TopoTarget signs an agreement with potential value of USD 350 million with Spectrum Pharmaceuticals
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 TopoTarget signs an
agreement with potential value of USD 350 million with Spectrum Pharmaceuticals for the development and
commercialisation of Belinostat in North America and India Announcement No. 02-10, 2 February, 2010 Page 2 of 3
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.
For further information, please contact:
Peter Buhl Jensen
CEO
Telephone +45 39 17 94 99
Mobile +45 21 60 89 22
or visit: www.topotarget.com
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© 2009