TopoTarget A/S
Symbion
Fruebjergvej 3
DK 2100 Copenhagen
DenmarkTel: +45 39 17 83 92
Fax: +45 39 17 94 92
CVR-nr: 25695771
www.topotarget.com
To the Copenhagen Stockexchange
Announcement no. 02-07 / Copenhagen, 21 Feburary 2007
SAVENE™ IS SELLING
Copenhagen, 21 February 2007 - TopoTarget A/S (CSE: TOPO) announces status of
the Savene™ sales in Europe. For 2006, the company forecasts a cash burn of DKK
162 million compared to the previous forecast of DKK 140-160 million.
The sales of TopoTarget's first product, Savene™, are doing well. Sales figures
for the first months in the European market show that doctors and nurses have
adopted Savene™.
“Already in January and February our sales have been sufficient to pay the
salary of the sales people”, says Peter Buhl Jensen, CEO of TopoTarget.
TopoTarget's expectations to the market size are as previously indicated, i.e.
approximately EUR 40-50 millions per year.
Savene™ is a targeted drug used for the prevention of severe tissue damage
caused by anthracycline extravasation (i.e. the accidental leaking of
chemotherapeutics into healthy tissue). Savene™ is now the “gold standard” and
the only approved and evidence-based medical treatment of this type of accident.
TopoTarget launched Savene™ in Europe in October 2006. Since the launch, the
Savene™ has been sold in 12 European countries, all at a price of EUR 9,750.
Sales totalled DKK 2.0 million in 2006, and in 2007 TopoTarget has generated
sales of DKK 1.8 million.
”We are optimistic with regard to the future sales”, says Peter Buhl Jensen.
”The 98% success rate in our trials has resulted in very positive responses from
doctors and nurses to our specialist sales force”
Peter Buhl Jensen explains that treatment guidelines vary from one hospital to
the next and from country to country because a number of in-effective treatments
have become common “in order to at least do something”. All these current
treatments are cases of malpractice, and we now face the task of ensuring that
patients avoid this accident in the future.
Education is achieved through scientific papers, scientific meetings and
international guidelines, aiming to ensure that Savene™ becomes known as the
only evidence-based medical treatment and, by extension, is recognised as being
good medical practice.
”Our sales staff is focused on changes to national and local guidelines, and
once these guidelines have been revised, Savene™ sales are expected to rise”,
says Peter Buhl Jensen.
Price and reimbursement negotiations in some countries are cumbersome and
involve long processing times. However, TopoTarget was pleased to learn that our
specialist sales force has been met with very positive reactions to Savene™ at
the hospitals where we have marketed the product. In addition, the market
response indicates a continuing clear medical need for Savene™ in all markets.
The process involved in obtaining the expected marketing authorisation for
Totect™ (the brand used for Savene™ in the USA) is proceeding according to plan.
A marketing application was filed with the FDA on 31 January 2006, and on 12
April 2006, the FDA granted priority review status to the product. On 2 August
2006, TopoTarget received an approvable letter from the FDA. The FDA asked
TopoTarget to clarify certain specific production issues before they give their
final approval. TopoTarget responded in November 2006 and expects to receive
approval for Totect™ at the end of May 2007.
Because of higher marketing costs in both Europe and the USA and additional
costs for the product development of belinostat (PXD101), TopoTarget now
projects a pre-tax loss for 2006 of approximately DKK 179 million and a cash
burn of about DKK 162 million.
This guidance should be compared with our most recently provided guidance in
connection with TopoTarget's interim report for the nine months ended 30
September 2006, when our full-year guidance was for a pre-tax loss of DKK
150-170 million and a cash burn of DKK 140-160 million.
A more specific update on Savene™, Totect™ and the company's guidance for 2007
will be announced on 14 March 2007 in connection with the publication of
TopoTarget's annual report for 2006.
TopoTarget A/S
For further information please contact:
Dr. Peter Buhl Jensen Phone +45 39 17 83 41
Chief Executive Officer Mobile +45 21 60 89 22
Leif Hamø Phone +45 39 17 83 45
Chief Financial Officer Mobile +45 40 43 40 83
About Savene™
Savene™ 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.
Savene™ 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™ blocks the activity of the topoisomerase enzyme and
prevents the effect of anthracyclines.
In the USA the drug will be marketed under the brand name Totect™.
About TopoTarget
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 Hwww.topotarget.com.H
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
