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

Change the Conversation About Opioid Addiction

Watch this video. Help change the opioid conversation. Kelly Clark, MD, former State Senator Patrick Kennedy and other leaders in the field appeal to all of us to stop blaming addicts for their physical addiction. It’s the chemistry of the brain not the character of the individual that makes them an opioid addict.

Braeburn Pharmaceuticals and Camurus announce start of Phase 3 trial of long-acting buprenorphine treatments for opioid dependence

Princeton, New Jersey and Lund, Sweden — 15 December 2015 — Braeburn Pharmaceuticals and Camurus today announced that the first patient has been enrolled in a Phase 3 clinical trial of CAM2038, long-acting subcutaneous buprenorphine injections for treatment of opioid dependence. The Phase 3 trial is designed to demonstrate the long-term safety and clinical efficacy of CAM2038 weekly and monthly injections in patients with opioid dependence. The study is a part of the pivotal registration program for CAM2038 for which Braeburn and Camurus have received guidance from both US Food and Drug Administration (FDA) and the European Medical Agency (EMA).

“Patients with opioid dependence need and deserve new treatment options. Our vision is to bring a suite of individualized long-acting treatments to patients struggling with opioid dependence as quickly as possible,” said Behshad Sheldon, President and CEO of Braeburn Pharmaceuticals. “The beginning of this Phase 3 trial with the CAM2038 formulations is another important step in our efforts to contain and diminish the negative impacts of opioid addiction.”

The Phase 3 study is an open-label international, multi-center, 12-month (48-week) safety trial assessing CAM2038 Once Weekly (q1w) and Once Monthly (q4w) in patients with opioid use disorder. The study includes both new entrants who are actively seeking treatment, and patients currently receiving maintenance treatment with sublingual buprenorphine. New entrants to treatment are initiated with the CAM2038 weekly product. Dose adjustments and switching between the weekly and monthly products is allowed during the study.

“Participation in this study represents an opportunity to assist in the development of novel ways of administering treatment for opioid dependence,” said Dr. Jakob Billeskov Jansen, M.D., Center for Addiction Treatment, Aarhus, Denmark. “The CAM2038 long-acting injections may solve several difficulties relating to currently available daily medications and may ultimately become an important tool for helping patients in the management of their condition towards long-term recovery.”

“Starting enrollment of patients in this global Phase 3 trial represents a key milestone in the development of our long-acting buprenorphine products. Along with the recently started Phase 2 opioid blockade study and a second Phase 3 trial under initiation, it forms the basis for forthcoming regulatory submissions,” said Fredrik Tiberg, President and CEO, Camurus.

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.braeburnpharma.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 research-based pharmaceutical company committed to developing and commercialising 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 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 international pharmaceutical companies. The company’s share is listed on Nasdaq Stockholm under the ticker “CAMX”. For more information, visit www.camurus.com.

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

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

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