Milan (Italy), June 30, 2017 – MolMed S.p.A. (“MolMed”) and TTY Biopharm Company Ltd (“TTY”) today announce they signed an exclusive license and distribution agreement which defines all terms and conditions to import, use, market, sell and/or distribute Zalmoxis for the treatment of haematological malignancies in Taiwan, Hong Kong, Singapore, Thailand, Philippines, Vietnam and Malaysia, as anticipated on February 7, when the companies signed a term sheet defining the main terms and conditions.
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).
Under the terms and conditions of today’s agreement, the application of Marketing Authorization of Zalmoxis in the interested territories will be carried-out by and at the cost of TTY which will eventually perform further clinical studies, if needed to obtain regulatory approval, and will conduct all associated regulatory activities after marketing authorization including market access and price & reimbursement. Furthermore, TTY may promote TK008 study enrolment and, possibly, be responsible for engaging hospitals and authorities to allow the performance of it in the interested territories.
Under today agreement, MolMed will receive an upfront payment, potential regulatory and sales milestone payments up to euro 13.5 million, as well as royalty payments in the range of 10% to 20% on annual net sales generated in each country covered by the agreement.
This press release is written in compliance with public disclosure obligations established by Consob’s (Italian securities & exchange commission) Issuers Regulation.
MolMed S.p.A. is a medical biotechnology company focused on research, development and clinical validation of novel anticancer therapies. MolMed’s pipeline includes anti-tumour therapeutics in clinical and preclinical development: Zalmoxis® (TK) is a cell-based therapy enabling bone marrow transplants from partially compatible donors, in absence of post-transplant immune-suppression prophylaxis, currently in Phase III in high-risk acute leukaemia and granted a Conditional Marketing Authorisation by the European Commission; NGR-hTNF is a novel therapeutic agent for solid tumours which displays antitumor activity through its specific binding to blood vessels feeding the cancer and to the concentration of immune system cells into the tumour mass, currently investigated in a broad clinical programme, involving more than 1000 treated patients; CARCD44v6 is an immune gene therapy project potentially effective for many haematological malignancies and several epithelial tumours, currently in preclinical development. MolMed also offers top-level expertise in cell and gene therapy to third parties to develop, conduct and validate projects from preclinical to Phase III trials, including scale-up and cGMP manufacturing of viral vectors and patient-specific genetically engineered cells. MolMed is headquartered at the San Raffaele Biotechnology Department (DIBIT) in Milan, Italy, and an operating unit at OpenZone in Bresso (Milan, Italy). MolMed is listed on the main market (MTA) of the Milan stock exchange managed by Borsa Italiana (Reuters: MLMD.MI).
TTY Biopharm Co., Ltd. (TWO: 4105), is a leading large-scale company which develops new medical entities, including innovative therapeutic modalities to fulfil unmet medical needs and devotes to R&D and manufacture on specialty products in drug delivery systems, i.e., liposome and microsphere technology. TTY is well-known for its continuous self-innovation and accumulated knowledge, technology and networked relationships from 1960. Globally, TTY has led in super-generic drugs and special formulations and had dealer distribution networks around the world and three main Asian subsidiaries in Vietnam, Philippines and Thailand; in Taiwan, TTY has ranked in top 1% of largest biopharmaceutical companies in oncology and critical infection fields. TTY has succeeded in penetrating its own R&D products into international regions and has become the best partner with global companies. TTY is not satisfied with triumphing in Taiwan and certain Asian markets only. In the future, based on its expertise in Asian markets, TTY will continue to strengthen its position in international markets through developing high-barriers and prove of concept new drugs and bio-drugs with innovative formulations. TTY’s collaboration and investments in developing drugs and innovative agents of novel ingredients will be expected. A long-term and sustainable growth will be thrived.
For further information:
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This press release may contain certain forward-looking statements. Although the Company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, including scientific, business, economic and financial factors, which could cause actual results to differ materially from those anticipated in the forward-looking statements. The company assumes no responsibility to update forward-looking statements or adapt them to future events or developments. This document does not constitute an offer or invitation to subscribe or purchase any securities of MolMed S.p.A..