Form 6-K GLAXOSMITHKLINE PLC For: Jul 29
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 July,
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
as permitted by Regulation S-T Rule 101(b)(7): ____
Issued: 29 July 2019, London UK - LSE Announcement
ViiV Healthcare submits regulatory application to European
Medicines Agency for investigational cabotegravir to be used in
combination with rilpivirine as the first monthly, injectable
treatment for HIV
The marketing application is based on phase III ATLAS and FLAIR
pivotal trials in which the once-monthly, injectable treatment
regimen showed similar efficacy and safety to daily, 3-drug oral
treatment
London, 29 July 2019 - ViiV Healthcare, the global specialist HIV
company majority owned by GSK, with Pfizer Inc. and Shionogi
Limited as shareholders, today announced the submission of a
marketing authorisation application (MAA) to the European Medicines
Agency (EMA) for the investigational, once-monthly, injectable
cabotegravir, which will be used in combination with Janssen's
once-monthly, injectable rilpivirine to treat HIV-1 infection in
adults whose viral load is suppressed and who are not resistant to
cabotegravir or rilpivirine. The application also includes data for
cabotegravir oral tablets, intended for use as oral lead-in therapy
prior to the commencement of injectable
therapy.
Deborah Waterhouse, CEO of ViiV Healthcare, said: "ViiV Healthcare is proud to be sending a
regulatory submission to the EMA for what will be a
first-of-its-kind treatment. If approved, this long-acting,
injectable regimen of cabotegravir and rilpivirine has the
potential to give people living with HIV one month between doses
with similar safety and efficacy as today's standard of care - an
oral, 3-drug regimen taken every day. We are excited to be one step
closer to delivering this long-acting therapy to patients in
Europe."
The submission is based on the global ATLAS (Antiretroviral Therapy
as Long-Acting Suppression) and FLAIR (First Long-Acting Injectable
Regimen) pivotal phase III studies that included more than 1,100
patients from 16 countries and demonstrated the combination of
cabotegravir and rilpivirine, injected monthly, was as effective as
a daily, oral, 3-drug regimen in maintaining viral suppression
throughout the 48-week study period. The ATLAS and FLAIR studies
are part of ViiV Healthcare's innovative clinical trial programme
for 2-drug regimens (2DRs).
Kimberly Smith, M.D., Head of Global Medical Research and Strategy
at ViiV Healthcare, said: "This
regulatory submission supports ViiV Healthcare's commitment to
developing new and innovative options for people living with HIV to
manage their virus. We are proud to be at the forefront of this
innovation for patients by potentially changing the frequency of
therapy from 365 days per year to just 12."
This application to the EMA follows the recent submission of a New
Drug Application (NDA) for the 2DR of cabotegravir and rilpivirine,
as well as cabotegravir oral tablets, to the US Food and Drug
Administration (FDA) in April 2019. In June, this submission was
granted a Priority Review Designation by the FDA with an expected
action date of December 29, 2019. ViiV Healthcare and Janssen also
plan to submit additional regulatory applications for cabotegravir
and rilpivirine to other regulatory agencies in the coming
months.
About ATLAS and FLAIR
ATLAS (NCT02951052) is
a phase III, open-label, active-controlled, multicentre,
parallel-group, non-inferiority study designed to assess the
antiviral activity and safety of a 2-drug regimen of long-acting,
injectable cabotegravir and rilpivirine, dosed every four weeks,
compared to continuation of current oral anti-retroviral therapy
(ART) of two nucleoside reverse transcriptase inhibitors (NRTIs)
plus an integrase strand transfer inhibitor (INI), non-nucleoside
reverse transcriptase inhibitor (NNRTI), or protease inhibitor (PI)
among virally suppressed individuals. The primary endpoint for
ATLAS is the proportion of participants with plasma HIV-1 RNA
≥50 c/mL per the FDA Snapshot algorithm at Week 48 (Missing,
Switch, or Discontinuation = Failure, Intent-to-Treat Exposed
[ITT-E] population). Subjects were required to be virally
suppressed for six months or greater, on first or second regimen,
with no prior failure.
