• Zalmoxis® serves as adjunctive treatment in haplo-identical hematopoietic stem-cell transplantation for adult patients with high-risk hematological malignancies

• Germany is the first European country in which patients could benefit from this therapeutic solution

• The product was developed by the Italian biotechnology company MolMed S.p.A., which in 2017 granted to the biopharmaceutical company Dompé the right to conduct all activities aimed at promoting, marketing, and distributing Zalmoxis® in all member countries of the current European Economic Area (EEA).

Milan, 25 January 2018 - Dompé, an Italian biopharmaceutical company, announces the submission of the medical dossier for Zalmoxis® to the Federal Joint Committee on 15 January 2018. With this, the company fulfilled an important prerequisite for the launch of the therapy in Germany. Zalmoxis® is developed and produced by MolMed S.p.A., primary medical biotechnology company focused on research, development and clinical validation of innovative therapies to treat cancer, based in Italy. Per a Europe-wide licensing and distribution agreement, Dompé, one of the leading Italian companies in the biopharmaceutical industry, oversees the product’s promotion and marketing in Germany.

Zalmoxis® is MolMed’s first patient-specific therapy that genetically modifies allogeneic T cells. It is intended as adjunctive treatment in stem cell transplantation (HSCT) of adult patients, who have a high-risk of being affected by diseases that harm the blood system. Zalmoxis® can be now prescribed and reimbursed in Germany at a price valid for twelve months during which the additional benefits of this innovative therapy for patients will be assessed by the German authorities.

“We share great satisfaction for the introduction of Zalmoxis® in Germany”, said Eugenio Aringhieri, CEO of Dompé. "It represents a significant step forward for German patients who, as of today, have a solid solution to a genuine health problem. This achievement is based on innovation and strengthens the value of our partnership with MolMed and of course of our commitment to bring new therapeutic answers for unmet medical needs. We expect that this therapy will soon become available to all Italian patients as well. "

The therapy is based on of genetically modified allogeneic T cells, which are given to transplant patients to help the body fight off infections, control severe complications, enhance the success of the transplant and support long-lasting anti-leukemia effects.

Riccardo Palmisano, MolMed’s CEO, commented: “As a company, we are very proud that we can provide patients in Germany with Zalmoxis® . This is a remarkable milestone for a premium Italian research, development, and manufacturing journey and a result that once again confirms the value of our partnership with Dompé, partner of choice for the future development of such an innovative therapy”.