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

 

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

Braeburn Pharmaceuticals Announces Probuphine Data Published in the Journal of the American Medical Association

Study Results Find FDA-approved Six-month Buprenorphine Implant to be Non-inferior to Continued Sublingual Buprenorphine for Maintenance Treatment of Opioid Use Disorder

Princeton, N.J.–July 19, 2016Braeburn Pharmaceuticals announces that the results of the first comparative trial to evaluate efficacy and safety of a six-month buprenorphine implant relative to sublingual buprenorphine in patients with opioid use disorder were published online today in the Journal of the American Medical Association. The study found that participants who were clinically stable on sublingual buprenorphine maintained stability when transferred to the six-month buprenorphine implant, and that they were more likely to sustain abstinence from illicit opioids throughout the six months than participants who remained on sublingual buprenorphine.

“This study demonstrates the efficacy of the six-month buprenorphine implant, an innovative approach to treating stable patients with opioid use disorder. In the Probuphine implant and sublingual buprenorphine groups, 81/84 (96.4%) and 78/89 (87.6%) of participants, respectively, were responders,” said lead author, Richard N. Rosenthal, MD, Center for Addictive Disorders, Department of Psychiatry, Icahn School of Medicine at Mount Sinai, N.Y. “While the trial was designed to assess non-inferiority, the buprenorphine implant was shown to be superior to sublingual buprenorphine based on the responder rate, with a p value of 0.03.”

“We are proud that the results of this rigorously-conducted study have been published in such a prestigious medical journal,” said Behshad Sheldon, President and CEO of Braeburn Pharmaceuticals. “Opioid use disorder is an underserved chronic disease and we are pleased to have added to the clinical evidence base for the use of medication in the treatment of this deadly disease.”

The study showed that Probuphine was non-inferior to sublingual buprenorphine on the primary endpoint of at least 4 of 6 months with no illicit opioid use by drug testing and self-report among opioid-dependent adults previously stabilized on sublingual buprenorphine. Additionally, relative to participants using sublingual buprenorphine, participants maintained on Probuphine were more likely to sustain abstinence from illicit opioids. At 6 months 85.7% of the Probuphine implant group remained abstinent each month relative to 71.9% of the sublingual buprenorphine group (p=0.03). Non-implant and implant-related adverse events (AEs) occurred in 48.3% and 23% of the buprenorphine implant group and 52.8% and 13.5% of participants in the sublingual buprenorphine group, respectively.

“This is the first time a population of patients who are stable on buprenorphine have been studied for six months in a double-blind, double-dummy trial, which represents the most rigorous type of clinical studies. It is critical to continue to generate this type of evidence in opioid use disorder,” said Frank Vocci, President of Friends Research Institute in Baltimore.

Study Design

This randomized, double-blind, double-dummy, active-controlled, 26-week, multicenter study in clinically stable adults receiving 8 mg or less sublingual buprenorphine evaluated the safety and efficacy of 4 Probuphine implants compared with daily sublingual buprenorphine in 177 patients. The study was conducted at 21 United States office-based buprenorphine outpatient treatment sites. Eligible participants had a primary diagnosis of Opioid Use Disorder; were aged 18 to 65 years; received sublingual buprenorphine as an outpatient at a stable dose of 8 mg or less and showed no evidence of opioid withdrawal or illicit opioid-positive urine samples for at least 90 days prior to study entry.

Study Results
Primary Outcomes

In the buprenorphine implant and sublingual buprenorphine groups, 81/84 (96.4%) and 78/89 (87.6%) of participants, respectively, were responders. The difference was 8.8% (1-sided 97.5% CI, 0.009 to ∞; p <0.001 for non-inferiority; p = 0.03 for superiority) on the primary outcome measure vs sublingual buprenorphine. In a sensitivity analysis for all randomized participants, with all missing urine samples imputed as positive and no illicit opioid use for all 6 months, 70/87 (80.5%) participants receiving buprenorphine implants and 60/90 (66.7%) receiving sublingual buprenorphine were abstinent, resulting in a proportion difference of 13.8% (2-sided 95% CI, −0.266 to −0.010; p = 0.038). Additional sensitivity analyses all demonstrated non-inferiority and were consistent with primary efficacy results. Including an analysis by the FDA, that was based on imputation methods and treatment of supplemental use, they determined that Probuphine satisfied the non-inferiority in an evaluation of the proportion of patients with no evidence of illicit opioid use throughout the 6 month period. Probuphine n=55 (63%) versus sublingual n=57 (64%).

Secondary Outcomes

Relative to sublingual buprenorphine, a larger proportion of participants receiving buprenorphine implants demonstrated no evidence of illicit opioid use throughout 6 months of treatment. At 6 months, cumulative abstinence was 72/84 (85.7%) for buprenorphine implants vs 64/89 (71.9%) for sublingual buprenorphine (hazard ratio [HR] 13.8, 95% CI 0.018–0.258, p = 0.03). This difference became statistically significant starting at month 3 and was sustained throughout month 6. Time to first evidence of illicit opioid use was also significantly longer for buprenorphine implants relative to sublingual buprenorphine (HR 0.49, 95% CI 0.25–0.97, p = 0.04).

