Fast Company Honors Braeburn Pharmaceuticals as Innovative

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”

Probuphine® Implant Receives J-Code

New Field Force Deployed to Advance Commercialization Efforts

 

Princeton, N.J.—January 13, 2017—Braeburn Pharmaceuticals, Inc. today announced that the Centers for Medicare & Medicaid Services (CMS) has granted a Healthcare Common Procedure Coding System (HCPCS) code, or permanent J-code, for Probuphine, the first and only six-month buprenorphine implant for the maintenance treatment of opioid addiction. The new J-code (J0570) became effective January 1, 2017 and coincides with the activation of a new field force to drive the next phase of Probuphine adoption.

 

“With patients and providers urgently needing access to evidence-based treatment for opioid addiction, we are pleased that CMS granted a J-code for Probuphine,” said Behshad Sheldon, President and CEO, Braeburn Pharmaceuticals. “We anticipate that the new code and our expanded commercial team will advance adoption of Probuphine and broaden access for appropriate patients with opioid use disorder.”

 

HCPCS codes are used by healthcare professionals to identify services and procedures for which they bill public or private health insurance programs. The codes included in the HCPCS set, which is based on the American Medical Association’s Current Procedural Terminology, are maintained by CMS and universally accepted by all payers.

 

About Probuphine

 

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 a short outpatient office procedure and is removed in a similar manner. Probuphine is available through a closed distribution system. 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.

 

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.

 

Contacts:


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

 

Braeburn and CEO Behshad Sheldon Win Stevie Awards

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.

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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 .

About Probuphine

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.

Media Contact:

Coltrin & Associates on behalf of Braeburn Pharmaceuticals

Caleb Cluff

212-221-1616

Caleb_Cluff@coltrin.com

Probuphine® Wins Popular Science’s “Best of What’s New” Award

Probuphine® Wins Popular Science’s “Best of What’s New” Award

Princeton, New Jersey, October 27, 2016 — Braeburn Pharmaceuticals, Inc. has been awarded a “Best of What’s New” award for its Probuphine (buprenorphine) implant, the first and only implant for the maintenance treatment of opioid addiction in clinically stable patients. Each year Popular Science chooses 12 of the most transformative advances in health and has selected Probuphine as one of this year’s winners.

Probuphine was developed to offer a new way to treat opioid addiction, a disease that has reached epidemic proportions and according to the CDC in 2014 claimed the lives of 78 people in the U.S. each day. Probuphine contains buprenorphine, a drug that reduces the symptoms of withdrawal and cravings for opioids. Buprenorphine-containing products have been successfully used to treat opioid dependence since 2002. As a six-month subdermal implant, Probuphine received fast track designation by the FDA for its potential to reduce the risks of diversion, abuse and accidental pediatric exposure.

“We are honored that Probuphine was recognized by Popular Science as an innovative way to treat opioid use disorder,” said Behshad Sheldon, President and Chief Executive Officer, Braeburn Pharmaceuticals. “Patients with opioid addiction deserve to have as many novel approaches available to them as those with other chronic diseases. Probuphine provides up to six months of treatment after a single in-office procedure.”

“The Best of What’s New awards honor the innovations that shape the future” says Kevin Gray, Executive Editor, Popular Science. “From life-saving technology to incredible space engineering to gadgets that are just breathtakingly cool, this is the best of what’s new.”

About Best of What’s New

Each year, the editors of Popular Science review thousands of products in search of the top 100 tech innovations of the year—breakthrough products and technologies that represent a significant leap in their categories. The winners, the Best of What’s New, are awarded inclusion in the much-anticipated November/December issue of Popular Science, which has been the most widely read issue of the year since the debut of Best of What’s New in 1988. Best of What’s New awards are presented to 100 new products and technologies in 11 categories: Automotive, Aviation, Computing, Engineering, Gadgets, Entertainment, Security, Software, Home, Health and Recreation.

About Popular Science

Founded in 1872, Popular Science is the world’s largest science and technology magazine, with a circulation of 1.3 million and 6.8 million bi-monthly readers. In each issue, Popular Science reports on the intersection of science and everyday life, with an eye toward what’s new and why it matters. Popular Science is published by Bonnier Active Media, a subsidiary of Bonnier Corporation.

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. Probuphine, Braeburn’s long -acting 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 CAM2038, weekly and monthly subcutaneous injection depot formulations of buprenorphine, being investigated in opioid addiction and pain and a risperidone six-month implant being investigated in schizophrenia. More information on Braeburn can be found at www.braeburnpharmaceuticals.com.

About Probuphine

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 that includes counseling and psychosocial support.

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. For more information, visit www.probuphine.com.

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.

###
Media Contacts:

MSLGROUP

Sherry Feldberg

781-684-0770

braeburnpharma@publicisgroupe.net

Coltrin & Associates, Inc.

Caleb Cluff

212-221-1616

caleb_cluff@coltrin.com