Bristol-Myers Squibb Enters into Agreement that Provides an Exclusive Option to Acquire F-star Alpha Ltd. & its Novel HER2-Ta...
October 28 2014 - 7:00AM
Business Wire
Bristol-Myers Squibb Company (NYSE:BMY) and F-star Alpha Ltd.
today announced that the companies, together with the F-star Alpha
Ltd. shareholders, have entered into an agreement that provides
Bristol-Myers Squibb the exclusive option to acquire F-star Alpha
Ltd, and gain worldwide rights to its lead asset FS102. FS102 is a
novel Phase 1 ready Human Epidermal growth factor
Receptor 2 (HER2)-targeted therapy in development for
the treatment of breast and gastric cancer among a well-defined
population of HER2-positive patients who do not respond or become
resistant to current therapies.
“This agreement is consistent with our R&D strategy to
develop promising treatments that address areas of high unmet
medical need, and provides the opportunity to complement our
oncology portfolio with a novel targeted therapy,” said Francis
Cuss, MB BChir, FRCP, executive vice president and chief scientific
officer, Bristol-Myers Squibb. “We look forward to working with
F-star and leveraging our broad clinical expertise in oncology to
uncover the full potential of FS102.”
“We are thrilled that a company with the oncology experience and
expertise of Bristol-Myers Squibb will be advancing our first
clinical asset with the potential to provide a significant
improvement over the current standard of care for a defined group
of patients with HER2-positive cancer,” said John Haurum, M.D.,
D.Phil., chief executive officer at F-star Biotechnology Ltd. “In
addition to the important improvement of cancer therapy FS102 may
provide to patients, this program also provides validation of the
Modular Antibody Technology platform as a powerful engine to
discover and rapidly develop novel targeted biologics.”
HER2 is a highly validated target in breast and gastric cancers,
and plays a significant role in the growth of tumors and subsequent
poor clinical outcome for patients with breast cancer and other
solid tumors. Therapies that target HER2 have shown success in
improving patient outcomes; however, a high proportion of
HER2-positive patients do not respond to currently available
treatments, and those who do may eventually develop resistance.
FS102 is a HER2 targeted Fcab™ that has the potential to
eliminate cancer cells through a novel mechanism of action in a
biomarker-defined patient population. FS102 works differently than
current HER2-targeted therapies, with the potential to overcome
resistance that has developed against other HER2-targeted drugs. It
binds to a unique site on HER2 and then induces programmed cell
death in HER2-positive tumour cells. In preclinical studies, FS102
has demonstrated encouraging efficacy against certain HER2-positive
cancers and major regression in tumors, including those that are
refractory to treatment with trastuzumab plus pertuzumab.
Under the terms of the agreement, Bristol-Myers Squibb will make
payments aggregating to $50 million that consist of an option fee
for the right to acquire F-star Alpha Ltd., payment for certain
rights and licenses from F-star Alpha Ltd. and a clinical milestone
payment upon initiation of the Phase 1 trial. Bristol-Myers Squibb
will be responsible for conducting and funding development of FS102
during the option period. Bristol-Myers Squibb can exercise the
option to acquire F-star Alpha Ltd. in its sole discretion upon its
decision to commence a Phase 2b trial. Total aggregate
consideration may reach $475 million, which includes the payments
aggregating to $50 million, the option exercise fee, and milestone
payments upon the commencement of a Phase 3 clinical trial and
regulatory approvals in the U.S. and Europe.
About F-star
F-star GmbH and its wholly-owned subsidiary F-star Biotechnology
Ltd. (F-star) is a biopharmaceutical company dedicated to
developing novel bispecific antibody products that provide a
significant improvement over the current standard of care. In 2013,
F-star established an asset-centric vehicle structure through the
formation of F-star Alpha Ltd., which included out-licensing of
FS102 from F-star to F-star Alpha Ltd.
Given its strong patent position, F-star is the only
biopharmaceutical company with the ability to create and develop
Fcabs and bispecific antibodies by modifying the constant region of
an antibody. In particular, F-star’s Modular Antibody Technology
enables rapid discovery and development of bispecific antibodies by
engineering additional binding sites into the constant region of an
antibody. This technology offers unprecedented speed and ease in
the development and manufacturing of genuine bispecific antibody
products. Using the Modular Antibody Technology, F-star generates
bispecific antibodies (mAb2) that possess the favourable
characteristics of traditional monoclonal antibodies, without the
production challenges often associated with other antibody formats.
F-star is now applying its proprietary technology to the
development of a pipeline of product candidates. For more
information visit www.f-star.com.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose
mission is to discover, develop and deliver innovative medicines
that help patients prevail over serious diseases. For more
information, please visit www.bms.com or follow us on Twitter at
http://twitter.com/bmsnews.
Bristol-Myers Squibb Forward-Looking Statement
This press release contains “forward-looking statements” as that
term is defined in the Private Securities Litigation Reform Act of
1995 regarding the research, development and commercialization of
pharmaceutical products. Such forward-looking statements are based
on current expectations and involve inherent risks and
uncertainties, including factors that could delay, divert or change
any of them, and could cause actual outcomes and results to differ
materially from current expectations. No forward-looking statement
can be guaranteed. Among other risks, there can be no guarantee
that the investigational compounds discussed in this release will
be successfully developed or approved for any of the indications
described in this release or that we will exercise our option to
acquire F-star. Forward-looking statements in this press release
should be evaluated together with the many uncertainties that
affect Bristol-Myers Squibb's business, particularly those
identified in the cautionary factors discussion in Bristol-Myers
Squibb's Annual Report on Form 10-K for the year ended December 31,
2013, in our Quarterly Reports on Form 10-Q and our Current Reports
on Form 8-K. Bristol-Myers Squibb undertakes no obligation to
publicly update any forward-looking statement, whether as a result
of new information, future events or otherwise.
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Bristol-Myers SquibbMedia:Ken Dominski,
609-252-5251ken.dominski@bms.comLaura Hortas,
609-252-4587laura.hortas@bms.comorInvestors:Ranya Dajani,
609-252-5330ranya.dajani@bms.comRyan Asay,
609-252-5020ryan.asay@bms.comorF-starJohn Haurum, + 44 7881
244 040Chief Executive Officerjohn.haurum@f-star.comJane Dancer, +
44 7739 174 297Chief Business
Officerjane.dancer@f-star.comorMedia:Suda Communications LLCMaureen L. Suda, +1
585-387-9248
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