a7869v
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 August 2022
Commission
File Number 001-15170
GSK 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: 11 August 2022, London UK
Statement: Zantac (ranitidine) litigation
● FDA
and EMA have concluded there is no evidence of a causal association
between ranitidine therapy and the development of
cancer.
● Substantial
scientific evidence supports FDA/EMA
conclusion.
● Plaintiff
litigation inconsistent with the scientific consensus, GSK will
vigorously defend all claims.
In response to recent speculative commentary regarding U.S. Zantac
litigation, GSK plc (LSE/NYSE: GSK) today
issued the following statement regarding Zantac (ranitidine) and
N-nitrosodimethylamine (NDMA).
There have
been no material developments to what has been previously
disclosed.
GSK, independent cancer researchers, the U.S. Food & Drug
Administration, and the European Medicines Agency, have all
undertaken extensive reviews of available data and conducted
numerous investigations into this issue since
2019.
Based on these investigations and experiments, GSK, the FDA, and
the EMA have all independently concluded that there is no evidence
of a causal association between ranitidine therapy and the
development of cancer in patients.
●
In
November 2019, the FDA determined that levels of NDMA in ranitidine
products are similar to levels in common foods like grilled and
smoked meats, and that it would conduct tests to fully understand
if ranitidine forms NDMA in the human body.
●
In
September 2020, the EMA's comprehensive review of epidemiological
and post marketing data concluded there is "no evidence of a causal
association between ranitidine therapy and the development of
cancer in patients."
●
In
June 2021, the FDA reported that its testing did not support that
ranitidine is converted to NDMA in a general, healthy population,
and after reviewing the epidemiological studies found that
"…no consistent signals emerged across studies, and studies
with comparison to active controls found no association between
ranitidine and overall or specific cancer risk."
These conclusions pertain to all forms of cancer, including but not
limited to bladder, breast, colorectal, esophageal, kidney, liver,
lung, pancreatic, prostate, and stomach. Even epidemiologic
experts hired by the Multi-District Litigation (MDL) Plaintiffs'
Steering Committee concluded in their expert reports that the
"evidence was not sufficient to support an opinion that use of
ranitidine can cause breast, prostate, kidney, lung, or colorectal
cancer."
Scientific Research
Since the issue concerning the presence of NDMA in ranitidine arose
in 2019, the scientific community has actively focused on
understanding whether there is a link between ranitidine and
cancer. There have been 11 epidemiological studies conducted in
that time looking at human data regarding the use of
ranitidine.
The resulting scientific consensus is that the totality of the
reliable evidence does not support that ranitidine increases the
risk of any type of cancer:
●
Adami
et al. (2021): "If a causal association existed, we would expect to
observe stronger associations with a larger number of prescriptions
and, most likely, with longer follow-up, yet such patterns were not
evident." "Our results, which do not support any carcinogenic
effect on esophagus, stomach, liver or pancreas, should be
reassuring for millions of concerned past users of
ranitidine."
●
Cardwell
et al. (2021): "[T]here was little evidence of difference in
bladder cancer risk when directly comparing ranitidine users with
users of non-ranitidine histamine-2 receptor agonists," but
"…the use of ranitidine particularly long term use was
associated with an increased risk of bladder cancer [compared to
non-use or PPIs]." Further studies are necessary to attempt
to replicate this finding.
●
Norgaard et al. (2021): Compared to H2RAs and
compared to PPIs, "we did not observe any consistent or substantial
increase in risks of bladder cancer and we consistently across
sub-analyses observed no increased risk [of] kidney cancer in
ranitidine users," and "we found no
dose-response association [with bladder cancer] when restricting to
persons who redeemed at least five and persons who redeemed at
least 10 prescriptions," and "starting follow-up time 10 years
after the 10th prescription
did not suggest any associations [with bladder
cancer]."
●
Iwagami
et al. (2021): "…we found no evidence of an increased risk of
cancer in people receiving ranitidine and nizatidine compared with
people receiving other H2 blockers overall, by follow-up length, by
cumulative dose, or by cancer site. These results may
alleviate concerns of patients exposed to ranitidine/nizatidine,
although further research with longer follow-up and including older
people may be needed."
●
Kantor
et al. (2021): "Ranitidine use was not associated with overall
cancer risk . . . [or] with risk of common cancers (lung, breast,
prostate, and colorectum). . . . Compared to non-use, ranitidine
use was positively associated with liver cancer; however, this
association was attenuated when directly compared to omeprazole,
which may reflect residual confounding by indication (or another
jointly-related factor)."
