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. 17-07 / Copenhagen, 30 May 2007
TopoTarget has received an approvable letter for Totect
Copenhagen, Denmark - 30 May 2007 - TopoTarget A/S (Copenhagen Stock Exchange:
TOPO) announces that the US Food and Drug Administration (FDA) has issued an
approvable letter for Totect™ for the treatment of anthracycline extravasation.
The FDA has informed TopoTarget that a technical issue remains to be resolved
with respect to the approval, and thus TopoTarget has received an “approvable”
reply instead of the expected “approved”. In general, the FDA sends an
approvable letter if the application substantially meets the requirements and
if the agency believes that it can approve the application when additional
satisfactory information has been submitted and reviewed by the FDA.
A Totect™ treatment kit consists of the active compound and a liquid solvent in
which the compound is to be dissolved. TopoTarget's application had included
two alternative solvents from two different subsuppliers. One of the
subsuppliers will need to forward supporting documentation to the FDA to
comply with the FDA's requirements. “We are happy that we are closer to an
approval, and that we have succeeded in resolving a number of technical issues,
but it is frustrating that this technical complication arose in the eleventh
hour. I am confident that we will receive the approval, but a delay is
unavoidable. Nevertheless, we continue to believe that we will be able to
launch Totect™ for the US market in the second half of 2007,” says Peter Buhl
Jensen, CEO of TopoTarget.
PLEASE NOTE THAT THE FOLLOWING PARAGRAPH HAS BEEN CORRECTED
The required further documentation will be submitted by TopoTarget's
subsupplier/TopoTarget with the aim of ensuring that both solvents comply with
the FDA's requirements. The alternative subsupplier intends to submit the
documentation to the FDA on June 7. TopoTarget is confident that this is
sufficient but should there be unclarified questions, the company can choose to
reduce the FDA application to only include one subsupplier.
Totect™, the US brand used for Savene™, which was launched in the major
European markets in October 2006, is used as a therapy when the
chemotherapeutic agent anthracycline accidentally leaks into the surrounding
healthy tissue.
Savene™ is the only approved treatment of the serious tissue damage that may
result from accidents with chemotherapy. Despite the utmost caution being taken
when anthracyclines are used in chemotherapy, accidents occur in up to 1% of
all treatments. This may damage a patient's tissue and cause painful scarring,
leading to severe injury and malformations. In addition, it may lead to a
postponement of the chemotherapy.
Savene™/Totect™ has obtained Orphan Drug status in Europe and the United
States, providing marketing exclusivity for periods of ten and seven years,
respectively.
TopoTarget still expects to be able to launch Totect in the US during second
half of 2007 and consequently does not expect to change the outlook for the
2007 financial result.
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
About Totect™ (Savene™)
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. 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.
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 includ-ing the timing for commencement and completion of clinical
trials and with respect to cash burn guidance. Such statements are based on
management's current expecta-tions 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 technolo-gies; technological uncertainty and product development
risks; uncertainty of addi-tional 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.
