GSK (LSE/NYSE: GSK) and Spero Therapeutics, Inc. (Nasdaq:
SPRO) today announced they have entered into an exclusive license
agreement for Spero’s late-stage antibiotic asset, tebipenem HBr.
Tebipenem HBr is being developed as the first oral carbapenem
antibiotic for the treatment of 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 realizing 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 cUTI. 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 cUTI, providing patients with an alternative to
in-hospital intravenous (IV) therapy. Tebipenem HBr’s potential as
an at-home, oral option can potentially be of significant benefit
by reducing hospital resource utilization. In addition, our
partnership with GSK strengthens our balance sheet and shareholder
base.”
Spero expects to start a new phase 3 clinical trial in
2023, following encouraging US FDA regulatory feedback on the
proposed clinical trial design.
Financial Terms
GSK will receive an exclusive license to develop
and commercialize tebipenem pivoxil and tebipenem pivoxil HBr in
all territories, except Japan, and certain other Asian countries,
territories which will be retained by Spero partner, Meiji Seika.
Under the license agreement, Spero will be responsible for the
execution and costs of the follow-up Phase 3 clinical trial of
tebipenem HBr. GSK will be responsible for the execution and costs
of additional development, including Phase III regulatory filing
and commercialization activities for tebipenem HBr outside of the
Meiji Seika territory.
Under the terms of the license agreement, Spero
will receive an upfront payment of $66 million for GSK to secure
rights to the medicine. Remaining potential payments are milestone
based, and are 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 license agreement and
pursuant to a stock purchase agreement between GSK and Spero, GSK
has agreed to make a $9 million common stock investment in Spero,
purchasing 7,450,000 shares of Spero’s common stock 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 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 license following Hart-Scott-Rodino
clearance.
As of June 30, 2022, Spero had cash, cash
equivalents, and marketable securities of $45.4 million. Based on
the previously announced restructuring and the cessation of
commercialization activities for the tebipenem HBr program, along
with the initial cash payment of $66 million from the GSK licensing
transaction, Spero believes that its current cash runway will be
sufficient to fund the company beyond 2024.
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 β-lactam class marketed by Meiji Seika Pharma Co. Ltd.
(Meiji) in Japan as Orapenem® since 2009 for
pediatric 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 the
treatment of drug-resistant Gram-negative bacterial
infections. Tebipenem HBr is being developed for the treatment
of complicated urinary tract infections, including acute
pyelonephritis (AP), 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 Food and Drug Administration
(FDA) for the treatment of cUTI and AP. Following feedback
from the FDA, at Spero’s recent Type A meeting, Spero will conduct
an additional Phase 3 trial to support the regulatory file.
Tebipenem HBr Research
Support
Select tebipenem HBr studies 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 GSKGSK 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 in Antibiotics
GSK has been developing and supplying
antibiotics for more than 70 years, and research and development
continues 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 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 who
have limited treatment options; tebipenem HBr is not
FDA-approved.
For more information,
visit https://sperotherapeutics.com.
GSK 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 Therapeutics 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, the
potential receipt of milestone payments, and royalties on future
sales under the license agreement and Spero’s cash runway. 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 FDA 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; whether Spero’s cash resources
will be sufficient to fund its continuing operations for the
periods and/or trials anticipated; 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.
Investor Relations: Ted JenkinsVice
President, Investor RelationsTJenkins@sperotherapeutics.com (617)
798-4039
Media Inquiries: Matt Dick, Health Media
RelationsZeno Groupmatt.dick@zenogroup.com301-509-8532
Spero Therapeutics (NASDAQ:SPRO)
Historical Stock Chart
From Mar 2024 to Apr 2024
Spero Therapeutics (NASDAQ:SPRO)
Historical Stock Chart
From Apr 2023 to Apr 2024