TIDMGSK
RNS Number : 6995K
GlaxoSmithKline PLC
23 September 2016
Issued: 23 September 2016, London UK - LSE Announcement
GSK announces US regulatory submission for sirukumab in
rheumatoid arthritis
GlaxoSmithKline plc (LSE/NYSE: GSK) today announced the
submission of a Biologics License Application (BLA) to the United
States Food and Drug Administration (FDA) by Janssen Biotech, Inc.,
(JBI), seeking approval of a subcutaneous formulation of sirukumab,
a human anti-interleukin (IL)-6 monoclonal antibody, for the
treatment of adult patients with moderately to severely active
rheumatoid arthritis (RA) who have failed or are intolerant to one
or more disease-modifying antirheumatic drugs (DMARDs).
Sirukumab is being co-developed for RA as part of a
collaboration with Janssen Biologics (Ireland) ("Janssen"), an
affiliate of JBI.
Paul-Peter Tak, GSK's Chief Immunology Officer & Senior Vice
President R&D Pipeline, said: "We are pleased with the progress
being made to seek regulatory approval of sirukumab in adult
patients who, despite the use of conventional and biologic
therapies, still suffer from moderately to severely active
rheumatoid arthritis. If approved, sirukumab would provide these
patients with another treatment option. This US submission follows
one made for Europe earlier this month and we look forward to the
outcome of the regulatory authority reviews."
Sirukumab is an investigational human monoclonal IgG1 kappa
antibody that selectively binds with high affinity to the IL-6
cytokine, a naturally occurring protein that plays a role in
autoimmune conditions. It is one of the 40 assets profiled to
investors at GSK's R&D event in November 2015 and belongs to
the company's immuno-inflammation portfolio - one of six core areas
of scientific research and development alongside oncology, vaccines
and infectious, respiratory and rare diseases.
Approval is being sought for the subcutaneous formulation of
sirukumab in two presentations, a single-dose prefilled syringe and
a single-dose autoinjector. The data to support the file are based
on a comprehensive phase III clinical development programme
involving more than 3,000 patients.
A regulatory submission to the European Medicines Agency (EMA)
was announced on
12 September 2016. Sirukumab is currently not approved as a
treatment for any indication anywhere in the world.
About the phase III clinical programme in rheumatoid
arthritis
The phase III clinical programme in patients with active RA
includes five studies investigating sirukumab 50mg and 100mg
administered subcutaneously in combination with conventional DMARDs
or as a monotherapy every four or two weeks, respectively. Data has
been generated from the completed and ongoing studies to support
the file.
- SIRROUND-D study: in patients who had an inadequate response
to disease-modifying antirheumatic drugs (DMARDs).
- SIRROUND-T study: in patients who had an inadequate response
or were intolerant to anti-TNF<ALPHA> agents
- SIRROUND-H study: in patients with an inadequate response or
were intolerant to methotrexate (MTX) or for whom MTX was
inappropriate.
- SIRROUND-M study: in Japanese patients who had an inadequate
response to MTX or sulfasalazine.
- SIRROUND-LTE study: a long-term extension study for patients
completing SIRROUND-D and SIRROUND-T.
Top-line results of SIRROUND-D, SIRROUND-T and SIRROUND-H were
announced in December 2015 and primary results from the SIRROUND-D
study were announced in June 2016. Primary results from the
SIRROUND-T and SIRROUND-H studies will be presented at an upcoming
scientific congress. Complete results for all studies will be
submitted for publication in peer-reviewed journals.
About the collaboration
In December 2011, GSK and Janssen entered into a licensing and
co-development agreement with respect to sirukumab. Under the
terms, GSK has exclusive rights to commercialise sirukumab in
North, Central and South America, while Janssen retains
commercialisation rights in the rest of the world, including
Europe. Global profit will be shared equally between the two
companies. Prior to the agreement, Janssen had been developing
sirukumab for RA.
As part of the collaboration, a phase III programme began in
August 2012 to investigate sirukumab for the treatment of
moderately to severely active RA.
Janssen is responsible for the FDA and EMA regulatory files. The
collaboration gives both companies the option to investigate
sirukumab for other indications beyond RA. An ongoing GSK phase III
study, announced in November 2015, is currently investigating
sirukumab in Giant Cell Arteritis. In addition, plans to start a
phase II study for asthma in 2016 were disclosed at GSK's R&D
day.
About rheumatoid arthritis
Rheumatoid arthritis is a chronic, systemic inflammatory
condition that is characterised by pain, joint swelling, stiffness,
joint destruction, disability and decreased quality of life. It is
estimated more than 23.5 million people worldwide are affected by
the condition, for which there is no cure.
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:
UK Media enquiries: Simon Steel +44 (0) 20 (London)
8047 5502
David Daley +44 (0) 20 (London)
8047 5502
Namrata Taak +44 (0) 20 (London)
8047 5502
US Media enquiries: Sarah Spencer +1 215 751 (Philadelphia)
3335
Mary Anne +1 919 483 (North
Rhyne 0492 Carolina)
Jenni Ligday +1 202 715 (Washington,
1049 DC)
Analyst/Investor Ziba Shamsi +44 (0) 20 (London)
enquiries: 8047 5543
Tom Curry + 1 215 751 (Philadelphia)
5419
Gary Davies +44 (0) 20 (London)
8047 5503
James Dodwell +44 (0) 20 (London)
8047 2406
Jeff McLaughlin +1 215 751 (Philadelphia)
7002
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 'Risk factors'
in the company's Annual Report on Form 20-F for
2015.
Registered in England & Wales:
No. 3888792
Registered Office:
980 Great West Road
Brentford, Middlesex
TW8 9GS
This information is provided by RNS
The company news service from the London Stock Exchange
END
MSCSESFFDFMSELU
(END) Dow Jones Newswires
September 23, 2016 08:00 ET (12:00 GMT)
Gsk (LSE:GSK)
Historical Stock Chart
From Apr 2024 to May 2024
Gsk (LSE:GSK)
Historical Stock Chart
From May 2023 to May 2024