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
as permitted by Regulation S-T Rule 101(b)(7): ____
Issued: 21 December 2019, London UK - LSE Announcement
ViiV Healthcare receives complete response letter from US FDA for
use of investigational cabotegravir and rilpivirine long-acting
regimen in the treatment of HIV
London, 21 December 2019 -
ViiV Healthcare, the global specialist HIV company majority owned
by GSK, with Pfizer Inc. and Shionogi Limited as shareholders,
received a complete response letter (CRL) from the US Food and Drug
Administration (FDA) regarding its application for cabotegravir and
rilpivirine long-acting regimen for treatment of HIV-1 infection in
virologically suppressed adults.
The reasons given in the CRL relate to Chemistry Manufacturing and
Controls (CMC). There have been no reported safety issues related
to CMC and there is no change to the safety profile of the products
used in clinical trials to date. ViiV Healthcare will work
closely with the FDA to determine the appropriate next steps for
this New Drug Application.
Cabotegravir is an integrase strand transfer
inhibitor developed by ViiV Healthcare and rilpivirine is
a non-nucleoside reverse transcriptase
inhibitor developed by Janssen Sciences Ireland UC.
The cabotegravir and rilpivirine long-acting regimen is an
investigational product and not approved anywhere in the
world.
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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Audrey Abernathy
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+1 919 605 4521
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Stephen Rea
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+44 78 8126 9009
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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:
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Kathleen Quinn
Sarah Elton-Farr
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+1 202 603 5003
+44 (0) 20 8047 5194
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Danielle Smith
James Dodwell
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+44 (0) 20 8047 0932
+44 (0) 20 8047 2406
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Jeff McLaughlin
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+1 215 751 7002
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This announcement contains inside information for the purposes of
Article 7 of EU Regulation 596/2014. The person responsible for
arranging the release of this announcement on behalf of GSK is V.A.
Whyte, Company Secretary.
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
23, 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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