Reckitt Benckiser’s decision to discontinue the supply of Suboxone tablets could not have come at a better time for Titan Pharmaceuticals (OTC: TTNP). Titan is well positioned to bring out new drug applications for buprenorphine-based products for treatment of opioid addiction and dependence. Reckitt Benckiser’s voluntary withdrawal decision was based on the analysis of data from the U.S. Poison Control Center that showed consistently higher rates of accidental unsupervised pediatric exposure with Suboxone tablets. Reckitt’s decision opens a $400 million market for play.
Titan, a California-based biopharmaceutical company engaged in the development of proprietary therapeutics primarily for the treatment of central nervous system disorders, is currently developing the drug Probuphine. Probuphine, a subcutaneous implantable formulation of buprenorphine designed using ProNeura technology, delivers six months of buprenorphine without any risk of accidental pediatric exposure. The process involves implanting Probuphine, which releases buprenorphine slowly and continuously over the next six months.
The company has already completed two Phase III trials and two long-term safety analysis studies with Probuphine. Earlier in the month of February, the company declared the results of an open-label, six-month safety re-treatment study of opioid dependence patients. These patients have previously completed a full six months of treatment in Titan’s confirmatory Phase III clinical trial of the investigational drug Probuphine. The re-treatment study conducted in 85 patients showed toleration to Probuphine with a low incidence of undesirable events.
Between April 19 and 22, 2012, the company made a poster presentation at the American Society of Addiction Medicine describing the positive efficacy and safety results from its confirmatory Phase III clinical trial evaluating Probuphine. Rodman & Renshaw initiated an outperform rating for Titan Pharmaceuticals on May 14, 2012.
On September 14, 2012, the company said that it has entered into a stock purchase and option agreement with another pharmaceutical company for the potential license of Probuphine. As per the agreement, Titan realized $4.25 million as non-refundable proceeds by selling 3.4 million shares of common stock to the potential partner at a price of $1.25 per share. From $0.72 on September 13, 2012, the share price of Titan appreciated by 44% to attain $1.04 in a matter of four days. In its second quarter earnings report, Titan reported being in talks with three more potential partners. Titan expects to file the new drug application for Probuphine by October 2012 and seek a priority review.
Titan Pharmaceuticals ended the day at $1.05 per share, up $0.071 or 7.3% on a volume of 732,105 shares.
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