• Alembic to expand their U.S. commercial portfolio with FDA-approved PIVYA for the treatment of women with uncomplicated urinary tract infections

• PIVYA expected to be available in the U.S. in the 4th quarter of 2025.

LONDON, UK / ACCESS Newswire / July 3, 2025 / UTILITY therapeutics Ltd. (UTILITY), a biotechnology company focused on the development of PIVYA (pivmecillinam 185 mg tablets), a penicillin class antibacterial approved by the U.S. Food and Drug Administration (FDA) for the treatment of uncomplicated urinary tract infection (uUTI), today announced that it has been acquired by Alembic Pharmaceuticals, Inc. (Alembic).

PIVYA marked the first antibiotic in approximately 20 years to earn FDA approval for uUTI, a common bacterial infection that afflicts millions of women annually. The FDA approved PIVYA in April 2024 for use in female patients 18 years of age and older with uUTI caused by susceptible isolates of Escherichia coli, Proteus mirabilis and Staphylococcus saprophyticus. PIVYA has a unique mechanism of action that targets the cell wall of gram-negative bacteria.

Additional U.S. prescribing information about PIVYA can be found at www.pivya.com.

"We are thrilled that Alembic Pharmaceuticals understands the clinical and commercial value of PIVYA and will bring this proven treatment to female patients in need across the U.S.," said Tom Hadley, President and CEO of UTILITY therapeutics. "With current therapies failing and the armament of uUTI antibiotics perilously thin, PIVYA provides U.S. clinicians with a new and effective treatment option that has a long safety record. We are grateful for the support of our Board of Directors and investors, including the AMR Action Fund, whose collective support was instrumental in helping us obtain FDA approval for PIVYA."

The UTILITY therapeutics Ltd. Board of Directors and Observers includes:

• Alan S. Roemer, MBA, MPH, Chairman of the Board

• Morten Sommer, PhD, Co-Founder

• Rasmus Toft-Kehler, PhD, Co-Founder

• Andrew Davis, Independent Director

• Larry Edwards, Independent Director

• Thomas Hadley, President & CEO

• Henry Skinner, PhD, MJur, MBA, AMR Action Fund

• Tero Wennberg, PhD, Observer, LEO Pharma

• Henni-Karoliina Ropponen, PhD, Observer, AMR Action Fund

"The acquisition of UTILITY and the commercialization of PIVYA are important steps in Alembic's strategic goal to provide branded pharmaceutical products to the U.S. healthcare market," said Craig Salmon, President of Alembic Pharmaceuticals, Inc. "PIVYA will further enhance Alembic's ability to build long-term value by combining global research, regulatory, and manufacturing strengths with a sharpened focus on specialty segments. Alembic plans to make PIVYA available in the U.S. in the 4^th quarter of 2025."

"I am excited to see Alembic drive the commercialization of PIVYA, which is uniquely positioned to help millions of American women with urinary tract infections," said Dr. Morten Sommer, Professor of microbiology at the Technical University of Denmark, and co-founder and board member of UTILITY therapeutics. "With a novel mechanism of action, not previously deployed in the U.S., PIVYA can become a cornerstone of the treatment of urinary tract infections based on its first-line positioning in the Infectious Disease Society of America treatment guidelines. On behalf of the co-founders, investors, and Board of Directors, we are excited that PIVYA will help address the societal impact of the uUTI disease burden in women."

About PIVYA (pivmecillinam oral tablets 185mg)

PIVYA, an oral prodrug of mecillinam, is a penicillin class antibacterial indicated for the treatment of female patients 18 years of age and older with uncomplicated urinary tract infections (uUTI) caused by susceptible isolates of Escherichia coli, Proteus mirabilis and Staphylococcus saprophyticus.

Mecillinam demonstrated in vitro activity against Enterobacterales in the presence of some beta-lactamases and extended-spectrum beta-lactamases (ESBL) of the following groups: CTX-M, SHV, TEM, AmpC. The inhibitory action of mecillinam on PBP-2 results in low cross-resistance with certain beta-lactams. The frequency of resistance to mecillinam in E. coli range from
8×10^-8 to 2×10^-5 when exposed to 32-256 times MIC.

