Date: 2017-04-28
Type of information: Commercialisation agreement
Compound: Zalmoxis® - cell therapy product TK
Company: Molmed (Italy) Megapharm (Israel)
Therapeutic area: Cancer - Oncology - Rare diseases - Transplantation
Type agreement: licensing -commercialisation
Action mechanism:
- cell therapy. Zalmoxis® is a cell therapy product, based on the use of genetically engineered donor T cells with a retroviral vector encoding for a truncated form of the human low affinity nerve growth factor receptor (LNGFR) and the herpes simplex I virus thymidine kinase (HSV-TK Mut2). Zalmoxis® innovative therapy is based on genetically engineering donor immune system T cells to carry an inducible “suicide gene”. Administered to patients following HSCT from partially compatible donors (haploidentical HSCT), these cells foster an anti-leukaemia effect by eliminating post-transplant immunosuppression prophylaxis and inducing a rapid immune reconstitution. The suicide gene in the modified T cells makes them susceptible to ganciclovir or valganciclovir. If the patient develops graft-versus-host disease, ganciclovir/valganciclovir is given, which kills the modified T cells that have the suicide gene, so preventing further development of the disease.
- Zalmoxis® is an advanced therapy medicinal product (ATMP). The product is conditionally authorised by the European Commission for adult patients affected by leukaemia or other high-risk haematological malignancies, and is the first patient-specific cell therapy used in combination with haplo-identical haematopoietic stem cell transplant (haplo-HSCT).
Disease: adjunctive treatment in hematopoietic stem cell transplantation (HSCT) for patients affected by high risk leukaemia
Details:
- • On April 28, 2017, MolMed and Megapharm announced
that they signed a distribution and license agreement which defines all terms and conditions for the supply, registration, promotion and distribution of Zalmoxis® in Israel, as anticipated on December 1, 2016, when the companies signed a term sheet defining the main terms and conditions.
Under the terms and conditions of this agreement Zalmoxis® will be distributed and marketed by Megapharm, once approved by the Israeli Ministry of Health (MOH) and included in the Israeli National Health Basket of drugs by the MOH. Furthermore, Megapharm will be responsible for conducting all regulatory activities after marketing authorisation in Israel, including market access and price & reimbursement.
- • On December 1st, 2016, MolMed and Megapharm announced they signed a term sheet defining the main terms and conditions for supply, registration, promotion and distribution of Zalmoxis® in Israel. Within April 30th, 2017, the terms contained in this agreement shall be incorporated into a definitive contract, pursuant to which Megapharm will be appointed by MolMed as the exclusive licensee, under certain terms and conditions, to market, sell and distribute Zalmoxis® in Israel.
- Under the terms and conditions of this agreement, after the signature of the definitive contract Zalmoxis® will be distributed and marketed by Megapharm, once approved by the Israeli Ministry of Health (MOH) and included in the Israeli National Health Basket of drugs by the MOH. Furthermore, Megapharm will be responsible for conducting all regulatory activities after marketing authorisation in Israel, including market access and price & reimbursement.
Financial terms:
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Is general: Yes