Safety

Serious AEs (SAEs) occurred in 5 participants; 3 in the sublingual buprenorphine group (biliary colic, chronic cholecystitis, bronchitis) and 2 in the buprenorphine implant group (convulsions, worsening bipolar I disorder). One buprenorphine implant participant discontinued due to an AE (muscle spasms).

Medication-related and implant-related AEs were consistent with the known safety profile of buprenorphine and the previously published implantation procedure. Buprenorphine implants were associated with higher incidences of local site AEs vs sublingual buprenorphine. There were no cases of migration of implants beyond the local insertion site.

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 not distributed by pharmacies; 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 Opioid Use Disorder and Buprenorphine

Opioid use disorder is a chronic brain disease and one of the fastest growing public health epidemics in America. In the U.S., 2.5 million people struggle with opioid addiction and, according to the Centers for Disease Control, 78 people die each day from the disease. There is a growing body of evidence that opioid addiction is not a choice or a moral failing, but the result of genetic predisposition combined with environmental factors. Nonetheless, individuals struggling with this disease continue to be stigmatized. Research has also shown that opioid use disorder is best treated with a combination of medication and psychosocial support. The majority of individuals with opioid addiction cannot sustain recovery without long-term outpatient medical treatment.

Buprenorphine is a partial opioid agonist, which may help individuals to stop opioid use without experiencing withdrawal symptoms. Before FDA approval of Probuphine, buprenorphine was only available in oral form which must be taken daily.

About Braeburn Pharmaceuticals

Braeburn Pharmaceuticals, an Apple Tree Partners company, is a pharmaceutical company focused on long-acting therapeutic treatment options that are 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 CAM2038, weekly and monthly subcutaneous injection depot formulations of buprenorphine, being investigated in opioid addiction and pain; a risperidone six-month implant being investigated in schizophrenia; and a novel molecule, ATI-9242, being investigated for treatment of schizophrenia. More information on Braeburn can be found at www.braeburnpharmaceuticals.com.

Media Contacts:

MSLGROUP
Sherry Feldberg or Rachel Gross
781-684-0770
braeburnpharma@publicisgroupe.net

Coltrin & Associates, Inc.
Caleb Cluff
212-221-1616
caleb_cluff@coltrin.com

First Patients Have Received Probuphine® (buprenorphine) Implant

Over 1,000 Health Care Professionals Have Now Been Certified and are now able to Provide Probuphine as an option to Patients

PRINCETON, N.J. — June 20, 2016—Braeburn Pharmaceuticals announces that 10 patients have already been treated with the Probuphine (buprenorphine) Implant, making them the first people in the United States to receive this new medication that was recently approved by the Food and Drug Administration (FDA) on May 26, 2016.

Dr. Steven Chavoustie, of the Segal Institute for Clinical Research in Miami, Florida; Dr. Mike Frost, medical director, Eagleville Hospital in Conshohocken, Pennsylvania; Dr. Marc Maskowitz, Paincare Medical Practice in Sacramento, California and Dr. Matthew Torrington, Los Angeles, California were the first doctors to implant Probuphine since approval.

To date, more than 1,100 healthcare providers in 44 states have been certified to provide this new medication to patients. More than 5,000 healthcare providers have requested additional information on Probuphine training and will have the opportunity to participate in one of 252 training sessions in 55 U.S. cities this summer, bringing the total number of certified physicians to more than 2,000 by the end of July and a total of more than 4,000 healthcare providers by the end of 2016.

“The Braeburn team is relentlessly focused on healthcare provider implant training and insurance reimbursement in order to ensure swift access to Probuphine for patients,” said President and CEO Behshad Sheldon, Braeburn Pharmaceuticals. “We hope the Probuphine Healthcare Provider Locator on ProbuphineREMS.com will make it simpler for patients to find treating physicians in their area.”

“The large number of qualified healthcare providers signing up for the Probuphine trainings is proof that the medical community sees the potential this new option may offer their patients,” said Dr. Chavoustie who collaborated with the FDA to finalize the training program on the procedures. “Prior to attending the training sessions, many of the participating healthcare providers surveyed their patients currently stable on low to moderate doses of oral buprenorphine and found that they share the same excitement that Probuphine is now available.”

Insurers have also expressed strong interest in discussing how they would provide coverage for Probuphine. Several BCBS plans as well as United Healthcare were among those that approved reimbursement for the first patients implanted.

Qualified healthcare providers that are interested in attending a certification course in their area can register at www.probuphineREMS.com or by calling 1-866-397-8939. Patients can locate certified healthcare providers in their area that have been certified to implant patients by using the physician locator at www.probuphineREMS.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 be used as part of a complete treatment program to include counseling and psychosocial support.