●
Kim
S. et al. (2021): "We found no significant difference in terms of
gastric cancer development among the three study groups (control,
other histamine-2 blockers, and ranitidine), suggesting that the
intake of ranitidine, even if it contains NDMA, may not be
associated with an increased risk of developing gastric
cancer."
●
Kumar
et al. (2021): "[O]ur results . . . demonstrate that the true
gastric carcinogenic impact of NDMA[1] containing ranitidine in
persons in the US with HP (H. pylori) is likely minimal to
nonexistent, providing reassurance to those who have taken
ranitidine . . . . In time-specific analyses, there was no period
in which ranitidine was associated with future GC [gastric cancer],
suggesting there is no discernable difference in formulation of the
medication over time." "There is no demonstrable association
between ranitidine use and future gastric cancer among individuals
with HP on long-term acid suppression."
●
Liu
et al. (2020): "Our results revealed a marked increase in the
prescription of acid-suppression medications immediately before
gastric cancer diagnosis suggesting the role of reverse
causation."
●
Kim
YD et al. (2021): "Use of ranitidine was not associated with an
increased odds of developing gastrointestinal malignancies compared
to omeprazole or famotidine use."
●
Yoon
et al. (2021): "We found no evidence that exposure to NDMA through
ranitidine increases the risk of
cancer."
●
McDowell
et al. (2021): "Only two medicines were significantly associated
with an increased risk of pancreatic cancer [metronidazole and
ranitidine]. However, neither exhibited strong evidence of an
exposure-response relationship with cancer
risk."
Litigation status
GSK has been named as a defendant in approximately 3,000 filed
personal injury cases in federal and state court and numerous
unfiled claims registered in a census established by the Court
presiding over the Zantac Multidistrict Litigation (MDL)
proceeding. Class actions alleging economic injury and a
third-party payer class action also have been filed in federal
court.
In the MDL, plaintiffs were required to identify the types of
cancer that they wished to pursue and identified 10 different
types. In November 2021, plaintiffs withdrew from consideration
breast cancer and kidney cancer, reducing the number of types of
cancer from 10 to 8. In January 2022, the MDL plaintiffs withdrew
from consideration colorectal, prostate, and lung and will proceed
only as to the following five types of cancer: bladder, esophageal,
gastric, liver, and pancreatic, although plaintiffs in state courts
continue to pursue these claims.
On 6 February 2020, the US product liability litigation was
assigned MDL status in the Southern District of Florida. The Group
has filed several rounds of Motions to Dismiss in the MDL resulting
in the following position: 1) the Court ruled in favour of the
Group's motion on innovator liability; that issue is on appeal; 2)
the Court ruled in favour of Defendants with respect to the Third
Party Payor Class Action; Plaintiffs opted not to replead their
action and these issues are now on appeal; 3) the Court dismissed
RICO claims from the Economic Loss Class Action but allowed the
class to move forward on plaintiffs misbranding theory; and 4) the
Medical Monitoring and Economic Loss class actions are allowed to
move forward. Generics, retailers, and packagers have been
dismissed from the cases.
Outside the US, there are several class actions and in excess of
100 personal injury cases pending against GSK in Canada, along with
a class action in Israel. Among the state court cases naming GSK, a
trial in California is currently scheduled to begin 13 February
2023 and trials in Madison County, Illinois are to proceed on 22
August 2022 and February 2023.
Whilst GSK has served Haleon with notice of potential claims in
relation to possible liabilities connected to OTC Zantac under the
relevant indemnification provisions, contained in the documentation
relating to the formation of the Consumer Healthcare JV, it is not
possible, at this stage, to meaningfully assess whether the outcome
will result in a probable outflow, or to quantify or reliably
estimate what liability (if any) that Haleon may have to GSK under
the relevant indemnities.
The overwhelming weight of the scientific evidence supports the
conclusion that there is no increased cancer risk associated with
the use of ranitidine. Suggestions to the contrary are therefore
inconsistent with the science, and GSK will vigorously defend
itself against all meritless claims alleging
otherwise.
About GSK
GSK is a global biopharma company with a purpose to unite science,
technology, and talent to get ahead of disease together. Find out
more at gsk.com/company
GSK enquiries
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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 in the Company's
Annual Report on Form 20-F for 2021, GSK's Q2 Results for 2022 and
any impacts of the COVID-19 pandemic.
Registered in England & Wales:
No.
3888792
Registered Office:
980
Great West Road
Brentford,
Middlesex
TW8
9GS
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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GSK plc
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(Registrant)
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Date: August
12, 2022
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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 GSK plc
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