{"id":687829,"date":"2022-09-22T02:03:09","date_gmt":"2022-09-22T06:03:09","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/gsk-and-spero-therapeutics-announce-exclusive-license-agreement-for-late-stage-antibiotic-asset-tebipenem-hbr\/"},"modified":"2022-09-22T02:03:09","modified_gmt":"2022-09-22T06:03:09","slug":"gsk-and-spero-therapeutics-announce-exclusive-license-agreement-for-late-stage-antibiotic-asset-tebipenem-hbr","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/gsk-and-spero-therapeutics-announce-exclusive-license-agreement-for-late-stage-antibiotic-asset-tebipenem-hbr\/","title":{"rendered":"GSK and Spero Therapeutics Announce Exclusive License Agreement for Late-Stage Antibiotic Asset, Tebipenem HBr"},"content":{"rendered":"
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\n The exclusive license allows GSK to commercialize tebipenem HBr in all territories, except Japan and certain other Asian countries<\/em>
\n \n <\/p>\n

\n Spero Therapeutics receives $66 million upfront, with potential for future milestone payments, and tiered royalties. <\/em>\n <\/p>\n

\n GSK to purchase $9 million in shares of Spero common stock<\/em>\n <\/p>\n

LONDON and CAMBRIDGE, Mass., Sept. 22, 2022 (GLOBE NEWSWIRE) — GSK (LSE\/NYSE: GSK) and Spero Therapeutics, Inc.\u00a0(Nasdaq: SPRO) today announced they have entered into an exclusive license agreement for Spero\u2019s 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.<\/p>\n

Luke Miels, Chief Commercial Officer, GSK said, \u201cThere 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\u2019s 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.\u201d<\/p>\n

\u201cSpero\u2019s agreement with GSK provides a critical step towards fully realizing the value tebipenem HBr can potentially provide to physicians, payors, and patients,\u201d said Ankit Mahadevia, M.D., Chief Executive Officer of\u00a0Spero. \u201cWe 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\u2019s 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.\u201d<\/p>\n

Spero\u00a0expects to start a new phase 3 clinical trial in 2023, following encouraging US FDA regulatory feedback on the proposed clinical trial design.<\/p>\n

\n Financial Terms<\/strong>\n <\/p>\n

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.<\/p>\n

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:<\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
\n Event<\/strong>\n <\/td>\n\n Milestone payments <\/strong>(up to)<\/td>\n<\/tr>\n
Delivery of phase III programme<\/td>\n$150m<\/td>\n<\/tr>\n
Total commercial milestone payments based on first sale (US\/EU)<\/td>\n$150m<\/td>\n<\/tr>\n
\u00a0<\/td>\n\u00a0<\/td>\n<\/tr>\n
\n Sales milestone events<\/strong>\n <\/td>\n\u00a0<\/td>\n<\/tr>\n
Net sales greater than $200m<\/td>\n$25m<\/td>\n<\/tr>\n
Net sales greater than $300m<\/td>\n$25m<\/td>\n<\/tr>\n
Net sales greater than $400m<\/td>\n$25m<\/td>\n<\/tr>\n
Net sales greater than $500m<\/td>\n$50m<\/td>\n<\/tr>\n
Net sales greater than $750m<\/td>\n$50m<\/td>\n<\/tr>\n
Net sales greater than $1,000m<\/td>\n$50m<\/td>\n<\/tr>\n
Total sales milestone payments:<\/td>\n$225m<\/td>\n<\/tr>\n
Royalties<\/td>\nLow-single digit to low-double digit (if sales exceed $1bn) tiered royalties on net product sales.<\/td>\n<\/tr>\n<\/table>\n

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\u2019s 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.<\/p>\n

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.<\/p>\n

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.<\/p>\n

\n About Tebipenem HBr<\/strong>\n <\/p>\n

Tebipenem HBr (tebipenem pivoxil hydrobromide; formerly SPR994) is Spero\u2019s novel late-stage development asset, an oral formulation of tebipenem pivoxil, a carbapenem antibiotic of the \u03b2-lactam class marketed by\u00a0Meiji Seika Pharma Co. Ltd. (Meiji) in\u00a0Japan\u00a0as Orapenem\u00ae\u00a0since 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.\u00a0Tebipenem 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\u00a0US Food and Drug Administration (FDA)\u00a0for the treatment of cUTI and AP. Following feedback from the FDA, at Spero\u2019s recent Type A meeting, Spero will conduct an additional Phase 3 trial to support the regulatory file.<\/p>\n

\n Tebipenem HBr Research Support<\/strong>\n <\/p>\n

Select tebipenem HBr studies have been funded in part with federal funds from the\u00a0Department of Health and Human Services;\u00a0Office of the Administration for Strategic Preparedness and Response;\u00a0Biomedical Advanced Research and Development Authority, under contract number HHSO100201800015C.<\/p>\n

\n About GSK<\/strong>
\n
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<\/p>\n

\n GSK in Antibiotics<\/strong>\n <\/p>\n

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 \u2013 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\u202f2-4 new antibiotics\u202fto patients\u202fby 2030, through sustainable investment in the antibiotic pipeline.\u00a0<\/p>\n

\n About\u00a0Spero<\/strong>\u00a0Therapeutics<\/strong><\/p>\n

Spero Therapeutics, headquartered in Cambridge, Massachusetts,\u00a0is 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.<\/p>\n