Molteni Farmaceutici Plans For EU Entry Of Titan’s Six-Month Buprenorphine Implant
Executive Summary
Molteni Farmaceutici/Titan’s Sixmo, the first six-month buprenorphine implant just approved for EU marketing, could be a valued option for a sizeable number of patients.
Florence, Italy-based Molteni Farmaceutici expects to start marketing Sixmo, the first six-month implant containing the partial opioid agonist buprenorphine, in the EU in the next six months, when it will enter a diverse and competitive market.
This includes generic versions of buprenorphine immediate-release oral tablets, sublingual tablets, transdermal patches and injections. The market is also in transition, with Indivior PLC submitting in 2018 a once-monthly Sublocade (buprenorphine) injection for EU approval, and just last week announcing completed validation by the EMA of a marketing authorization application for a Suboxone (buprenorphine and naloxone) sublingual film.
Molteni has licensed Sixmo from the US company, Titan Pharmaceuticals Inc., which already markets the implant as Probuphine in the US, and both companies call the EU approval of the product, announced on 26 June, a “major milestone”. The product is also approved for marketing in Canada.
During the 2019 third quarter and early fourth quarter, Molteni will be seeking pricing approvals for Sixmo in various EU countries, and Titan expects patient treatment to start in certain regions by the end of 2019, company president and CEO Sunil Bhonsle remarked in its first-quarter earnings call. The Italian company will work first in countries it expects to give the quickest pricing approvals, he added.
Molteni is a manufacturer and marketer of specialty opioid products, whose growth strategy includes ramping up its business activities outside of Italy. It is aiming to have turnover in foreign markets accounting for around 30% of total turnover over the next few years. Company turnover currently is around €75m annually, with around 19% coming from ex-Italy markets.
Sixmo will become part of that growth strategy: Molteni entered into a licensing agreement with Titan for the implant in March 2018, under which Molteni paid an upfront fee of €2m and will make further milestone and royalty payments; Sixmo was recommended for approval in April (Also see "European CHMP Opinions and MAA Updates" - Pink Sheet, 30 Apr, 2019.).
Well-Controlled Patients
Sixmo is expected to be used after patients have gained control over their addiction with immediate-release products; it is approved in the EU for the substitution treatment of opioid dependence in clinically stable adult patients who require no more than 8mg/day of sublingual buprenorphine, within a framework of medical, social and psychological treatment. One possible downside of the implant is that it is removed at the end of six months in an outpatient procedure.
The EU is considered to be the world’s second-largest market for buprenorphine-based products, and Titan says it is considering opportunities to market Probuphine in countries outside the EU and US.
Other opioid-related products are also part of Molteni’s growth strategy; in May, the company entered into an agreement with Shionogi & Co. Ltd. to market that company’s therapy for opioid-induced constipation, Rizmoic (naldemidine), in Italy and Poland, in adult patients previously treated with a laxative. Rizmoic was approved by the European Commission in February 2019 and is expected to be launched in the two countries in 2020. Sandoz International GMBH has licensed rights to the therapy in some other European markets (Also see "Deal Watch: Lilly Takes Global Rights To Centrexion Non-Opioid Pain Candidate" - Scrip, 28 May, 2019.).