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 the OMX
Announcement No. 32-07 / Copenhagen, 7 September 2007
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.
TopoTarget A/S
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
President
Ulla Hald Buhl Mobile +45 21 70 10 49
Director of IR and Communications
Background information
About 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 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.
About TopoTarget
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 pre-clinical 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.
