Bristol-Myers Squibb is Committed to Enhancing Patient Care
Through Delivery of Cancer Treatments by Subcutaneous
Injection
Halozyme to Receive $105 Million Upfront Payment, Plus Future
Milestones and Royalties
Provides Bristol-Myers Squibb Access to ENHANZE
technology for up to 11 Targets
Bristol-Myers Squibb Company (NYSE:BMY) and Halozyme
Therapeutics, Inc. (NASDAQ:HALO) today announced a global
collaboration and license agreement to develop subcutaneously
administered Bristol-Myers Squibb immuno-oncology medicines using
Halozyme’s ENHANZE® drug-delivery technology.
“We are excited to partner with Halozyme to pursue potential new
approaches to how our medicines are delivered to patients,” said
Murdo Gordon, chief commercial officer, Bristol-Myers Squibb.
“Through our work with Halozyme, we hope to improve the patient
treatment experience by developing flexible and convenient
treatment delivery options.”
The Halozyme ENHANZE technology is based on a proprietary
recombinant human hyaluronidase enzyme (rHuPH20) that temporarily
degrades hyaluronan -- a glycosaminoglycan or chain of natural
sugars in the body -- to aid in the dispersion and absorption of
other injected therapeutic drugs. This technology may allow for
more rapid delivery of large volume injectable medications, such as
medications that are currently delivered intravenously, through
subcutaneous delivery.
“Bristol-Myers Squibb has one of the industry’s most advanced
and extensive immuno-oncology portfolios with a clear commitment to
patient-centered innovation,” said Dr. Helen Torley, president and
chief executive officer of Halozyme. “Through this collaboration we
are excited to explore the potential for ENHANZE to expand the
number of cancer patients who may receive their therapies as a
rapidly administered subcutaneous injection.”
Under the terms of the agreement, Halozyme will receive an
initial $105 million for access to the ENHANZE technology.
Bristol-Myers Squibb has designated multiple immuno-oncology
targets including programmed death 1 (PD-1) and has an option to
select additional targets within five years from the effective
date. The collaboration may extend to a maximum of 11 targets.
Halozyme has the potential to earn milestone payments of up to $160
million for each of the nominated collaboration targets and
additional milestone payments for combination products, subject to
achievement of specified development, regulatory and sales-based
milestones. In addition, Bristol-Myers Squibb will pay Halozyme
royalties on sales of products using the ENHANZE technology
developed under the collaboration.
The agreement is subject to customary anti-trust clearance by
the U.S. Justice Department and Federal Trade Commission pursuant
to the Hart-Scott-Rodino Act.
For Bristol-Myers Squibb, the transaction is expected to be
dilutive to Non-GAAP earnings per share (EPS) in 2017 and 2018 by
approximately $0.01, and by approximately $0.05 in 2019.
About ENHANZE® Technology
Halozyme’s proprietary ENHANZE® drug-delivery technology
is based on its patented recombinant human hyaluronidase enzyme
(rHuPH20). rHuPH20 has been shown to remove traditional limitations
on the volume of biologics that can be delivered subcutaneously
(just under the skin). By using rHuPH20, some biologics and
compounds that are administered intravenously may instead be
delivered subcutaneously. ENHANZE may also benefit subcutaneous
biologics by reducing the need for multiple injections. This
delivery has been shown in studies to reduce health care
practitioner time required for administration and shorten time for
drug administration.
About Bristol-Myers Squibb & Immuno-Oncology
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 about Bristol-Myers Squibb, visit us
at BMS.com or follow us
on LinkedIn, Twitter, YouTube and Facebook.
At Bristol-Myers Squibb, patients are at the center of
everything we do. Our vision for the future of cancer care is
focused on researching and developing transformational
Immuno-Oncology (I-O) medicines for hard-to-treat cancers that
could potentially improve outcomes for these patients.