FLAIR (NCT02938520) is
a phase III, randomised, open-label, multicentre, parallel-group,
non-inferiority study designed to assess the antiviral activity and
safety of a 2-drug regimen of intramuscular, long-acting,
injectable cabotegravir and rilpivirine in virologically suppressed
adults living with HIV, following 20 weeks of induction therapy
with Triumeq (abacavir, dolutegravir and lamivudine tablets). The
primary endpoint for FLAIR is the proportion of participants
with plasma HIV-1 RNA ≥50 c/mL per the FDA Snapshot algorithm
at Week 48 (Missing, Switch, or Discontinuation = Failure,
Intent-to-Treat Exposed [ITT-E] population).
About cabotegravir
Cabotegravir is an investigational integrase inhibitor (INI) and is
not approved by regulatory authorities anywhere in the world.
Cabotegravir is being developed by ViiV Healthcare for the
treatment and prevention of HIV. It is being evaluated as a
long-acting formulation for intramuscular injection and also as a
once-daily oral tablet for use as a lead-in, to establish the
tolerability of cabotegravir prior to long-acting
injection.
About rilpivirine
EDURANT® (rilpivirine) is a once-daily non-nucleoside reverse
transcriptase inhibitor (NNRTI) used for the treatment of HIV-1
infection in combination with other antiretroviral agents in
antiretroviral treatment-naïve patients 12 years of age and
older and weighing at least 35-kg with a viral load ≤ 100,000
HIV RNA copies/mL. Long-acting, injectable rilpivirine is not
approved by regulatory authorities anywhere in the
world.
Rilpivirine was developed by Janssen Sciences Ireland UC, one of
the Janssen Pharmaceutical Companies of Johnson & Johnson.
Rilpivirine is approved in the US and EU as EDURANT® as a 25mg
tablet taken once-a-day and is always taken with a meal. The most
common side effects of EDURANT include: depression, headache,
trouble sleeping (insomnia) and rash.
Important Safety Information
(ISI) for EDURANT® (Rilpivirine)
Note: this is taken from the US label and local variations apply.
Please refer to applicable local labelling.
About EDURANT® (Rilpivirine)
●
EDURANT® (rilpivirine)
is a prescription medicine that is used with other antiretroviral
medicines to treat Human Immunodeficiency Virus-1 (HIV-1) in people
12 years of age and older and who weigh at least 77 lbs (35
kg):
- Have never taken
HIV medicines before, and
- Have
an amount of HIV in their blood (called "viral load") that is no
more than 100,000 copies/mL
●
EDURANT® is
not recommended for patients less than 12 years of age or who weigh
less than 77 lbs (35 kg)
IMPORTANT SAFETY INFORMATION
Who should not take EDURANT®?
Do not take EDURANT® if you also take:
●
anti-seizure
medicines:
o carbamazepine
o oxcarbazepine
o phenobarbital
o phenytoin
●
anti-tuberculosis
(anti-TB) medicines:
o rifampin
o rifapentine
●
proton
pump inhibitor (PPI) medicine for certain stomach or intestinal
problems:
o esomeprazole
o lansoprazole
o omeprazole
o pantoprazole
sodium
o rabeprazole
●
more
than 1 dose of the steroid medicine dexamethasone or
dexamethasone sodium phosphate
●
St. John's wort (Hypericum
perforatum)
What should I tell my healthcare provider before taking
EDURANT®?
Before taking EDURANT®, tell your healthcare provider about
all your medical conditions, including if you:
●
have
or had liver problems, including hepatitis B or C virus
infection
●
have
kidney problems
●
have
ever had a mental health problem
●
are
pregnant or plan to become pregnant. It is not known if
EDURANT® will harm your unborn baby. Tell your healthcare
provider if you become pregnant during treatment with
EDURANT®.
●
are breastfeeding or plan to
breastfeed. Do not breastfeed if you take
EDURANT®.
o You
should not breastfeed if you have HIV-1 because of the risk of
passing HIV-1 to your baby.
o It
is not known if EDURANT® passes into your breast milk. Talk
with your healthcare provider about the best way to feed your baby
during EDURANT® treatment.
Tell your healthcare provider about all the medicines you take,
including prescription and
over-the-counter medicines, vitamins, and herbal
supplements.
Do not start taking a new medicine without telling your healthcare
provider. Your healthcare
provider can tell you if it is safe to take EDURANT® with
other medicines.
How should I take EDURANT®?
●
Take
EDURANT® every day exactly as your healthcare provider tells
you to.
●
Take EDURANT® 1 time each
day with a meal. A
protein drink alone does not replace a meal.
●
Do
not change your dose or stop taking EDURANT® without first
talking with your healthcare provider. Stay under the care of your
healthcare provider during treatment with
EDURANT®.