Probuphine is the only six-month treatment for opioid dependence that delivers buprenorphine continuously using Titan Pharmaceuticals’ ProNeura™ technology. Probuphine is not distributed by pharmacies; qualified healthcare providers can register for Probuphine training at www.probuphineREMS.com or by calling 1-866-397-8939. Patients can locate certified healthcare providers at www.probuphineREMS.com by using the physician locator.

Probuphine is significantly lower cost than a six month-course of other long-acting medications for opioid addiction.

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 Opioid Use Disorder and Buprenorphine
Opioid use disorder is a chronic brain disease and one of the fastest growing public health epidemics in America. In the U.S., 2.5 million people struggle with opioid addiction and, according to the Centers for Disease Control, 78 people die each day from the disease. There is a growing body of evidence that opioid addiction is not a choice or a moral failing, but the result of genetic predisposition combined with environmental factors. Nonetheless, individuals struggling with this disease continue to be stigmatized. Research has also shown that opioid use disorder is best treated with a combination of medication and psychosocial support. The majority of individuals with opioid addiction cannot sustain recovery without long-term outpatient medical treatment.

Buprenorphine is a partial opioid agonist, which may help individuals to stop opioid use without experiencing withdrawal symptoms. Before FDA approval of Probuphine, buprenorphine was only available in oral form which must be taken daily.

About Braeburn Pharmaceuticals

Braeburn Pharmaceuticals, an Apple Tree Partners company, is a pill-free pharmaceutical company delivering precision 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; a risperidone six-month implant being investigated in schizophrenia; and a novel molecule, ATI-9242, for treatment of schizophrenia. More information on Braeburn, can be found at www.braeburnpharmaceuticals.com.


Media Contacts:

MSLGROUP
Sherry Feldberg or Rachel Gross
781-684-0770
braeburnpharma@publicisgroupe.net

Coltrin & Associates, Inc.
Caleb Cluff
212-221-1616
caleb_cluff@coltrin.com

Probuphine® (buprenorphine) Implant Phase 3 Data Presented at CPDD Annual Scientific Meeting

Results Demonstrate the Superiority of Probuphine for Abstinence from Opioids for Patients over Six Months

Princeton, NJ and Palm Springs, CA — June 16, 2016—Braeburn Pharmaceuticals presented data yesterday from the poster of the Phase 3 study of Probuphine, a six-month subdermal buprenorphine implant for the long-term maintenance treatment of opioid dependence, at the 78th Annual Scientific Meeting of The College on Problems of Drug Dependence (CPDD). The U.S. Food and Drug Administration (FDA) approved Probuphine on May 26, 2016.

The study demonstrates that participants who were clinically stable on sublingual buprenorphine maintained stability when transferred to Probuphine and that they were more likely to sustain abstinence from illicit opioids throughout the six months than participants who remained on sublingual buprenorphine.

Primary efficacy analysis originally presented showed that 96.4 percent of participants in the Probuphine group had at least four months without evidence of drug use versus 87.6 percent in the sublingual buprenorphine group, demonstrating superiority of Probuphine with a p value of 0.034.

Additional sensitivity analyses were conducted to support the robustness of the primary analysis, including the following that were presented at CPDD:
– Statistically significant difference between Probuphine and sublingual buprenorphine in the proportion of subjects for all 6 months without evidence of illicit opioid use (85.7% versus 71.9%, p=0.03). Imputation of all missing values as positive for illicit opioids also demonstrated significant difference (80.5% versus 67.4%, p=0.05).
– A more conservative approach, including the use of supplemental sublingual buprenorphine as non-responders as well as imputing all missing values as positive for illicit opioid use, illustrated similar results for Probuphine and sublingual buprenorphine (63.2% versus 53.9%, p=0.21).

“Non-adherence to medication approved to treat opioid dependence is a leading cause of relapse,” said Frank J. Vocci, Ph.D., president and senior research scientist, Friends Research Institute. “The study results show that more participants in the implant group sustained at least four months of abstinence from opioids than participants in the sublingual buprenorphine group. Implanted just under the skin, Probuphine encourages treatment adherence and adds a new treatment for doctors to utilize to address the opioid dependence epidemic.”

“In the three weeks since we received FDA approval for Probuphine, we have trained over 800 Healthcare Providers who have already begun treating their patients with Probuphine,” said Behshad Sheldon, CEO, Braeburn Pharmaceuticals. “We recognize the importance to both physicians and patients of this new treatment for opioid dependence and are working to train 5,000 healthcare providers before the end of the year. We are currently conducting training sessions every weekend to accommodate the interest that has been expressed from qualified healthcare providers.”

For more information about training healthcare providers can visit www.ProbuphineREMS.com or call 1-866-397-8939.

About Probuphine

Probuphine is the only six-month treatment for opioid dependence and was developed using ProNeura™, Titan Pharmaceuticals’ (NASDAQ: TTNP) 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. Probuphine implants are 26 millimeters long and 2.5 millimeters in diameter, or about the size of a matchstick. Each implant contains the equivalent of 80 mg of buprenorphine and is placed under the skin in the inner side of the upper arm.

