LONDON and SAN DIEGO, June 22,
2021 /PRNewswire/ -- ViiV Healthcare, the global
specialist HIV company majority owned by GlaxoSmithKline plc
("GSK"), with Pfizer Inc. and Shionogi Limited as shareholders, and
Halozyme Therapeutics, Inc. (Nasdaq: HALO) today announced a global
collaboration and license agreement that gives exclusive access to
Halozyme's ENHANZE® drug delivery technology, recombinant human
hyaluronidase PH20 enzyme (rHuPH20), for specific targets used in
the treatment and prevention of HIV.
Under the terms of the agreement, ViiV Healthcare will make an
upfront payment of $40 million to
Halozyme for the exclusive license to four HIV small and large
molecule targets and is obligated to make potential future payments
of up to $175 million in development
and commercial milestones per target, subject to achievement of
specified development and commercial milestones, including certain
specified sales milestones. Halozyme will also be entitled to
receive mid-single digit royalties on sales of commercialised
medicines using the technology.
The PH20 enzyme breaks down a substance called hyaluronan (HA)
that is found in the body's subcutaneous space (under the skin)
that acts as a barrier to the flow of fluid. By breaking down HA
locally at the injection site and temporarily removing that
barrier, large amounts of fluid can be injected into the
subcutaneous space and dispersed. This facilitates the rapid
delivery of large volume fluids by subcutaneous injection,
potentially reducing the treatment burden of injectable drugs and
providing optimised treatment options to patients. The HA is
restored under the skin via normal processes within 24-48
hours.
Halozyme's technology provides ViiV Healthcare with more
opportunities to develop ultra-long acting medicines (dosing
intervals of three months or longer) with its long-acting portfolio
and pipeline products. Plans are underway to initiate the first
experiments with the technology by the end of 2021 for
investigational, long-acting cabotegravir for prevention of HIV,
which is currently administered every two months.
"Many people living with HIV and those vulnerable to HIV tell us
that for a variety of reasons, taking medicine every day is a
challenge, and we have listened to them," said Kimberly Smith, M.D., MPH, Head of Research
& Development at ViiV Healthcare. "We believe long-acting
medicines are the future of HIV therapies and will help address
these unmet needs. Our collaboration with Halozyme will keep us at
the forefront of developing additional, innovative new options for
HIV treatment and prevention as we work towards reducing the burden
of HIV treatment."
"We are excited to partner with ViiV Healthcare to create new
delivery options for innovative medicines for HIV," said
Helen Torley, M.B. Ch. B., M.R.C.P.,
president and chief executive officer, Halozyme. "This
collaboration demonstrates the potential value of our technology to
facilitate rapid, large volume subcutaneous injections of not only
more traditional medicines but also long-acting injectables,
including small molecules, which in turn may further extend dosing
intervals for people taking medicines for the treatment and
prevention of HIV."
The license gives ViiV exclusive use of Halozyme's proprietary
rHuPH20 technology for four, specific HIV medicine targets that
will expand opportunities for development of nearly all of ViiV's
pipeline assets. These assets are integrase inhibitors, reverse
transcriptase inhibitors limited to nucleoside reverse
transcriptase inhibitors (NRTI) and nucleoside reverse
transcriptase translocation inhibitors (NRTTIs), capsid inhibitors
and broadly neutralising monoclonal antibodies (bNAbs), that bind
to the gp120 CD4 binding site.
Halozyme has licensed its technology to 11 pharmaceutical and
biotechnology companies, for potential use in oncology,
autoimmune disease, rare disease and infectious disease with
products currently approved in oncology and immune deficiency
indications. In addition, Halozyme currently has a Cooperative
Research and Development Agreement with the National Institute of
Allergy and Infectious Diseases' Vaccine Research Center in the US,
which includes a bNAb, N6LS, that ViiV Healthcare licensed from the
National Institutes of Health in 2019.
