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.
Titan and Molteni, a closely-held pharmaceutical company focused on treatments for pain and drug addiction, expect to enter into the definitive license and distribution agreement during the first quarter of 2018.
Under the accord, Molteni will pay Titan an upfront, non-refundable license fee of €2 million on execution of the license and distribution agreement, plus potential additional regulatory milestone payments totaling €4 million, and tiered royalties on net sales of Probuphine ranging in percentage from the low-teens to the mid-twenties.
Molteni also will have the right by June 30, 2019, to expand its territory to include one or both of the following groups: one, the Middle East and North Africa and two, the Commonwealth of Independent States (comprised of 11 former Soviet Republics), for a payment to Titan of €1 million per group.
“We believe this partnership with Molteni offers an opportunity to significantly expand the commercialization of Probuphine beyond the United States, and also to provide Titan with additional financial resources to further advance our pipeline of other ProNeura-based product candidates,” Titan president and CEO, Sunil Bhonsle, said in a statement.
“Molteni’s strong track record of success launching and commercializing innovative new pharmaceutical products in Europe, combined with its focus on the pain and drug addiction markets, makes it an ideal partner for Titan as we work to increase Probuphine’s global uptake,” he added.
On November 27, the European Medicines Agency accepted for review Titan’s marketing authorization application seeking approval of a Probuphine label that will permit the marketing of the product for use in a broad population of opioid use disorder patients, starting with initial treatment and continuing through maintenance treatment.
Molteni has the option to terminate the license and distribution agreement if the broad label is not approved by the EMA.
Molteni operates directly and through its network of specialized partners in more than 30 countries and it is a preferred partner of international organizations and non-governmental organizations, such as UNICEF, UNDP, IDA Foundation and Global Fund.
“We believe Probuphine will dramatically improve the current paradigm of drug addiction treatment across Europe and we look forward to working together with Titan in order to maximize this opportunity,” said Molteni president, Giovanni Seghi.
