Alembic Pharmaceuticals has acquired Utility Therapeutics, a biotechnology firm engaged in developing the antibacterial PIVYA (pivmecillinam 185 mg tablets).
The consideration of the deal is approximately $12m, which will be paid in instalments over time, contingent upon achieving specific milestones.
PIVYA, an oral prodrug of mecillinam, is claimed to be the first antibiotic in roughly two decades to receive approval from the US Food and Drug Administration (FDA) for the treatment of uncomplicated urinary tract infections (uUTI).
The FDA authorised its use in April 2024 for female patients aged 18 and older suffering from uUTIs caused by susceptible strains of Escherichia coli, Proteus mirabilis, and Staphylococcus saprophyticus.
Utility president and CEO Tom Hadley said: “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 US.
“With current therapies failing and the armament of uUTI antibiotics perilously thin, PIVYA provides US clinicians with a new and effective treatment option that has a long safety record.”
Utility holds exclusive commercial rights in the US to two antibiotics previously approved in Europe: pivmecillinam and mecillinam. These medications are indicated for treating urinary tract infections, with pivmecillinam being specifically approved for women with uncomplicated cases.
PIVYA operates through a unique mechanism targeting the cell walls of Gram-negative bacteria, including those producing extended-spectrum beta-lactamases. The antibiotic shows activity against Enterobacterales in the presence of certain beta-lactamases and extended-spectrum beta-lactamases such as CTX-M, SHV, TEM, and AmpC.
Mecillinam’s inhibitory action on PBP-2 leads to low cross-resistance with certain other beta-lactams.
As part of its portfolio, Utility also considers mecillinam for potential development as a first-line therapy in intravenous form for complicated urinary tract infections within hospital settings.
