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 23 March
2018
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.
Yes
No x
Issued:
23 March 2018, London UK - LSE
ViiV Healthcare gains CHMP positive opinion for Juluca
(dolutegravir/rilpivirine) in Europe
London, 23 March 2018 - ViiV
Healthcare, the global specialist HIV company, majority owned by
GlaxoSmithKline, with Pfizer Inc. and Shionogi Limited as
shareholders, today announced that the European Committee for
Medicinal Products for Human Use (CHMP) has issued a Positive
Opinion recommending marketing authorisation for Juluca
(dolutegravir/rilpivirine) for the treatment of HIV infection in
adults who are virologically suppressed (HIV-1 RNA less than 50
copies per mL) on a stable antiretroviral regimen for at least six
months with no history of virological failure and no known or
suspected resistance to any non-nucleoside reverse transcriptase
inhibitor or integrase inhibitor. The 2-drug regimen comprises
dolutegravir 50mg (ViiV Healthcare) and rilpivirine 25mg (Janssen
Sciences Ireland UC).
Deborah
Waterhouse, Chief Executive Officer at ViiV Healthcare commented:
"Today is an important milestone for people living with HIV in
Europe. It takes us a step closer to offering the first,
single-pill, 2-drug regimen with the opportunity to reduce the
number of drugs needed to treat HIV in those who are virologically
suppressed; Juluca is expected to be the smallest single-pill
regimen in the market. ViiV Healthcare is committed to delivering
advances in HIV care, including providing innovative treatment
options that meet the evolving needs of people living with HIV and
we are willing to challenge the traditional HIV treatment paradigms
to deliver these advances."
The CHMP positive opinion follows the United States Food and Drug
Administration approval of Juluca in November 2017 for the treatment of HIV-1
infection in adults to replace the current antiretroviral regimen
in those who are virologically suppressed (HIV-1 RNA less than 50
copies per mL) on a stable antiretroviral regimen for at least 6
months with no history of treatment failure and no known
substitutions associated with resistance to the individual
components of dolutegravir/rilpivirine;[1] and is supported by data from two pivotal phase
III clinical trials, SWORD-1 and SWORD-2, and a pivotal
bioequivalence study.[2],[3]
Positive
data from the SWORD studies, recently published in The Lancet (5th January 2018), showed that the
dolutegravir and rilpivirine regimen is non-inferior to three and
four drug regimens in maintaining virologic suppression (HIV-1 RNA
less than 50 copies per mL) through 48 weeks in adults who are
infected with HIV-1 and have no history of resistance or treatment
failure, in both pooled and individual analyses of the SWORD-1 and
SWORD-2 studies (dolutegravir+rilpivirine 486/513 [95%] current
antiretroviral regimen 485/511 [95%], [adjusted difference -0.2%
(95% confidence interval: -3.0%, 2.5%), pooled analysis]).
Virologic suppression rates were similar between treatment
arms.2
John C
Pottage, Jr, MD, Chief Scientific and Medical Officer, ViiV
Healthcare, commented: "We believe no one should have to take more
medicines than they need, and dolutegravir/rilpivirine represents
our first 2-drug regimen that could reduce the number of
antiretrovirals people living with HIV in Europe take daily, whilst
maintaining the efficacy of traditional three-drug regimens. Our
research efforts are exploring a number of two-drug regimen
treatment options that look beyond viral load and may address
unresolved issues, such as long-term toxicity and reducing the
number of drugs used in dosing."
A CHMP
opinion is one of the last regulatory steps before marketing
authorisation is granted by the European Commission (EC). The final
EC decision on European approval for dolutegravir/rilpivirine is
anticipated towards the end of the second quarter of
2018.
-
Ends -
Notes to editors
In June
2014, ViiV Healthcare and Janssen Sciences Ireland UC, one of the
Janssen Pharmaceutical Companies of Johnson & Johnson,
announced a collaboration to investigate the potential of combining
dolutegravir and rilpivirine in a single pill in order to expand
the treatment options available to people living with
HIV.
About HIV
HIV
stands for the Human Immunodeficiency Virus. Unlike some other
viruses, the human body cannot get rid of HIV, so once someone has
HIV they have it for life. There is no cure for HIV, but effective
treatment can control the virus so that people with HIV can enjoy
healthy and productive lives.
