FORM 6-K
SECURITIES AND EXCHANGE COMMISSION
Washington D.C. 20549
Report of Foreign Issuer
Pursuant to Rule 13a-16 or 15d-16 of
the Securities Exchange Act of 1934
For
period ending 02 June
2017
GlaxoSmithKline plc
(Name
of registrant)
980 Great West Road, Brentford, Middlesex, TW8 9GS
(Address
of principal executive offices)
Indicate
by check mark whether the registrant files or
will
file annual reports under cover Form 20-F or Form 40-F
Form
20-F x Form 40-F
--
Indicate
by check mark whether the registrant by furnishing the
information
contained in this Form is also thereby furnishing the
information
to the Commission pursuant to Rule 12g3-2(b) under the
Securities
Exchange Act of 1934.
Issued:
Thursday 01 June 2017, London UK - LSE announcement
ViiV Healthcare submits regulatory applications for the first HIV
maintenance regimen comprising only two medicines
- EU and US submissions for single tablet
combining dolutegravir and rilpivirine
- Priority review voucher submitted in US with
anticipated target action date of 6 months
London,
UK 01 June 2017 - GSK and ViiV Healthcare, the global specialist
HIV company majority-owned by GSK, with Pfizer Inc. and Shionogi
Limited as shareholders, today announced regulatory submissions to
the European Medicines Agency (EMA) and US Food and Drug
Administration (FDA) for a single-tablet, two-drug regimen of
dolutegravir (Tivicay, ViiV Healthcare) and rilpivirine (Edurant,
Janssen Sciences Ireland UC) for the maintenance treatment of HIV-1
infection.
The
submissions are based on the SWORD studies that included more than
one thousand patients who previously achieved viral suppression on
a three- or four-drug (integrase inhibitor, non-nucleoside reverse
transcriptase inhibitor, or protease inhibitor-based)
antiretroviral regimen. The results of these studies were presented
at the 2017 Conference on Retroviruses and Opportunistic Infections
(CROI) in February.
A
recently acquired priority review voucher was submitted to the FDA
along with the dolutegravir and rilpivirine 2-drug regimen New Drug
Application (NDA). Under the Prescription Drug User Fee Act, the
anticipated target action date is six months after receipt of the
application by the FDA. The $130 million cost of the voucher will
be reported as an R&D expense in GSK's Q2 2017 Adjusted
results.
Use of
dolutegravir and rilpivirine as a two-drug regimen for HIV-1
maintenance therapy is investigational and not approved anywhere in
the world.
Deborah
Waterhouse, CEO ViiV Healthcare said, "As people living with HIV
plan their lives, there is a need for new options to best manage
their lifelong treatment. At ViiV Healthcare, we are not only
developing potential new medicines to treat and prevent HIV
infection, we are challenging the traditional HIV treatment
paradigm to develop new treatment regimens. We look forward to
working with regulatory authorities to bring this new single
tablet, two-drug regimen to appropriate people living with
HIV."
John C
Pottage, Jr, MD, Chief Scientific and Medical Officer, ViiV
Healthcare, commented,
"Traditionally,
we have used a regimen of three or more drugs to maintain HIV viral
suppression, but to best serve people living with HIV we must
always question the status quo. We believed that dolutegravir would
have the right profile to be a core agent in a two-drug regimen.
Data from the SWORD studies supported our hypothesis that a
two-drug regimen of dolutegravir and rilpivirine could maintain
viral suppression and these regulatory submissions mark what may be
a step change in HIV treatment. We are grateful to the study
participants and clinicians who have contributed so much to making
these submissions possible."
Notes to editors
In June
2014, ViiV Healthcare and Janssen Sciences, one of the Janssen
Pharmaceutical Companies of Johnson & Johnson, announced a
partnership to investigate the potential of combining dolutegravir
and rilpivirine in a single tablet in order to expand the treatment
options available to people living with HIV.