INDICATION STATEMENT

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.

CONTRAINDICATIONS

  • Hypersensitivity to buprenorphine or any other ingredients in PROBUPHINE (e.g., EVA).

WARNINGS AND PRECAUTIONS

  • Serious Complications from Insertion and Removal: 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. All Healthcare Providers must successfully complete a live training program on the insertion and removal procedures and become certified in the PROBUPHINE REMS program, prior to performing insertions or prescribing PROBUPHINE implants.
  • Addiction, Abuse and Misuse: Buprenorphine can be abused in a manner similar to other opioids. Monitor patients for conditions indicative of diversion or progression of opioid dependence and addictive behaviors.
  • Respiratory and CNS Depression: Significant respiratory depression and death have occurred in association with buprenorphine particularly when taken by the intravenous (IV) route in combination with benzodiazepines or other CNS depressants (including alcohol). Consider dose reduction of CNS depressants when used concomitantly.
  • Neonatal Opioid Withdrawal Syndrome: Neonatal opioid withdrawal syndrome(NOWS) is an expected and treatable outcome of prolonged use of opioids during pregnancy.
  • Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid.
  • Unintentional Pediatric Exposure: In the event an implant protrudes or comes out, keep the implant away from children. Buprenorphine can cause severe, possibly fatal, respiratory depression in children.
  • Risk of Opioid Withdrawal with Abrupt Discontinuation: If treatment is temporarily interrupted or discontinued, monitor patients for withdrawal and treat appropriately.
  • Risk of Hepatitis, Hepatic Events: Monitor liver function tests prior to initiation and during treatment.
  • Risk of Withdrawal in Patients Dependent on Full Agonist Opioids: Verify that patient is clinically stable on transmucosal buprenorphine and not dependent on full agonists before inserting PROBUPHINE.
  • Treatment of Emergent Acute Pain: Treat pain with a non-opioid analgesic whenever possible. If opioid therapy is required, monitor patients closely because higher doses may be required for analgesic effect.
  • Most common side effects of PROBUPHINE include: headache, insomnia, rhinorrhea, upper respiratory tract infection, nausea, anxiety, back pain, depression, constipation, and vomiting.

Please read the full prescribing information, including boxed warning and Medication Guide, which you can access at https://braeburnpharmaceuticals.com/wp-content/uploads/2016/05/Probuphine-Full-Prescribing-Information.pdf.

To report SUSPECTED ADVERSE REACTIONS, contact Braeburn at 1-844- 859-6341 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

About Opioid Use Disorder and Buprenorphine
Opioid use disorder is a chronic brain disease and one of the fastest growing public health epidemics in America. In the U.S., 2.5 million people struggle with opioid addiction and, according to the Centers for Disease Control, 78 people die each day from the disease. There is a growing body of evidence that opioid addiction is not a choice or a moral failing, but the result of genetic predisposition combined with environmental factors. Nonetheless, individuals struggling with this disease continue to be stigmatized. Research has also shown that opioid use disorder is best treated with a combination of medication and psychosocial support. The majority of individuals with opioid addiction cannot sustain recovery without long-term outpatient medical treatment.

Buprenorphine is a partial opioid agonist, which may help individuals to stop opioid use without experiencing withdrawal symptoms. Buprenorphine is currently only available in oral form and must be taken daily.

About Braeburn Pharmaceuticals

Braeburn Pharmaceuticals, an Apple Tree Partners company, is a pill-free pharmaceutical company delivering precision 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; a risperidone six-month implant being investigated in schizophrenia; and a novel molecule, ATI-9242, for treatment of schizophrenia. More information on Braeburn, can be found at www.braeburnpharmaceuticals.com.

Media Contacts:

MSLGROUP
Sherry Feldberg or Rachel Gross
781-684-0770
braeburnpharma@publicisgroupe.net

Coltrin & Associates, Inc.
Caleb Cluff
212-221-1616
caleb_cluff@coltrin.com

Braeburn Pharmaceuticals Announces Commercialization Plans for Probuphine® (buprenorphine) Implant, Six-Month Treatment for Opioid Dependence

First Wave of Healthcare Providers Being Trained in 55 Cities over the Next Six Weeks

Probuphine Will Be Available to Patients in June 2016

PRINCETON, N.J. — May 31, 2016—Braeburn Pharmaceuticals announces plans to make Probuphine available to healthcare providers and patients in June, immediately following Food and Drug Administration (FDA) approval on May 26, 2016. Probuphine is the first implant for the maintenance treatment of opioid dependence in patients who have sustained clinical stability on low-to-moderate doses of buprenorphine, specifically 8 mg or less per day. Probuphine will not be distributed by pharmacies; patients can only receive the treatment from certified healthcare providers who have been specially trained to insert the implants just under the skin of the inside of the upper arm through an in-office procedure.

