TIDMGSK
RNS Number : 6201C
GlaxoSmithKline PLC
22 June 2021
Issued: 22 June 2021, London UK
ViiV Healthcare and Halozyme enter global collaboration and
license agreement for ENHANZE(R) drug delivery technology to enable
development of "ultra long-acting" medicines for HIV
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
London and San Diego, 22 June 2021 - 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(R) 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(R) 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(R) 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(R) 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(R).
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/about-us .
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 (London)
5502
Tim Foley +44 (0) 20 8047 (London)
5502
Kristen Neese +1 804 217 8147 (Philadelphia)
Kathleen Quinn +1 202 603 5003 (Washington
DC)
Analyst/Investor James Dodwell +44 (0) 20 8047 (London)
enquiries: 2406
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)
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(R), the possible method of action of
ENHANZE(R), its potential application to aid in the dispersion and
absorption of other injected therapeutic drugs and statements
concerning certain other potential benefits of ENHANZE(R) 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(R) 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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END
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