The European Commission approved Titan Pharmaceuticals’ (NASDAQ:TTNP) Sixmo, the brand name for its Probuphine implant in the European Union.
The EC’s decision, received by Titan’s European marketing partner, Molteni, applies to all 28 EU member states, where Sixmo is now approved for substitution treatment for opioid dependence in clinically stable adult patients who require no more than 8 mg/day of sublingual buprenorphine, within a framework of medical, social and psychological treatment.
“The EU is the third major market in which Probuphine has been approved, and as the world’s second largest market for buprenorphine-based products, we believe Sixmo could be a valuable treatment option for European healthcare providers and patients,” Titan president and CEO, Sunil Bhonsle, said in a statement.
“In addition, we continue to consider opportunities to commercialize Probuphine in other territories,” he added.
In March 2018, Molteni acquired the European intellectual property related to Probuphine, including the MAA under review by the EMA, and gained 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.
Molteni’s managing director, Giuseppe Seghi Recli, said the registration of Sixmo marks the company’s entry in the long-term buprenorphine market, “strengthening our leadership in our core addiction market, as we strongly believe Sixmo represents a valuable option for a sizeable number of patients and physicians.”
