TotectTreatment for Anthracycline Extravasation
Update: Totect Now FDA Approved - September 6, 2007
TopoTarget elaborates on the specific initiatives to obtain FDA approval of Totect
COPENHAGEN, Denmark - 31 May 2007 - TopoTarget A/S elaborates on the specific initiatives to obtain FDA approval of Totect (for the treatment of anthracycline extravasation) for marketing in the US market.
In response to a number of enquiries based on our announcement no. 17-07 dated 30 May 2007 concerning the conditional approval of Totect by the Food and Drug Administration (FDA), TopoTarget wishes to elaborate on the specific initiatives to obtain approval of Totect for marketing in the US market.
Due to a technical issue at one of our two alternative subcontractors, as announced, TopoTarget has received an approvable letter from the FDA. TopoTarget has subsequently been in and maintains an ongoing dialogue with our subcontractors, the FDA and our regulatory advisers in the United States. Against this background, we are confident that this minor technical issue may be solved to the full satisfaction of the FDA and ourselves. Once TopoTarget has received the results of the technical investigations, these results will be evaluated relative to our regulatory and marketing strategy, including the wording of the final text and design of the label and package insert for the Totect product, which are also subject to FDA approval.
If it turns out that we cannot resolve the small technical issue in a satisfactory manner, we may opt to include only the already approved subcontractor in our application.
Against this background, TopoTarget expects to launch Totect in the US market in the second half of 2007, and we therefore do not expect any changes to our financial performance for 2007.
For further information please contact:
Dr. Peter Buhl Jensen Phone +45 39 17 83 41
Chief Executive Officer Mobile +45 21 60 89 22
About Totect (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.
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.
TopoTarget (OMX - The Nordic Exchange: TOPO) is a biopharmaceutical company, headquartered in Denmark and with subsidiaries in the UK, Germany and the USA, 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 enzyme regulators (mainly HDAC, mTOR, and topoisomerase II inhibitors) and a strong development foundation has been built. TopoTarget has a broad portfolio of small molecule preclinical drug candidates and seven drugs are in clinical development, including both novel anti-cancer therapeutics and new cancer indications for existing drugs. Savene is TopoTarget's first product on the market. In addition to organic growth, TopoTarget consistently looks for opportunities to strengthen and expand its activities through acquisitions and in-licensing. 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 nonclinical 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 exposure; 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: May 2007
- Totect Approved in the United States - September 7, 2007