TopoTarget signs deal with potentional value of USD 350 mio. with Spectrum for dev. and commercialisation of Belinostat in North America and India
02-02-10 kl. 2/2 2010 11:11 | 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
-A telephone conference will be held today at 13:00 CET. Dial-in details:
+4570265040-
? Potential value of USD 350 million plus double digit royalties
? TopoTarget to receive USD 30 million cash upfront
? TopoTarget and Spectrum will jointly develop belinostat with Spectrum
contributing 70% of future development costs
? Spectrum territory includes North America, India and a first right of offer
for the Chinese market
? TopoTarget can use data to commercialise belinostat in Europe, Japan and rest
of the world
Copenhagen, Denmark & Irvine, California, US - 2 February, 2010 - TopoTarget
A/S (NASDAQ-OMX: TOPO.CO) and Spectrum Pharmaceuticals Inc. (NASDAQ: SPPI)
announced today an agreement to co-develop and commercialise belinostat,
TopoTarget's lead anticancer drug for cancer in North America and India.
Belinostat, an HDAC inhibitor, is in registrational clinical trial in
Peripheral T-Cell Lymphoma (PTCL) as monotherapy and in a randomized phase 2
clinical trial for cancer of unknown primary site (CUP) in combination with
carboplatinum and paclitaxel (BelCaP). Belinostat is currently being
investigated in 20 clinical trials in haematological and solid cancers in
monotherapy as well as in combination therapies.
"We are very happy to enter into collaboration with Spectrum - a highly
committed successful US biotech company specialised in development of oncology
and haematology products and expert marketeers" said MD, Professor Peter Buhl
Jensen, Chief Executive Officer of TopoTarget. "The partnership with Spectrum
significantly strengthens the global development of belinostat for the
treatment of multiple cancers as well as its successful commercialisation".
"The addition of belinostat addresses our key strategic goal of lincensing a
late-stage anti-cancer compound," said Rajesh C. Shrotriya, MD, Chairman, Chief
Executive Officer, and President of Spectrum Pharmaceuticals. "Belinostat's
current registrational program is comprehensive and focused in that it targets
key hematological indications such as PTCL and other solid tumor indications.
Belinostat has the potential to be a best-in-class HDAC inhibitor for both
hematological and solid tumors. We look forward to advancing belinostat in
PTCL and other solid tumor indications, with the goal of providing cancer
patients with more effective treatment options as quickly and efficiently as
possible."
Under the terms of the agreement, TopoTarget will receive an upfront payment of
USD 30 million in cash. The total potential value of up-front and milestones
(for both development and sales) of the agreement, in the event of full
commercial success could exceed USD 350. In addition, TopoTarget will receive a
double digit royalty on sales of belinostat as well as one million Spectrum
shares. Spectrum commits to fund 100% of the costs for the ongoing PTCL study;
TopoTarget will fund 100% of the ongoing CUP study. Spectrum and TopoTarget
will split the development costs in a 70 to 30 ratio for future development of
belinostat.
Under the agreement it is now expected that the BELIEF trial will be finalised
and NDA filed with the FDA in 2011 the previous timeline announced by
TopoTarget was December 2010. The CUP trial will be fully recruited in 2010 -
the previous timeline announced by TopoTarget was H1 2010. In addition other
randomised clinical trials in indications such as in lungcancer (NSCLC) are
expected to be initiated.
Taking into account the 70:30 cost sharing arrangement under the collaboration,
the sign on fee and existing cash resources excluding any other partnerships
TopoTarget will, as a result of entering into the Agreement with Spectrum, have
sufficient cash resources for at least two to three years. The agreement also
includes diligence provisions on development and commercialisation as well as
an option to co-promote under certain conditions.
Belinostat an HDACi is a novel way of treating cancer. Belinostat has been
developed to address the serious issue of drug resistance - in addition to
having its own cancer cell killing effect as monotherapy belinostat
resentizises the sensitivity to several anticancer agents including platins,
taxanes and topoisomerase II drugs where resistance has been developed.
Today's news does not change TopoTarget's 2009 full-year financial guidance.
The impact on 2010 will be included in TopoTarget's financial outlook for 2010
to be announced 25 March 2010.
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 2 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 1 clinical trial for patients with advanced solid tumors and lymphomas.
These NCI-sponsored clinical studies are being conducted under a Clinical
Trials Agreement with TopoTarget. 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.
About Spectrum Pharmaceuticals
Spectrum Pharmaceuticals is a commercial-stage biotechnology company with a
focus in oncology. The Company's strategy is comprised of acquiring and
developing a broad and diverse pipeline of late-stage clinical and commercial
products; establishing a commercial organization for its approved drugs;
continuing to build a team with people who have demonstrated skills, passion,
commitment and have a track record of success in its areas of focus; and,
leveraging the expertise of partners around the world to assist it in the
execution of its strategy. For more information, please visit the Company's
website at www.sppirx.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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announcement no 02-10 tt signs agreement with potential value of usd 350 mio with spectrum for development + commercialisation of belinostat in north america + india.pdf 