“Now that the FDA has approved Probuphine, Braeburn’s top priorities are to train and certify healthcare providers to make Probuphine available to patients across the country and to establish insurance coverage as quickly as possible,” said President and CEO Behshad Sheldon, Braeburn Pharmaceuticals. “Braeburn is confident in Probuphine’s value and is exploring reimbursement approaches with insurers including value-based programs. A payment assistance program will also be put in place to ensure access to Probuphine for patients.”

Braeburn has received requests for information on Probuphine training from more than 5,000 healthcare providers, and several insurers have expressed interest in discussing the addition of Probuphine to their formularies. To ensure swift access to Probuphine, Braeburn is conducting 262 Probuphine training sessions across 55 cities over the next six weeks. The architect of the training program, Dr. Steven Chavoustie, gynecologist at the Segal Institute for Clinical Research, Miami, and Braeburn Pharmaceuticals collaborated with the FDA to finalize the training program on the procedures.

“We began training this past weekend, including a session on Memorial Day,” said Dr. Chavoustie. “The first 121 healthcare providers are now certified to provide treatment with Probuphine. We look forward to the safe and effective use of this new alternative in battling the devastating disease of opioid addiction.”

Braeburn will continue to hold training sessions frequently throughout the year and expects to train at least 2,000 healthcare providers over the next six weeks and will have the capacity to train more than 4,000 healthcare providers by the end of 2016. Qualified healthcare providers can register for Probuphine training here or by calling 1-866-397-8939. A Probuphine healthcare provider locator is available at www.probuphineREMS.com.

Probuphine will be priced at $4,950 for a six-month course of treatment which is significantly lower than a six month-course of other long-acting medications for opioid dependence. A specialty distributor will send Probuphine directly to trained and certified providers.

Probuphine is the only treatment for opioid dependence that delivers buprenorphine continuously for six months. Based on preliminary pharmacoeconomic modeling data that was presented at two recent academic conferences, Academy of Managed Care Pharmacy (AMCP) and Council of State and Territorial Epidemiologists (CSTE), Probuphine patients were predicted to have a 45% lower chance of relapse, an 80% lower chance of going to rehab and a 98% lower chance of pediatric exposure s vs. patients taking oral buprenorphine.

As part of the value-based reimbursement programs that Braeburn is discussing with insurers, Braeburn is prepared to provide a rebate if the overall cost of care for a group of patients taking Probuphine exceeds the cost of treatment for the same patients in a prior six month period, or a comparable group of patients taking other forms of buprenorphine (or other available opioid addiction medication) for a six month period.

About Probuphine

Probuphine is the only six-month treatment for opioid dependence and was developed using ProNeura™, Titan Pharmaceuticals’ (NASDAQ: TTNP) 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. Probuphine implants are 26 millimeters long and 2.5 millimeters in diameter, or about the size of a matchstick. Each implant contains the equivalent of 80 mg of buprenorphine and is placed under the skin in the inner side of the upper arm.

INDICATION STATEMENT

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.

CONTRAINDICATIONS

  • Hypersensitivity to buprenorphine or any other ingredients in PROBUPHINE (e.g., EVA).

WARNINGS AND PRECAUTIONS

  • Serious Complications from Insertion and Removal: 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. All Healthcare Providers must successfully complete a live training program on the insertion and removal procedures and become certified in the PROBUPHINE REMS program, prior to performing insertions or prescribing PROBUPHINE implants.
  • Addiction, Abuse and Misuse: Buprenorphine can be abused in a manner similar to other opioids. Monitor patients for conditions indicative of diversion or progression of opioid dependence and addictive behaviors.
  • Respiratory and CNS Depression: Significant respiratory depression and death have occurred in association with buprenorphine particularly when taken by the intravenous (IV) route in combination with benzodiazepines or other CNS depressants (including alcohol). Consider dose reduction of CNS depressants when used concomitantly.
  • Neonatal Opioid Withdrawal Syndrome: Neonatal opioid withdrawal syndrome(NOWS) is an expected and treatable outcome of prolonged use of opioids during pregnancy.
  • Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid.
  • Unintentional Pediatric Exposure: In the event an implant protrudes or comes out, keep the implant away from children. Buprenorphine can cause severe, possibly fatal, respiratory depression in children.
  • Risk of Opioid Withdrawal with Abrupt Discontinuation: If treatment is temporarily interrupted or discontinued, monitor patients for withdrawal and treat appropriately.
  • Risk of Hepatitis, Hepatic Events: Monitor liver function tests prior to initiation and during treatment.
  • Risk of Withdrawal in Patients Dependent on Full Agonist Opioids: Verify that patient is clinically stable on transmucosal buprenorphine and not dependent on full agonists before inserting PROBUPHINE.
  • Treatment of Emergent Acute Pain: Treat pain with a non-opioid analgesic whenever possible. If opioid therapy is required, monitor patients closely because higher doses may be required for analgesic effect.
  • Most common side effects of PROBUPHINE include: headache, insomnia, rhinorrhea, upper respiratory tract infection, nausea, anxiety, back pain, depression, constipation, and vomiting.