●
Do
not miss a dose of EDURANT®.
●
If you take an H2-receptor
antagonist (famotidine, cimetidine, nizatidine, or ranitidine), you
should take these medicines at least 12 hours before or at least 4
hours after you take EDURANT®.
●
If
you take antacids, or other products that contain aluminum, calcium
carbonate, or magnesium hydroxide, you should take these medicines
at least 2 hours before or at least 4 hours after you take
EDURANT®.
●
If
you miss a dose of EDURANT® within 12 hours of the time
you usually take it, take your dose of EDURANT® with a meal as
soon as possible. Then, take your next dose of EDURANT® at the
regularly scheduled time. If you miss a dose of EDURANT® by
more than 12 hours of the time you usually take it, wait and
then take the next dose of EDURANT® at the regularly scheduled
time.
●
Do
not take more than your prescribed dose to make up for a missed
dose.
●
If
you take too much EDURANT®, call your healthcare provider or
go to the nearest hospital emergency room right away.
What are the possible side effects of EDURANT®?
EDURANT® can cause serious side effects
including:
●
Severe skin rash and allergic
reactions. Skin rash is a
common side effect of EDURANT®. Skin rash can be serious. Call
your healthcare provider right away if you get a rash. In some
cases, rash and allergic reaction may need to be treated in a
hospital.
If you get a rash with any of the following
symptoms, stop taking EDURANT® and
get medical help right away:
o fever
o skin
blisters
o mouth
sores
|
o trouble breathing or
swallowing
o pain on the right side
of the stomach (abdominal) area
o dark-colored urine
"tea colored"
|
o redness or swelling of
the eyes (conjunctivitis)
|
|
o swelling of the face,
lips, mouth, tongue, or throat
|
|
●
Change in liver
enzymes. People with a
history of hepatitis B or C virus infection or who have certain
liver function test changes may have an increased risk of
developing new or worsening liver problems during treatment with
EDURANT®. Liver problems have also happened during treatment
with EDURANT® in people without a history of liver disease.
Your healthcare provider may need to do tests to check your liver
enzymes before and during treatment with
EDURANT®.
●
Depression or mood changes. Tell your healthcare provider right
away if you have any of the following symptoms:
o feeling
sad or hopeless
o feeling
anxious or restless
o have
thoughts of hurting yourself (suicide) or have tried to hurt
yourself
●
Changes in body
fat can happen in people
who take HIV medicine. These changes may include increased amount
of fat in the upper back and neck ("buffalo hump"), breast, and
around the middle of your body (trunk). Loss of fat from the legs,
arms, and face may also happen. The exact cause and long-term
health effects of these problems are not known.
●
Changes in your immune system
(Immune Reconstitution Syndrome) can happen when you start taking HIV medicines.
Your immune system may get stronger and begin to fight infections
that have been hidden in your body for a long time. Tell your
healthcare provider right away if you start having any new symptoms
after starting your HIV-1 medicine.
The most common side effects of EDURANT®
include depression,
headache, trouble sleeping (insomnia), and
rash.
This is not a complete list of all side effects. If you experience
these or other symptoms, contact your healthcare provider right
away. Do not stop taking EDURANT® or any other medications
without first talking to your healthcare provider.
You are encouraged to report side
effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch, or
call 1-800-FDA-1088. You may also report side effects to
Janssen Products, LP, at 1-800-JANSSEN
(1-800-526-7736).
Please see accompanying full Product Information for more
details.
Full US prescribing information including is available
at:
http://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/EDURANT-pi.pdf
For the EU Summary of Product Characteristics, please
visit:
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002264/WC500118874.pdf
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 as a shareholder 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:
|
Melinda
Stubbee
|
+1 919
491 0831 (US)
|
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Audrey
Abernathy
|
+1 919
605 4521 (US)
|
|
|
|
GSK
Global Media enquiries:
|
Simon
Steel
|
+44 (0)
20 8047 5502 (UK)
|
Analyst/Investor
enquiries:
|
Kristen
Neese
Sarah
Elton-Farr
|
+1 804
217 8147 (US)
+44 (0)
20 8047 5194 (UK)
|
|
Danielle
Smith
James
Dodwell
|
+44 (0)
20 8047 0932 (UK)
+44 (0)
20 8047 2406 (UK)
|
|
Jeff
McLaughlin
|
+1 215
751 7002 (US)
|
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: July 29, 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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