MolMed S.p.A.
MILAN : MLM

MolMed S.p.A.

June 18, 2012 01:33 ET

The European Patent Office Grants MolMed a New Patent on Its Anticancer Drug NGR-hTNF

MILAN, ITALY--(Marketwire - June 18, 2012) - MolMed S.p.A. (MILAN:MLM) announces today that it received the official notification from the European Patent Office of the decision to grant a patent covering the therapeutic use of its investigational anticancer drug NGR-hTNF for the treatment of mesothelioma, a pleural cancer caused by exposure to asbestos. The grant will take effect on 4 July 2012, when it will be published in the European Patent Bulletin. NGR-hTNF is currently being investigated in the only ongoing Phase III trial for relapsed mesothelioma, as well as in a randomised Phase II trial as first line maintenance therapy for mesothelioma patients who completed the standard chemotherapy.

This new European patent on NGR-hTNF (EP2285416) becomes part of a large proprietary patent family which comprises 11 additional patent applications filed in the most important pharmaceutical markets, including the United States, Japan, Canada, Australia and China. The patent will afford protection until 2029 with the possibility of term extension, and will give right to market exclusivity in 38 European countries, including the European Union member states, Eastern Europe countries, Switzerland and Turkey.

This patent will further strengthen the intellectual property position on NGR-hTNF, consisting of seven patent families, which, with the grant of this patent, will include 116 granted patents and 28 pending applications. The patent portfolio relevant to NGR-hTNF covers in particular the following elements: product, targeting technology, synergistic combinations with other anticancer drugs, effective compositions, therapeutic uses and the specific treatment of mesothelioma.

Claudio Bordignon, MolMed's Chairman and CEO, comments: "The grant of this new European patent, covering NGR-hTNF for the specific therapeutic indication in mesothelioma, reinforces MolMed's extended market exclusivity on the drug and is of remarkable relevance to us, as it expressly covers the therapeutic indication of NGR-hTNF in a pivotal Phase III clinical trial. I must underline that relapsed malignant pleural mesothelioma is a very aggressive disease for which no consolidated and efficacious therapy exists. Due to the long-term effects of exposure to asbestos, the incidence of mesothelioma is increasing in many parts of the world and it is expected to grow further in the next 10-20 years. This is one of the fundamental reasons for us to develop novel therapeutic options against this tumour."

The pivotal Phase III trial (NGR015) for the treatment of relapsed malignant pleural mesothelioma is ongoing in 35 participating centres in Europe (Italy, the UK, Ireland, Poland and Belgium), the US, Canada and Egypt. To date, more than 200 patients have been enrolled on a planned trial population of 390 patients. The trial is expected to include more than 40 centres worldwide, with primary data analysis expected in 2013. MolMed presented at ASCO 2012 long-term follow up data of a completed Phase II trial in mesothelioma: the 3-year follow-up results on 57 patients in relapse, receiving NGR-hTNF given either every three weeks or once a week, show that the survival rates for patients receiving the dose-dense schedule are five-fold higher. These results provide an important indication for the optimal treatment schedule together with a clear signal of antitumor activity.

This press release is written in compliance with public disclosure obligations established by CONSOB (Italian securities & exchange commission) resolution no. 11971 of 14.5.1999, as subsequently amended.

About NGR-hTNF

NGR-hTNF is a vascular targeting agent with unique mode of action, and a first-in-class compound in the class of peptide/cytokine complexes able to selectively target the tumour vasculature. It consists of a tumour homing peptide (NGR) that selectively binds tumour blood vessels, fused to the human cytokine TNF. NGR-hTNF is undergoing clinical development both as monotherapy and in combination therapy, in seven indications. Currently ongoing randomised trials of NGR-hTNF include a Phase III trial in mesothelioma and four Phase II trials for non-small-cell lung cancer, soft tissue sarcomas, ovarian cancer and mesothelioma as first-line maintenance therapy. Other Phase II trials of NGR-hTNF include completed trials for mesothelioma, for liver cancer and for colorectal cancer, and ongoing trials for small-cell lung cancer and for ovarian cancer. NGR-hTNF has been granted Orphan Drug designation for the treatment of mesothelioma and of liver cancer in both the EU and the US.

About MolMed

MolMed S.p.A. is a biotechnology company focused on research, development and clinical validation of novel anti-tumour therapies. In addition to NGR-hTNF, MolMed's pipeline includes another novel therapeutic in clinical development: TK, a cell-based therapy enabling bone marrow transplants from partially compatible donors, in Phase III in high-risk acute leukaemia. 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 production of clinical-grade viral vectors, and manufacturing of patient-specific genetically engineered cells. MolMed is headquartered at the San Raffaele Biomedical Science Park in Milan, Italy. The Company's shares are listed on the Milan Stock Exchange, at the Standard segment (class I) of the MTA managed by Borsa Italiana. (MILAN:MLM).

DISCLAIMER

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.

Share capital as of 30/05/2011: € 43,609,036.42 fully paid

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