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 April 2022
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: 13 April 2022, London UK
GSK reaches agreement to acquire late-stage biopharmaceutical
company Sierra Oncology for $1.9bn
● Sierra Oncology's differentiated momelotinib has
the potential to address the critical unmet medical needs of
myelofibrosis patients with anaemia
● Momelotinib complements GSK's existing expertise
in haematology, with Sierra Oncology anticipating US regulatory
submission in Q2 this year and EU submission in the second half of
2022
● Sales contribution expected to start in 2023 with
significant growth potential thereafter
● Supports development of strong portfolio of new
specialty medicines and vaccines
GlaxoSmithKline plc (LSE/NYSE: GSK) and Sierra Oncology, Inc
(Nasdaq: SRRA) today announced that the companies have entered into
an agreement under which GSK will acquire Sierra Oncology, a
California-based, late-stage biopharmaceutical company focused on
targeted therapies for the treatment of rare forms of cancer, for
$55 per share of common stock in cash representing an approximate
total equity value of $1.9 billion (£1.5
billion).
Myelofibrosis is a fatal cancer of the bone marrow impacting the
normal production of blood cells. Anaemia represents a high
unmet medical need in patients with myelofibrosis. At diagnosis,
approximately 40% of patients are already anaemic, and it is
estimated that nearly all patients will eventually develop
anaemia.[1],[2] Patients
treated with the most commonly used JAK inhibitor will often
require transfusions, and more than 30% will discontinue treatment
due to anaemia.[3] Anaemia
and transfusion dependence are strongly correlated with poor
prognosis and decreased overall survival.[4]
Momelotinib has a differentiated mode of action
with inhibitory activity along key signalling
pathways. This activity may lead to beneficial treatment
effects on anaemia and reduce the need for transfusions while also
treating symptoms. In January 2022, Sierra Oncology announced
positive topline results from the MOMENTUM phase III trial. The
study met all its primary and key secondary endpoints,
demonstrating that momelotinib achieved a statistically significant
and clinically meaningful benefit on symptoms, splenic response,
and anaemia.
Luke Miels, Chief Commercial Officer, GSK said: "Sierra Oncology complements our commercial
and medical expertise in haematology. Momelotinib offers a
differentiated treatment option that could address the
significant unmet medical needs of myelofibrosis patients with
anaemia, the major reason patients discontinue treatment. With
this proposed acquisition, we have the opportunity to potentially
bring meaningful new benefits to patients and further strengthen
our portfolio of specialty medicines."
Stephen Dilly, MBBS, PhD, President and Chief Executive Officer,
Sierra Oncology said:
"Uniting with GSK creates the best opportunity for Sierra Oncology
to realise its mission of delivering targeted therapies that treat
rare forms of cancer while also delivering compelling and certain
value for our stockholders. Now we have a partner with a global
infrastructure and oncology expertise that enables us to deliver
momelotinib to patients as quickly as possible and on a global
scale."
Momelotinib complements GSK's Blenrep (belantamab mafodotin), building on GSK's
commercial and medical expertise in haematology. The proposed
acquisition aligns with GSK's strategy of building a strong
portfolio of new specialty medicines and vaccines. If the
transaction is completed and momelotinib is approved by
regulatory authorities, GSK expects momelotinib will
contribute to GSK's growing specialty medicines business, with
sales expected to begin in 2023, with significant growth potential
and a positive benefit to the Group's adjusted operating margin in
the medium term.
Financial considerations
Under the terms of the agreement, the acquisition will be effected
through a one-step merger in which the shares of Sierra Oncology
outstanding will be cancelled and converted into the right to
receive $55 per share in cash. Subject to customary
conditions, including the approval of the merger by at least a
majority of the issued and outstanding shares of Sierra Oncology,
and the expiration or earlier termination of the waiting period
under the Hart-Scott-Rodino Antitrust Improvements Act of
1976, the transaction is expected to close in the third
quarter of 2022 or before.
The per share price represents a premium of approximately 39 per
cent to Sierra Oncology's closing stock price on 12 April
2022 and a premium of approximately 63 per cent to
Sierra's volume-weighted
average price (VWAP) over the last 30 trading days. Sierra Oncology's Board of
Directors has unanimously recommended that Sierra's stockholders
vote in favour of the approval of the merger. Additionally,
stockholders of Sierra Oncology holding approximately 28 per cent
of Sierra's outstanding shares, have agreed to vote their shares in
favour of approval of the merger.