Please read the full prescribing information, including boxed warning and Medication Guide, which you can access at https://braeburnpharmaceuticals.com/wp-content/uploads/2016/05/Probuphine-Full-Prescribing-Information.pdf.

To report SUSPECTED ADVERSE REACTIONS, contact Braeburn at 1-844- 859-6341 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

About Opioid Use Disorder and Buprenorphine
Opioid use disorder is a chronic brain disease and one of the fastest growing public health epidemics in America. In the U.S., 2.5 million people struggle with opioid addiction and, according to the Centers for Disease Control, 78 people die each day from the disease. There is a growing body of evidence that opioid addiction is not a choice or a moral failing, but the result of genetic predisposition combined with environmental factors. Nonetheless, individuals struggling with this disease continue to be stigmatized. Research has also shown that opioid use disorder is best treated with a combination of medication and psychosocial support. The majority of individuals with opioid addiction cannot sustain recovery without long-term outpatient medical treatment.

Buprenorphine is a partial opioid agonist, which may help individuals to stop opioid use without experiencing withdrawal symptoms. Buprenorphine is currently only available in oral form and must be taken daily.

About Braeburn Pharmaceuticals

Braeburn Pharmaceuticals, an Apple Tree Partners company, is a pill-free pharmaceutical company delivering precision 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; a risperidone six-month implant being investigated in schizophrenia; and a novel molecule, ATI-9242, for treatment of schizophrenia. More information on Braeburn, can be found at www.braeburnpharmaceuticals.com.


Media Contacts:

Sherry Feldberg or Rachel Gross
781-684-0770
braeburnpharma@publicisgroupe.net

Braeburn Pharmaceuticals Announces FDA Approves Probuphine® (buprenorphine) Implant: The First Implant for Treatment of Opioid Dependence

Patients and Providers Have a New Option to Combat Opioid Dependence

PRINCETON, N.J.—May 26, 2016—Braeburn Pharmaceuticals announces that the U.S. Food & Drug Administration (FDA) approved Probuphine, the first implant for the maintenance treatment of opioid dependence in patients who have sustained clinical stability on low-to-moderate doses of buprenorphine, specifically 8 mg or less per day. Probuphine delivers buprenorphine continuously for up to six months and should be used as part of a complete treatment program to include counseling and psychosocial support.

“Patients and their doctors now have Probuphine as a new option for the six-month treatment of opioid dependence. Opioid addiction is a chronic disease and should be treated the same way we treat other serious, chronic diseases—with evidence-based medicine,” said President and CEO Behshad Sheldon, Braeburn Pharmaceuticals. “With 78 people in the U.S. dying each day from opioids, it’s important that patients have more treatments to choose from as no one option will work for everyone. Probuphine is the first of what we hope will be many new and innovative approaches to treating this disease. We are grateful to all of the patients, investigators and to NIDA for their help and dedication that has brought us to this point. ”

Buprenorphine is a commonly prescribed medication for the treatment of opioid dependence. Until today, it has only been available in sublingual (oral) formulations. Probuphine received a priority review based on the potential to reduce accidental pediatric exposure.

“Probuphine is the first treatment for opioid dependence that provides long-term delivery of an evidence-based medicine,” said Richard Rosenthal, Professor of Psychiatry, Icahn School of Medicine at Mount Sinai, Medical Director of Addiction Psychiatry, Mount Sinai Behavioral Health System. “Probuphine offers clinically stable patients a new way to continue taking medicine, ensuring the dose prescribed is the dose taken.”

The systemic side effects for Probuphine are similar to those that are seen with buprenorphine and in the Probuphine clinical trials included: headache, insomnia, upper respiratory tract infection, nausea, anxiety, back pain, depression, constipation, and vomiting. In addition, common implant site reactions included pain, itching, redness and swelling.

“Probuphine represents a significant step forward in addressing the serious lack of new treatment options in the last 15 years. With strong support from the President and the Secretary of Health and Human Services this year to expand access to medication assisted treatment, addiction specialists like myself are more confident we will be able to get more patients the treatment they desperately need,” said Kelly J. Clark, MD, MBA, DFASAM, DFAPA, President Elect, American Society of Addiction Medicine, Chief Medical Officer, CleanSlate Centers. “Opioid dependence touches people from all walks of life, no matter their socioeconomic status, race or gender; the more we educate and innovate the better chance we have at reducing the prevalence of this terrible disease.”

“Buprenorphine is an effective treatment for opioid dependence but was previously only available in pill or film formulation which can be lost, forgotten or stolen,” said Frank J. Vocci, Ph.D., president and senior research scientist, Friends Research Institute. “Probuphine’s inherent value as an implant is that patients receive constant levels of buprenorphine for up to six months without having to administer treatment on a daily basis. This is an unprecedented benefit of a treatment for opioid dependence.”

