Key recent accomplishments include:
•Acceptance of the NDA for Probuphine for the maintenance treatment of opioid dependence in adult patients and the granting of Priority Review designation by the FDA was announced in January 2013. The Psychopharmacologic Drugs Advisory Committee (PDAC) of the FDA is scheduled to review the NDA for Probuphine on March 21, 2013 and the target PDUFA date for the FDA to complete its review of the Probuphine NDA is April 30, 2013. •Execution of a license agreement with Braeburn Pharmaceuticals for the exclusive commercialization rights to Probuphine in the U.S. and Canada, pursuant to which Titan received a non-refundable up-front payment of $15.75 million and is entitled to receive a $50 million milestone payment upon approval of the NDA by the FDA, tiered royalties on net sales of Probuphine ranging from the mid-teens to the low twenties, up to $130 million upon achievement of specified sales milestones, up to $35 million upon achievement of specified regulatory milestones related to additional indications for Probuphine. •Completion of a new Probuphine manufacturing facility and demonstration of commercial scale manufacturing capability. •Successful completion of an investigational non-clinical study into the feasibility of a long-term, around the clock, non-fluctuating dopamine agonist treatment for Parkinson's disease.
"This has been a breakthrough year for Titan and was capped off by the FDA's acceptance of our NDA submission for Probuphine and its Priority Review designation," said Sunil Bhonsle, president of Titan Pharmaceuticals. "Ahead of us is the upcoming advisory committee meeting later this week and the target PDUFA date of April 30, 2013. If approved for the maintenance treatment of opioid dependence in adults, Probuphine will enter a market currently approaching $1.5 billion in annual sales of daily dosed sublingual buprenorphine formulations in the U.S."
"The board is very pleased with the progress in 2012 and is fully engaged in pursuing the goals for this year," said Marc Rubin, M.D., executive chairman of Titan Pharmaceuticals. "With the Braeburn Pharmaceuticals team's proven track record of successful commercialization and product launches, we are strongly positioned to realize the value of Probuphine for our shareholders and to reach our ultimate goal of bringing a novel treatment option for opioid dependence to patients, their families and healthcare providers."
Fourth Quarter 2012 Results
Total revenues for the fourth quarter of 2012 were approximately $3.3 million, consisting of approximately $0.9 million in royalty revenue on net sales of Fanapt, which were paid by Titan to Deerfield Management in accordance with the terms of the agreements entered into in 2011, and approximately $2.3 million in licensing revenues, consisting of approximately $1.7 million associated with the premium paid for Titan's common stock by an affiliate of Braeburn Pharmaceuticals pursuant to the September 2012 stock purchase and option agreement and approximately $0.6 million related to the recognition of the non-refundable up-front license fee from Braeburn in December 2012. Total revenues for the fourth quarter of 2011 were approximately $1.4 million, consisting of approximately $1.3 million in Fanapt royalties and approximately $0.1 million in grant revenues.
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