Halozyme’s drug delivery technology provides the opportunity
to administer large volume subcutaneous injections that may enable
dosing intervals of every three months and up to six months or
longer for ViiV’s pipeline of HIV medicines
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.
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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/.
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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ViiV Healthcare Media enquiries: Melinda Stubbee +1 919
491 0831 (North Carolina) Audrey Abernathy +1 919 605 4521 (North
Carolina)
GSK enquiries: Media enquiries: Simon Steel +44 (0) 20
8047 5502 (London) Tim Foley +44 (0) 20 8047 5502 (London) Kristen
Neese +1 804 217 8147 (Philadelphia) Kathleen Quinn +1 202 603 5003
(Washington DC)
Analyst/Investor enquiries: James Dodwell +44 (0) 20 8047 2406
(London) Sonya Ghobrial +44 (0) 7392 784784 (Consumer) Mick Readey
+44 (0) 7990 339653 (London) Jeff McLaughlin +1 215 751 7002
(Philadelphia) Frannie DeFranco +1 215 751 4855 (Philadelphia)
Halozyme enquiries: Al Kildani +1 858 704 8122 (San Diego)
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