GSK will account for the transaction as a business combination and
expects it to be accretive to adjusted EPS in 2024, the expected
first full year of momelotinib's sales. New GSK reaffirms its
full-year 2022 guidance, the medium-term outlook for 2021-2026 of
more than 5% sales and 10% adjusted operating profit CAGR* at
CER**, and long-term sales ambition.
The value of the gross assets of Sierra Oncology to be acquired (as
of 31 December 2021) is $109 million (£83 million at the rate
of £1 = $1.312, being the 31 March 2022 spot rate). The net
losses of the business were $95 million for the 12 months ended 31
December 2021 (£70 million, at the rate of £1 = $1.38,
being the average rate for the period).
* CAGR: Compound Annual Growth Rate; **CER: Constant Exchange
Rate
Advisors
PJT Partners is acting as financial advisor and Cleary Gottlieb
Steen & Hamilton LLP is serving as legal counsel to GSK in
connection with the transaction. Lazard is acting as financial
advisor and Wilson Sonsini Goodrich & Rosati, is serving as
legal counsel to Sierra Oncology.
About Sierra Oncology
Sierra Oncology is a late-stage biopharmaceutical company based in
San Mateo, California, on a mission to deliver targeted therapies
that treat rare forms of cancer. In addition to momelotinib, the
pipeline consists of two assets in phase I SRA515 and SRA737.
SRA515 is a selective bromodomain-containing protein 4 (BRD4)
bromodomain and extra-terminal domain (BET) inhibitor with a novel
bivalent binding mode that inhibits both protein bromodomains, and
SRA737 is a novel checkpoint kinase 1 (CHK1)
inhibitor.
About myelofibrosis
Myelofibrosis is a fatal disorder of the bone marrow where fibrous
scar tissue gradually replaces normal bone marrow, limiting its
ability to make blood cells (haematopoiesis). This may cause
anaemia (reduced red blood cells), leading to shortness of breath
or fatigue; increased risk of infection due to decreased white
blood cells; or increased risk of bleeding or bruising due to
reduced platelet counts. Organs such as the spleen or liver may
start to produce blood cells. This is known as extramedullary
haematopoiesis, which causes splenomegaly or hepatomegaly (enlarged
spleen or liver). Myelofibrosis affects approximately 20,000
patients in the US.
About momelotinib
Momelotinib has a differentiated mode of action with inhibitory
ability along three key signalling
pathways: activin A receptor,
type I (ACVR1)/activin receptor-like
kinase-2 (ALK2), Janus kinase
(JAK) 1, and JAK2. This
activity may lead to beneficial treatment effects on anaemia and
reduce transfusion dependence while treating myelofibrosis symptoms
and splenic response.
About the MOMENTUM phase III trial
MOMENTUM is a global, randomised, double-blind phase III clinical
trial of momelotinib versus danazol in patients with myelofibrosis.
Patients were symptomatic and anaemic and had been previously
treated with an FDA-approved JAK inhibitor. The study was designed
to evaluate the safety and efficacy of momelotinib for the
treatment and reduction of the key hallmarks of the disease:
symptoms, blood transfusions (due to anaemia) and
splenomegaly.
The primary endpoint of the study was a Total Symptom Score (TSS)
reduction of ≥50% over the 28 days immediately before the end
of Week 24 compared to baseline TSS, using the Myelofibrosis
Symptom Assessment Form (MFSAF). Secondary endpoints included
Transfusion Independence (TI) rate for ≥12 weeks immediately
before the end of Week 24 with maintained haemoglobin levels
≥ 8 g/dL and Splenic Response Rate (SRR) based on splenic
volume reduction of ≥35% at Week 24. The study enrolled 195
patients based on a planned 180 patients across 21
countries.
Danazol was selected as the treatment comparator, given its use to
ameliorate anaemia in patients with myelofibrosis, as recommended
by the National Comprehensive Cancer Network (NCCN) and the
European Society of Medical Oncology (ESMO) guidelines. Patients
were randomized 2:1 (momelotinib n = 130 and DAN n = 65) to receive
either momelotinib or danazol. After 24 weeks of treatment,
patients on danazol were allowed to cross over to receive
momelotinib. Early cross over to momelotinib was available for
confirmed symptomatic splenic progression.
