MolMed: AIFA Determina on reimbursement regime and market price for the proprietary cell therapy Zalmoxis® published on the Official Gazette

MolMed: AIFA Determina on reimbursement regime and market price for the proprietary cell therapy Zalmoxis® published on the Official Gazette

Milan (Italy), February 15th 2018 - MolMed S.p.A. (MLMD.MI, "the Company"), medical biotechnology company focused on research, development, manufacturing and clinical validation of innovative therapies to treat cancer, announces the publication on the Official Gazette of Italian Republic No. 37, dated February, 14th 2018, of AIFA Determination no 139/2018 of January, 29th 2018, on reimbursement regime and market price for the proprietary medicine Zalmoxis®, indicated as additional treatment in haplo-identical haematopoietic stem cell transplant (haplo-HSCT) for the treatment of adult patients affected by leukaemia or other high-risk haematological malignancies.

The Determina will be effective from the fifteenth day subsequent to its publication on the Official Gazette of the Italian Republic and Zalmoxis®, given the nature of the product, will be a hospital-only dispensed therapy.

As already announced on December 13rd 2017, AIFA recognized a reimbursement ex-factory price, excluding VAT, for Zalmoxis® of 149,000 EUR per infusion, gross of discounts foreseen by law, also agreeing on a flat fee per patient and a safeguard clause on sales for the first 24 months.

About MolMed

MolMed S.p.A. is a biotechnology company focused on research, development, manufacturing and clinical validation of innovative anticancer therapies. MolMed's product portfolio includes proprietary anti-tumor therapies in clinical and preclinical development: Zalmoxis® (TK) is a cell therapy based on donor T cells genetically engineered to enable bone marrow transplants from partially compatible donors for patients with high-risk hematological malignancies, eliminating post-transplant immunosuppression prophylaxis and inducing a rapid immune reconstitution. Zalmoxis® received Orphan Drug Designation and is currently in Phase III in a high-risk population of acute leukemia patients, but has already obtained a Conditional Marketing Authorisation by the European Commission in the second half of 2016 as well as reimbursement conditions in Italy at the end of 2017 and in Germany at the beginning of 2018. Still focusing on this cell & gene technology, the company is developing a therapy based on Chimeric Antigen Receptor (CAR), specifically the CAR-T CD44v6, an immune gene therapy project, currently in advanced preclinical development, potentially effective for hematological malignancies and several solid epithelial tumours. MolMed is also the first company in Europe to have obtained the GMP manufacturing authorization for cell & gene therapies for its proprietary products (Zalmoxis®) as well as for third parties and/or in partnership (Strimvelis, a GSK gene therapy for the ADA-SCID). With reference to GMP development and manufacturing activities for third parties, MolMed signed numerous partnership agreements with leading European and US companies. In the framework of innovative anticancer therapies, MolMed's pipeline also includes NGR-hTNF, a therapeutic agent for solid tumours investigated in a broad clinical programme, involving more than 1,000 treated patients. MolMed, founded in 1996 as an academic spin-off of the San Raffaele Scientific Institute, is listed on the main market (MTA) of the FROM GENES TO THERAPY

Milan stock exchange managed by Borsa Italiana since March 2008. MolMed is headquartered and based in Milan, at the San Raffaele Biotechnology Department (DIBIT) and has an operating unit at OpenZone in Bresso.

For further information:

Ilaria Candotti

Investor Relations & Communication Manager MolMed S.p.A.

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Marcella Ruggiero

Press agent

SEC Relazioni Pubbliche e Istituzionali s.r.l.

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