TopoTarget A/S Symbion Fruebjergvej 3 DK 2100 Copenhagen Denmark Tel: +45 39 17 83 92 Fax: +45 39 17 94 92 CVR-nr: 25695771 www.topotarget.com To OMX Nordic Exchange Copenhagen Announcement No. 10-08 / Copenhagen, April 2, 2008 TopoTarget Announces Allowance of Valproic Acid Patent in Europe Covering Savicol™ Copenhagen, Denmark - April 2, 2008 - TopoTarget A/S (OMX: TOPO) today announced that a patent related to the histone deacetylase inhibitor valproic acid (VPA), the active ingredient of TopoTarget´s drug product Savicol™, has been allowed in Europe. Corresponding applications are pending in major territories including the US, Japan, India, China, Mexico and Brazil. The allowed application EP04 010 333 covers TopoTarget's novel formulation of VPA now called Savicol™. This is a tablet formulation with biphasic release kinetics i.e. some of the drug is released quickly and some slowly in order to give high and constant therapeutic drug levels over a long time period. The allowed application has broad claims to VPA tablets with biphasic release kinetics and to their use in diverse indications such as Familial Adenomatous Polyposis and cancer. Savicol™ is based on a novel and proprietary, orally available formulation of VPA. VPA is a molecule which acts as an HDAC inhibitor, preferentially for HDAC class I isoenzymes, which are involved in excessive cell proliferation and tumorigenesis. Furthermore, the Savicol™ formulation allows a specific pharmacokinetic release pattern of VPA expected to effectively inhibit these target enzymes. The HDAC inhibitory effect of VPA has already been demonstrated in Phase I trials on the basis of biomarker monitoring of histone acetylation. Pivotal phase II trials are ongoing and data from these trials are expected during 2008. Savicol™ was granted Orphan Drug status for Familial Adenomatous Polyposis in Europe in 2004 and in the US in 2005. “This formulation principle now utilized in TopoTarget´s drug product Savicol™ distinguishes it from any other VPA containing medication available and thus represents a unique advantage,” said Peter Buhl Jensen, Chief Executive Officer of TopoTarget A/S. “This patent is part of TopoTarget's strategy to vigorously protect our product portfolio with a robust patent estate”. Today's news does not change TopoTarget's full-year financial guidance. TopoTarget A/S For further information, please contact: Ulla Hald Buhl Telephone +45 39 17 83 92 Director IR & Communications Mobile +45 21 70 10 49 Background information About Savicol™ Savicol™ is based on a novel and proprietary, orally available formulation of valproic acid (VPA). VPA is a molecule which acts as an HDAC inhibitor, preferentially for HDAC class I isoenzymes, which are involved in excessive cell proliferation and tumourigenesis. Furthermore, the Savicol™ formulation allows a specific pharmacokinetic release pattern of valproic acid expected to effectively inhibit these target enzymes. The HDAC inhibitory effect of VPA has already been demonstrated in Phase I trials on the basis of biomarker monitoring of histone acetylation. Savicol™ was granted Orphan Drug status for the FAP indication in Europe in 2004 and in the US in 2005. About TopoTarget TopoTarget (OMX: TOPO) is a biotech company, headquartered in Denmark and with subsidiaries in the US, Switzerland, Germany and the UK, dedicated to finding ''Answers for Cancer'' and developing improved cancer therapies. TopoTarget is founded and run by clinical cancer specialists and combines years of hands-on clinical experience with in-depth understanding of the molecular mechanisms of cancer. Focus lies on highly predictive cancer models and key cancer targets (including HDACi, NAD+, mTOR, FasLigand and topoisomerase II inhibitors) and a strong development foundation has been built. TopoTarget has a broad portfolio of small molecule pre-clinical drug candidates and nine drugs (both small molecules and protein based) are in clinical development, including both novel anti-cancer therapeutics and new cancer indications for existing drugs. Savene®/Totect™ were approved by EMEA in 2006 and the FDA in 2007 and is TopoTarget's first product on the market. For more information, please refer to www.topotarget.com. TopoTarget Safe Harbour Statement This announcement may contain forward-looking statements, including statements about our expectations of the progression of our preclinical and clinical pipeline including the timing for commencement and completion of clinical trials and with respect to cash burn guidance. Such statements are based on management's current expectations and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. TopoTarget cautions investors that there can be no assurance that actual results or business conditions will not differ materially from those projected or suggested in such forward-looking statements as a result of various factors, including, but not limited to, the following: The risk that any one or more of the drug development programs of TopoTarget will not proceed as planned for technical, scientific or commercial reasons or due to patient enrolment issues or based on new information from non-clinical or clinical studies or from other sources; the success of competing products and technologies; technological uncertainty and product development risks; uncertainty of additional funding; TopoTarget's history of incurring losses and the uncertainty of achieving profitability; TopoTarget's stage of development as a biopharmaceutical company; government regulation; patent infringement claims against TopoTarget's products, processes and technologies; the ability to protect TopoTarget's patents and proprietary rights; uncertainties relating to commercialization rights; and product liability expo-sure; We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, unless required by law.
TopoTarget Announces Allowance of Valproic Acid Patent in Europe covering Savicol™
| Source: Topotarget