FDA Acceptance of NDA for CAM2038 for Opioid Use Disorder

Braeburn Announces FDA Acceptance with Priority Review of New Drug Application for CAM2038 Buprenorphine Depot for the Treatment of Opioid Use Disorder
– If approved, CAM2038 will provide patients and HCPs with weekly and monthly dosing options for the treatment of opioid use disorder, with the goal of improving treatment adherence and reducing the burdens associated with daily medication. Continue reading “FDA Acceptance of NDA for CAM2038 for Opioid Use Disorder”

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”

2016 International Society of Addiction Medicine Meeting

Probuphine® Implant for Opioid Dependence Featured at 2016 International Society of Addiction Medicine Meeting

PRINCETON, N.J. and SOUTH SAN FRANCISCO, Calif. and MONTREAL, Oct. 28, 2016 /PRNewswire/ — Braeburn Pharmaceuticals, Inc. and Titan Pharmaceuticals, Inc. (NASDAQ: TTNP) today announced that three Probuphine presentations were featured at the International Society of Addiction Medicine (ISAM) annual meeting in Montreal last week. Probuphine, a subdermal implant, is the first commercially available six-month maintenance treatment for opioid dependence.

According to the World Health Organization (WHO), an estimated 69,000 people die from opioid overdose each year worldwide. Addiction medicine professionals from around the world met at ISAM’s 18th annual meeting to exchange ideas and explore new, innovative approaches to treating addiction. Probuphine was featured prominently among the 200 abstracts and 30 posters selected by ISAM. Specific presentations included:

Risk Evaluation and Mitigation Strategy (REMS) program data: A description of the Probuphine REMS program that was implemented to train and certify healthcare providers to prescribe and implant Probuphine. As part of the REMS program, healthcare providers are required to successfully complete the program prior to implanting or prescribing Probuphine. The first groups of healthcare providers were trained two days after Probuphine was FDA-approved on May 26, 2016. A total of 2,400 healthcare providers were certified in the first eight weeks after approval. The trained Probuphine providers practice across specialties including family medicine/general practice, psychology/neurology, anesthesiology, and emergency medicine, among others.
Buprenorphine implants, extended-release injectable naltrexone and sublingual buprenorphine were evaluated using a Markov Model. Buprenorphine implants were found to have clinical and economic benefits in clinically stable adults due to little or no potential for abuse or diversion and the sustained delivery of buprenorphine for up to six months. An earlier version of this data was featured as a poster presentation at the Academy of Managed Care Pharmacy (AMCP) annual meeting in April 2016
Probuphine Pivotal Trial Results: Data from this landmark double-blind, double-dummy trial were the basis for Braeburn’s New Drug Application that led to FDA approval of Probuphine, which was developed using ProNeura™, Titan’s long-term continuous drug delivery platform. These data were presented earlier this year at the American Society of Addiction Medicine (ASAM) annual meeting in April 2016 and also published in the Journal of American Medical Association (JAMA) in July 2016. Highlights included data that showed clinically-stable patients were maintained over a six-month period when transferred to Probuphine. In addition, 96.4% of patients using Probuphine remained free from illicit opioid use over the six-month course of treatment.
“Sparking conversation and educating the global addiction medicine leaders on the potential value of Probuphine is essential to making the treatment available to more patients and providers,” said Behshad Sheldon, President and CEO, Braeburn Pharmaceuticals. “The continued interest and discussion about Probuphine at forums like ISAM’s annual meeting indicates the need for more treatment options to better customize care for individual patients.”

“As the only six-month long-term maintenance treatment for opioid dependence on the market today, Probuphine stands to play a significant role in treating opioid addiction,” said Sunil Bhonsle, President and CEO, Titan. “We are pleased with the strong interest the medical community has expressed in Probuphine at forums such as ISAM, and during the successful training program implemented by Braeburn, and look forward to seeing Probuphine become more accessible to providers and patients.”

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.

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., 2.6 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 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 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 commercial rights for the U.S. and Canada for Probuphine to Braeburn Pharmaceuticals. Approved by the FDA in May 2016, Probuphine is 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 and hypothyroidism, where maintaining consistent, around the clock blood levels of medication may benefit the patient and improve medical outcomes. For more information about Titan, please visit www.titanpharm.com.

