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
- Overall sales for the combined Q3-Q4 should not be adversely affected -
The supplier of TopoTarget's product Totect® in the US has been experiencing
difficulties which have lead to a temporary suspension in the supply of product
from TopoTarget to its US distributors. The manufacturer has been working in
close contact with the regulatory authorities to rectify the problem and
expects to recommence manufacturing of Totect® in early October. While there is
currently limited stock to supply end users, the suspension in restocking of
distributors will affect reported sales of Totect® for the Q3 period. Provided
the manufacturer recommences production in October as anticipated, overall
sales for the combined Q3/Q4 periods should not be adversely affected.
TopoTarget retains it guidance for the 2009 year of a loss before tax of
approximately DKK 140 to DKK 160 million.
TopoTarget A/S
For further information, please contact:
Peter Buhl Jensen Telephone +45 39 17 94 99
CEO Mobile +45 21 60 89 22
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 anti-cancer chemotherapeutics
called anthracyclines. Savene®/Totect® blocks the activity of the topoisomerase
enzyme and prevents the effect of anthracyclines.
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 TopoTarget
TopoTarget (OMX: TOPO) is an international biotech company headquartered in
Denmark, dedicated to finding ''Answers for Cancer'' and developing improved
cancer therapies. The company was founded and is run by clinical cancer
specialists and combines years of hands-on clinical experience with in-depth
understanding of the molecular mechanisms of cancer.
TopoTarget has a broad clinical pipeline but is currently focusing on the
development of belinostat, which has shown proof of concept as monotherapy in
treating haematological malignancies and positive results in solid tumours
where it can be used in combination with full doses of chemotherapy, and is in
a pivotal trial in PTCL. TopoTarget's expertise in translational research is
utilizing 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.
