UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR
15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the
month of June 2021
Commission
File Number 001-15170
GlaxoSmithKline plc
(Translation
of registrant's name into English)
980 Great West Road, Brentford, Middlesex, TW8 9GS
(Address
of principal executive office)
Indicate
by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
Form
20-F . . . .X. . . . Form 40-F . . . . . . . .
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(1): ____
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(7): ____
Issued: 22 June 2021, London UK
ViiV Healthcare and Halozyme enter global collaboration and license
agreement for ENHANZE® 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® 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/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 7002
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(Philadelphia)
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Frannie
DeFranco
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+1 215
751 4855
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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.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorised.
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GlaxoSmithKline plc
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(Registrant)
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Date: June
22, 2021
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By:/s/ VICTORIA
WHYTE
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Victoria Whyte
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Authorised
Signatory for and on
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behalf
of GlaxoSmithKline plc
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