TopoTarget announces next Phase II clinical placebo controlled trial with Avugane™ in acne vulgaris

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


To the Copenhagen Stock Exchange
Announcement No. 13-07 / Copenhagen, 24 April 2007 


TopoTarget announces next Phase II clinical placebo controlled trial with
Avugane™ in acne vulgaris 


Copenhagen, Denmark - 24 April 2007 - TopoTarget A/S (CSE: TOPO) announced
today that a Phase II clinical trial has been initiated, testing Avugane™, a
topical valproic acid - an HDAC inhibitor drug - in the treatment of acne
vulgaris. This double-blind, randomised Phase II study comprises four trial
arms, testing three different dose strengths of Avugane™ compared to a placebo
control group.  The trial follows the positive results with Avugane™ as
previously announced. 

This new Phase II study will investigate the efficacy and safety in a
four-armed trial with three different dose strengths of topically applied
Avugane™ in the treatment of mild to moderate acne vulgaris in comparison with
a placebo controlled study arm. Patients in this study will be treated over 12
weeks, and the clinical end points include the evaluation of therapeutic
efficacy based on counts of facial acne lesions as well as safety and
tolerability measurements. 

Prof. Dr. Hans Christian Wulf, the coordinating investigator of this new Phase
II trial at Bispebjerg Hospital, Copenhagen, commented: 
“Avugane™ comprises a novel mechanism-of-action in the treatment of acne
vulgaris. The results obtained in the completed Phase II study show that
Avugane™ may represent a new and interesting therapeutic option for patients
who do not respond effectively to current standard medications. It will be very
interesting to define the optimal dose strengths which may subsequently be used
in advanced clinical development.” 

In a previous Phase II clinical trial, topical monotherapy with Avugane™ and
treatment with the marketed standard product, isotretinoin, a vitamin A
analogue, resulted in a comparable reduction in total counts of facial acne
lesions. However, Avugane™ showed indications of an accelerated clinical
response, and induced a reduction of inflammatory as well as non-inflammatory
types of acne lesions. Furthermore, Avugane™ was predominantly assessed by the
patients to be “well” tolerated, indicating a better local tolerability of
Avugane™ compared with isotretinoin. 

  
“We will continue the promising development of Avugane™ to further validate its
therapeutic efficacy, while in parallel seeking an out-licencing partner with
expertise in the field of dermatology.  Avugane™ targets acne vulgaris which
represents a significant unmet medical need and we are very encouraged by the
therapeutic results obtained in our previous trial. Accordingly, we look
forward to investigating the further potential of the drug”, said Peter Buhl
Jensen, CEO of TopoTarget. 

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

Tim Corcoran			Telephone	 +44 1235 443 713
Chief Operating Officer		Mobile	 +44 787 656 1027


Background information

About Acne Vulgaris
Acne vulgaris is the most common inflammatory skin disorder among adolescents. 
Approximately 80% of all adolescents show signs of acne in various degrees and
15% of adolescents suffer from acne so severely that they need clinical
treatment.  The more severe forms of acne typically have a significant effect
on patients' physical and psychological well-being.  Furthermore, many patients
fail to respond adequately to available treatments or suffer from adverse
effects associated with such treatments.  The global sales of topical therapies
for acne are estimated at USD 1.65 billion in 2005  and are expected to grow to
annual sales of USD 1.83 billion in 2008 (Source: Fox Analytics; Business
Insight, The Dermatology Market Outlook to 2011). Traditional treatments for
mild to moderate facial inflammatory acne include over-the-counter topical
medications for mild cases, and prescription topical medications or oral
antibiotics for mild to moderate cases.  For more severe forms of acne, oral
treatment with the retinoid product isotretinoin is used. 

About  Avugane™ 
Avugane™ comprises a novel and proprietary gel-based formulation of the
moderate strength HDAC inhibitor, valproic acid, for topical therapy of
inflammatory skin diseases including indications such as acne vulgaris,
psoriasis and atopic dermatitis. The pathogenesis of acne vulgaris is
multifactorial, being influenced by hormonal, microbiological, and
immunological factors as well as proliferative cellular mechanisms which are
targeted specifically by the HDAC inhibitory activity of Avugane™. Avugane™ is
a repurpose of the marketed drug, valproic acid, used in the treatment of
epilepsy. This means that a large part of the work involved in demonstrating
the safety of the drug has already been performed. 

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 regula-tors (mainly HDAC, mTOR, and topoisomerase
II inhibitors) and a strong development foundation has been built. TopoTarget
has a broad portfolio of small molecule preclini-cal 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 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
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
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.