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”
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.
Dennis H. Langer, M.D., J.D. has served as a Director of several biotechnology, specialty pharmaceutical, and diagnostic companies, and has been CEO and/or co-founder of several health care companies. From 2005 to 2010, Dr. Langer served as a Managing Partner of Phoenix IP Ventures, a private equity/venture capital firm specializing in life sciences. Previously, he was President, North America, of Dr. Reddy’s Laboratories, Limited. From September 1994 until January 2004, Dr. Langer held several high-level positions at GlaxoSmithKline plc, and its predecessor, SmithKline Beecham, including most recently as a Senior Vice President of Research and Development. Prior to SmithKline Beecham, Dr. Langer was President and CEO of Neose Technologies, Inc., and before that held R&D and marketing positions at Eli Lilly, Abbott and Searle. At the beginning of his career, he was a Chief Resident at Yale University School of Medicine, and held clinical fellowships at Harvard Medical School and the National Institutes of Health. Dr. Langer serves as a Director of Myriad Genetics, Inc., Dicerna Pharmaceuticals, Inc., Delcath Systems, Inc., and several private companies. Previously, Dr. Langer served as a Director of Ception Therapeutics, Inc. (acquired by Cephalon, Inc.), Cytogen Corporation (acquired by EUSA Pharma Inc.), Pharmacopeia, Inc. (acquired by Ligand Pharmaceuticals, Inc.), Sirna Therapeutics, Inc. (acquired by Merck and Co., Inc.), and Transkaryotic Therapies, Inc. (acquired by Shire plc). Dr. Langer is a Clinical Professor in the Department of Psychiatry, Georgetown University School of Medicine. Dr. Langer received a J.D. from Harvard Law School, an MD from Georgetown University School of Medicine, and a B.A. in Biology from Columbia University.
FOR IMMEDIATE RELEASE
Princeton, New Jersey – December 9, 2015 – Braeburn Pharmaceuticals, Inc. and partner Titan Pharmaceuticals (NASDAQ: TTNP) today announced that the U.S. Food and Drug Administration has scheduled a meeting of the Psychopharmacologic Drugs Advisory Committee (PDAC) on Jan. 12, 2016 to review the New Drug Application (NDA) for Probuphine® for the maintenance treatment of opioid addiction. The meeting notice appears in today’s Federal Register and can be found at http://federalregister.gov/a/2015-30970. The NDA was resubmitted to the FDA in August 2015, and accepted by the FDA in September 2015. An agency action date has been set for Feb. 27, 2016.
“The data from the final phase 3 trial, which was designed in collaboration with the FDA in response to questions raised in the complete response letter, is compelling and we look forward to presenting it on January 12,” said Braeburn Pharmaceuticals President and CEO Behshad Sheldon. “More long-term treatments are needed to help people stay in recovery, and we remain excited about the potential for Probuphine to be the first of many new options for people with opioid addiction.”
“The Braeburn team has been interacting closely with the FDA, and we continue to support them as the Probuphine NDA advances,” said Titan Pharmaceuticals President Sunil Bhonsle. “We look forward to a successful meeting.”
Probuphine is an investigational subdermal implant designed to deliver buprenorphine continuously for six months following a single treatment, and to promote patient compliance and retention. Buprenorphine, which is the active ingredient in multiple FDA-approved drug products for the treatment of opioid addiction, is currently available in tablet and film formulations that require self-administration by patients on a daily basis.
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 an outpatient office procedure, and removed in a similar manner at the end of the treatment period.
The efficacy and safety of Probuphine has been studied in several clinical trials, including the double blind, double dummy final Phase 3 study, which provided positive results (announced June 2015) in the comparison of maintenance treatment with Probuphine to maintenance treatment with daily sublingual buprenorphine in stable patients receiving a daily dose of 8mg or less of buprenorphine; the previously reported 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 Opioid Addiction
According to recent estimates, there are 2.4 million people with opioid addiction 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. Sales of buprenorphine drug products for treatment of opioid addiction in 2014 were approximately $1.75 billion in the United States.
About Braeburn Pharmaceuticals
Braeburn Pharmaceuticals, an Apple Tree Partners company, is a pill-free pharmaceutical company delivering precision medicine in neuroscience. In September 2015 the Food and Drug Administration (FDA) accepted for review Braeburn’s New Drug Application for its lead candidate, Probuphine®, a six-month buprenorphine implant for treatment of opioid addiction. The Agency set February 27, 2016 as the target date for action.