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

Titan Pharmaceuticals, Inc.
Sunil Bhonsle
President
(650)-244-4990

Investors:
Stephen Kilmer
(650) 989-2215
skilmer@titanpharm.com

Media:
Susan Thomas
(650) 989-2216
sthomas@titanpharm.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

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

Titan Pharmaceuticals and Braeburn Pharmaceuticals Announce FDA Advisory Committee Recommends Approval of Probuphine, First 6-Month Implant to Treat Opioid Addiction

SOUTH SAN FRANCISCO, CA and PRINCETON, NJ – January 12, 2016 Titan Pharmaceuticals, Inc. (NASDAQ:TTNP) and partner Braeburn Pharmaceuticals today announced that the Psychopharmacologic Drugs Advisory Committee (PDAC) of the U.S. Food and Drug Administration (FDA) voted 12 to 5 in favor of approving Probuphine, the first long-acting, subdermal buprenorphine implant for the maintenance treatment of opioid addiction, in stable patients receiving 8mg or less per day of buprenorphine. The Committee’s vote followed presentation and discussion of data regarding Probuphine’s efficacy, safety, and risk-benefit profile. The New Drug Application (NDA) for Probuphine was resubmitted to the FDA in August 2015, and accepted by the FDA in September 2015. A target agency action date has been set for February 27, 2016.

At the meeting, Braeburn presented efficacy data from the most recent clinical trial confirming the effectiveness of Probuphine as a six-month maintenance treatment for opioid dependence in the population studied. Multiple sensitivity analyses were also presented by both Braeburn and the FDA to evaluate the robustness of the results, which consistently favored Probuphine. Braeburn also presented summary safety findings with a focus on the Probuphine insertion and removal procedures. Braeburn’s proposed Risk Evaluation and Mitigation Strategy (REMS) was presented jointly by Braeburn and the FDA.

“Medication offers the best chance for people with opioid addiction to sustain recovery, but as evidenced by the moving comments from patients, physicians and advocates at today’s meeting, the few, current options are not enough to address the tremendous needs of the vast population dealing with this complex disease,” said Braeburn Pharmaceuticals President and CEO Behshad Sheldon. “Our vision is to bring change to this underserved population. We are fully committed to making a lasting impact on the way this disease is treated.”

“New treatment options for the millions of patients and their families suffering from opioid addiction are desperately needed, and we appreciate the Committee’s comprehensive review of Probuphine,” said Titan Pharmaceuticals President and CEO Sunil Bhonsle. “Probuphine has the potential to be the first marketed product to provide maintenance treatment of opioid addiction continuously for six months following a single procedure. As a subdermal implant, Probuphine could increase patient compliance, decrease the risk of diversion and improve patients’ quality of life. We look forward to the Agency completing its review of the NDA.”

An open public hearing was included as part of today’s Advisory Committee Meeting, and demonstrated the public’s intense desire for new treatment options like Probuphine, to become available for people with opioid addiction. For over an hour, patients, advocates, physicians and clinical trial investigators spoke urging the Committee to recommend approval of Probuphine. In addition to these remarks, several letters were read, including one from mental health and addiction activist Rep. Patrick J. Kennedy, who stated, “Adding Probuphine to the short list of approved products to treat addiction is a first step in meeting the goals of government officials, while offering patients a long-term option for treatment. The active agent, buprenorphine, is already the go-to choice for providers and patients alike. The ability to now deliver the medication in a safer way for individuals, their families and society is truly a breakthrough.”

The FDA is not obligated to follow the recommendations of its Advisory Committee, but will consider the Committee’s guidance as it completes its review of the Probuphine NDA.

About Opioid Addiction
According to recent estimates, there are 2.5 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 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 dependence, 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 previously been studied in several clinical trials, including a 163-patient, placebo-controlled study over a 24-week period (published in the Journal of the American Medical Association (JAMA)), and a follow on study of 287 patients (published in the journal Addiction).

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.

