USPTO issues Notice of Allowance for Titan Pharmaceuticals' Probuphine patent application

Dec 1 2009

Titan Pharmaceuticals, Inc (Pink Sheets:TTNP) today announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for Titan’s United States patent application directed to the use of Probuphine for the treatment of opiate addiction.

The patent application is U.S. Application No. 10/453,377 filed June 2, 2003 titled “Implantable polymeric device for sustained release of buprenorphine”. The newly allowed claims include subject matter covering a method for treating patients diagnosed with opiate addiction using a small implantable rod shaped polymeric matrix comprising buprenorphine blended with ethylene vinyl acetate (EVA) copolymer which is capable of continuously releasing the medicine over an extended period of three months or more resulting in a novel, therapeutically effective, steady state plasma level of buprenorphine.

“We are very pleased to announce receipt of this Notice of Allowance issued by the USPTO,” said Sunil Bhonsle, President of Titan. “This represents an important element for establishing the long term value of Probuphine, and upon issuance, these allowed patent claims are expected to provide intellectual property protection for Probuphine to middle of 2023.”

“Probuphine represents an innovative technology that offers a number of potential advantages over existing therapies and may improve treatment outcome,” said Marc Rubin, MD, Executive Chairman of Titan. “Specifically, as an implantable delivery system, it may significantly improve treatment compliance over an extended period while also reducing the risk of drug diversion.”

Probuphine Development Program

Probuphine has been shown to be safe and effective in the three Phase 3 studies that have been completed to date, specifically:

• A six-month, double-blind, placebo-controlled safety and efficacy trial,
• A six-month, open-label re-treatment safety trial, and
• A pharmacokinetic safety study.

Data from these studies have been presented at the International Society of Addiction Medicine 2008 Annual Meeting in Cape Town, South Africa, and the American Society of Addiction Medicine 2009 Annual Meeting in New Orleans, LA. Also, Titan recently announced that the National Institutes of Health (NIH) has awarded a two year $7.6 million grant in support of the confirmatory Phase 3 clinical study of Probuphine for the treatment of opiate addiction.