In January 2022, Sierra Oncology reported top-line results from the
MOMENTUM phase III trial showing that the study met the primary
endpoint of TSS reduction of ≥50% with 25% in the
momelotinib arm versus 9% in the control arm (p=0.0095).
Additionally, the trial met its secondary endpoints of TI with 31%
in the momelotinib arm versus 20% in the control arm (one-sided
p=0.0064; non-inferiority) and SRR based on splenic volume
reduction of ≥35% with 23% in the momelotinib arm versus
3% in the control arm (p=0.0006). Grade 3 or worse adverse events
in the randomised treatment period were 54% in the momelotinib arm
and 65% in the control arm. Serious treatment-emergent adverse
events were 35% in the momelotinib arm and 40% in the control
arm.
These data will support Sierra Oncology's planned regulatory
submissions with health authorities. The complete data from the
MOMENTUM phase III trial will be presented at a forthcoming medical
conference.
Additional information and where to find it
This communication is being made in respect of the proposed
acquisition of Sierra Oncology, Inc. ("Sierra") by GlaxoSmithKline
plc ("GSK"). In connection with the proposed acquisition,
Sierra intends to file with the Securities and Exchange Commission
(the "SEC") and mail to its stockholders a proxy statement (the
"Proxy Statement") in connection with the solicitation of proxies
to approve the transaction. Sierra's stockholders
are urged to read the Proxy Statement and any other relevant
documents filed with the SEC or delivered to Sierra's stockholders
in connection with the transaction when such materials become
available because they will contain important information
about the transaction and the parties to the
transaction. The Proxy Statement and all
other documents filed by or caused to be filed by Sierra with the
SEC will be available at no charge on the SEC's website at
www.sec.gov. You may read and copy those documents or other
information filed by Sierra at the SEC public reference room at 100
F Street, N.E., Washington, D.C. 20549. Please call the SEC at
1-800-0330 for further information on the public reference room. A
free copy of the Proxy Statement and all other documents filed by
or caused to be filed by Sierra with the SEC will also be available
by visiting Sierra's website (https://www.sierraoncology.com).
Participants in the Solicitation
Sierra, GSK, and certain of their respective directors and
executive officers may be deemed to be participants in the
solicitation of proxies from Sierra's stockholders with respect to
the proposed acquisition. Information about Sierra's directors and
executive officers is available in Sierra's proxy statement dated
April 23, 2021 for its 2021 Annual Meeting of Stockholders.
Information about GSK's directors and executive officers can be
found in GSK's Annual Report on Form 20-F for 2021. Other
information regarding the participants in the proxy solicitation
and a description of their direct and indirect interests, by
security holdings or otherwise, will be contained in the Proxy
Statement and all other relevant materials to be filed with the SEC
or delivered to Sierra's stockholders regarding the proposed
combination when such materials become available. Sierra's
stockholders are urged to read such materials when they become
available
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 GSK's Annual
Report on Form 20-F for 2021 and any impacts of the COVID-19
pandemic.
Definitions of Adjusted results, CER growth, CAGR and new GSK are
set out on pages 61 and 62 of GSK's fourth quarter 2021 earnings
release and pages 56 and 59 of the GSK 2021 Annual Report.
The assumptions and basis for GSK's Guidance and Outlook are set
out on page 69 of the GSK 2021 Annual Report.
