Totect Approved in the United States
COPENHAGEN, Denmark – 7 September 2007 – TopoTarget A/S (OMX:TOPO) has announced that Totect has been approved by the Food and Drug Administration (FDA) for marketing in the US. In October 2006, Totect was launched in Europe under the Savene brand. Totect is the only approved drug for the treatment of extravasation resulting from intravenous anthracycline chemotherapy.
"I'm extremely happy that the US patients will now benefit from our product. I'm proud of TopoTarget and of the fact that our innovative treatment for this feared accident has now been validated by the FDA," says Peter Buhl Jensen, CEO of TopoTarget. "The Totect US approval is a major breakthrough for TopoTarget, and for the Danish biotech industry at large."
Totect is used as a therapy when anthracycline, intravenously administered, accidentally leaks into the surrounding healthy tissue. Anthracyclines are chemotherapeutic agents used to treat a large number of cancers and constitute one of the cornerstones in the treatment of breast cancer and leukaemia.
The use of dexrazoxane (the active ingredient in Totect/Savene) for anthracycline extravasation is patented. Totect/Savene has obtained Orphan Drug status in the US and in Europe. This status is granted to products developed for rare but serious diseases and provides marketing exclusivity for seven years in the US and ten years in Europe.
TopoTarget USA has developed a comprehensive educational strategy to build awareness of these serious accidents and the innovative treatment provided by Totect.
"We have established TopoTarget USA Inc. and are ready with our own sales people to launch Totect in the US. We are committed to working with the oncology societies, including the Oncology Nurses Society, to provide educational programs to enhance extravasation awareness and support revision of anthracycline extravasation treatment guidelines for the US to include Totect," says John L. Parsons Jr., President of TopoTarget USA, Inc.
John Parsons is an experienced marketeer and has successfully launched and marketed more than 20 pharmaceutical products in the US market. He has assembled a team of experienced oncology professionals from major oncology pharmaceutical companies in the US.
The approval of Totect does not change TopoTarget's financial guidance for 2007.
For further information, please contact:
Dr. Peter Buhl Jensen Telephone +45 39 17 83 41
Chief Executive Officer Mobile +45 21 60 89 22
John Parsons Mobile +1 973 970 8537
Ulla Hald Buhl Mobile +45 21 70 10 49
Director of IR and Communications
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 anti-cancer chemotherapeutics called anthracyclines. Totect blocks the activity of the topoisomerase enzyme and prevents the effect of anthracyclines.
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 Totect/Savene) 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.
TopoTarget (OMX: TOPO) is a biotech company, headquartered in Denmark and with subsidiaries in the UK, Germany, Switzerland and the US, 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 preclinical drug candidates and eight 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 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.
Posted: September 2007