Thanks to the agreement, MolMed gains back the product marketing rights to re-start its commercial development and receives from Dompé 100% of the deferred contribution contractually foreseen for the year 2018.
MILAN, Italy I November 12, 2018 I MolMed (MLMD.MI) (“the Company”), a clinical stage biotechnology company focusing on research, development, manufacturing, and clinical validation of cell & gene therapies to treat cancer and rare diseases, and Dompé farmaceutici S.p.A. (“Dompé”), announce today the mutual termination of the License and Distribution Agreement signed on July 26th, 2017.
According to the termination contract, Dompé will return to MolMed the marketing rights of Zalmoxis® related to all the European Union countries, Switzerland, Turkey and Australia, together with all the current activities, to guarantee continuity and the interest of the patients to whom the product is intended.
In order to ensure the continuity of the ongoing activities, Dompé will support MolMed in the transition phase that is expected to be completed by early 2019.
As part of the contract termination agreement, Dompé will pay Euro 3 million to MolMed, which corresponds to 100% of the deferred contribution still due to MolMed for the year 2018; these resources will allow MolMed to finance the continuation of the current clinical trial, during the search for a new partner with which to restart the commercial development of the product in the shortest possible time.
Zalmoxis®, first patient-specific cell therapy for the treatment of leukemia and other high risk hematologic tumours in adult patients, used in association of the haploidentical transplantation of hematopoietic stem cells, has recently been renewed by EMA at the CMA (Conditional Marketing Authorization) which confirm its validity in terms of efficacy and safety.
Riccardo Palmisano, CEO of MolMed, commented: “We are pleased to have found a mutual solution, which required time in order to protect, the patients’ interests, the value of the product and the needs of both parties. Our energies will now be focused on ensuring that Zalmoxis® will continue to be available to patients. In fact, we remain highly confident in this orphan drug, whose efficacy and tolerability were underlined during the first international hematological clinic congress (International Academy for Clinical Hematology, “IACH”) held recently, highlighting the ability of this therapy to respond to a still unmet clinical need”.
Sergio Dompé, CEO of Dompé farmaceutici, stated: “Dompé will concentrate its resources on the launch of its new ophthalmological product, on the geographical expansion of its network and on the internal R&D pipeline“
About MolMed
MolMed S.p.A. is a clinical stage biotech company focused on research, development, manufacturing and clinical validation of innovative anticancer therapies. MolMed’s product portfolio includes proprietary anti-tumor therapies in both 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 Authorization 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 new CAR pipeline based on Chimeric Antigen Receptor; the most advanced product, the CAR-T CD44v6, currently in advanced preclinical development, and is potentially effective both for some hematological malignancies and several solid epithelial tumors. Following the authorization request submitted to European Regulatory Agencies, MolMed plans to commence during the first half of 2019, human clinical trials in the AML and MM indications. In addition, the Company is developing a new CAR pipeline, both autologous and allogeneic, the last one based on NK (Natural Killer) cells. 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, an Orchard 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. MolMed, founded in 1996 as an academic spin-off of the San Raffaele Scientific Institute, is listed on the main market (MTA) of the 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.
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, Spain and United States (San Francisco and Boston). For more information: www.dompe.com
SOURCE: MolMed
Post Views: 22
Thanks to the agreement, MolMed gains back the product marketing rights to re-start its commercial development and receives from Dompé 100% of the deferred contribution contractually foreseen for the year 2018.
MILAN, Italy I November 12, 2018 I MolMed (MLMD.MI) (“the Company”), a clinical stage biotechnology company focusing on research, development, manufacturing, and clinical validation of cell & gene therapies to treat cancer and rare diseases, and Dompé farmaceutici S.p.A. (“Dompé”), announce today the mutual termination of the License and Distribution Agreement signed on July 26th, 2017.
According to the termination contract, Dompé will return to MolMed the marketing rights of Zalmoxis® related to all the European Union countries, Switzerland, Turkey and Australia, together with all the current activities, to guarantee continuity and the interest of the patients to whom the product is intended.
In order to ensure the continuity of the ongoing activities, Dompé will support MolMed in the transition phase that is expected to be completed by early 2019.
As part of the contract termination agreement, Dompé will pay Euro 3 million to MolMed, which corresponds to 100% of the deferred contribution still due to MolMed for the year 2018; these resources will allow MolMed to finance the continuation of the current clinical trial, during the search for a new partner with which to restart the commercial development of the product in the shortest possible time.
Zalmoxis®, first patient-specific cell therapy for the treatment of leukemia and other high risk hematologic tumours in adult patients, used in association of the haploidentical transplantation of hematopoietic stem cells, has recently been renewed by EMA at the CMA (Conditional Marketing Authorization) which confirm its validity in terms of efficacy and safety.
Riccardo Palmisano, CEO of MolMed, commented: “We are pleased to have found a mutual solution, which required time in order to protect, the patients’ interests, the value of the product and the needs of both parties. Our energies will now be focused on ensuring that Zalmoxis® will continue to be available to patients. In fact, we remain highly confident in this orphan drug, whose efficacy and tolerability were underlined during the first international hematological clinic congress (International Academy for Clinical Hematology, “IACH”) held recently, highlighting the ability of this therapy to respond to a still unmet clinical need”.
Sergio Dompé, CEO of Dompé farmaceutici, stated: “Dompé will concentrate its resources on the launch of its new ophthalmological product, on the geographical expansion of its network and on the internal R&D pipeline“
About MolMed
MolMed S.p.A. is a clinical stage biotech company focused on research, development, manufacturing and clinical validation of innovative anticancer therapies. MolMed’s product portfolio includes proprietary anti-tumor therapies in both 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 Authorization 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 new CAR pipeline based on Chimeric Antigen Receptor; the most advanced product, the CAR-T CD44v6, currently in advanced preclinical development, and is potentially effective both for some hematological malignancies and several solid epithelial tumors. Following the authorization request submitted to European Regulatory Agencies, MolMed plans to commence during the first half of 2019, human clinical trials in the AML and MM indications. In addition, the Company is developing a new CAR pipeline, both autologous and allogeneic, the last one based on NK (Natural Killer) cells. 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, an Orchard 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. MolMed, founded in 1996 as an academic spin-off of the San Raffaele Scientific Institute, is listed on the main market (MTA) of the 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.
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, Spain and United States (San Francisco and Boston). For more information: www.dompe.com
SOURCE: MolMed
Post Views: 22
