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

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

Milan (Italy), July 26, 2017 - MolMed S.p.A. ("MolMed") and Dompé farmaceutici S.p.A. ("Dompé") 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 Switzerland, Turkey and Australia.

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 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, MolMed'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 just started 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's 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

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further enriched. This allows us to continue the interaction with the scientific community worldwide, with the aim of giving answers to Patients' needs."

This press release is written in compliance with public disclosure obligations established by Consob's (Italian securities & exchange commission) Issuers Regulation.

About MolMed

MolMed S.p.A. is a medical biotechnology company focused on research, development and clinical validation of novel anticancer therapies. MolMed's pipeline includes anti-tumour therapeutics in clinical and preclinical development: Zalmoxis® (TK) is a cell-based therapy enabling bone marrow transplants from partially compatible donors, in absence of post-transplant immune-suppression prophylaxis, currently in Phase III in high-risk acute leukaemia and granted a Conditional Marketing Authorisation by the European Commission; NGR-hTNF is a novel therapeutic agent for solid tumours which displays antitumor activity through its specific binding to blood vessels feeding the cancer and to the concentration of immune system cells into the tumour mass, currently investigated in a broad clinical programme, involving more than 1000 treated patients; CAR- CD44v6 is an immune gene therapy project potentially effective for many haematological malignancies and several epithelial tumours, currently in preclinical development. MolMed also offers top-level expertise in cell and gene therapy to third parties to develop, conduct and validate projects from preclinical to Phase III trials, including scale-up and cGMP manufacturing of viral vectors and patient-specific genetically engineered cells. MolMed is headquartered at the San Raffaele Biotechnology Department (DIBIT) in Milan, Italy, and an operating unit at OpenZone in Bresso (Milan, Italy). MolMed is listed on the main market (MTA) of the Milan stock exchange managed by Borsa Italiana (Reuters: MLMD.MI).

About Dompé

Dompé is one of the leading biopharmaceutical companies in Italy. It focuses on the development of innovative therapeutic solutions for diseases with a high social impact for which therapeutic options are lacking. Based in Italy, Dompé has its headquarters in Milan. Its research efforts focus on unmet therapeutic needs such as diabetes, organ transplantation, ophthalmology and oncology. The industrial pole of L'Aquila (Abruzzo) is home to a world class biotechnology plant developing drugs for Primary Care for the markets of about 40 countries worldwide. Dompé has its offices also in Albania, France, Germany, Great Britain, Spain and United States (Boston). For more information: www.dompe.com

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For further information: MolMed:

Laura Villa

Investor Relations & Communication Director

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Dompé:

Benedetta Bitozzi

Public Affairs & Corporate Communications Manager

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Press agent Federico Ferrari

SEC Relazioni Pubbliche e Istituzionali s.r.l. phone: [phone] - mobile [phone]

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Press agent Lea Ricciardi

APCO Worldwide

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DISCLAIMER

This press release may contain certain forward-looking statements. Although the Company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, including scientific, business, economic and financial factors, which could cause actual results to differ materially from those anticipated in the forward-looking statements. The company assumes no responsibility to update forward-looking statements or adapt them to future events or developments. This document does not constitute an offer or invitation to subscribe or purchase any securities of MolMed S.p.A..

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