MolMed S.p.A. Management Shareholder Information Investor

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MolMed S.p.A. Management Shareholder Information Investor Powered By Docstoc
					               MolMed S.p.A.
               via Olgettina, 58
            I-20132 Milan, Italy
              VAT: 11887610159
                                   MolMed is a medical biotechnology
          phone: +39 0221277.1
          fax: +39 0221277.325     company with a primary focus on
                                                                                2004: Entrance of 3 new shareholders
           developing novel and effective
                                                                                      through a capital increase of € 20
                                   therapies for treating tumours.
                                                                                      million:   Fininvest,    H-Equity
                 Management        MolMed is building up an integrated                SICAR and Delfin
                                   strategy, by the development of both
             Claudio Bordignon                                                  2007: Overall capital increase of € 26
             President and CEO     effective targeting of the tumour mass
                                                                                      million since 2005
                                   in the acute stage, and highly
                Marina Del Bue     selective therapies to eliminate             2008: IPO of 25% of shares, resulting in
               General Manager     residual disease.                                  € 56 million of proceeds. Shares
                Enrico Cappelli                                                       are traded on the Milan Stock
         Chief Financial Officer                                                      Exchange since March 5, 2008
                                   MolMed has a strong pipeline, with 2
                 Holger Neecke     products in several different clinical       Strategy for growth: a full
 Director Business Development     trials, and 3 leads in preclinical or R&D    industrial project built on a sound
                                   stage, based on different biotech-based      science basis
               Cynthia Giuliani
                                   approaches: cell-based therapy with
     Director Human Resources
                                   genetic    engineering,   and     vascular
                                                                                • Focus on      oncology     indications
                                                                                  needing new options
             Daniele Pieraccioli   targeting.
  Director Intellectual Property                                                • Efficient clinical & pharmaceutical
                                   MolMed has 90 highly skilled employees         development, independently or with
                 Paolo Rizzardi    in a total staff of 110. Its management        partners
              Director Research    team combines scientific excellence
                                   with industrial and management               • In-house   GMP manufacturing        of
                  Raul Ziliotto    expertise.                                     cell/gene therapy products
    Director Drug Development                                                   • Diversified pipeline to create value
                                   MolMed is located in Milan (Italy),
                   Marco Dieci     within the San Raffaele Biomedical             for shareholders
 Director Operations, Qualified    Science Park, the leading Italian
                        Person     biomedical research institution.             Highlights 2008
              Antonio Lambiase                                                  • Start of Phase III trial of TK therapy
  Director Clinical Development    Corporate History                              in high-risk acute leukaemias
                                   1996: Incorporation as a joint venture
                                         between Boehringer Mannheim
                                                                                • Orphan Drug designation to NGR-
   Shareholder Information                                                        hTNF   for    the    treatment      of
                                         and Science Park Raf, to provide
 MolMed (Milan:MLM) is a public                                                   mesothelioma in both EU and US
                                         cell therapy services
    company listed at the Milan
                                   1999: Acquisition of Boehringer by           • Promising clinical results for NGR-
        Stock Exchange, on the                                                    hTNF in Phase II trials as single agent
                                         Roche, which sells its equity
  Standard segment (class I) of                                                   in 3 indications: colorectal and liver
                                         stake to the investment fund
       the Mercato Telematico                                                     cancer, and mesothelioma
                                         EDCP (now AIRAIN)
   Azionario managed by Borsa
                        Italiana   2000: Evolution    from     service to       • Ongoing Phase II trials of NGR-hTNF
                                         product company                          in combination therapy: with Xelox in
  Investor Relations contact       2002: Acquisition and incorporation of         colorectal    cancer,     and    with
                                         the research company Genera              doxorubicin in small-cell lung cancer
                 Holger Neecke
        phone: +39 0221277.205           S.p.A.                                   and in ovarian cancer
           fax: +39 0221277.325
   Product pipeline