About Probuphine

Probuphine was developed using ProNeura™, Titan Pharmaceuticals’ (NASDAQ: TTNP) 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. Probuphine implants are 26 millimeters long and 2.5 millimeters in diameter, or about the size of a matchstick. Each implant contains the equivalent of 80 mg of buprenorphine and is placed under the skin in the inner side of the upper arm.

INDICATION STATEMENT

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.

CONTRAINDICATIONS

  • Hypersensitivity to buprenorphine or any other ingredients in PROBUPHINE (e.g., EVA).

WARNINGS AND PRECAUTIONS

  • Serious Complications from Insertion and Removal: 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. All Healthcare Providers must successfully complete a live training program on the insertion and removal procedures and become certified in the PROBUPHINE REMS program, prior to performing insertions or prescribing PROBUPHINE implants.
  • Addiction, Abuse and Misuse: Buprenorphine can be abused in a manner similar to other opioids. Monitor patients for conditions indicative of diversion or progression of opioid dependence and addictive behaviors.
  • Respiratory and CNS Depression: Significant respiratory depression and death have occurred in association with buprenorphine particularly when taken by the intravenous (IV) route in combination with benzodiazepines or other CNS depressants (including alcohol). Consider dose reduction of CNS depressants when used concomitantly.
  • Neonatal Opioid Withdrawal Syndrome: Neonatal opioid withdrawal syndrome(NOWS) is an expected and treatable outcome of prolonged use of opioids during pregnancy.
  • Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid.
  • Unintentional Pediatric Exposure: In the event an implant protrudes or comes out, keep the implant away from children. Buprenorphine can cause severe, possibly fatal, respiratory depression in children.
  • Risk of Opioid Withdrawal with Abrupt Discontinuation: If treatment is temporarily interrupted or discontinued, monitor patients for withdrawal and treat appropriately.
  • Risk of Hepatitis, Hepatic Events: Monitor liver function tests prior to initiation and during treatment.
  • Risk of Withdrawal in Patients Dependent on Full Agonist Opioids: Verify that patient is clinically stable on transmucosal buprenorphine and not dependent on full agonists before inserting PROBUPHINE.
  • Treatment of Emergent Acute Pain: Treat pain with a non-opioid analgesic whenever possible. If opioid therapy is required, monitor patients closely because higher doses may be required for analgesic effect.
  • Most common side effects of PROBUPHINE include: headache, insomnia, rhinorrhea, upper respiratory tract infection, nausea, anxiety, back pain, depression, constipation, and vomiting.

Please read the full prescribing information, including boxed warning and Medication Guide, which you can access at https://braeburnpharmaceuticals.com/wp-content/uploads/2016/05/Probuphine-Full-Prescribing-Information.pdf.

To report SUSPECTED ADVERSE REACTIONS, contact Braeburn at 1-844- 859-6341 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

About Opioid Use Disorder and Buprenorphine
Opioid use disorder is a chronic brain disease and one of the fastest growing public health epidemics in America. In the U.S., 2.5 million people struggle with opioid addiction and, according to the Centers for Disease Control, 78 people die each day from the disease. There is a growing body of evidence that opioid addiction is not a choice or a moral failing, but the result of genetic predisposition combined with environmental factors. Nonetheless, individuals struggling with this disease continue to be stigmatized. Research has also shown that opioid use disorder is best treated with a combination of medication and psychosocial support. The majority of individuals with opioid addiction cannot sustain recovery without long-term outpatient medical treatment.

Buprenorphine is a partial opioid agonist, which may help individuals to stop opioid use without experiencing withdrawal symptoms. Buprenorphine is currently only available in oral form and must be taken daily.

About Braeburn Pharmaceuticals
Braeburn Pharmaceuticals, an Apple Tree Partners company, is a pill-free pharmaceutical company delivering precision 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; a risperidone six-month implant being investigated in schizophrenia; and a novel molecule, ATI-9242, for treatment of schizophrenia. More information on Braeburn, can be found at www.braeburnpharmaceuticals.com.

Media:
Sherry Feldberg or Rachel Gross
781-684-0770
braeburnpharma@publicisgroupe.net

Probuphine® Phase III Data Presented at American Society of Addiction Medicine (ASAM) Annual Meeting

Results Support the Safety and Efficacy of Six-month Treatment for Opioid Dependence

PRINCETON, NJ & BALTIMORE—April 15, 2016— Braeburn Pharmaceuticals announces presentation of data from the Phase 3 study of Probuphine, a six month subdermal buprenorphine implant for the long-term maintenance treatment of opioid addiction, today at the 47th Annual American Society of Addiction Medicine (ASAM) Conference. ASAM is a professional society representing over 3,700 physicians, clinicians and associated professionals in the field of addiction medicine. The study demonstrated that participants who were clinically stable on sublingual buprenorphine maintained stability when transferred to Probuphine and that they were more likely to sustain abstinence from illicit opioids throughout the six months than participants who remained on sublingual buprenorphine. Today’s presentation of these findings is the first at a scientific medical meeting. The FDA is expected to make a decision on the approval of Probuphine by May 27, 2016.