Long-acting therapeutic treatment options can be essential to improving patient outcomes and facilitating recovery in these conditions, which are often complicated by stigma and present significant public health challenges. 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. Candidates include: Probuphine®, a six-month buprenorphine implant for treatment of opioid addiction; CAM2038, weekly and monthly subcutaneous injection depot formulations of buprenorphine for treatment of opioid addiction and pain; a risperidone six-month implant for treatment of schizophrenia; and a novel molecule, ATI-9242, for treatment of schizophrenia. More information on Braeburn, can be found at www.braeburnpharmaceuticals.com.
About Titan Pharmaceuticals
Titan Pharmaceuticals Inc. (NASDAQ: TTNP), based in South San Francisco, CA, is a specialty pharmaceutical company developing proprietary therapeutics primarily for the treatment of serious medical disorders. The company’s lead product candidate is Probuphine®, a novel and long-acting formulation of buprenorphine for the long-term maintenance treatment of opioid dependence. Probuphine employs Titan’s proprietary drug delivery system ProNeura™, which is capable of delivering sustained, consistent levels of medication for three months or longer. Titan has granted U.S. and Canadian commercial rights for Probuphine to Braeburn Pharmaceuticals. If approved, Probuphine would be the first and only commercialized treatment of opioid dependence to provide continuous, around-the-clock blood levels of buprenorphine for six months following a single procedure. The ProNeura technology has the potential to be used in developing products for treating other chronic conditions, such as Parkinson’s disease, where maintaining consistent blood levels of a therapeutic agent may benefit the patient and improve medical outcomes. For more information about Titan, please visit www.titanpharm.com.
FOR IMMEDIATE RELEASE
PRINCETON, NJ, September 11, 2013 – Braeburn Pharmaceuticals, today announced that former FDA Commissioner Frank E. Young, M.D., Ph.D., has joined the management team as Executive Vice President, Clinical and Regulatory Affairs. If approved, Braeburn’s first product will be Probuphine®, a buprenorphine implant for the maintenance treatment of opioid addiction, currently under review at the U.S. Food and Drug Administration (FDA). Braeburn has licensed rights from Titan Pharmaceuticals, Inc. to commercialize Probuphine in the U.S. and Canada.
“I joined Braeburn Pharmaceuticals because helping people overcome the life-threatening risks and health hazards of opioid addiction while supporting their journey to recovery is among the highest priorities of public health today. I am impressed with Braeburn’s commitment to develop therapies to mitigate health problems associated with opioid addiction,” said Dr. Young. “I look forward to working with FDA and the Braeburn team to satisfy fully FDA’s concerns.”
“Dr. Young brings extensive knowledge and experience to the Braeburn team at this important time for our company,” said Behshad Sheldon, President and Chief Operating Officer of Braeburn Pharmaceuticals. “As we continue to work collaboratively with FDA, we are confident that Dr. Young’s counsel will help us navigate the process and expedite the evaluation of Probuphine to make this novel treatment option available to patients suffering from opioid addiction.”
Dr. Young served as Commissioner of the U.S. Food and Drug Administration from 1984 to 1989 during the Reagan and Bush administrations. Subsequently, he served as Deputy Assistant Secretary in the George 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. More recently, Dr. Young served as 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.
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 confirmatory study of 287 patients (published in the journal Addiction).
In October 2012, FDA granted Probuphine priority review designation, based upon its potential for improved compliance and diversion resistance. In March 2013, the FDA’s Psychopharmacologic Drugs Advisory Committee (PDAC) voted ten in favor, four against to approve Probuphine. In April 2013, the FDA issued a Complete Response Letter (CRL) and on September 4, 2013, a meeting request was submitted to the FDA to discuss the response to the CRL for Probuphine.
Braeburn Pharmaceuticals, an Apple Tree Partners company, develops and commercializes innovative medical products and is 100% dedicated to the field of addiction. If FDA approves the new drug application (NDA), the company’s first product will be Probuphine®, a buprenorphine implant currently under FDA priority review for the maintenance treatment of opioid dependence. Braeburn’s executive team has decades of experience successfully bringing medically significant pharmaceuticals and medical devices to market, as well as a deep understanding of clinical development and quality assurance processes.
Helen Shik/Sherry Feldberg
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.
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, 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.