HIV has largely become a chronic treatable disease with improved
access to antiretroviral treatment. This has led to a 22% drop in
global HIV mortality between 2009 and 2013,[4] but more can be done for the estimated 36.7
million people living with HIV4
of which 160,000
were newly diagnosed in the Europe region
alone in 2016.[5]
About dolutegravir/rilpivirine
Dolutegravir/rilpivirine
was approved by the US Food and Drug Administration (FDA) on
21st November 2017, as a
complete regimen for the treatment of HIV-1 infection in adults who
are virologically suppressed (HIV-1 RNA less than 50 copies per mL)
on a stable antiretroviral regimen for at least 6 months with no
history of treatment failure and no known substitutions associated
with resistance to the individual components of
dolutegravir/rilpivirine.1
Dolutegravir/rilpivirine
is a 2-drug regimen, once-daily, single pill that combines the
integrase strand transfer inhibitor (INSTI) dolutegravir (50mg),
with the non-nucleoside reverse transcriptase inhibitor (NNRTI)
rilpivirine (25mg) taken once-daily as a complete HIV regimen for
people living with HIV who are virologically
suppressed.
Two
essential steps in the HIV life cycle include reverse transcription
- when the virus turns its RNA (ribonucleic acid) copy into DNA
(deoxyribonucleic acid) - and integration - the moment when viral
DNA becomes part of the host cell's DNA. These processes require
two enzymes called nucleoside reverse transcriptase and integrase.
NNRTIs and INSTIs interfere with the action of these two enzymes to
prevent the virus from replicating. This decrease in replication
can lead to less virus being available to cause subsequent
infection of uninfected cells.
ViiV
Healthcare has also submitted regulatory marketing applications in
Canada, Australia and Switzerland.
About the SWORD phase III programme for dolutegravir (Tivicay) and
rilpivirine (Edurant)2
The
SWORD 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 (full 148-week data will be shared in 2019). In the SWORD
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
Juluca
and Tivicay are trademarks owned by the ViiV Healthcare group of
companies.
EDURANT
is a registered trademark of Janssen Sciences Ireland
UC.
Important Safety Information for dolutegravir/rilpivirine in
Europe: Please
refer to the full European Summary of Product Characteristics for
full prescribing information for dolutegravir and
rilpivirine.
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 - 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
ViiV
Healthcare Limited, the global specialist HIV company, is majority
owned by GlaxoSmithKline plc, with Pfizer Inc. and Shionogi
Limited. 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 2017.
ViiV
Healthcare Media enquiries:
|
Patricia
O'Connor
|
+44 208
047 5982
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Marc
Meachem
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+1 919
483 8756
|
|
|
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GSK
Global Media enquiries:
|
Simon
Steel
|
+44 (0)
20 8047 5502
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David
Daley
|
+44 (0)
20 8047 5502
|
|
|
|
Analyst/Investor
enquiries:
|
Sarah
Elton-Farr
|
+44 (0)
20 8047 5194
|
|
Tom
Curry
|
+ 1 215
751 5419
|
|
Gary
Davies
|
+44 (0)
20 8047 5503
|
|
James
Dodwell
|
+44 (0)
20 8047 2406
|
|
Jeff
McLaughlin
|
+1 215
751 7002
|
|
|
|
References
[1] Juluca (dolutegravir and rilpivirine) Prescribing
Information. Initial U.S Approval: 2017
[2] Llibre JM et al. Efficacy, safety, and tolerability of
dolutegravir-rilpivirine for the maintenance of virological
suppression in adults with HIV-1: phase 3, randomised,
non-inferiority SWORD-1 and SWORD-2 studies. The Lancet. Published online January 5,
2018 http://dx.doi.org/10.1016/S0140-6736(17)33095-7.
[3] Metha R, et al. Bioequivalence of a fixed dose
combination tablet of dolutegravir and rilpivirine in healthy
subjects. Presented at the 18th Workshop on Clinical Pharmacology
of Antiviral Therapy, 2017. Chicago, United States.
[4] World Health Organization. Global Update on the
health sector response to HIV, 2014. July 2014. Available at:
http://apps.who.int/iris/bitstream/10665/128494/1/9789241507585_eng.pdf?ua=1.
Last accessed March 2018.
[5] World Health Organization. Infographic. Available
at: http://www.euro.who.int/en/health-topics/communicable-diseases/hivaids/data-and-statistics/infographic-newly-diagnosed-hiv-infections-in-the-who-european-region,-2016.
Last accessed March 2018.
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: March
23, 2018
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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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