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
PRINCETON, USA and MONTREAL, CANADA — February 1st, 2016 — Braeburn Pharmaceuticals, Inc. (“Braeburn”) and Knight Therapeutics Inc. (TSX: GUD) (“Knight”), a leading Canadian specialty pharmaceutical company, announced today that they have entered into an agreement whereby Knight received the exclusive rights to commercialize PROBUPHINE® in Canada. PROBUPHINE® is an investigational subdermal implant designed to deliver buprenorphine continuously for six months following a single treatment, promoting patient compliance and retention as well as helping to prevent accidental paediatric exposure. Under the terms of this sublicense agreement, Knight will also handle all ongoing regulatory and commercial activities for PROBUPHINE® in Canada.
“According to the Canadian Drug Policy Coalition, overdose deaths from opioids have risen sharply in Canada and now account for approximately half of all drug related deaths in the country,” said Behshad Sheldon, President and CEO of Braeburn. “Partnering with Knight Therapeutics is another step in our vision to making a lasting impact on how this chronic disease is treated in North America.”
“We are pleased that we can be instrumental in bringing PROBUPHINE® to Canada,” said Jonathan Ross Goodman, President and Chief Executive Officer of Knight. “Once approved by Health Canada, PROBUPHINE® will be the first product to offer treatment for opioid addiction for six months following a single treatment. This innovative product has the potential to address an important unmet need for opioid dependent patients.”
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 approved drug products for the treatment of opioid dependence, is currently available in sublingual and buccal formulations that require self-administration by patients on a daily basis.
Probuphine was developed using ProNeura™, the continuous drug delivery system developed by Titan Pharmaceuticals, Inc. (“Titan”) 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. Titan licensed the rights to commercialize Probuphine in the U.S. and Canada in 2012.
The efficacy and safety of Probuphine has previously been studied in several clinical studies. The most recent study enrolled 177 subjects who were randomized to receive either the Probuphine implants or sublingual tablets, for a treatment period of six months. Subjects in one group received four Probuphine implants plus daily placebo sublingual tablets. A second group received four placebo implants plus daily sublingual buprenorphine/naloxone tablets (≤8mg/day).
The study met its primary objective of showing non-inferiority based on comparison of the proportion of treatment responders in each treatment arm. A responder was defined as having at least four out of six months free of illicit opiates based on urine testing and subject self-report. Additional analyses consistently demonstrated that Probuphine was non-inferior to sublingual buprenorphine/naloxone arm.
About Braeburn Pharmaceuticals Inc.
Braeburn, an Apple Tree Partners company, is a pill-free pharmaceutical company delivering precision medicine in neuroscience. In September 2015, the U.S. 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. On January 12, 2016 the FDA Psychopharmacologic Drugs Advisory Committee recommended approval by a vote of 12 to 5. The agency has 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 Knight Therapeutics Inc.
Knight Therapeutics Inc., headquartered in Montreal, Canada, is a specialty pharmaceutical company focused on acquiring or in-licensing innovative pharmaceutical products for the Canadian and select international markets. Knight Therapeutics Inc.’s shares trade on TSX under the symbol GUD. For more information about Knight Therapeutics Inc., please visit the company’s web site at www.gud-knight.com or www.sedar.com.
This document contains forward-looking statements for Knight Therapeutics Inc. and its subsidiaries. These forward looking statements, by their nature, necessarily involve risks and uncertainties that could cause actual results to differ materially from those contemplated by the forward-looking statements. Knight Therapeutics Inc. considers the assumptions on which these forward-looking statements are based to be reasonable at the time they were prepared, but cautions the reader that these assumptions regarding future events, many of which are beyond the control of Knight Therapeutics Inc. and its subsidiaries, may ultimately prove to be incorrect. Factors and risks, which could cause actual results to differ materially from current expectations are discussed in Knight Therapeutics Inc.’s Annual Report and in Knight Therapeutics Inc.’s Annual Information Form for the year ended December 31, 2014. Knight Therapeutics Inc. disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information or future events, except as required by law.
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Braeburn Pharmaceuticals, Inc.