a2350a
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 September 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: 22 September 2022, London UK
GSK and Spero Therapeutics announce exclusive licence agreement for
tebipenem HBr, a late-stage antibiotic that may treat complicated
urinary tract infections
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The
exclusive licence allows GSK to commercialise tebipenem HBr in all
regions except for Japan and certain other Asian
countries
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Spero Therapeutics receives $66
million upfront, with potential for future milestone payments and
tiered royalties
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GSK to purchase $9 million in
shares of Spero common stock
GSK plc (LSE/NYSE: GSK) and Spero Therapeutics, Inc. (Nasdaq: SPRO)
today announced they have entered into an exclusive licence
agreement for tebipenem pivoxil hydrobromide (tebipenem HBr), a
late-stage antibiotic being developed by Spero, as the first oral
carbapenem antibiotic to potentially treat complicated urinary
tract infections (cUTI), including pyelonephritis, caused by
certain bacteria.
Luke Miels, Chief Commercial Officer, GSK, said: "There
is a high unmet medical need for a novel oral antibiotic as an
alternative to intravenous hospital therapy for drug-resistant
complicated urinary tract infections. Tebipenem HBr complements
GSK's infectious disease strategy and is consistent with our
commitment to find value-enhancing opportunities to build a strong
late-stage portfolio. Tebipenem HBr has a clear US FDA regulatory
path to potential approval, which could significantly benefit
patients with complicated urinary tract
infections."
"Spero's agreement with GSK provides a critical step towards fully
realising the value tebipenem HBr can potentially provide to
physicians, payors, and patients," said Ankit Mahadevia, M.D.,
Chief Executive Officer of Spero. "We are thrilled to collaborate with GSK on
developing tebipenem HBr for patients suffering from complicated
urinary tract infections. With their antibiotic expertise and
global commercial reach, GSK is ideally positioned to launch
tebipenem HBr following regulatory approval as the first oral
treatment for complicated urinary tract infections, providing
patients with an alternative to in-hospital intravenous therapy.
Tebipenem HBr's potential as an at-home, oral option can
potentially be of significant benefit by reducing hospital resource
utilisation. In addition, our partnership with GSK strengthens our
balance sheet and shareholder base."
Spero will start a new phase III clinical trial in 2023, following
encouraging US FDA regulatory feedback on the proposed clinical
trial design.
Financial terms
GSK will receive an exclusive licence to develop and commercialise
tebipenem pivoxil HBr in all countries except Japan and certain
other Asian countries that Spero partner Meiji Seika will retain.
Under the licence agreement, Spero will be responsible for the
execution and costs of the remaining phase III clinical trial of
tebipenem HBr. GSK will be responsible for the execution and costs
of additional clinical development, including regulatory submission
and commercialisation activities for tebipenem HBr in the countries
mentioned above.
Under the terms of the licence agreement, GSK will make an upfront
initial payment to Spero of $66 million to secure rights to the
medicine. Remaining potential payments are milestone-based, as
follows.
Event
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Milestone payments (up
to)
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Delivery of phase III programme
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$150m
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Total commercial milestone payments based on first sale
(US/EU)
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$150m
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Sales milestone events
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Net sales greater than $200m
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$25m
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Net sales greater than $300m
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$25m
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Net sales greater than $400m
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$25m
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Net sales greater than $500m
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$50m
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Net sales greater than $750m
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$50m
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Net sales greater than $1,000m
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$50m
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Total sales milestone payments:
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$225m
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Royalties
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Low-single digit to low-double digit (if sales exceed $1bn) tiered
royalties on net product sales.
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In connection with the licence agreement and under a stock purchase
agreement between GSK and Spero, GSK has agreed to make a $9
million investment in Spero common stock, purchasing 7,450,000
shares at a purchase price of approximately $1.20805 per share, not
to exceed 19.99% beneficial ownership of Spero by GSK and its
affiliates.
The transactions are expected to close in the fourth quarter of
2022, subject to customary closing conditions, including the
expiration of the waiting period under the Hart-Scott-Rodino
Antitrust Improvements Act of 1976, as amended. The closing of the
equity investment is conditioned upon the effectiveness of the
licence following Hart-Scott-Rodino clearance.
About tebipenem HBr
Tebipenem HBr (tebipenem pivoxil hydrobromide; formerly SPR994) is
Spero's novel late-stage development asset, an oral formulation of
tebipenem pivoxil, a carbapenem antibiotic of the b-lactam class
marketed by Meiji Seika Pharma Co. Ltd. (Meiji) in Japan as
Orapenem® since 2009 for paediatric infections limited to
pneumonia, otitis media and sinusitis. Carbapenems are an important
subclass of antibiotics because they have been observed to be safe
and effective in treating drug-resistant Gram-negative bacterial
infections. Tebipenem HBr is being developed to treat cUTIs,
including acute pyelonephritis caused by certain bacteria. If
approved, tebipenem HBr would be the first oral carbapenem
antimicrobial to receive marketing approval in the United States.