We are leading the scientific understanding of I-O through our
extensive portfolio of investigational compounds and approved
agents. Our differentiated clinical development program is studying
broad patient populations across more than 50 types of cancers with
14 clinical-stage molecules designed to target different immune
system pathways. Our deep expertise and innovative clinical trial
designs position us to advance the I-O/I-O, I-O/chemotherapy,
I-O/targeted therapies and I-O radiation therapies across multiple
tumors and potentially deliver the next wave of therapies with a
sense of urgency. We also continue to pioneer research that will
help facilitate a deeper understanding of the role of immune
biomarkers and how a patient’s tumor biology can be used as a guide
for treatment decisions throughout their journey.
We understand making the promise of I-O a reality for the many
patients who may benefit from these therapies requires not only
innovation on our part but also close collaboration with leading
experts in the field. Our partnerships with academia, government,
advocacy and biotech companies support our collective goal of
providing new treatment options to advance the standards of
clinical practice.
About Halozyme
Halozyme Therapeutics is a biotechnology company focused on
developing and commercializing novel oncology therapies that target
the tumor microenvironment. Halozyme’s lead proprietary program,
investigational drug PEGPH20, applies a unique approach to
targeting solid tumors, allowing increased access of
co-administered cancer drug therapies to the tumor in animal
models. PEGPH20 is currently in development for metastatic
pancreatic cancer, non-small cell lung cancer, gastric cancer,
metastatic breast cancer and has potential across additional
cancers in combination with different types of cancer therapies. In
addition to its proprietary product portfolio, Halozyme has
established value-driving partnerships with leading pharmaceutical
companies including Bristol-Myers Squibb for its ENHANZE® drug
delivery technology. Halozyme is headquartered in San Diego. For
more information visit www.halozyme.com.
Halozyme Safe Harbor Statement
In addition to historical information, the statements set forth
above include forward-looking statements including, without
limitation, statements concerning the possible activity, benefits
and attributes of ENHANZE, the possible method of action of
ENHANZE, its potential application to aid in the dispersion and
absorption of other injected therapeutic drugs, the number of
collaborative targets actually chosen, whether such products are
ultimately developed or commercialized, whether milestones
triggering milestone payments will be achieved, and statements
concerning facilitating more rapid delivery of injectable
medications through subcutaneous delivery that involve risk and
uncertainties that could cause actual results to differ materially
from those in the forward-looking statements. The forward-looking
statements are typically, but not always, identified through use of
the words "believe," "enable," "may," "will," "could," "intends,"
"estimate," "anticipate," "plan," "predict," "probable,"
"potential," "possible," "should," "continue," and other words of
similar meaning. Actual results could differ materially from the
expectations contained in forward-looking statements as a result of
several factors, including unexpected expenditures and costs,
unexpected results or delays in receipt of Hart-Scott-Rodino
clearance, development and regulatory review, regulatory approval
requirements, unexpected adverse events and competitive conditions.
These and other factors that may result in differences are
discussed in greater detail in Halozyme’s most recent Annual and
Quarterly Reports filed with the Securities and Exchange
Commission. Except as required by law, Halozyme undertakes no duty
to update forward-looking statements to reflect events after the
date of this release.
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 about Bristol-Myers Squibb, visit us at BMS.com or
follow us on LinkedIn, Twitter, YouTube and Facebook.
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 proposed technology or medicine delivery
system will be successfully developed or approved for any of the
indications described in this release. The actual financial
impact of this transaction may differ from the expected financial
impact described in this press release. 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, 2016 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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version on businesswire.com: http://www.businesswire.com/news/home/20170914005187/en/
Halozyme:Jim Mazzola, 858-704-8122ir@halozyme.comorChris
Burton, 858-704-8352ir@halozyme.comorBristol-Myers
SquibbMedia:Lisa McCormick Lavery,
609-252-7602lisa.mccormicklavery@bms.comorKen Dominski,
609-252-5251ken.dominski@bms.comorInvestors:Tim Power,
609-252-7509timothy.power@bms.comorBill Szablewski,
609-252-5894william.szablewski@bms.com
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