Titan Pharmaceuticals Inc (TTNP)

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Probuphine® Implant for Opioid Dependence Featured at 2016 International Society of Addiction Medicine Meeting
October 28, 2016 8:00 AM EDT
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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.



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