MolMed S.p.A.

MolMed S.p.A.

August 17, 2011 00:48 ET

Key European Patent Granted for MolMed's TK Cell Therapy

MILAN, ITALY--(Marketwire - Aug. 17, 2011) - MolMed S.p.A. (MILAN:MLM) announces that today the European Patent Office granted a key patent covering the gene forming the basis of TK, MolMed's investigational cell therapy product currently in Phase III for the treatment of high-risk leukaemia.

The new European composition of matter patent (EP1781789) is part of a large patent family owned by MolMed and covers a non-splicing variant of the HSV-TK gene, i.e. a variant that is transcribed in a stable and unmodifiable manner. The patent, affording patent protection until 2025 with the possibility of a 5-year term extension, guarantees market exclusivity in 29 designated countries within the European Patent Convention, including all major countries of the European Union, Switzerland and Turkey. Equivalent patent applications are pending in the United States, Japan and important emerging markets.

Claudio Bordignon, MolMed's chairman and CEO, comments: "With the grant of this new European patent, MolMed obtains market exclusivity on a technology developed by our scientists, which assures that all TK cells are sensitive to the antiviral drug ganciclovir; this allows to promptly eliminate all TK cells in case of occurrence of Graft-versus-Host disease (GvHD) through administration of the drug. This full control of GvHD gives access to bone marrow transplantation to all patients lacking a fully matched donor."

The new European patent strengthens the intellectual property position of MolMed on TK, consisting of 11 patent families - all granted patents in Europe - covering the following components of the TK technology: the retroviral vector carrying the HSV-TK gene for therapeutic use, the non-splicing variants of the gene, the marking and selection of transduced human cells and all relevant production processes, including the manufacturing of TK cells in a closed system. The overall TK intellectual property portfolio consists of a total of 137 granted patents and 16 pending applications.

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 TK

TK is a cell therapy product, based on the use of genetically engineered donor T cells in association with bone marrow transplants from healthy donors, and particularly from partially compatible family donors. Add-back of TK has the potential to allow the retention of immune-protection and anti-leukaemia effects of donor T cells, while promptly controlling and abrogating the possible onset of GvHD. TK is currently in Phase III for high-risk leukaemia: the trial (TK008) is actively enrolling patients in Italy, and MolMed received a IND from the U.S. Food and Drug Administration (FDA) that will allow to include clinical centres in the United States. TK has been granted Orphan Drug designation 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 antitumour therapies. In addition to TK, MolMed's pipeline includes another anticancer therapeutic in clinical development, NGR-hTNF - a novel vascular targeting agent (VTA) - in Phase III in malignant pleural mesothelioma and in Phase II in seven indications: colorectal, lung (small-cell and non-small-cell), liver and ovarian cancer, soft tissue sarcomas and mesothelioma as first-line maintenance therapy. 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.


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.

Tax identification number 11887610159

Office of Milan Company Register number 11887610159

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

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