Alembic Pharmaceuticals has acquired UTILITY therapeutics, expanding its portfolio with the addition of Pivya (pivmecillinam 185 mg tablets), a penicillin class antibacterial for treating uncomplicated urinary tract infections (uUTIs).
In April 2024, Pivya received approval from the US Food and Drug Administration (FDA) for uUTIs.
uUTI is caused by strains of Proteus mirabilis, Escherichia coli and Staphylococcus saprophyticus. The drug's unique mechanism targets gram-negative bacteria cell walls effectively.
Alembic Pharmaceuticals president Craig Salmon stated: "The acquisition of UTILITY and the commercialisation of Pivya are important steps in Alembic's strategic goal to provide branded pharmaceutical products to the US healthcare market.
"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 speciality segments. Alembic plans to make Pivya available in the US in the fourth quarter of 2025."
Pivya has been proven safe in three studies. The most common adverse reactions are diarrhoea, nausea, vulvovaginal candidiasis, genital pruritus and headache.
UTILITY Therapeutics co-founder and board member Dr Morten Sommer stated: "I am excited to see Alembic drive the commercialisation of Pivya, which is uniquely positioned to help millions of American women with urinary tract infections.
"With a novel mechanism of action, not previously deployed in the US, 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."
