TIDMGSK
RNS Number : 2349A
GSK PLC
22 September 2022
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
-- The exclusive licence allows GSK to commercialise tebipenem
HBr in all regions except for Japan and certain other Asian
countries
-- Spero Therapeutics receives $66 million upfront, with
potential for future milestone payments and tiered royalties
-- 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 Milestone payments (up
to)
Delivery of phase III programme $150m
-------------------------------
Total commercial milestone
payments based on first
sale (US/EU) $150m
-------------------------------
Sales milestone events
-------------------------------
Net sales greater than
$200m $25m
-------------------------------
Net sales greater than
$300m $25m
-------------------------------
Net sales greater than
$400m $25m
-------------------------------
Net sales greater than
$500m $50m
-------------------------------
Net sales greater than
$750m $50m
-------------------------------
Net sales greater than
$1,000m $50m
-------------------------------
Total sales milestone payments: $225m
-------------------------------
Royalties Low-single digit to low-double
digit (if sales exceed
$1bn) tiered royalties
on net product sales.
-------------------------------
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
<BETA>-lactam class marketed by Meiji Seika Pharma Co. Ltd.
(Meiji) in Japan as Orapenem(R) 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.
-- 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.
-- 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
Media: Tim Foley +44 (0) 20 8047 (London)
5502
Madeleine Breckon +44 (0) 20 8047 (London)
5502
Kathleen Quinn +1 202 603 5003 (Washington DC)
Lyndsay Meyer +1 202 302 4595 (Washington DC)
Investor Relations: Nick Stone +44 (0) 7717 618834 (London)
James Dodwell +44 (0) 20 8047 (London)
2406
Mick Readey +44 (0) 7990 339653 (London)
Josh Williams +44 (0) 7385 415719 (London)
Jeff McLaughlin +1 215 751 7002 (Philadelphia)
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
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
RNS may use your IP address to confirm compliance with the terms
and conditions, to analyse how you engage with the information
contained in this communication, and to share such analysis on an
anonymised basis with others as part of our commercial services.
For further information about how RNS and the London Stock Exchange
use the personal data you provide us, please see our Privacy
Policy.
END
MSCDDGDCISDDGDB
(END) Dow Jones Newswires
September 22, 2022 02:00 ET (06:00 GMT)
Gsk (LSE:GSK)
Historical Stock Chart
From Feb 2024 to Mar 2024
Gsk (LSE:GSK)
Historical Stock Chart
From Mar 2023 to Mar 2024