ODAC (FDA's US Oncologic Drugs Advisory Committee) backs T cell lymphoma PTCL and CTCL compounds

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


Copenhagen, Denmark - September 4, 2009 - TopoTarget A/S (OMX: TOPO) commented
today on the FDA's Oncologic Drugs Advisory Committee (ODAC) Advisory Panel
10-4 vote which stated that pralatrexate would have a reasonable likelihood of
benefiting patients with relapsed or refractory peripheral T-cell lymphoma
(PTCL) and that this recommendation may lead to an approval for pralatrexate in
PTCL patients. Further more the ODAC committee recommended the approval of
romidepsin for the treatment of Cutaneous T-cell Lymphoma (CTCL) - if approved
by the FDA romidepsin will be the second HDACi drug on market which
substantiates the future of this novel drug class in anticancer treatment. 

We are pleased that the ODAC panel recognized the need for new therapeutics to
treat PTCL, a disease with a poor prognosis for which there is no specifically
approved drug and no accepted standard of care. Here as in other cancer
diseases, a single agent is not curative and the need for combination therapy
of active drugs was emphasized. Belinostat is active in PTCL and belinostat can
be safely combined with all tested modern chemotherapeutic drugs. Therefore
TopoTarget believes that belinostat offers this opportunity to PTCL patients. 

TopoTarget is enrolling PTCL patients in the pivotal BELIEF trial. The BELIEF
trial is designed under a Special Protocol Assessment (SPA) already in
agreement with the FDA, the US health authorities. This is an agreement on the
design of a pivotal trial. TopoTarget also has a Fast Track designation which
supports the Company's rapid market entry strategy. TopoTarget plans to file
for full approval in December 2010. Accordingly TopoTarget does not anticipate
that the September 24 FDA approval decision on pralatrexate will impact the
potential approval of belinostat based upon a successful BELIEF trial. 

About Advisory Committees

The Food and Drug Administration, to assist in its mission to protect and
promote the public health, uses 48 committees and panels to obtain independent
expert advice on scientific, technical, and policy matters. 

Today's news does not change TopoTarget's full-year financial guidance.



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 belinostat
Belinostat is a promising small molecule HDAC inhibitor being investigated for
its role in the treatment of a wide range of solid tumors and hematologic
malignancies either as a single-agent, or in combination with other active
anti-cancer agents, including carboplatin, paclitaxel, doxorubicin, idarubicin,
cis-retinoic acid, azacytidine and Velcade® (bortezomib) for injection. HDAC
inhibitors represent a new mechanistic class of anti-cancer therapeutics that
target HDAC enzymes, and have been shown to: arrest growth of cancer cells
(including drug resistant subtypes); induce apoptosis, (programmed cell death);
promote differentiation; inhibit angiogenesis; and sensitize cancer cells to
overcome drug resistance when used in combination with other anti-cancer
agents. Company-sponsored trials of IV-administered belinostat include a
pivotal trial in peripheral T-cell lymphoma (PTCL), a randomized controlled
Phase II trial in cancer of unknown primary (CUP), and studies in ovarian,
colorectal and soft tissue sarcoma patients. NCI-sponsored trials (single agent
and in combination with anti-cancer therapeutics) with IV-administered
belinostat include studies in hepatocellular, thymoma, Myelodysplastic Syndrome
(MDS), and other solid and hematologic cancers. Continuous intravenous
administration (CIV) is being evaluated in clinical trials in solid tumours as
well as in AML.  An oral formulation of belinostat is also being evaluated in a
Phase I clinical trial for patients with advanced solid tumors and lymphomas.
Furthermore TopoTarget has a Cooperative Research and Development Agreement
(CRADA) with the NCI to conduct preclinical and nonclinical studies on
belinostat in order to better understand its anti-tumor activity and to provide
supporting information for clinical trials. 

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. 

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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
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there can be no assurance that actual results or business conditions will not
differ materially from those projected or suggested in such forward-looking
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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.