   TK                                                                  NGR-hTNF
   Therapy enabling safe and effiective haplo-HSCT                     Vascular targeting agent to treat solid tumours
   TK is the only therapy that specifically addresses the              NGR-hTNF (ARENEGYR) is a first-in-class vascular
   issue of enabling safe and effective haematopoietic stem            targeting agent (VTA): it is a fusion protein obtained
   cell transplantation from a partially compatible donor              from the combination of a tumour homing peptide (NGR)
   (haplo-HSCT) to treat high-risk leukaemia patients,                 with the human cytokine Tumour Necrosis Factor (hTNF).
   without elimination of donor T cells. Haplo-HSCT is                 While anti-angiogenesis agents inhibit the growth of new
   normally hampered by a severe immune reaction against               tumour blood vessels, NGR-hTNF targets exixting blood
   patient’s tissues, known as GvHD, mediated by donor T               vessels feeding the tumour, through specific binding of
   cells. The standard way to prevent GvHD is the                      the NGR peptide to the tumour vessel endothelium.
   elimination of donor T cells from the graft, but this               NGR-hTNF is currently in clinical development either as
   procedure heavily reduces the effectiveness of the                  single agent or in combination with different
   transplant, because donor T cells have key therapeutic              chemotherapeutic agents, for 5 types of solid tumours.
   effects, since they protect the patient from infections             In 2008, NGR-hTNF was granted Orphan Drug designation
   and from residual leukaemia cells, while the immune                 for the treatment of mesothelioma, both in EU and in
   system reconstitutes from the transplanted stem cells.              the US.
   With the TK therapy, patients can receive donor T cells             Clinical development: ongoing trials
   as add-backs to haplo-HSCT: this is made possible by
   genetic enginnering of donor T cells with insertion of the          •   Phase II trials as single agent, for colorectal and
   TK gene, allowing to control and abrogate GvHD in case                  hepatocellular carcinomas, and for malignant pleural
   of onset, through the simple administration of                          mesothelioma
   ganciclovir.                                                        •   Phase II trials in combination with doxorubicin, for
   TK was granted Orphan Drug designation both in the EU                   small-cell lung and ovarian carcinomas;
   (2003) and in the US (2005).                                        •   Phase II trial in combination with Xelox, for
   Clinical development: completed and ongoing trials                      colorectal carcinoma
   •    Phase I/II trial in Europe for high-risk leukaemia: the        •   Phase I trial as single agent at high doses
        completed study showed the safety of TK therapy,               •   Phase I trial in combination with cisplatin
        and a great improvement in patients’ survival, thanks
        to rapid and sustained immune-reconstitution
   •    Phase III trial for high-risk leukaemia: started in Italy      NGR-IFNγ and NGR-IL12
        in 2008, planned to become a multicentric trial in             MolMed’s VTA programme includes two additional
        Europe and in the US                                           molecules, combining the tumour homing peptide NGR
   •    Phase I trial for leukaemia: started in Japan in               with the cytokines interferon-gamma (NGR-IFNγ) and
        October 2008, conducted by Takara Bio Inc, MolMed’s            interleukin 12 (NGR-IL12): the two projects are in the
        Asian partner for cell and gene-based therapies                preclinical and discovery stage, respectively.

Product                         Indication (trial code)             Res Precl        Phase I         Phase II            Phase III
TK                             High-risk leukaemia (TK007, TK008)

NGR-hTNF         Solid tumours [ MTD] (EORTC)
                 Solid tumours [low dose] (NGR002)
                 Colorectal cancer (NGR006)
 single agent    Hepatocarcinoma (NGR008)
                 Mesothelioma (NGR010)
                 Solid tumours [high dose] (NGR013)
                 Small cell lung cancer (NGR007)
                 Solid tumours (NGR003)
 + doxorubicin   Ovarian cancer (NGR012)
 + XELOX regimen Colorectal cancer (NGR005)
 + cisplatin     Solid tumours (NGR004)
                 Lung cancer/NSCLC
NGR-IFNγ         Solid tumours
NGR-IL12         Solid tumours
Legenda for clinical trials:      completed    ongoing    planned

                                                                                                           Update May 2009