To NASDAQ OMX Copenhagen A/S Announcement No. 06-10 / Copenhagen, 2 March, 2010
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
Copenhagen, Denmark – 2 March, 2010 – TopoTarget A/S (NASDAQ OMX: TOPO) announced today that SpePharm Holding, BV acquired the rights to Savene® for 6 million Euros. The acquisition includes all the Savene® European assets and the transition of the TopoTarget sales team in Europe to SpePharm. Totect®, the US trademark for the same product, will remain with TopoTarget and continue to be promoted by the TopoTarget US sales team.
The divestiture of Savene® in Europe and the rest of the world outside of North and South America reflects the continued focus of TopoTarget on the clinical development and commercialisation of Belinostat. The divestiture funds (5 million Euros plus the value of stock payable on settlement plus a double digit royalty on net sales capped at EU 1 million), will be used to fuel the growth of the Belinostat clinical development program for the anticipated filing and approval in the US for PTCL and to continue the development of selected high potential indications. The partnering with Spectrum in the US has increased TopoTarget’s development and marketing resources and provides TopoTarget with a strong partner to launch Belinostat.
“Belinostat, the main product of the Company, is a pipeline within a molecule with blockbuster potential on which in February we signed a deal with Spectrum Pharmaceuticals with a potential value of USD 350 million deal plus royalties. Based on our core strategy and commitment to our shareholders to focus on the development and commercialisation of Belinostat for the treatment of cancer patients we have made the decision to divest the European marketing and sales of Savene” said Francois Martelet, MD, CEO of TopoTarget.
“We believe that SpePharm will continue the successful sales of Savene® as we integrate this medically important orphan drug product for the treatment of patients with anthracycline extravasations, developed and launched by the Topotarget team, into our portfolio.”, said Jean-François Labbé, Managing Director and CEO of SpePharm.
Today’s news does not change TopoTarget’s 2009 full-year financial guidance.
TopoTarget A/S For further information, please contact: Francois Martelet Telephone +45 39 17 94 99 CEO Page 1 of 3 TopoTarget announces the European divestiture of Savene® to SpePharm Holding, BV and reconfirms the focus to develop and commercialise Belinostat Background information
About Savene®/Totect® Savene®/Totect® is a catalytic inhibitor of Topoisomerase II, an enzyme found in the cell nucleus. Topoisomerase enzymes are essential for cell growth and proliferation and the target for a group of anticancer chemotherapeutics called anthracyclines. Savene®/Totect® blocks the activity of the topoisomerase enzyme and prevents the effect of anthracyclines. Contraindications: None known Warnings: Pregnancy Category D Precautions: Totect is a cytotoxic drug. When administered to patients receiving anthracycline containing cytotoxic therapy, additive cytotoxicity may occur. Treatment with Totect is associated with leukopenia, neutropenia, and thrombocytopenia. Hematological monitoring should be performed. Reversible elevations of liver enzymes may occur with dexrazoxane. Patients with Moderate or Severe Renal Insufficiency: Greater exposure to dexrazoxane may in occur in patients with compromised renal function. The Totect dose should be reduced by 50% in patients with creatinine clearance values <40mL/min. Dimethylsulfoxide (DMSO) should not be used in patients who are receiving dexrazoxane to treat anthracycline-induced extravasation. Laboratory Tests: Blood counts and liver enzymes should be monitored. Adverse Reactions: Dexrazoxane has been studied previously as a cytotoxic agent. Adverse reactions of nausea/vomiting, diarrhea, stomatitis, bone marrow suppression (neutropenia, thrombocytopenia), altered liver function (increased AST/ALT), and infusion site burning have been observed. These adverse reactions have been reversible. Savene®/Totect® is used as a detoxifying agent, administered intravenously as an antidote following an extravasation. An extravasation is a serious clinical accident in which anthracyclines accidentally leak into surrounding tissue. The high concentration of drug causes severe and cumulative damage to the skin, subcutaneous tissue, muscle and nerves. Current treatment often involves surgical removal of the tissue followed by plastic surgery and rehabilitation. The use of dexrazoxane (the active ingredient in Savene®/Totect®) to treat anthracycline extravasation is protected by patent in several countries including EU and the US. The US patent number is 6,727,253 B2.
About SpePharm Holding, BV SpePharm Holding, B.V., a Dutch company with its registered office in Amsterdam, is a pan-European specialty pharmaceutical company focused on acquiring, registering and marketing high medical value specialty medicines essentially for the hospital market. Particular areas of therapeutic interest are oncology, critical and supportive care. SpePharm was founded in September 2006 by Jean-François Labbé together with leading life science investment firms TVM Capital and Signet Healthcare Partners (part of the Sanders Morris Harris Group). Paul Capital Healthcare, one of the largest dedicated healthcare investors globally, made an equity investment in SpePharm in August 2008, and provided additional non-dilutive financing for SpePharm. Jean-François Labbé is a former top executive of Hoechst Marion Roussel and Parke Davis with over 30 years of experience in international pharmaceutical management. SpePharm completed two pan-European license/distribution agreements in 2007 and 2008 for respectively MuGard® and Xerotin® and also acquired in 2008 the full rights for Europe and other territories worldwide to dantrolene sodium (Dantrium® / Dantrolen® /Dantamacrin®) from Procter & Gamble Pharmaceuticals. To date SpePharm has an established commercial presence in the UK, Germany and Italy. For further information on SpePharm see www.spepharm.com
About TopoTarget TopoTarget (NASDAQ OMX: TOPO) is an international biotech company headquartered in Denmark, dedicated to finding ''Answers for Cancer'' and developing improved cancer therapies. TopoTarget currently focuses, in collaboration with Spectrum Pharmaceuticals, Inc., on the development in pivotal studies of its lead drug candidate, Belinostat, which has shown proof of concept as monotherapy in treating haematological malignancies and positive results in solid tumours. Belinostat can be used in combination with full doses of chemotherapy, and is in a pivotal trial within PTCL (peripheral T-cell lymphoma). TopoTarget's expertise in translational research is based on utilising its highly predictive in vivo and in vitro cancer models. TopoTarget is directing its efforts on key cancer targets, including HDACi, NAD+, mTOR, FASLigand and topoisomerase II inhibitors. The Company's first marketed product, Savene®/Totect®, was approved by EMEA in 2006 and the FDA in 2007, and is marketed by TopoTarget's own sales force in Europe and the US. 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.