Titan Pharmaceuticals (NASDAQ:TTNP) received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency for marketing authorization of Sixmo, the brand name for Titan’s Probuphine implant in the EU. Probuphine is already commercially available in the U.S. and Canada.
Sixmo is indicated 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.
CHMP’s positive opinion of Sixmo now goes to the European Commission, which is expected to issue a decision for Sixmo covering all 28-member states of the European Union around the end of June 2019.
Last year, Molteni & C. dei F.lli Alitti Società di Esercizio 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.
“Obtaining this positive CHMP opinion is an important step toward bringing this unique six-month buprenorphine treatment to people in Europe living with opioid dependence, and represents a significant milestone for Titan, as well as for our commercialization partner, Molteni,” Titan’s president and CEO, Sunil Bhonsle, said in a statement.
In addition to Molteni’s pending launch in Europe, Mr. Bhonsle said Titan is exploring other opportunities to commercialize Probuphine in other regions around the world to help reduce the significant social, economic and health burden associated with opioid dependence.
Molteni’s managing director, Giuseppe Seghi Recli, said the company believes Sixmo’s unique six-month treatment period will offer European healthcare providers and patients with opioid dependence an attractive, novel treatment option. “This significant achievement is in line with our European strategy of growth along our main therapeutic areas.”