This communication includes forward-looking statements related to
Sierra, momelotinib and the acquisition of Sierra by GSK, that are
subject to risks, uncertainties and other factors. All statements
other than statements of historical fact are statements that could
be deemed forward-looking statements, including all statements
regarding the intent, belief or current expectation of Sierra and
members of its senior management team and can typically be
identified by words such as "believe," "expect," "estimate,"
"predict," "target," "potential," "likely," "continue," "ongoing,"
"could," "should," "intend," "may," "might," "plan," "seek,"
"anticipate," "project" and similar expressions, as well as
variations or negatives of these words. Forward-looking statements
include, without limitation, statements regarding the business
combination, similar transactions, prospective performance, future
plans, events, expectations, performance, objectives and
opportunities and the outlook for Sierra's business; the commercial
success of Sierra's products; the anticipated timing of clinical
data and regulatory filings or approvals relating to products; the
possibility of favourable or unfavourable results from clinical
trials; the anticipated benefits of the acquisition; filings and
approvals relating to the transaction; the expected timing of the
completion of the transaction; the parties' ability to complete the
transaction; and the accuracy of any assumptions underlying any of
the foregoing. Investors are cautioned that any such
forward-looking statements are not guarantees of future performance
and involve risks and uncertainties and are cautioned not to place
undue reliance on these forward-looking statements. Actual results
may differ materially from those currently anticipated due to a
number of risks and uncertainties. Risks and uncertainties that
could cause the actual results to differ from expectations
contemplated by forward-looking statements include: uncertainties
as to the timing of the completion of the merger; the possibility
that various closing conditions for the transaction may not be
satisfied or waived, including that the required approval of
Sierra's stockholders may not be obtained or that required
regulatory approvals may not be obtained or are obtained subject to
conditions that are not anticipated; the occurrence of any event,
change or other circumstance that could give rise to the
termination of the merger agreement; the failure to realize
anticipated benefits of the proposed acquisition when expected or
at all; potential adverse reactions or changes to business
relationships resulting from the proposed acquisition, including
the effect of the announcement on the ability of Sierra to retain
and hire key personnel; risks that the proposed acquisition
disrupts the current plans and operations of Sierra; transaction
costs; risks associated with potential litigation related to the
transaction; and other risks and uncertainties described from time
to time in documents filed with the SEC by Sierra, including
current reports on Form 8-K, quarterly reports on Form 10-Q and
annual reports on Form 10-K, as well as the proxy statement to be
filed by Sierra, or in GSK's Annual Report on Form 20-F for 2021
filed with the SEC by GSK. All forward-looking statements are based
on information currently available to GSK and Sierra, and neither
GSK nor Sierra assumes any obligation to update any forward-looking
statements.
About GSK
GSK is a science-led global healthcare company. For further
information please visit www.gsk.com/about-us.
GSK enquiries:
|
|
|
|
Media
enquiries:
|
Tim
Foley
|
+44 (0)
20 8047 5502
|
(London)
|
|
Dan
Smith
|
+44 (0)
20 8047 5502
|
(London)
|
|
Kristen
Neese
|
+1 804
217 8147
|
(Philadelphia)
|
|
Kathleen
Quinn
|
+1 202
603 5003
|
(Washington
DC)
|
|
Lyndsay
Meyer
|
+1 202
302 4595
|
(Washington
DC)
|
|
|
|
|
Analyst/Investor
enquiries:
|
Nick
Stone
|
+44 (0)
7717 618834
|
(London)
|
|
Sonya
Ghobrial
|
+44 (0)
7392 784784
|
(Consumer)
|
|
James
Dodwell
|
+44 (0)
20 8047 2406
|
(London)
|
|
Mick
Readey
|
+44 (0)
7990 339653
|
(London)
|
|
Josh
Williams
|
+44 (0)
7385 415719
|
(London)
|
|
Jeff
McLaughlin
|
+1 215
751 7002
|
(Philadelphia)
|
|
Frannie
DeFranco
|
+1 215
751 4855
|
(Philadelphia)
|
Registered in England & Wales:
No.
3888792
Registered Office:
980
Great West Road
Brentford,
Middlesex
TW8
9GS
[1] Naymagon L et al.
HemaSphere (2017) 1:1(e1)
[2]Journal of Hematology &
Oncology volume 15, Article number: 7 (2022)
[3] Ruxolitinib
discontinuation syndrome: incidence, risk factors, and management
in 251 patients with myelofibrosis | Blood Cancer Journal
(nature.com)
[4] Prognostic
relevance of anemia and transfusion dependency in myelodysplastic
syndromes and primary myelofibrosis - PMC
(nih.gov)
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.
|
GlaxoSmithKline plc
|
|
(Registrant)
|
|
|
Date: April
13, 2022
|
|
|
|
|
By:/s/ VICTORIA
WHYTE
--------------------------
|
|
|
|
Victoria Whyte
|
|
Authorised
Signatory for and on
|
|
behalf
of GlaxoSmithKline plc
|
GSK (NYSE:GSK)
Historical Stock Chart
From Sep 2024 to Oct 2024
GSK (NYSE:GSK)
Historical Stock Chart
From Oct 2023 to Oct 2024