Date: 2017-07-25
Type of information: Commercialisation agreement
Compound: Zalmoxis®
Company: Molmed (Italy) Dompé (Italy)
Therapeutic area: Cancer - Oncology - Rare diseases
Type agreement: commercialisation - supply
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 administered following haploidentical haematopoietic stem-cell transplantation (HSCT) from partially compatible donors to adult patients with leukaemia and other high-risk haematologic malignancies. It is administered from the 21st day post-transplantation and foresees up to a maximum of 4 infusions per patient based on the achievement of immune-reconstitution.
- Zalmoxis® is an advanced therapy medicinal product (ATMP).
Disease: leukaemia or other high-risk haematological malignancies, in combination with haplo-identical haematopoietic stem cell transplant (haplo-HSCT)
Details:
- • On July 25, 2017, MolMed and Dompé farmaceutici 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.
Financial terms:
- 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 €12,5 million as R&D contributions in the 2017 – 2020 timeframe, and up to €31 million as sales milestones, depending on annual net sales generated in each country covered by the agreement.
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