Safe Harbor Statement
The press release may contain “forward-looking statements” within the meaning of Section 27A

of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to the Company’s development program and any other statements that are not historical facts. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to difficulties or delays in development, testing, regulatory approval, production and marketing of the Company’s drug candidates, adverse side effects or inadequate therapeutic efficacy of the Company’s drug candidates that could slow or prevent product development or commercialization, the uncertainty of patent protection for the Company’s intellectual property or trade secrets. Such statements are based on management’s current expectations, but actual results may differ materially due to various factors, including those risks and uncertainties mentioned or referred to in this press release.

Contacts:
Titan Pharmaceuticals, Inc.
Sunil Bhonsle, President
(650)-244-4990

Media
Susan Thomas
(650) 989-2216
sthomas@titanpharm.com

Investors
Stephen Kilmer
(650) 989-2215
skilmer@titanpharm.com

For Braeburn Pharmaceuticals
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

Dr. Frank Young of Braeburn Pharmaceuticals Receives 2015 Distinguished Scientist Award from American College of Toxicology

Dr. Frank Young of Braeburn Pharmaceuticals Receives 2015 Distinguished Scientist Award from American College of Toxicology

FOR IMMEDIATE RELEASE

Princeton, New Jersey— November 9, 2015—Braeburn Pharmaceuticals announced today that Frank E. Young, MD, PhD, Executive Vice President, Regulatory and Medical, accepted the 2015 Distinguished Scientist Award by the American College of Toxicology (ACT). Dr. Young also presented the keynote address at the annual awards luncheon, which took place at the Association’s 36th Annual Meeting this week. ACT is a professional organization of about 1000 toxicologists with a mission to educate, lead, and serve professionals in toxicology and related disciplines by promoting the exchange of information and perspectives on applied toxicology and safety assessment.

The ACT Distinguished Scientist Award is presented to an individual who “has made outstanding contributions to toxicology, its relationship to the regulation of chemicals, and/or the improvement of public health.”

“I am deeply honored to receive this year’s ACT Distinguished Scientist Award,” said Dr. Young. “I have been afforded many extraordinary opportunities to serve in academia, government and the private sector, all of which built on my original training and research as a pathologist. Toxicology is fundamental to modern society because it is the framework for ensuring human safety amidst scientific and technological advances. Through my role at Braeburn, I am thankful to apply my toxicology expertise in an effort to bring innovative and safe treatments to patient populations in dire need of new options.”

Dr. Young has contributed over 200 scientific publications in the fields of biotechnology and pathology, including development of some of the earliest cloning enzymes. Dr. Young is a member of the National Academy of Medicine of the National Academies of Sciences, Engineering and Medicine. He has received a Secretary’s Special Citation, Department of Health and Human Services, the Inspector General’s Award for Outstanding Integrity, PHS Surgeon General’s Exemplary Service Medal and the 2006 Distinguished Alumnus Award from SUNY Upstate Medical University.

“Braeburn is privileged to have Dr. Young on its senior management team and is benefitting tremendously from his unparalleled depth of experience and insight,” said Behshad Sheldon, President and CEO of Braeburn. “His passion for improving public health runs deep. His keen understanding of the magnitude of the public health challenges posed by our current opioid abuse epidemic and the need for effective treatments are invaluable as we work closely with the FDA to secure regulatory approval for Probuphine, the first long-acting implant for the treatment of opioid addiction.”

“Opioid addiction is the greatest public health challenge our nation has faced since the AIDS epidemic in the 1980s,” said Dr. Young. “I was proud to play a critical role in expediting the development and commercialization of new medicines to treat HIV and AIDS when I was FDA Commissioner. Opioid addiction is an even greater national challenge given the scope of the epidemic, its devastating consequences and the dire need for more proven treatment options. But just as the prognosis for HIV and AIDS has improved greatly, I believe we can achieve similar results in opioid addiction through development of innovative treatment options such as Probuphine.”

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.

