Titan Pharmaceuticals (NASDAQ:TTNP) has entered into a definitive asset purchase, supply and support agreement with closely-held L. Molteni & C. dei F.lli Alitti Società di Esercizio S.p.A. of Italy, through which Molteni has acquired the European intellectual property related to Probuphine, including the MAA under review by the EMA, and will have the exclusive right to commercialize the Titan-supplied Probuphine product in Europe, as well as certain countries of the Commonwealth of Independent States, the Middle East and North Africa.Read More
Titan Pharmaceuticals (NASDAQ:TTNP) is in discussions with Braeburn Pharmaceuticals about their partnership for the development and commercialization of Probuphine, the first six-month maintenance treatment of opioid dependence.Read More
Titan Pharmaceuticals (NASDAQ:TTNP) has entered into a binding term sheet with L. Molteni & C. dei F.lli Alitti Società di Esercizio S.p.A. of Italy, giving Molteni an exclusive license to commercialize Probuphine in the European Union, including the UK and Northern Ireland, Switzerland, Norway, Iceland, Liechtenstein, Bosnia, Serbia, Montenegro, Macedonia and Albania.Read More
Titan Pharmaceuticals (NASDAQ:TTNP) has entered into a venture loan and security agreement with Horizon Technology Finance (NASDAQ:HRZN), which provides Titan with up to $10-million of available borrowing capacity.Read More
Titan Pharmaceuticals (NASDAQ:TTNP) has entered into a cooperative research and development agreement with Walter Reed Army Institute of Research and Southwest Research Institute to evaluate development of ProNeura-based implants for a long-term regimen in the prevention of malaria.Read More
Titan Pharmaceuticals (NASDAQ:TTNP) and its marketing partner, closely-held Braeburn Pharmaceuticals, received a potential shot in the arm as the White House called for expanded access to treatment in the war on opioid addition.Read More
Drug Deliver Business News has carried an article about Titan Pharmaceuticals (NASDAQ:TTNP) and its Probuphine implant, the first marketed product to provide maintenance treatment for opioid addiction continuously for six months following a single administration procedure.Read More
Titan Pharmaceuticals’ (NASDAQ:TTNP) Probuphine implant and marketing partner, closely-held Braeburn Pharmaceuticals, were featured in three presentations at the International Society of Addiction Medicine (ISAM) annual meeting in Montreal last week.
Probuphine, a subdermal implant of buprenorphine, is the first commercially available six-month maintenance treatment for opioid dependence. The FDA approved Probuphine in May.Read More
Titan Pharmaceuticals’ (NASDAQ: TTNP) Probuphine implant has been recognized as one of the "12 Most Important Innovations of the Year" in the health category in Popular Science's annual Best of What's New issue.
Probuphine, a subdermal implant developed using Titan's proprietary ProNeura technology, was approved by the FDA in May, becoming the first commercially available long-term maintenance treatment of opioid dependence in clinically stable patients on 8 mg or less a day of oral buprenorphine.Read More
Titan Pharmaceuticals (NASDAQ:TTNP) has received a $15-million milestone payment from development and commercialization partner, Braeburn Pharmaceuticals, following FDA approval of Probuphine, the first six-month maintenance treatment of opioid dependence.
Under terms of the licensing agreement, closely-held Braeburn will pay Titan tiered royalties on net sales in the U.S. and Canada at rates ranging from the mid-teens to low-twenties. In addition, Titan is eligible for up to $165-million in milestone payments based on achievement of certain annual sales targets.Read More
The FDA has approved Titan Pharmaceuticals’ (NASDAQ:TTNP) Probuphine implant, the first product for the long-term maintenance treatment of opioid dependence in clinically stable patients on 8 mg or less a day of oral buprenorphine.
“Opioid abuse and addiction have taken a devastating toll on American families. We must do everything we can to make new, innovative treatment options available that can help patients regain control over their lives,” said FDA commissioner Robert M. Califf, M.D. in a statement. “Today’s approval provides the first-ever implantable option to support patients’ efforts to maintain treatment as part of their overall recovery program.”Read More
The FDA has extended its action date to consider approval of a NDA for Probuphine for the maintenance treatment of opioid addiction by the standard period to May 27 from Feb. 27.
Following the Psychopharmacologic Advisory Committee meeting in January, which recommended approval of Probuphine, the FDA requested additional changes to the Risk Evaluation and Mitigation Strategy (REMS) portion of the NDA, which were promptly submitted by Titan Pharmaceuticals’ (NASDAQ:TTNP) development and commercialization partner, closely-held Braeburn Pharmaceuticals.Read More
The Psychopharmacologic Drugs Advisory Committee of the FDA voted 12-to-5 in favor of approving Titan Pharmaceuticals’ (NASDAQ:TTNP) Probuphine, the first long-acting, subdermal buprenorphine implant for the maintenance treatment of opioid addiction, in stable patients receiving 8mg or less per day of buprenorphine.
The committee’s vote followed presentation and discussion of data regarding Probuphine’s efficacy, safety, and risk-benefit profile. The FDA accepted the NDA for Probuphine last September and set an action PDUFA date for Feb. 27.Read More