TopoTarget announces the European divestiture of Savene® to SpePharm Holding, BV and reconfirms the focus to develop and commercialise Belinostat
02-03-10 kl. 2/3 2010 12:59 | TopoTarget 0,00 (0,00%)
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 - 2 March, 2010 - TopoTarget A/S (NASDAQ OMX: TOPO)
announced today that SpePharm Holding, BV acquired the rights to Savene® for 6
million Euros. The acquisition includes all the Savene® European assets and the
transition of the TopoTarget sales team in Europe to SpePharm. Totect®, the US
trademark for the same product, will remain with TopoTarget and continue to be
promoted by the TopoTarget US sales team.
The divestiture of Savene® in Europe and the rest of the world outside of North
and South America reflects the continued focus of TopoTarget on the clinical
development and commercialisation of Belinostat. The divestiture funds (5
million Euros plus the value of stock payable on settlement plus a double digit
royalty on net sales capped at EU 1 million), will be used to fuel the growth
of the Belinostat clinical development program for the anticipated filing and
approval in the US for PTCL and to continue the development of selected high
potential indications. The partnering with Spectrum in the US has increased
TopoTarget's development and marketing resources and provides TopoTarget with a
strong partner to launch Belinostat.
"Belinostat, the main product of the Company, is a pipeline within a molecule
with blockbuster potential on which in February we signed a deal with Spectrum
Pharmaceuticals with a potential value of USD 350 million deal plus royalties.
Based on our core strategy and commitment to our shareholders to focus on the
development and commercialisation of Belinostat for the treatment of cancer
patients we have made the decision to divest the European marketing and sales
of Savene" said Francois Martelet, MD, CEO of TopoTarget.
"We believe that SpePharm will continue the successful sales of Savene® as we
integrate this medically important orphan drug product for the treatment of
patients with anthracycline extravasations, developed and launched by the
Topotarget team, into our portfolio.", said Jean-François Labbé, Managing
Director and CEO of SpePharm.
Today's news does not change TopoTarget's 2009 full-year financial guidance.
TopoTarget A/S
For further information, please contact:
Francois Martelet Telephone +45 39 17 94 99
CEO
Background information
About Savene®/Totect®
Savene®/Totect® 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 anticancer chemotherapeutics called anthracyclines.
Savene®/Totect® blocks the activity of the topoisomerase enzyme and prevents
the effect of anthracyclines. Contraindications: None known Warnings: Pregnancy
Category D Precautions: Totect is a cytotoxic drug. When administered to
patients receiving anthracycline containing cytotoxic therapy, additive
cytotoxicity may occur. Treatment with Totect is associated with leukopenia,
neutropenia, and thrombocytopenia. Hematological monitoring should be
performed. Reversible elevations of liver enzymes may occur with dexrazoxane.
Patients with Moderate or Severe Renal Insufficiency: Greater exposure to
dexrazoxane may in occur in patients with compromised renal function. The
Totect dose should be reduced by 50% in patients with creatinine clearance
values <40mL/min. Dimethylsulfoxide (DMSO) should not be used in patients who
are receiving dexrazoxane to treat anthracycline-induced extravasation.
Laboratory Tests: Blood counts and liver enzymes should be monitored. Adverse
Reactions: Dexrazoxane has been studied previously as a cytotoxic agent.
Adverse reactions of nausea/vomiting, diarrhea, stomatitis, bone marrow
suppression (neutropenia, thrombocytopenia), altered liver function (increased
AST/ALT), and infusion site burning have been observed. These adverse reactions
have been reversible. Savene®/Totect® 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. The use of dexrazoxane (the
active ingredient in Savene®/Totect®) to treat anthracycline extravasation is
protected by patent in several countries including EU and the US. The US patent
number is 6,727,253 B2.
About SpePharm Holding, BV
SpePharm Holding, B.V., a Dutch company with its registered office in
Amsterdam, is a pan-European specialty pharmaceutical company focused on
acquiring, registering and marketing high medical value specialty medicines
essentially for the hospital market. Particular areas of therapeutic interest
are oncology, critical and supportive care. SpePharm was founded in September
2006 by Jean-François Labbé together with leading life science investment firms
TVM Capital and Signet Healthcare Partners (part of the Sanders Morris Harris
Group). Paul Capital Healthcare, one of the largest dedicated healthcare
investors globally, made an equity investment in SpePharm in August 2008, and
provided additional non-dilutive financing for SpePharm. Jean-François Labbé is
a former top executive of Hoechst Marion Roussel and Parke Davis with over 30
years of experience in international pharmaceutical management. SpePharm
completed two pan-European license/distribution agreements in 2007 and 2008 for
respectively MuGard® and Xerotin® and also acquired in 2008 the full rights for
Europe and other territories worldwide to dantrolene sodium (Dantrium® /
Dantrolen® /Dantamacrin®) from Procter & Gamble Pharmaceuticals. To date
SpePharm has an established commercial presence in the UK, Germany and Italy.
For further information on SpePharm see www.spepharm.com
About TopoTarget
TopoTarget (NASDAQ OMX: TOPO) is an international biotech company headquartered
in Denmark, dedicated to finding ''Answers for Cancer'' and developing improved
cancer therapies. TopoTarget currently focuses, in collaboration with Spectrum
Pharmaceuticals, Inc., on the development in pivotal studies of its lead drug
candidate, Belinostat, which has shown proof of concept as monotherapy in
treating haematological malignancies and positive results in solid tumours.
Belinostat can be used in combination with full doses of chemotherapy, and is
in a pivotal trial within PTCL (peripheral T-cell lymphoma). TopoTarget's
expertise in translational research is based on utilising 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.
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.
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