TopoTarget A/S
Symbion
Fruebjergvej 3
DK 2100 Copenhagen Ø
Denmark
Tel: +45 39 17 83 92
Fax: +45 39 17 94 92
CVR-nr: 25695771
www.topotarget.com
Copenhagen, 20 February 2008 - TopoTarget A/S (OMX: TOPO) announces growth in
sales of Savene® in Europe and positive sales figures in the US following a
successful launch of Totect™ in Q4 2007. This announcement serves to provide
updated information to the market following intense interest in the progress of
sales of Savene®/Totect™ from investors.
Sales of TopoTarget's first marketed product, Savene® and Totect™ are
progressing well. European sales figures show that European doctors and nurses
are increasingly adopting the product to have in stock and ready for use, in
case a cancer patient experiences an anthracycline extravasation. In the US,
sales are growing following a successful product launch of Totect™ in October
last year.
Total sales of Savene®/Totect™ in 2007 were DKK 21.9 million (approx. EUR 2.9
million). Total number of kits sold is 325.
In Europe Savene® sales for 2007 totalled DKK 19.3 million (approx. EUR 2.6
million). This compared to total European sales during 2006 of DKK 2 million
(approx. EUR 0.3 million). In Europe sales grew 39% in Q4 compared to Q3, and
year on year sales in Europe grew 220% in Q4 2007 compared to Q4 2006. Number
of kits sold in the EU in 2007 is 290.
Totect™ was launched during the fourth quarter of 2007 and US sales totalled
DKK 2.6 million (approx. EUR 0.3 million). Number of kits sold in the US in
2007 is 35.
Additionally, as part of TopoTarget's strategy to find high quality
distribution partners for certain European markets, the company has signed an
agreement with Adienne Pharma for the distribution of Savene® in Italy.
“We are pleased that the experience and efforts of our European sales team are
translating, into positive sales figures and that the trend matches our
expectations,” said Dr. Peter Buhl Jensen, Chief Executive Officer of
TopoTarget “It is also very encouraging that in a few European countries, where
Savene® has been known for the longest period of time, we are already selling
above expected market penetration levels.“
TopoTarget estimates a combined US and European market for Savene®/Totect™ of
EUR 40-50 million annually.
Savene®/Totect™ is the only approved and evidence-based treatment for the
treatment of anthracycline extravasation (i.e. the accidental leaking of
chemotherapeutics into healthy tissue). Savene® is now the “gold standard” in
Europe and the recommended treatment for anthracycline extravasation in
guidelines from the European Oncology Nursing Society (EONS). Totect™ has
already gathered strong support from key opinion leaders in the US and initial
sales are progressing positively. Out of a strong field of applicants the
company has employed a specialist sales team of ten highly experienced people
and has an agreement with AmeriSource Bergen for distribution in the US.
TopoTarget launched Savene® in Europe in October 2006 and Totect™ in the US in
October 2007. Savene® is sold at a price of EUR 9.750. The price of Totect™ in
the US is USD 14.750.
In 2007 TopoTarget generated total sales of DKK 21.9 million. In Europe Savene®
sold for DKK 19.3 million (approx. EUR 2.6 million) during 2007 as shown in the
table below. Q1: DKK 3.7 million (approx. EUR 0.5 million), Q2: DKK 4.6 million
(approx. EUR 0.6 million), Q3: DKK 4.6 million (approx. EUR 0.6 million) and
Q4: DKK 6.4 million (approx. EUR 0.9 million).
In the US Totect™ was launched during Q4 2007 and sales totalled DKK 2.6
million during this period.
TopoTarget A/S
For further information please contact:
Ulla Hald Buhl Telephone +45 39 17 83 92
Director IR & Communications Mobile +45 21 70 10 49
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 a biotech company, headquartered in Denmark and with
subsidiaries in the US, Switzerland, Germany and the UK, 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 nine 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™ were approved by EMEA in 2006 and the FDA in 2007 and 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.
