Titan Pharmaceuticals And Molteni Announce Positive EU CHMP Opinion For Probuphine®
- Probuphine to be marketed in the European Union under the brand name "Sixmo" -
Titan Pharmaceuticals, Inc. (PRNewsfoto/Titan Pharmaceuticals, Inc.)
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Titan Pharmaceuticals, Inc.
Apr 29, 2019, 07:00 ET
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SOUTH SAN FRANCISCO, Calif., April 29, 2019 /PRNewswire/ -- Titan Pharmaceuticals, Inc. (NASDAQ: TTNP) today announced that the Committee for Medicinal Products for Human Use ("CHMP") of the European Medicines Agency ("EMA") has adopted a positive opinion recommending the granting of a marketing authorization for the medicinal product Sixmo, the brand name for Probuphine (buprenorphine) implant in the European Union ("EU"). 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.
The CHMP is a scientific committee composed of representatives from the EU, Iceland, Norway and Liechtenstein. The CHMP reviews medical product applications on their scientific and clinical merit and provides advice to the European Commission ("EC"), which has the authority to approve medicines for the EU.
The CHMP's positive opinion of Sixmo will now be transmitted to the EC, which is expected to issue the Commission Decision for Sixmo for all 28 member states of the EU around the end of June 2019. The translations of the Product Information Annexes, which include the Summary of Product Characteristics (SmPC), will be provided and reviewed in parallel in all EU official languages.
In March 2018, Titan entered into a definitive asset purchase, supply and support agreement with Molteni & C. dei F.lli Alitti Società di Esercizio S.p.A. ("Molteni") through which 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.
"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," said Titan's President and CEO, Sunil Bhonsle. "With Probuphine already approved and commercially available in the United States and Canada, we are looking forward to supporting Molteni as it prepares for Sixmo's pending European launch, while we also continue to work together to evaluate pursuing opportunities to commercialize the product in additional 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, commented, "We are pleased that our close collaboration with Titan over the past year has resulted in this positive CHMP opinion for Sixmo. In the world's second largest market for buprenorphine-based products, we believe 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."
About Probuphine
Probuphine is the only subdermal implant designed to deliver buprenorphine continuously for six months following insertion.
Probuphine was developed using ProNeura™, the continuous drug delivery system developed by Titan that consists of a small, solid implant made from a mixture of ethylene-vinyl acetate and a drug substance. The resulting construct is a solid matrix that is placed subdermally, normally in the upper arm in an outpatient office procedure, and removed in a similar manner at the end of the treatment period. The U.S. Food and Drug Administration ("FDA") approved Probuphine in May 2016, and it is the first and only buprenorphine implant available for the maintenance treatment of opioid addiction in eligible patients.
IMPORTANT SAFETY INFORMATION INCLUDING INDICATION AND BOXED WARNING
Indication
PROBUPHINE is an implant that contains the medicine buprenorphine. PROBUPHINE is used to treat certain adults who are addicted to (dependent on) opioid drugs (either prescription or illegal). PROBUPHINE is indicated for the maintenance treatment of opioid dependence in patients who have achieved and sustained prolonged clinical stability on low-to-moderate doses (doses no more than 8 mg per day) of a transmucosal buprenorphine-containing product.
PROBUPHINE is part of a complete treatment program that also includes counseling and behavioral therapy.
