Spectrum Pharmaceuticals (NasdaqGM:SPPI), a commercial-stage
biotechnology company with a primary focus in oncology, today announced
that it has entered into a co-development and commercialization
agreement with TopoTarget A/S for Belinostat, a novel histone
deacetylase (HDAC) inhibitor. Belinostat is currently in a
registrational trial, under a Special Protocol Assessment (SPA), as a
monotherapy for relapsed or refractory Peripheral T-Cell Lymphoma
(PTCL), an indication in which it has been granted Orphan Drug and Fast
Track designation by the U.S. Food and Drug Administration (FDA).
Belinostat is also under investigation in a randomized Phase 2 trial, as
a combination therapy with carboplatin and paclitaxel, for cancer of
unknown primary (CUP). Additionally, the NCI is currently conducting
several clinical trials of Belinostat in a variety of hematological and
solid tumors, both as monotherapy as well as combination therapy.
“We believe that this partnership will bring together synergies in our
combined capabilities that will result in significant efficiencies in
Belinostat’s development”
“The addition of Belinostat addresses our key strategic goal of
in-licensing a late-stage anti-cancer compound,” said Rajesh C.
Shrotriya, MD, Chairman, Chief Executive Officer, and President of
Spectrum Pharmaceuticals. “With this collaboration, we have now
completed our strategic initiatives relating to in-licensing of
compounds with near term commercialization opportunities. 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. With that goal in mind, we
currently expect to file the NDA in PTCL in 2011. TopoTarget has laid a
solid foundation from which we will further develop Belinostat.”
“So far, Belinostat has demonstrated some unique and differentiating
attributes. If approved, it would give Spectrum access to potentially
large markets while allowing for enhanced coordination with our marketed
drugs, ZEVALIN and FUSILEV,” added Amar Singh, Spectrum’s Chief
Commercial Officer. “The recent expansion of our commercial
infrastructure positions us to prepare for another successful launch in
the near future”.
“We believe that this partnership will bring together synergies in our
combined capabilities that will result in significant efficiencies in
Belinostat’s development,” said Professor Peter Buhl Jensen, MD, Chief
Executive Officer of TopoTarget A/S. “Spectrum as a partner is ideally
suited to exploit the full benefits of the drug for cancer patients.”
Under terms of the agreement, Spectrum licensed the rights to Belinostat
for North America and India, and an option for China, in exchange for an
upfront cash payment of $30 million, potential milestone payments of up
to $320 million, and one million shares of Spectrum common stock based
upon the successful achievement of certain development, regulatory and
commercial milestones, as well as double-digit royalties on net sales of
Belinostat. Spectrum and TopoTarget will jointly fund development
activities, whereby clinical trial costs will be 70% borne by Spectrum,
and 30% by TopoTarget for new trials to be initiated.