About the SWORD phase III programme for dolutegravir (Tivicay) and
rilpivirine (Edurant)
The
phase III programme evaluates the efficacy, safety, and
tolerability of switching to dolutegravir plus rilpivirine from
current integrase inhibitor-, non-nucleoside reverse transcriptase
inhibitor-, or boosted protease inhibitor-based antiretroviral
regimen in HIV-1-infected adults who are virologically suppressed
with a three or four-drug regimen. SWORD-1 (NCT02429791) and
SWORD-2 (NCT02422797) are replicate 148-week, randomised,
open-label, non-inferiority studies to assess the antiviral
activity and safety of a two-drug, daily oral regimen of
dolutegravir plus rilpivirine compared with current antiretroviral
therapy. In the clinical trials, dolutegravir and rilpivirine are
provided as individual tablets.
The
primary endpoint is the proportion of patients with plasma HIV-1
RNA <50 copies per millilitre (c/mL) at Week 48. Key secondary
endpoints include evaluation of the development of viral
resistance, measurements of safety and tolerability, and changes in
renal, bone and cardiovascular biomarkers. The studies also include
exploratory measures to assess change in health-related quality of
life, willingness to switch and adherence to treatment
regimens.
For
more information on the trials please visit:
www.clinicaltrials.gov
Tivicay
is a registered trademark of the ViiV Healthcare group of
companies
Edurant
is a registered trademark of Janssen Sciences Ireland
UC
TIVICAY (dolutegravir) tablets
Important Safety Information for TIVICAY® (dolutegravir)
10-, 25-, and 50-mg tablets, for oral use
The
following Important Safety Information (ISI) is based on the
Highlights section of the US Prescribing Information for TIVICAY
and local variations apply. Please consult the full Prescribing
Information for all the labeled safety information for TIVICAY or
please refer to applicable local labelling.
FDA INDICATIONS AND USAGE
TIVICAY
is a human immunodeficiency virus type 1 (HIV-1) integrase strand
transfer inhibitor (INSTI) indicated in combination with other
antiretroviral agents for the treatment of HIV-1 infection in
adults and pediatric patients weighing at least 30 kg.
Limitations
of Use:
●
Use of TIVICAY in
integrase strand transfer inhibitor (INSTI)-experienced patients
should be guided by the number and type of baseline INSTI
substitutions. The efficacy of TIVICAY 50 mg twice daily is reduced
in patients with an INSTI-resistance Q148 substitution plus 2 or
more additional INSTI-resistance substitutions including T66A,
L74I/M, E138A/K/T, G140S/A/C, Y143R/C/H, E157Q, G163S/E/K/Q, or
G193E/R.
CONTRAINDICATIONS
●
Previous
hypersensitivity reaction to dolutegravir.
●
Coadministration
with dofetilide.
WARNINGS AND PRECAUTIONS
●
Hypersensitivity
reactions characterized by rash, constitutional findings, and
sometimes organ dysfunction, including liver injury, have been
reported. Discontinue TIVICAY and other suspect agents immediately
if signs or symptoms of hypersensitivity reactions develop, as a
delay in stopping treatment may result in a life-threatening
reaction.
●
Patients with
underlying hepatitis B or C may be at increased risk for worsening
or development of transaminase elevations with use of TIVICAY.
Appropriate laboratory testing prior to initiating therapy and
monitoring for hepatotoxicity during therapy with TIVICAY is
recommended in patients with underlying hepatic disease such as
hepatitis B or C.
●
Redistribution/accumulation
of body fat and immune reconstitution syndrome have been reported
in patients treated with combination antiretroviral
therapy.
ADVERSE REACTIONS
The
most common adverse reactions of moderate to severe intensity and
incidence at least 2% (in those receiving TIVICAY in any one adult
trial) are insomnia, fatigue, and headache.
DRUG INTERACTIONS
●
Drugs that are
metabolic inducers may decrease the plasma concentrations of
dolutegravir.
●
TIVICAY should be
taken 2 hours before or 6 hours after taking cation-containing
antacids or laxatives, sucralfate, oral supplements containing iron
or calcium, or buffered medications. Alternatively, TIVICAY and
supplements containing calcium or iron can be taken together with
food.
