GSK and Spero Therapeutics announce exclusive licensing agreement for advanced stage antibiotic, Tebipenem HBr

Exclusive license allows GSK to market tebipenem HBr in all territories except Japan and some other Asian countries

Hope Therapeutics receives $ 66 million upfront, with the option of future milestone payments and tiered royalties.

GSK will purchase $ 9 million in Spero stock

LONDON and CAMBRIDGE, Mass., September 22, 2022 (GLOBE NEWSWIRE) – GSK (LSE / NYSE: GSK) and Spero Therapeutics, Inc. (Nasdaq: SPRO) today announced that they have entered into an exclusive licensing agreement for the deceased of I hope antibiotic asset in stage, tebipenem HBr. Tebipenem HBr was developed as the first oral carbapenem antibiotic for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, caused by certain bacteria.

Luke Miels, GSK Chief Commercial Officer, said: “There is an unmet medical need for a new oral antibiotic as an alternative to hospital intravenous therapy for drug-resistant complicated urinary tract infections. Tebipenem HBr complements the GSK’s infectious disease strategy and is consistent with our commitment to find value enhancement opportunities to build a robust late stage portfolio. Tebipenem HBr has a clear US FDA regulatory path towards potential approval, which could benefit significantly significant patients with complicated urinary tract infections “.

“Spero’s agreement with GSK represents a critical step towards fully realizing the value that tebipenem HBr can potentially provide to physicians, payers and patients,” said Ankit Mahadevia, MD, Spero’s chief executive. “We are thrilled to partner with GSK on the development of tebipenem HBr for cUTI patients. With its antibiotic expertise and global commercial reach, GSK is ideally placed to launch tebipenem HBr after regulatory approval as the first oral treatment for cUTI, providing patients with an alternative to in-hospital intravenous (IV) therapy . The potential of Tebipenem HBr as an oral home option can potentially be of significant benefit by reducing the use of hospital resources. Additionally, our partnership with GSK strengthens our balance sheet and shareholder base. ”

Hopefully, it plans to launch a new Phase 3 clinical trial in 2023, following the encouragement of US FDA regulatory feedback on the proposed clinical trial project.

Financial terms

GSK will receive an exclusive license to develop and commercialize tebipenem pivoxil and tebipenem pivoxil HBr in all territories, with the exception of Japan, and some other Asian countries, territories to be maintained by Spero’s partner, Meiji Seika. Under the licensing agreement, Spero will be responsible for the execution and costs of the tebipenem HBr follow-up Phase 3 clinical trial. GSK will be responsible for the execution and costs of further development, including Phase III regulatory registration and commercialization activities for tebipenem HBr outside the Meiji Seika territory.

Under the terms of the license agreement, Spero will receive an upfront payment of $ 66 million for GSK to secure the rights to the drug. The remaining potential payments are based on milestones and are as follows:

Event

Milestone payments (as far as)

Delivery of the Phase III program

$ 150 million

Total first sale-based commercial milestone payments (US / EU)

$ 150 million

Pivotal sales events

Net sales exceeding $ 200 million

$ 25 million

Net sales exceeding $ 300 million

$ 25 million

Net sales exceeding $ 400 million

$ 25 million

Net sales exceeding $ 500 million

$ 50 million

Net sales exceeding $ 750 million

$ 50 million

Net sales exceeding $ 1,000 million

$ 50 million

Total sales milestone payments:

$ 225 million

Royalties

Low to double digit royalties (if sales exceed $ 1 billion) on net product sales.

In connection with the licensing agreement and under a stock purchase agreement between GSK and Spero, GSK has agreed to make an investment in common stock of $ 9 million in Spero, purchasing 7,450,000 common shares of Spero at a purchase price of approximately $ 1.20805 per share, not to exceed 19.99% of Spero’s actual ownership by GSK and its affiliates.

Transactions are expected to close in the fourth quarter of 2022, subject to customary closing conditions, including the expiration of the holding period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended. The closing of the holding is subject to the effectiveness of the license following the Hart-Scott-Rodino authorization.

As of June 30, 2022, Spero had cash, cash equivalents and marketable securities of $ 45.4 million. Based on the previously announced restructuring and cessation of marketing activities for the HBr tebipenem program, along with the initial $ 66 million cash payment from the GSK licensing transaction, I hope its current cash footprint will be sufficient to finance the company beyond 2024.

