MolMed and Dompé signed strategic commercialization and supply agreements for Zalmoxis® in Europe

Milan (Italy), July 25, 2017. MolMed S.p.A. (“MolMed”) and Dompé farmaceutici S.p.A. (“Dompé”) today jointly announced having entered into a 15 year exclusive license and distribution agreement granting Dompé the exclusive right and obligation to conduct all activities aimed at promoting, marketing, exploiting, distributing and selling Zalmoxis in all member countries of the current European Economic Area (EEA) and an option right for Australia, Switzerland and Turkey.

Under the terms and conditions of the license and distribution agreement Dompé shall also perform and/or complete market access activities and take care of negotiating pricing and reimbursement of Zalmoxis in each interested country other than Italy. MolMed will be responsible for performing market access activities, pricing and reimbursement negotiations in Italy, maintaining the Conditional Marketing Authorization and complying with the post approval commitments imposed by EMA in order to obtain full Authorization for Zalmoxis.

Zalmoxis, MolMed’s first patient-specific cell therapy, is conditionally authorised by the European Commission for the treatment of adult patients affected by leukaemia or other high-risk haematological malignancies, in combination with haplo-identical haematopoietic stem cell transplant (haplo-HSCT).

Concurrently with the execution of the aforementioned contract, MolMed and Dompé have signed a manufacturing and supply agreement pursuant to which MolMed will be responsible for production, supply and delivery of Zalmoxis to the final users (in all countries), and Dompé will recognize a purchase price proportional to the reimbursed price of the product.

In addition to the purchase price, MolMed, on the basis of the license and distribution agreement, will receive up to euro 43,5 million, of which up to euro 12,5 million as R&D contributions in the 2017 – 2020 timeframe, and up to euro 31 million as sales milestones, depending on annual net sales generated in each country covered by the agreement.

“This agreement is a fundamental step towards maximizing Zalmoxis’ full potential, and exploit the European CMA obtained in 2016 said Riccardo Palmisano, MoMed’s CEO. Dompé represents the ideal strategic partner to obtain maximum success for our product: our companies share not only the strategy of developing breakthrough innovation addressed to unmet medical needs, but also solid common values and vision on the future. Dompé has both the right size and an indisputable successful commercial track record, and has the perfect momentum to guarantee utmost focus on Zalmoxis. We are extremely confident” concluded Palmisano “that the collaboration started today with one of the first Italian and European players who since the very beginning believed in biotech and now in advanced therapies, can lead to fully exploit Zalmoxis’ potential as a viable therapeutic solution for all Patients suffering of high-risk haematological malignancies, candidates for allogeneic transplant and lacking a fully compatible donor”

"An important agreement that will allow us to bring Zalmoxis to Patients, a gene therapy that is extremely consistent with the path that sees us committed in trying to find answers to still unmet and orphan therapeutic needs" Stated Eugenio Aringhieri, Dompé CEO. "Synergy of distinctive competences and common value priorities are the basis of this alliance with MolMed, one of the excellences of the “Made in Italy” biotech. For us this is the confirmation for an industrial project based on the value of innovation and for a pipeline that is further enriched. This allows us to continue the interaction with the scientific community worldwide, with the aim of giving answers to Patients’ needs."