REG - GSK PLC - GSK and Spero Therapeutics licence for tebipenem

GSKAnnouncement

22/09/2022 07:01

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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 β-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.

·      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
(https://www.gsk.com/en-gb/company/) .

 

 

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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.

 

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