not achieved and sustained prolonged clinical stability, while being maintained on buprenorphine 8 mg per day or less of a Subutex or Suboxone sublingual tablet or generic equivalent.
WARNING: IMPLANT MIGRATION, PROTRUSION, EXPULSION and NERVE DAMAGE ASSOCIATED WITH INSERTION and REMOVAL
Risk Associated with Insertion and Removal
Insertion and removal of PROBUPHINE are associated with the risk of implant migration, protrusion, expulsion resulting from the procedure. Rare but serious complications including nerve damage and migration resulting in embolism and death may result from improper insertion of drug implants inserted in the upper arm. Additional complications may include local migration, protrusion and expulsion. Incomplete insertions or infections may lead to protrusion or expulsion.
Because of the risks associated with insertion and removal, PROBUPHINE is available only through a restricted program called the PROBUPHINE REMS Program. All Healthcare Providers must successfully complete a live training program on the insertion and removal procedures and become certified, prior to performing insertions or prescribing PROBUPHINE implants. Patients must be monitored to ensure that PROBUPHINE is removed by a healthcare provider certified to perform insertions.
Please see additional Important Safety Information in the Package Insert that can be found at probuphine.com or by following this link http://probuphinerems.com/wp-content/uploads/2016/02/final-approved-pi.pdf.
Coltrin & Associates on behalf of Braeburn Pharmaceuticals
Enrique brings over 20 years of experience supporting business planning and operations in US, Japan, Europe and Latin America within major international corporations. At Braeburn Pharmaceuticals, Enrique leads all business analytics efforts. Prior to joining Braeburn, Enrique was Senior Director Global Commercialization and Portfolio Management at Otsuka Pharmaceuticals. Preceding Otsuka, Enrique held positions with increasing responsibilities at Bristol-Myers Squibb, The Coca-Cola Company and Procter & Gamble. Enrique holds a Bachelor of Science in Civil Engineering from UCAB, in his native Caracas, Venezuela and Postgraduate Diploma in Computer Science from Lausanne Institute of Technology in Switzerland.
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 medical devices. With professional qualifications in finance and law, David has held senior financial, legal and operational roles.
David is currently a Partner at Apple Tree Partners. Prior to Apple Tree Partners, David was Executive Vice President, Chief Financial Officer of HeartWare International, Inc. (NASDAQ: HTWR, ASX:HIN) 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. 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). Board responsibilities include: Gala Therapeutics, VytronUS.
Dr. Jerry Karabelas has held a number of senior executive positions in major pharmaceutical companies, including Head of Healthcare and CEO of Worldwide Pharmaceuticals for Novartis AG, where he had full responsibility for Novartis Pharma and Ciba Vision, as well as strategic and operational leadership of R&D. Dr. Karabelas was also Executive Vice President of SmithKline Beecham with responsibility for U.S. and European operations, regulatory, and strategic marketing. Most recently, Dr. Karabelas has chaired the boards of several biopharmaceutical companies, including Human Genome Sciences, Inc., Vanda Pharmaceuticals, Inc. and SkyePharma PLC. He currently chairs the boards of Inotek and Polyphor, AG and is a partner at Care Capital. Dr. Karabelas holds a Ph.D. in Pharmacokinetics from the Massachusetts College of Pharmacy.
Reed brings over 20 years’ leadership experience in the biotech and pharmaceutical industry and held key positions in the areas of Quality, Global Regulatory Affairs, Legal Affairs and Global Compliance. At Braeburn, Reed heads up the Quality and Compliance functions and serves as Braeburn’s Compliance Officer.
Prior to joining Braeburn, Reed held key positions at Jazz Pharmaceuticals and MedImmune, the biologics division of AstraZeneca. Reed’s experience includes the development and commercialization efforts of both small and large molecule therapeutics in the areas of Oncology, Neuroscience and Pain. She was instrumental in helping to build MedImmune’s compliance and privacy functions and was instrumental in growing AstraZeneca’s global compliance efforts. Reed holds a J.D. from the University of Baltimore School of Law, a M.S. in Pharmaceutical Regulatory Affairs and Quality Assurance from Temple University School of Pharmacy and B.S. in Environmental Science Biology from Kutztown University.