 

####

Media Contact:

Sherry Feldberg

MSLGROUP

781-684-0770

braeburnpharma@mslgroup.com

FDA grants Fast Track designation for development of CAM2038, long-acting buprenorphine injections to treat opioid addiction

FOR IMMEDIATE RELEASE

Precise delivery offers new treatment opportunity

First patient dosed with CAM2038 in Phase 2 opioid-blockade study

Princeton, New Jersey and Lund, Sweden — November 4, 2015 —Braeburn Pharmaceuticals and Camurus announced today that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for the CAM2038 weekly and monthly buprenorphine subcutaneous injection products under development for the treatment of opioid addiction.

“The CAM2038 suite of products offers a potential paradigm shift for treating opioid addiction: precise delivery of medicine while virtually eliminating the risks of diversion, abuse, misuse, and accidental pediatric exposure,” said Behshad Sheldon, President and CEO, Braeburn Pharmaceuticals. “The sense of urgency to address the opioid epidemic in our country is overwhelming. Granting fast track to the CAM2038 development program demonstrates the FDA’s recognition of the unmet need in this area as well as the agency’s leadership in enabling new opportunities to stem the tide of opioid addiction.”

Last year, Camurus and Braeburn entered into an agreement that gives Braeburn exclusive license rights in North America to CAM2038 products as treatments for opioid addiction and pain. The weekly and monthly CAM2038 injectable buprenorphine products have been evaluated, thus far, in 176 healthy volunteers and patients in three shorter-term clinical trials demonstrating a promising drug release, safety, and tolerability profile.

“CAM2038 is designed to be conveniently administered by healthcare professionals. By eliminating the need for daily dosing, CAM2038 has the potential to improve medication adherence and help patients avoid relapse, a critical aspect of a comprehensive approach to treating opioid addiction,” said Fredrik Tiberg, President and CEO, Camurus. “The flexibility of multi-dose, weekly and monthly injections also enables personalized medication during all stages of the buprenorphine treatment continuum.”

Braeburn and Camurus also announced today that the first patient has been dosed in a Phase 2 study designed to assess the effectiveness of CAM2038 in blocking the effects of other opioids. Braeburn and Camurus have worked closely with the FDA on the design of this study intended to provide important insight into CAM2038’s ability to block the effects of other opioids, ultimately supporting future regulatory submissions.

The results of this multi-site study are expected to provide guidance about optimizing individualized treatment for these patients, including during early stages of recovery.
“These long-acting formulations have the potential to change the delivery of opioid dependence treatment in the U.S. by decreasing the burdens for patients and physicians and decreasing the risks of buprenorphine diversion,” said Dr. Sharon Walsh, principal investigator at the University of Kentucky. “This study is an important step in the development of these potentially transformative buprenorphine products in the treatment for opioid dependence.”

“The CAM2038 products are part of our vision to address some of the important roadblocks to recovery that seem inherent in current treatment options for opioid addiction,” said Sheldon. “By offering pill-free solutions that administer treatment through innovative delivery systems, we believe we can dramatically improve patient outcomes, and even help to save and rebuild lives. We are committed to this important work, and will be striving to complete this study as expeditiously as possible, and to initiate our Phase 3 program by year end.”

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 CAM2038

The investigational CAM2038 buprenorphine subcutaneous injection products for treatment of opioid addiction are being developed as once-weekly and once-monthly formulations, each with multiple doses, to cover all phases of treatment from initiation through maintenance. The CAM2038 products are designed for administration by healthcare personnel to ensure proper delivery that minimizes the risks of diversion, abuse, misuse, and accidental exposure. The CAM2038 products have been evaluated in three Phase 1/2 clinical trials, which evaluated the safety and tolerability as well as pharmacokinetic and pharmacodynamic properties of the products in a total of 176 individuals (opioid-dependent patients and healthy volunteers under naltrexone blockage).

About Camurus

Camurus is a Swedish pharmaceutical company committed to developing and commercializing innovative and differentiated medicines for the treatment of severe and chronic conditions. New drug products with best-in-class potential are conceived based on the proprietary nanoscale FluidCrystal® drug delivery technologies and an extensive R&D expertise. Camurus’ clinical pipeline includes products for treatment of cancer, endocrine diseases, pain and addiction, developed in-house and in collaboration with global and specialty pharmaceutical companies. Camurus is a Sandberg Development group company. For more information, please visit www.camurus.com.

