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
To the OMX
Announcement No. 36-07 / Copenhagen, 16 October 2007
TopoTarget launches Totect™ in the US
- Only FDA-Approved Treatment for Anthracycline Extravasation -
Copenhagen, Denmark - 16 October 2007 - TopoTarget A/S (OMX: TOPO) - has
announced that TopoTarget USA, Inc., the US subsidiary of TopoTarget A/S , has
made Totect™ available to cancer facilities throughout the US. Totect™ is the
only FDA-approved treatment for extravasation from intravenous anthracycline
chemotherapy, the accidental leakage of chemotherapy drugs into surrounding
tissue. The company received approval from the US Food and Drug Administration
on 6 September 2007.
“While the number of patients who may be victims of this terrible accident may
be low, the cost to these patients and their families, the facilities and the
health care system overall can be astronomical,” said John L. Parsons,
president of TopoTarget USA, Inc. “It is sometimes difficult to prevent an
extravasation from occurring, but oncology nurses and physicians now have a way
to halt and reverse the devastating effects,” continued Parsons
More than 500,000 intravenous anthracycline chemotherapy treatments are
administered in the US each year.
According to Parsons, an estimated 3,600 oncology departments and centers could
benefit from having a Totect™ kit available in the event of an anthracycline
extravasation. TopoTarget USA, Inc. has recruited a sales force of 10 oncology
specialists. The company also distributes the treatment in Europe under the
name Savene™.
Extravasation occurs when intravenously administered chemotherapy drugs
accidentally leak out into surrounding tissue. This can occur if a patient is
receiving anthracycline chemotherapy intravenously or through a surgically
placed port. Extravasation with anthracyclines can lead to severe and
cumulative tissue necrosis including serious damage of the surrounding skin,
subcutaneous tissue, muscles and nerves. Currently, most patients who have
suffered from an anthracycline extravasation need surgery to remove the damaged
tissue and further plastic surgery. In addition, a patient cannot continue
with chemotherapy until the damaged area heals.
In the event of an anthracycline extravasation, early detection and rapid
treatment can prevent healthy tissue damage - within six hours of the
occurrence. In TopoTarget's clinical trials, only one of the 57 evaluable
patients required surgery, while 13 had late sequelae at the event, including
pain, fibrosis, atrophy and local sensory disturbance, which did not require
surgery and could continue with chemotherapy soon after treatment.
For further information on Totect™ visit www.totect.com.
The launch of Totect™ 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
CONTACT IN THE US:
Maria Gordon Shydlo or Deanna Decker
Padilla Speer Beardsley Telephone +1 (212) 752-8338
Background information
About TopoTarget
TopoTarget (OMX: TOPO) is a biotech company, headquartered in Denmark and with
subsidiaries in 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™ was 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.