USE IN SPECIFIC POPULATIONS
●
Pregnancy: TIVICAY
should be used during pregnancy only if the potential benefit
justifies the potential risk.
●
Lactation:
Breastfeeding is not recommended.
Please
visit the following link for the full U.S. prescribing and patient
information:
https://www.gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Tivicay/pdf/TIVICAY-PI-PIL.PDF#page=1
EDURANT® Consumer Indication and Important Safety Information
(ISI)
About
EDURANT®
●
EDURANT® (rilpivirine) is a prescription HIV medicine that is
used with other antiretroviral medicines to treat Human
Immunodeficiency Virus-1 (HIV-1) in patients:
- Who
have never taken HIV medicines before, and
- Who
have an amount of HIV in their blood (called "viral load") that is
no more than 100,000 copies/mL. Your healthcare professional will
measure your viral load
●
EDURANT® should be taken in combination with other HIV
medicines. Your healthcare professional will work with you to find
the right combination of HIV medicines
●
It is important that you remain under the care of your healthcare
professional during treatment with EDURANT®
●
EDURANT® is not recommended for patients less than 12 years of
age
EDURANT® does not cure HIV infection or AIDS. You should
remain on your HIV medications without stopping to ensure that you
control your HIV infection and decrease the risk of HIV-related
illnesses. Ask your healthcare professional about how to prevent
passing HIV to other people.
Please read Important Safety Information below, and talk to your
healthcare professional to learn if EDURANT® is right for
you.
Important Safety Information
Can EDURANT® be taken with other medicines?
EDURANT®
may affect the way other medicines work and other medicines may
affect how EDURANT® works and may cause serious side effects.
If you take certain medicines with EDURANT®, the amount of
EDURANT® in your body may be too low and it may not work to
help control your HIV infection, and the HIV virus in your body may
become resistant to EDURANT® or other HIV medicines that are
like it. To help get the right amount of medicine in your body, you
should always take EDURANT® with a meal. A protein drink alone
does not replace a meal.
Do not take EDURANT® if:
●
Your HIV infection has been previously treated with HIV
medicines
●
You are taking any of the following medicines:
-
Anti-seizure medicines: carbamazepine (Carbatrol®,
Equetro®, Tegretol®, Tegretol-XR®, Teril®,
Epitol®), oxcarbazepine (Trileptal®), phenobarbital
(Luminal®), phenytoin (Dilantin®, Dilantin-125®,
Phenytek®)
-
Anti-tuberculosis (anti-TB) medicines: rifampin (Rifater®,
Rifamate®, Rimactane®, Rifadin®), rifapentine
(Priftin®)
-
Proton pump inhibitor (PPI) medicine for certain stomach or
intestinal problems: esomeprazole (Nexium®, Vimovo®),
lansoprazole (Prevacid®), omeprazole (Prilosec®,
Zegerid®), pantoprazole sodium (Protonix®), rabeprazole
(Aciphex®)
- More
than 1 dose of the steroid medicine dexamethasone or dexamethasone
sodium phosphate
- St.
John's wort (Hypericum perforatum)
Especially tell your doctor if you take:
●
Rifabutin (Mycobutin®), a medicine to treat some bacterial
infections). Talk to your doctor or pharmacist about the right
amount of EDURANT® you should take if you also take
rifabutin
●
Medicines used to treat HIV
●
An antacid medicine that contains aluminum, magnesium hydroxide, or
calcium carbonate. Take antacids at
least 2 hours before or at least 4 hours after you take
EDURANT®
●
Medicines to block acid in your stomach, including cimetidine
(Tagamet®), famotidine (Pepcid®), nizatidine
(Axid®), or ranitidine hydrochloride (Zantac®). Take
these medicines at least 12 hours
before or at least 4 hours after you take
EDURANT®
●
Any of these medicines (if taken by mouth or injection):
clarithromycin (Biaxin®), erythromycin (E-Mycin®,
Eryc®, Ery-Tab®, PCE®, Pediazole®,
Ilosone®), fluconazole (Diflucan®), itraconazole
(Sporanox®), ketoconazole (Nizoral®), methadone
(Dolophine®), posaconazole (Noxafil®), telithromycin
(Ketek®), voriconazole (Vfend®)
This is not a complete list of medicines. Before starting
EDURANT®, be
sure to tell your healthcare professional about all the medicines
you are taking or plan to take, including prescription and
nonprescription medicines, vitamins, and herbal
supplements.