About Halozyme
Halozyme is a biopharmaceutical company
bringing disruptive solutions to significantly improve patient
experiences and outcomes for emerging and established
therapies. Halozyme advises and supports its
biopharmaceutical partners in key aspects of new drug development
with the goal of improving patients' lives while helping its
partners achieve global commercial success. As the innovators
of the ENHANZE® technology, which can reduce hours-long treatments
to a matter of minutes, Halozyme's commercially validated solution
has touched more than 500,000 patient lives via five commercialized
products across more than 100 global markets. Halozyme and
its world-class partners are currently advancing multiple
therapeutic programs intended to deliver innovative therapies, with
the potential to improve the lives of patients around the
globe. Halozyme's proprietary enzyme rHuPH20 forms the basis
of the ENHANZE® technology and is used to facilitate the delivery
of injected drugs and fluids, potentially reducing the treatment
burden of other drugs to patients. Halozyme has licensed its
ENHANZE® technology to leading pharmaceutical and biotechnology
companies including Roche, Baxalta, Pfizer, Janssen, AbbVie, Lilly,
Bristol-Myers Squibb, Alexion, argenx, Horizon Therapeutics and
ViiV Healthcare. Halozyme derives revenues from these
collaborations in the form of milestones and royalties as the
Company's partners make progress developing and commercializing
their products being developed with ENHANZE®. Halozyme is
headquartered in San Diego. For more information visit
www.halozyme.com.
About ViiV Healthcare
ViiV Healthcare is a global specialist HIV company established in
November 2009 by GlaxoSmithKline
(LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances
in treatment and care for people living with HIV and for people who
are at risk of becoming infected with HIV. Shionogi joined in
October 2012. The company's aims are
to take a deeper and broader interest in HIV/AIDS than any company
has done before and take a new approach to deliver effective and
innovative medicines for HIV treatment and prevention, as well as
support communities affected by HIV.
For more information on the company, its management, portfolio,
pipeline, and commitment, please visit www.viivhealthcare.com.
About GSK
GSK is a science-led global healthcare
company with a special purpose: to help people do more, feel
better, live longer. For further information please visit
www.gsk.com/en-gb/about-us/.
ViiV
Healthcare
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Media
enquiries:
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Melinda
Stubbee
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+1 919 491
0831
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(North
Carolina)
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Audrey
Abernathy
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+1 919 605
4521
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(North
Carolina)
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GSK
enquiries:
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Media
enquiries:
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Simon
Steel
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+44 (0) 20 8047
5502
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(London)
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Tim
Foley
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+44 (0) 20 8047
5502
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(London)
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Kristen
Neese
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+1 804 217
8147
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(Philadelphia)
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Kathleen
Quinn
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+1 202 603
5003
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(Washington
DC)
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Analyst/Investor
enquiries:
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James
Dodwell
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+44 (0) 20 8047
2406
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(London)
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Sonya
Ghobrial
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+44 (0) 7392
784784
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(Consumer)
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Mick
Readey
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+44 (0) 7990
339653
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(London)
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Jeff
McLaughlin
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+1 215 751
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(Philadelphia)
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Frannie
DeFranco
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(Philadelphia)
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Halozyme
enquiries:
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Al
Kildani
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+1 858 704
8122
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(San
Diego)
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Cautionary statement regarding forward-looking
statements
GSK cautions investors that any forward-looking
statements or projections made by GSK, including those made in this
announcement, are subject to risks and uncertainties that may cause
actual results to differ materially from those projected. Such
factors include, but are not limited to, those described in the
Company's Annual Report on Form 20-F for 2020 and any impacts of
the COVID-19 pandemic.
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 and statements concerning
certain other potential benefits of ENHANZE® including facilitating
more rapid delivery and administration of larger volumes of
injectable medications through subcutaneous delivery and
potentially lowering the treatment burden for patients, including
potential extension of dosing intervals for people taking medicines
for the treatment and prevention of HIV. These
forward-looking statements also include statements regarding the
product development and regulatory efforts of Halozyme's ENHANZE®
partner and Halozyme's potential receipt of payments associated
with achievement of certain development, regulatory and
sales-based milestones, and royalties on sales of commercialized
products. These forward-looking statements involve risks 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 uncertainties concerning whether development, regulatory
and sales-based milestones will be achieved, uncertainties
concerning whether collaborative products are ultimately developed
or commercialized, unexpected expenditures and costs, unexpected
results or delays in development and regulatory review including
potential delays caused by the current COVID-19 global pandemic,
unexpected regulatory approval requirements, unexpected adverse
events or patient outcomes 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.
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SOURCE Halozyme Therapeutics, Inc.