Media contacts:
Fredrik Tiberg, President & CEO
Tel: +46 (0)46 286 46 92
fredrik.tiberg@camurus.com
www.camurus.com

Jim Weinrebe
MSLGROUP Boston
781-684-0770
braeburnpharma@mslgroup.com

Braeburn Announces FDA’s Acknowledgment of Receipt of Probuphine® NDA Resubmission; Agency Action Expected by February 27, 2016

FOR IMMEDIATE RELEASE

Braeburn Announces FDA’s Acknowledgment of Receipt of Probuphine® NDA Resubmission

Agency Action Expected by February 27, 2016

Princeton, New Jersey – September 28, 2015 – Braeburn Pharmaceuticals, an Apple Tree Partners company, today announced that the U.S. Food and Drug Administration (FDA) has accepted Braeburn’s resubmission of the Probuphine New Drug Application (NDA) for review and set February 27, 2016 as the target date for Agency action. Probuphine®, licensed from Titan Pharmaceuticals, Inc. (OTCQB:TTNP), is an investigational, six-month buprenorphine HCl subdermal implant for the long-term maintenance treatment of opioid addiction. The Probuphine NDA resubmission includes results from a Phase 3 double-blind, double-dummy clinical study of Probuphine completed in May 2015.

“The FDA’s acceptance of the Probuphine NDA resubmission brings us one step closer to providing an innovative and potentially transformative treatment option to patients with opioid dependence,” said Behshad Sheldon, President and CEO of Braeburn Pharmaceuticals. “We are pleased to have submitted Probuphine for marketing approval at a time when stakeholders and policymakers at the national, state and local levels are searching for effective ways to increase access to high-quality and comprehensive addiction treatment while reducing the risk of diversion, misuse, abuse, and accidental exposure.”

On September 17, 2015, U.S. Health and Human Services Department (HHS) Secretary Sylvia Burwell announced that HHS intends to revise regulations to “provide a balance between expanding the supply of [buprenorphine], encouraging use of evidence-based [medication-assisted treatment], and minimizing the risk of drug diversion.” Long-acting buprenorphine implants and injectables are poised to play an important role in a comprehensive strategy to address the nation’s opioid abuse epidemic, consistent with HHS’s stated objectives. “If approved by the FDA, Probuphine has the potential to transform buprenorphine treatment by providing an evidence-based outpatient therapy that assures patients get the medicine they need while minimizing the risks of diversion and abuse,” said Jonathan M. Young, Vice President, Policy, Braeburn Pharmaceuticals.

“We have appreciated the FDA’s insights and guidance in developing the NDA resubmission,” said Frank E. Young, MD, PhD, Executive Vice President, Regulatory and Medical Affairs, Braeburn Pharmaceuticals. “We are pleased with the new data and information included in our NDA resubmission and we look forward to working closely with the FDA during the review process to help provide this important treatment option to patients who could benefit from it.”

About Opioid Addiction
According to recent estimates, there are 2.2 million people with opioid dependence 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 were available in the U.S. only from a limited number of approved facilities. 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 treatment. Sales of buprenorphine drug products for the treatment of opioid addiction in 2014 were approximately $1.75 billion in the United States.

About Probuphine®
Probuphine is an investigational subdermal implant designed to deliver buprenorphine around the clock 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 dependence, is currently available in tablet and film formulations that require self-administration by patients on a daily basis.

Probuphine was developed using ProNeura™, Titan Pharmaceuticals’ 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 previously been studied in several clinical trials, including a 163-patient, placebo-controlled study over a 24-week period (published in the Journal of the American Medical Association (JAMA)), and a follow-on study of 287 patients (published in the journal Addiction).

About Braeburn Pharmaceuticals
Braeburn Pharmaceuticals, an Apple Tree Partners company, is a late-stage pharmaceutical company focused on novel, long-acting implantable and injectable therapies for serious neurological and psychiatric disorders, including addiction, pain, and schizophrenia. 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 includes: 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. For more information on Braeburn, visit: www.braeburnpharmaceuticals.com.

Media contact:
Sonia Segal-Smith
MSLGROUP Boston
781-684-0770
braeburnpharma@mslgroup.com