Information about Tebipenem HBr

Tebipenem HBr (tebipenem pivoxil hydrobromide; formerly SPR994) is the new late stage development resource of Spero, 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 shown to be safe and effective in treating drug-resistant Gram-negative bacterial infections. Tebipenem HBr was 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 US marketing approval. Tebipenem HBr has obtained Qualified Infectious Disease Product (QIDP) and Fast Track designations from the US Food and Drug Administration (FDA) for the treatment of cUTI and AP. Following FDA feedback, at Spero’s recent Type A meeting, Spero will conduct an additional Phase 3 study to support the regulatory dossier.

Research support on Tebipenem HBr

Some studies of tebipenem HBr were funded in part with federal funds from the Department of Health and Human Services; Office of the Administration for Strategic Preparation and Response; Advanced Biomedical Research and Development Authority, with the contract number HHSO100201800015C.

About GSK
GSK is a global biopharmaceutical company aiming to unite science, technology and talent to tackle disease together. Find out more at gsk.com/company

GSK in antibiotics

GSK has been developing and supplying antibiotics for over 70 years, and research and development continue to investigate new tools to prevent and mitigate infectious diseases and overcome antimicrobial resistance. GSK is already a leader in the Access to Medicine Foundation’s Antimicrobial Resistance Benchmark and participates in the AMR Action Fund, which aims to bring 2-4 new antibiotics to patients by 2030, through sustainable investments in the antibiotic pipeline.

About Spero Therapeutic

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 multidrug-resistant bacterial infections and rare diseases.

  • Spero Therapeutics also has a next-generation intravenously administered polymyxin candidate product, SPR206, developed from its enhancement platform, which is under development for the treatment of multidrug-resistant Gram-negative infections in the hospital setting.

  • Tebipenem HBr is an investigational drug in the United States under development for the treatment of cUTI, including pyelonephritis, caused by certain bacteria, in adult patients who have limited treatment options; tebipenem HBr is not approved by the FDA.

For more information visit https://sperotherapys.com.

Forward-looking statements from GSK

GSK cautions investors that any forward-looking statements or projections made by GSK, including those contained in this announcement, are subject to risks and uncertainties which may cause actual results to differ materially from those anticipated. Such factors include, but are not limited to, those described in the Company’s annual report on Form 20-F for 2021, GSK’s second quarter results for 2022, and any impact of the COVID-19 pandemic.

Hope 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 licensing and participation transactions, the regulatory path to be followed for tebipenem HBr and potential FDA approval, the potential commercialization of tebipenem HBr and its future value, the potential receipt of pivotal payments and royalties on future sales under the licensing agreement and the Spero cash register. In some cases, forward-looking statements can be identified by terms such as “may”, “will”, “should”, “expect”, “plan”, “aim”, “anticipate”, “might”, “intent,” ” target “,” project “,” contemplate “,” believe “,” estimate “,” foresee “,” 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 due to various important factors, including the ability of Spero and GSK to obtain antitrust clearance and to conclude proposed transactions in a timely manner; whether tebipenem HBr will advance timely in the clinical trial process, or at all, taking into account the effects of possible regulatory delays, slower than expected patient enrollment, manufacturing challenges, clinical trial design and clinical outcomes; whether the results of such studies warrant submission for approval by the FDA or equivalent foreign regulatory agencies; whether the FDA will eventually approve tebipenem HBr and, if so, the timing of such approval; whether the FDA will request 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 and market acceptance of tebipenem HBr can be achieved; whether Spero’s cash resources will be sufficient to finance its ongoing activities for the periods and / or tests envisaged; and other factors discussed in the “Risk Factors” set forth in the documents I hope periodically submit to the US Securities and Exchange Commission. Forward-looking statements included in this press release represent Spero’s views as of the date of this press release. I hope he predicts that subsequent events and developments will change his views. However, although Spero may decide to update these forward-looking statements at some point in the future, it expressly disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Spero’s views at any date after the date of this press release.

Investor Relations:
Ted Jenkins
Vice President, Investor Relations
TJenkins@sperotherapeutics.com
(617) 798-4039

Media inquiries:
Matt Dick, Health Media Relations
Zenone Group
matt.dick@zenogroup.com
301-509-8532

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