TopoTarget Provides Update on Savicol™ Pivotal Phase II Study for the Treatment of FAP and Results from Two Pharmacokinetic (PK) Studies

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
TopoTarget Provides Update on Savicol™ Pivotal Phase II Study for the Treatment
of FAP and Results from Two Pharmacokinetic (PK) Studies 

Patient enrolment progressing 
Pharmacokinetic (PK) studies show treatment safe and well-tolerated


Copenhagen, Denmark - December 19, 2007 - TopoTarget A/S (OMX:  TOPO) today
announced an update on the status of the Savicol™ pivotal Phase II study for
the treatment of FAP, Familial Adenomatous Polyposis (an inherited
pre-disposition to develop colon cancer where standard treatment is removal of
the colon). Forty six patients out of a planned 66 patients have now been
enrolled and 26 patients have completed the first 6 months treatment. Thirteen
patients have completed the optional 6-months extension phase. 
The study is a blinded, randomized, placebo-controlled multi-center study
carried out in Germany, Denmark and Russia with two study arms, one where
patients receive Savicol™ - a novel, proprietary formulation of the
HDAC-inhibitor (HDACi) valproic acid (VPA) - and the other group receiving
placebo. After 6 months of treatment in one of these groups, the patients may
enter into an extension treatment period of another 6 months using active drug
treatment only. 
Recruitment is ongoing, with so far 46 out of a planned 66 patients included.
Of this group, 26 have completed the first 6 months of treatment. The efficacy
evaluation at the end of the initial 6-month treatment period includes an
endoscopic examination of the colon, assessment of polyp numbers and the
clinical appearance of the colon, and the analysis of biopsy material collected
for specific pathological investigations, including the analysis of colorectal
biomarkers. 

Pharmacokinetics (PK) characteristics of the new and proprietary formulation of
Savicol™ show the treatment to be safe and well-tolerated 

Two clinical PK studies with 36 healthy volunteers have been completed. The
absolute bioavailability of oral Savicol™ after fasting and with concomitant
food intake in comparison to an intravenously applied comparator was close to
100 %. Furthermore, serum level values of Savicol™ were recorded to follow a
dose proportional pattern at the investigated doses. In addition, a linear
pharmacokinetics for the examined dose range was observed. The single and
multiple doses of Savicol™ applied were in general well-tolerated. 

”We hope that Savicol™ could provide a much needed treatment for this serious
condition” said Dr. Peter Buhl Jensen, CEO of TopoTarget. “The PK studies show
that TopoTarget's formulation is safe and well-tolerated by patients.” 

Following the recent grant of US patent rights, protecting the use of Savicol™
for use in treating a range of cancer indications, TopoTarget is also currently
considering the possibility of expanding the development of Savicol™ into
selected cancer indications. 


Today's news does not change TopoTarget's full-year 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

Ulla Hald Buhl 	Telephone	+45 39 17 83 92
Director IR & Communications	Mobile	+45 21 70 10 49




Background information

About Savicol™
Savicol™ (formerly referred to as PEAC®) is based on a novel and proprietary,
orally available formulation of valproic acid (VPA). VPA is a molecule which
acts as an HDAC inhibitor, preferentially for HDAC class I isoenzymes, which
are involved in excessive cell proliferation and tumourigenesis. Furthermore,
the Savicol™ formulation allows a specific pharmacokinetic release pattern of
valproic acid expected to effectively inhibit these target enzymes. The HDAC
inhibitory effect of VPA has already been demonstrated in Phase I trials on the
basis of biomarker monitoring of histone acetylation. 
Savicol™ was granted Orphan Drug status for the FAP indication in Europe in
2004 and in the US in 2005. 
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.