PIVYA has been proven safe and effective in three clinical trials with the most common Adverse Reactions Occurring in ≥1% of Patients Receiving PIVYA (Adjusted for Study Size); Nausea (4.3%), Diarrhea (2.1%), Vulvovaginal candidiasis (1.8%), Genital pruritus (1.8%), and Headache (1.4%).

PIVYA demonstrated strong response in three controlled clinical trials comparing different PIVYA dosing regimens to placebo (Trial 1), to another oral antibacterial drug (Trial 2), or to ibuprofen (Trial 4) evaluated the efficacy of pivmecillinam for the treatment of uUTI. Efficacy was assessed in the Microbiological Intent-to-Treat (micro-ITT) population which included all randomized subjects with a positive baseline urine culture defined as ≥10⁵ colony-forming-units (CFU)/mL of a uropathogen where CFU count was available and no more than 2 species of microorganisms, regardless of colony count, and no baseline pathogen was non-susceptible to the active comparator. The composite response rates (composite endpoint of clinical cure and microbiological response), as well as clinical cure and microbiological response rates of the recommended 185 mg three times daily dosing regimen.

Composite Response Rates (Clinical Cure and Microbiological Response) at TOC in the uUTI trials (Micro ITT Population)

Clinical Cure Rates (Micro-ITT Population)

Microbiological Response Rates (Micro-ITT Population)

Contraindications

• Serious hypersensitivity reactions (e.g., anaphylaxis or Stevens-Johnson syndrome) to PIVYA or to other beta-lactam antibacterial drugs (e.g., penicillins and cephalosporins).

• Primary or secondary carnitine deficiency resulting from inherited disorders of mitochondrial fatty acid oxidation and carnitine metabolism such as carnitine transporter defect or other inborn errors of metabolism (e.g., methylmalonic aciduria, or propionic academia).

• Acute porphyria.

Warnings and precautions

• Hypersensitivity Reactions: Serious hypersensitivity reactions including anaphylaxis have been reported in patients receiving PIVYA. If hypersensitivity reactions occur, discontinue treatment with PIVYA and institute appropriate therapy.

• Severe Cutaneous Adverse Reactions (SCAR): Acute Generalized Exanthematous Pustulosis (AGEP), Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) have been reported with PIVYA. Monitor closely and discontinue PIVYA at the first signs or symptoms of SCAR or other signs of hypersensitivity.

• Carnitine Depletion: In patients at risk for reductions in serum carnitine, e.g., significant renal impairment or decreased muscle mass, consider alternative antibacterial therapies. PIVYA is not recommended when prolonged antibacterial treatment is necessary. Avoid concurrent treatment with valproic acid, valproate or other pivalate-generating drugs due to increased risk of carnitine depletion.

• Clostridioides difficile-Associated Diarrhea (CDAD): This has been reported with nearly all systemic antibacterial agents, including PIVYA. Evaluate if diarrhea occurs.

• Interference with Newborn Screening Test: Treatment of a pregnant individual with PIVYA prior to delivery may cause a false positive test for isovaleric acidemia in the newborn as part of newborn screening. Prompt follow-up of a positive newborn screening result for isovaleric acidemia is recommended.

About UTILITY therapeutics Ltd.

UTILITY has exclusive U.S. commercial rights to two European-approved antibiotics, pivmecillinam and mecillinam, for the treatment of urinary tract infections (UTI). Pivmecillinam is an oral prodrug of mecillinam that has been approved by the FDA for the treatment of women with uncomplicated urinary tract infections. PIVYA has a unique mechanism of action for infections caused by Gram-negative bacteria, including extended-spectrum beta-lactamases. Mecillinam, an intravenous (IV) formulation, may be developed as a first-line therapy for complicated UTI (cUTI) in the hospital setting.

For more information, contact

David Cobb, Alembic Pharmaceuticals
david.cobb@alembicusa.com
908-552-583

SOURCE: Utility Therapeutics Ltd.