Craig is an accomplished senior pharmaceutical executive with nearly 20 years experience in key leadership positions within major pharmaceutical companies. His primary focus has been on bringing innovative CNS treatments to market. He has extensive industry experience including Global, U.S. and Early Development marketing; portfolio prioritization; protocol development; global alliance management and business development. In his role at Braeburn he leads program management, product manufacturing, and commercialization efforts. Prior to joining Braeburn, Mr. Brown spent nine years at Otsuka Pharmaceuticals, Inc. where he oversaw the early development of the Global CNS pipeline and the global management of the CNS franchise. He was instrumental in launching ABILIFY®, which has achieved over 6 billion dollars in annual sales, and in the development of ABILIFY MAINTENA®. He was also responsible for the development of five investigational compounds (discovery through Phase IV), and played an integral role in the development process of CNS assets. In addition, while at Otsuka, his role included global alliance management with key partners including Bristol-Myers Squibb, Lundbeck and UCB Japan as well as the global management of Otsuka affiliates in U.S., Europe and Asia-Pacific. A Georgia State University Graduate, Mr. Brown began his pharmaceutical career as a territory manager at Bristol-Myers Squibb.
David brings over 20 years of pharmaceutical and biotechnology industry leadership experience in market access, reimbursement, government affairs, sales and marketing to Braeburn Pharmaceuticals. David has dedicated the last 8 years of his career to the advancement of medications for treatment of opioid addiction. Prior to Braeburn, he directed the Market Access and Government Affairs strategy and execution for Orexo US leading to exclusive product formulary positons with CVS Health, UHC and Wellcare Health Plans for Zubsolv. Prior to Orexo, David built the public sector organization for Reckitt Benckiser Pharmaceuticals and directed field activities related to coverage and reimbursement for the $1.6 billion Suboxone franchise.
David’s government affairs contributions were instrumental in the development of reimbursement methodology for biologic medicines as part of the 2003 Medicare Modernization Act, the passage of the 2008 Wellstone-Domenici Mental Health Parity Act and the successful effort to recognize addiction treatment as an essential health benefit in the 2010 Affordable Care Act.
David holds a B.S. in Public Administration from Indiana University-Bloomington.
Sonnie has nearly 20 years of leadership experience driving medical affairs and scientific programs across a range of therapeutic areas, including pain management, addiction medicine and cardiovascular disease. At Braeburn, Dr. Kim oversees clinical trial design and execution for products in development and leads all medical affairs activities. Prior to joining Braeburn Pharmaceuticals, Dr. Kim was with Otsuka America Pharmaceutical, Inc., as the Director of Medical Affairs/Hospital Medicine and integral in the pre- and post-launch medical affairs activities and programs for SAMSCA, including development of phase 4 program, building health economic models and forming Medical Science Liaison teams. Dr. Kim has previously been with WebMD, LLC, where she developed and deployed analytical tools to shape the strategy of WebMD’s Medscape Education program. Dr. Kim’s previous experience also includes roles as Vice President and Board member of Columbia Medcom Group, Inc., and its subsidiary, Medicallaince, Inc., and a teaching and clinical role at the University of Maryland School of Pharmacy. Dr. Kim holds a Doctorate of Pharmacy from the University of Maryland School of Pharmacy.
Frank brings over 45 years of experience in medicine, academia and government to his role as Braeburn’s Executive Vice President for Clinical and Regulatory Affairs. Dr. Young served as Commissioner of the U.S. Food and Drug Administration from 1984-1989 during the Reagan and Bush administrations. Subsequently he served as Deputy Assistant Secretary in the H.W. Bush administration, and Director of both the Office of Emergency Preparedness and the National Disaster Medical System during the Clinton Administration. Prior to entering government, Dr. Young served as Chairman of the Department of Microbiology and Professor of Microbiology, Pathology, Radiation Biology and Biophysics at the University of Rochester, New York, as well as Dean of the School of Medicine and Dentistry, Director of the Medical Center and Vice President for Health Affairs at the University of Rochester. Dr. Young has contributed to more than 200 scientific articles in the fields of biotechnology and microbiology, including development of some of the earliest cloning enzymes, vectors and vehicles. Dr. Young has extensive corporate experience through membership on over seven Board of Directors, consultant positions with over 21 companies and most recently Interim Vice President for Clinical and Regulatory Affairs at Bioventus LLC. He was co-founder and CEO of the Cosmos Alliance. Dr. Young also served as a partner of Essex Woodlands from 2006-2013 and continues as Adjunct Partner.