Tebipenem HBr has been granted Qualified Infectious Disease Product
(QIDP) and Fast Track designations by the US FDA for cUTI and acute
pyelonephritis treatment. Following feedback from the US FDA at
Spero's recent Type A meeting, Spero will conduct an additional
phase III trial to support the regulatory submission.
Tebipenem HBr research support
Select tebipenem HBr trials have been funded in part with federal
funds from the Department of Health and Human Services; Office of
the Administration for Strategic Preparedness and Response;
Biomedical Advanced Research and Development Authority, under
contract number HHSO100201800015C.
About Spero Therapeutics
Spero Therapeutics, headquartered in Cambridge, Massachusetts, is a
multi-asset, clinical-stage biopharmaceutical company focused on
identifying, developing, and commercializing novel treatments for
bacterial infections, including multi-drug resistant bacterial
infections and rare diseases.
●
Spero Therapeutics is developing
SPR720 as a novel oral therapy candidate for the treatment of a
rare, orphan pulmonary disease caused by non-tuberculous
mycobacterial infections.
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Spero Therapeutics also has an
IV-administered next-generation polymyxin product candidate,
SPR206, developed from its potentiator platform, which is in
development to treat multi-drug resistant Gram-negative infections
in the hospital setting.
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Tebipenem HBr is an
investigational drug in the United States being developed for the
treatment of cUTI, including pyelonephritis, caused by certain
bacteria, in adult patients with limited treatment options;
tebipenem HBr is not FDA-approved.
For more information, visit
https://sperotherapeutics.com.
GSK in antibiotics
GSK has been developing and supplying antibiotics for more than 70
years. Research and development continue to investigate new tools
to prevent and mitigate infectious disease - and get ahead of
antimicrobial resistance. GSK is already a leader on the
Antimicrobial Resistance Benchmark of the Access to Medicine
Foundation and participates in the AMR Action Fund, which aims to
bring 2-4 new antibiotics to patients by 2030
through sustainable investment in the antibiotic
pipeline.
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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Media:
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Tim Foley
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+44 (0) 20 8047 5502
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(London)
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Madeleine Breckon
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+44 (0) 20 8047 5502
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(London)
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Kathleen Quinn
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+1 202 603 5003
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(Washington DC)
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Lyndsay Meyer
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+1 202 302 4595
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(Washington DC)
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Investor Relations:
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Nick Stone
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+44 (0) 7717 618834
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(London)
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James Dodwell
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+44 (0) 20 8047 2406
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(London)
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Mick Readey
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+44 (0) 7990 339653
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(London)
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Josh Williams
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+44 (0) 7385 415719
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(London)
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Jeff McLaughlin
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+1 215 751 7002
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(Philadelphia)
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GSK
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.
Spero
forward-looking statements
This
press release may contain forward-looking statements. These
statements include, but are not limited to, statements about the
timing of the closing of the license and equity investment
transactions, the regulatory path forward for tebipenem HBr and
potential FDA approval, the potential commercialization of
tebipenem HBr and its future value, and the potential receipt of
milestone payments, and royalties on future sales under the license
agreement. In some cases, forward-looking statements can be
identified by terms such as "may," "will," "should," "expect,"
"plan," "aim," "anticipate," "could," "intent," "target,"
"project," "contemplate," "believe," "estimate," "predict,"
"potential" or "continue" or the negative of these terms or other
similar expressions. Actual results may differ materially from
those indicated by such forward-looking statements as a result of
various important factors, including Spero's and GSK's ability to
obtain antitrust clearance and close the proposed transactions in a
timely manner; whether tebipenem HBr will advance through the
clinical trial process on a timely basis, or at all, taking into
account the effects of possible regulatory delays, slower than
anticipated patient enrollment, manufacturing challenges, clinical
trial design and clinical outcomes; whether the results of such
trials will warrant submission for approval from the U.S. Food and
Drug Administration or equivalent foreign regulatory agencies;
whether the FDA will ultimately approve tebipenem HBr and, if so,
the timing of any such approval; whether the FDA will require any
additional clinical data or place labeling restrictions on the use
of tebipenem HBr that would delay approval and/or reduce the
commercial prospects of tebipenem HBr; whether a successful
commercial launch can be achieved and market acceptance of
tebipenem HBr can be established; and other factors discussed
in the "Risk Factors" set forth in filings that Spero periodically
makes with the U.S. Securities and Exchange Commission. The
forward-looking statements included in this press release represent
Spero's views as of the date of this press release. Spero
anticipates that subsequent events and developments will cause its
views to change. However, while Spero may elect to update these
forward-looking statements at some point in the future, it
specifically disclaims any obligation to do so. These
forward-looking statements should not be relied upon as
representing Spero's views as of any date subsequent to the date of
this press release.
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: September
22, 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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