Before
taking EDURANT®, also tell your health-care professional if
you have had or currently have liver problems (including hepatitis
B or C), have ever had a mental health problem, are pregnant or
planning to become pregnant, or breastfeeding. It is not known if
EDURANT® will harm your unborn baby.
You and
your health-care professional will need to decide if taking
EDURANT® is right for
you.
-
Do not breastfeed if you are taking
EDURANT®. You should not breastfeed if you have HIV
because of the chance of passing HIV to your baby
What are the possible side effects of EDURANT®? EDURANT®
can cause serious side effects including:
●
Severe skin rash and allergic
reactions. Call your doctor right away if you get a rash.
Stop taking EDURANT® and seek medical help right away if you
get a rash with any of the following symptoms: severe allergic
reaction causing swelling of the face, eyes, lips, mouth, tongue,
or throat (which may lead to difficulty swallowing or breathing);
mouth sores or blisters on your body; inflamed eye
(conjunctivitis); fever; dark urine; or pain on the right side of
the stomach area (abdominal pain)
●
Depression or mood changes.
Tell your doctor right away if you have any of the following
symptoms: feeling sad or hopeless, feeling anxious or restless,
have thoughts of hurting yourself (suicide), or have tried to hurt
yourself
●
Liver problems. 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. Liver
problems were also reported during treatment in some people without
a history of liver disease. Your health-care professional may need
to do tests to check liver function before and during
treatment
●
Changes in body shape or body
fat have been seen in some patients taking HIV medicines.
The exact cause and long-term health effects of these conditions
are not known
●
Changes in your immune
system (immune
reconstitution syndrome).
Your immune system may get stronger and begin to fight infections.
Tell your health-care professional right away if you start having
any new symptoms of infection
Other
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 professional right away. Do
not stop taking EDURANT® or any other medications without
first talking to your healthcare professional.
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.
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.
GSK - one of the world's leading research-based
pharmaceutical and healthcare companies - is committed to improving
the quality of human life by enabling people to do more, feel
better and live longer. For further information please visit
www.gsk.com.
GSK enquiries:
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UK
Media enquiries:
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David
Mawdsley
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+44 (0)
20 8047 5502
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(London)
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Simon
Steel
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+44 (0)
20 8047 5502
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(London)
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David
Daley
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+44 (0)
20 8047 5502
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(London)
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US
Media enquiries:
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Sarah
Alspach
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+1 202
715 1048
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(Washington,
DC)
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Sarah
Spencer
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+1 215
751 3335
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(Philadelphia)
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Analyst/Investor
enquiries:
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Sarah
Elton-Farr
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+44 (0)
20 8047 5194
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(London)
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Tom
Curry
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+ 1 215
751 5419
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(Philadelphia)
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Gary
Davies
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+44 (0)
20 8047 5503
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(London)
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James
Dodwell
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+44 (0)
20 8047 2406
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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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ViiV
Healthcare Media enquiries
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Sébastien
Desprez
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+44 (0)
20 8380 6275
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(London)
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Patricia
O'Connor
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+44 (0)
208 047 5982
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(London)
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Marc
Meachem
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+1 919
483 8756
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(North
Carolina)
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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 under Item 3.D
'Principal risks and uncertainties' in the company's Annual Report
on Form 20-F for 2016.
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Registered in
England & Wales:
No.
3888792
|
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Registered
Office:
980
Great West Road
Brentford,
Middlesex
TW8
9GS
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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
02, 2017
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By: 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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