Spero Therapeutics Announces Closing of Exclusive License Agreement with GSK for Tebipenem HBr
November 08 2022 - 8:05AM
Spero Therapeutics, Inc. (Nasdaq: SPRO) (Spero), a multi-asset
clinical-stage biopharmaceutical company, focused on identifying,
developing and commercializing treatments in high unmet need areas
involving rare diseases and multi-drug resistant (MDR) bacterial
infections, today announced the closing of its previously announced
exclusive license agreement with GlaxoSmithKline Intellectual
Property (No. 3) Limited (LSE/NYSE: GSK) (GSK) for tebipenem HBr,
an investigational drug being developed as the potentially first
oral carbapenem antibiotic for the treatment of complicated urinary
tract infections (cUTI), including pyelonephritis, caused by
certain bacteria.
Pursuant to the license agreement, Spero will be
receiving a $66 million upfront payment from GSK and is eligible to
receive up to $525 million in development, sales, and commercial
milestones payments, as well as low-single digit to low-double
digit tiered royalties on net product sales. In exchange, GSK has
been granted 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. In connection with
closing, pursuant to the license agreement and a previously
announced stock purchase agreement between the parties, an
affiliate of GSK has purchased 7,450,000 shares of Spero’s common
stock at a purchase price of $1.20805 per share, resulting in gross
proceeds to Spero of approximately $9 million.
Under the terms of the license agreement, Spero
is responsible for the execution and costs of a follow-up Phase 3
clinical trial of tebipenem HBr. GSK is responsible for the
execution and costs of additional development, including Phase 3
regulatory filing and commercialization activities for tebipenem
HBr outside of the Meiji Seika territory.
About Spero TherapeuticsSpero
Therapeutics, headquartered in Cambridge, Massachusetts, is a
multi-asset, clinical-stage biopharmaceutical company focused on
identifying, developing, and commercializing novel treatments for
serious bacterial infections, including MDR bacterial infections
and rare diseases.
- Spero Therapeutics is developing SPR720 as a novel
investigational oral candidate antimicrobial for the treatment of a
rare, orphan pulmonary disease caused by non-tuberculous
mycobacterial infections.
- Tebipenem HBr is an investigational oral carbapenem candidate
antimicrobial in development for the treatment of cUTI, including
pyelonephritis, including infections caused by MDR pathogens in
adult patients who have limited oral treatment options; tebipenem
HBr is not FDA-approved.
- Spero Therapeutics is developing SPR206 as an investigational
intravenous-administered next-generation polymyxin product
candidate developed from its potentiator platform, which is in
development to treat MDR Gram-negative infections in the hospital
setting.
For more information,
visit https://sperotherapeutics.com.
Forward Looking StatementsThis
press release may contain forward-looking statements. These
statements include, but are not limited to, statements about 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 the
design, initiation, timing, progress and results of Spero's
preclinical studies and clinical trials and its research and
development programs. 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 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 results obtained in
preclinical studies and clinical trials will be indicative of
results obtained in future clinical trials; Spero's reliance on
third parties to manufacture, develop, and commercialize its
product candidates, if approved; the ability to commercialize
Spero's product candidates, if approved; Spero's ability to retain
key personnel; 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 Contact:Ted JenkinsVice
President, Investor Relations and Strategic
FinanceIR@sperotherapeutics.com (617) 798-4039
Media Inquiries:Lora Grassilli, Health Media
RelationsZeno Grouplora.grassilli@zenogroup.com646-932-3735
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