“This was the first head to head comparison study of Probuphine and sublingual buprenorphine, demonstrating the efficacy of a long acting six month buprenorphine implant,” said co-lead investigator and author of the study Richard N. Rosenthal, M.D., Professor of Psychiatry and Medical Director of Addiction Psychiatry at the Icahn School of Medicine at Mount Sinai. “The study results show that participants in the implant group sustained clinical stability over the course of six months. The implant group was also more likely to remain free from illicit opioids at 85.7 % compared to 71.9 % of those maintained on sublingual buprenorphine. If approved, Probuphine could help expand access to medication to treat opioid use disorders, providing people with a new option.”

The double-blind, double-dummy study was designed to determine the efficacy and safety of Probuphine as a maintenance treatment. The primary endpoint of non-inferiority was met—the responder rate was 87.6 percent in the sublingual buprenorphine group and 96.4 percent in the Probuphine group. The results showed statistically significant superiority for the implant versus the oral formulation (p=0.034). Side effects from treatment with buprenorphine included constipation, gastroenteritis, nasopharyngitis, headache and depression. Implant site related side effects included pain, pruritus, bruising and erythema.

“Like any chronic disease, the ability to personalize treatment is key to long-term success and quality of life for opioid dependent individuals,” said Frank J. Vocci, Ph.D., president and senior research scientist, Friends Research Institute. “The data presented today on Probuphine provides hope for a new option that could address critical issues like medication compliance and the risks of oral buprenorphine.”

“We are proud to be presenting the results of our pivotal trial at this prestigious gathering of addiction specialists. We are indebted to the investigators and patients suffering from opioid addiction who participated in this study,” said Behshad Sheldon, president and CEO, Braeburn Pharmaceuticals. “We hope for a speedy conclusion to the FDA’s review of these data and to bring a potentially valuable new medicine to patients.”

About Opioid Dependence and Buprenorphine
Opioid dependence is a chronic brain disease and one of the fastest growing public health epidemics in America. In the U.S., 2.4 million people struggle with opioid dependence and, according to the Centers for Disease Control, 78 people die each day from the disease. Despite the growing body of evidence that opioid addiction is not a choice or a moral failing, individuals struggling with this disease continue to be stigmatized. Research has shown that opioid dependence is a pre-disposed genetic condition that is best treated with a combination of medication and counseling. Usually, opioid dependent individuals cannot sustain recovery without long-term medical assistance that includes opiate replacement therapy, such as buprenorphine.

Buprenorphine is an opioid antagonist, which allows individuals to stop opioid use without experiencing withdrawal symptoms. Buprenorphine is currently only available in oral form and must be taken daily. While highly effective, self-administration of buprenorphine can lead to issues related to compliance, misuse, abuse, and even pediatric exposure and overdose. Buprenorphine is the third most seized drug according to the U.S. Drug Enforcement Agency.

About Probuphine
Probuphine is currently undergoing final review by the U.S. Food and Drug Administration (FDA) following a 12 to 5 vote in January by the FDA’s Psychopharmacologic Drugs Advisory Committee (PDAC) in favor of approving Probuphine. If approved, Probuphine would be the first long-acting, subdermal buprenorphine implant for the maintenance treatment of opioid addiction. The implant was developed using Titan Pharmaceuticals’ proprietary platform technology, ProNeura™, a non-biodegradable drug delivery implant designed to provide continuous, long- term steady state levels of medication in the blood. It is administered in a short subdermal insertion procedure in a physician’s office and removed similarly at the end of the treatment period.

For more information about Probuphine, please visit www.braeburnpharmaceuticals.com.

About Braeburn Pharmaceuticals
Braeburn Pharmaceuticals, an Apple Tree Partners company, is a pill-free pharmaceutical company delivering precision medicine in neuroscience. 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.

###

Media:
Sherry Feldberg or Rachel Gross
MSLGROUP Boston
781-684-0770
braeburnpharma@mslgroup.com

Braeburn Pharmaceuticals and Knight Therapeutics Announce Canadian Sublicense Agreement for PROBUPHINE®

PRINCETON, USA and MONTREAL, CANADAFebruary 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.”

About PROBUPHINE®
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.

Forward-Looking Statement
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.

For further information, please contact:

Knight Therapeutics Inc.
Jeffrey Kadanoff, P.Eng., MBA
Chief Financial Officer
Tel: 514-484-GUD1 (4831)
Fax: 514-481-4116
Email: info@gud-knight.com
Website: www.gud-knight.com

Braeburn Pharmaceuticals, Inc.
Sherry Feldberg
MSLGROUP Boston
781-684-0770
braeburnpharma@mslgroup.com

Braeburn Pharmaceuticals and Titan Pharmaceuticals Announce Date of FDA Advisory Committee Review of Probuphine for Opioid Addiction

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.”

About Probuphine®
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.

CONTACT:
Media Contact:
Jim Weinrebe
MSLGROUP
781-684-0770
braeburnpharma@mslgroup.com