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 December, 2019
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
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Issued: 5 December 2019, London UK - LSE Announcement
PRESS RELEASE
ViiV Healthcare submits New Drug Application to the FDA for
fostemsavir, an investigational, first-in-class attachment
inhibitor for the treatment of HIV in adults with few treatment
options available
London, 5 December 2019 -
ViiV Healthcare, the global specialist HIV company majority owned
by GSK, with Pfizer Inc. and Shionogi Limited as shareholders,
today completed submission of a New Drug Application (NDA) to the
US Food and Drug Administration (FDA) seeking approval of
fostemsavir, an investigational, first-in-class attachment
inhibitor for the treatment of HIV-1 infection. Fostemsavir
is being developed for use in combination with other antiretroviral
agents in heavily treatment-experienced adults with
multidrug-resistant HIV-1 infection who are unable to form a
suppressive regimen due to resistance, intolerance or safety
considerations.
Antiretroviral medicines that can effectively suppress HIV have
been instrumental in decreasing disease progression, HIV
transmission, and AIDS-related deaths, but because of HIV's ability
to constantly change, some individuals can develop viral resistance
to antiretroviral medicines, causing their treatment regimens to
fail. Challenges with tolerability, safety, and drug-to-drug
interactions may further decrease the number of acceptable
antiretroviral therapies available to design effective treatment
regimens. There remains an unmet need for these individuals who are
considered heavily treatment-experienced and who are unable to
successfully suppress their HIV.
Deborah Waterhouse, CEO of ViiV
Healthcare, said:
"Fostemsavir may provide an important treatment option for the
group of people living with HIV who, for a variety of reasons, are
not able to suppress their virus with other medicines and could be
left with few or no treatments available to them. In keeping with
our mission of leaving no person with HIV behind, we have overcome
many barriers to bring this important new medicine to people living
with HIV, including investing in what is a very complex
manufacturing process. We look forward to working with the FDA to
make fostemsavir available to the people in the US who need
it."
This submission is supported by the data from the pivotal phase III
BRIGHTE study in heavily treatment-experienced people living with
multidrug-resistant HIV. The 96-week results from the BRIGHTE study
were most recently presented in July at
the 10th International
AIDS Society Conference on HIV Science (IAS 2019) in Mexico
City.
Kimberly Smith, M.D., Head of Research & Development at ViiV
Healthcare, said: "We've
made incredible strides in our understanding and treatment of HIV
over the past 30 years. However, the complexities of the virus mean
that unsuccessful treatment and antiviral resistance are still
major concerns for certain people living with HIV. Through our
perseverance in research and development, these individuals may
soon have an entirely new way to target and treat HIV with
fostemsavir, aiding them in their efforts to achieve viral
suppression."
Fostemsavir has been granted FDA Fast Track and Breakthrough
Therapy Designations. These programmes are intended to facilitate
and expedite the development and review of new drugs to address
unmet medical need in the treatment of a serious or
life-threatening condition. Eligibility for Breakthrough Therapy
Designation requires that preliminary clinical evidence indicate
that the drug may demonstrate substantial improvement on clinically
significant endpoint(s) over available therapies.
ViiV Healthcare plans to submit regulatory applications for
fostemsavir to the European Medicines Agency and other global
agencies in the coming months.
About BRIGHTE
The efficacy of fostemsavir in heavily treatment-experienced adults
with HIV-1 infection is based on 96-week data from the phase III,
partially-randomised, international, double-blind,
placebo-controlled BRIGHTE study (NCT02362503).
The BRIGHTE trial was conducted in 371 heavily
treatment-experienced adults living with HIV-1 infection with
multidrug resistance. All trial participants were required to have
a viral load ≥400 copies/mL and ≤2 classes of
antiretroviral medications remaining at baseline due to resistance,
intolerability, contraindication, or other safety concerns. Trial
participants were enrolled in either a randomised or nonrandomised
cohort defined as follows:
● Within the randomised cohort (n = 272),
participants had 1, but no more than 2, fully active and available
antiretroviral agent(s) at screening which could be combined as
part of an efficacious background regimen. Randomised participants
received either blinded fostemsavir 600 mg twice daily (n = 203) or
placebo (n = 69) in addition to their current failing regimen for 8
days of functional monotherapy. Beyond Day 8, randomised
participants received open-label fostemsavir 600 mg twice daily
plus an investigator-selected optimised background
therapy.
● Within the nonrandomised cohort (n = 99),
participants had no fully active and approved antiretroviral
agent(s) available at screening. Nonrandomised participants were
treated with open-label fostemsavir 600 mg twice daily plus OBT
from Day 1 onward. The use of an investigational drug(s) as a
component of the optimised background therapy was permitted in the
nonrandomised cohort.
The primary endpoint analysis, based on the adjusted mean decline
in HIV-1 RNA from Day 1 at Day 8 in the randomised cohort,
demonstrated superiority of fostemsavir to placebo (0.79 vs. 0.17
log10 copies/mL decline, respectively; P<0.0001,
Intent-to-Treat-Exposed [ITT-E] population). In the randomised
cohort, HIV-1 RNA <40 copies/mL was achieved in 53%, 54%, and
60% of subjects at Weeks 24, 48, and 96, respectively (ITT-E,
Snapshot algorithm). Mean changes in CD4+ cell count from baseline
continued to increase over time (i.e., 90 cells/mm3 at Week 24, 139
cells/mm3 at Week 48, and 205 cells/mm3 at Week 96). The most
common adverse reactions (incidence ≥5%, all grades) were
nausea and diarrhoea. The proportion of participants who
discontinued treatment with fostemsavir due to an adverse event was
7% at Week 96 (randomised: 5% and nonrandomised: 12%).
About fostemsavir
Fostemsavir, an investigational prodrug of temsavir, is a
first-in-class HIV-1 attachment inhibitor that works by binding
directly to the glycoprotein 120 (gp120) subunit on the surface of
the virus. By binding to this location on the virus, fostemsavir
blocks HIV from attaching to host immune system CD4+ T-cells and
other immune cells, thereby preventing HIV from infecting those
cells and multiplying. Because of this unique mechanism of action,
there is no demonstrated resistance to other classes of
antiretrovirals, which may help patients who have become resistant
to most other medicines. Fostemsavir is not yet approved by
regulatory authorities anywhere in the world and is being developed
by ViiV Healthcare for the treatment of HIV-1-infected heavily
treatment-experienced patients in combination with other
antiretroviral agents.
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 aim is 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.
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 under Item 3.D
'Principal risks and uncertainties' in the company's Annual Report
on Form 20-F for 2018.
ViiV
Healthcare Media enquiries:
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Melinda
Stubbee
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+1 919
491 0831
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Audrey
Abernathy
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+1 919
605 4521
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GSK
Global Media enquiries:
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Simon
Steel
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+44 (0)
20 8047 5502
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Analyst/Investor
enquiries:
|
Kristen
Neese
Sarah
Elton-Farr
|
+1 804
217 8147
+44 (0)
20 8047 5194
|
|
Danielle
Smith
James
Dodwell
|
+44 (0)
20 8047 0932
+44 (0)
20 8047 2406
|
|
Jeff
McLaughlin
|
+1 215
751 7002
|
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: December
5, 2019
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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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