AMDINOCILLIN PIVOXIL

Mumbai: Alembic Pharmaceuticals , Inc., the U.S. subsidiary of Alembic Pharmaceuticals Ltd., has acquired UK-based Utility Therapeutics Ltd. in a $12 million deal. The acquisition is indicated to mark the company's entry into the speciality and branded pharmaceuticals segment in the United States. The acquisition includes Pivya ( pivmecillinam ), a recently FDA-approved treatment for uncomplicated urinary tract infections . Approved in April 2024, Pivya will now be commercialized in the U.S. by Alembic. According to the company, the aim of the acquisition is to strengthen its U.S. presence and expand into branded prescription products. The company states that the acquisition will enhance its ability to deliver long-term value by combining global research, regulatory, and manufacturing capabilities with a focused approach to the U.S. specialty pharmaceutical market. “This acquisition gives us a strategic entry into the specialty and branded prescription products. It will give us exposure to the branded pharmaceutical market with a near-term commercial launch,” said Pranav Amin, Managing Director, Alembic Pharmaceuticals Ltd. By Online Bureau ,

Blujepa is one of five key approvals GSK is counting on this year. GSK is opening the door to a new era in urinary tract infection (UTI) treatment with its Blujepa, the first in a new class of oral antibiotics for the condition in nearly 30 years.Blujepa, also known as gepotidacin, has been cleared by the FDA to treat uncomplicated UTIs (uUTIs) that can be tied to E. coli, Klebsiella pneumoniae, Citrobacter freundii complex, Staphylococcus saprophyticus or Enterococcus faecalis in women 12 years of age and older. These types of UTIs are the most common infection for women, with more than half of all women experiencing one in their lifetime, making the antibiotic a much-needed new option for the up to 16 million U.S. women who are impacted annually. GSK tested the antibiotic in the phase 3 Eagle-2 and Eagle-3 trials, pitting its twice-daily option against longtime standard-of-care nitrofurantoin for five days.  In Eagle-2, Blujepa proved noninferior to nitrofurantoin in terms of therapeutic success, which occurred in 50.6% of participants compared with the other antibiotic’s 47%. Eagle-3 found statistically significant superiority for GSK’s med with 58.5% of those on Blujepa achieving therapeutic success versus 43.6% on the nitrofurantoin side.“We are proud to have developed Blujepa, the first in a new class of oral antibiotics for uUTIs in nearly three decades, and to bring another option to patients given recurrent infections and rising rates of resistance to existing treatments,” Chief Scientific Officer Tony Wood, Ph.D., said in a company release. GSK plans to launch Blujepa in the second half of this year.Blujepa sets itself apart from nitrofurantoin as well as newer options such as Iterum’s Orlynvah (sulopenem) and Utility Therapeutics’ Pivya (pivmecillinam) due to its unique mechanism of action and potential to overcome antimicrobial resistance, a growing threat that makes many treatments less effective.To put it simply, the drug is designed to specifically inhibit bacterial DNA in the E. coli class, which causes the majority of UTI infections, Wood explained in a recent media briefing. Antimicrobial resistance in the case of Blujepa doesn’t apply as much in the “broader sense” as it does for other drug classes, because the mechanism of cutting E. coli’s unique circular DNA during the transcription process is specific to E. coli. GSK is also testing the drug in gonorrhea, another treatment area that is particularly susceptible to drug resistance. Elsewhere in the pipeline is an option for complicated UTIs in Spero Therapeutics-partnered antibiotic tebipenem HBr, which is currently enrolling patients for a phase 3 study. That drug is meant to decrease hospitalizations for harder-to-treat infections, Wood noted.The less profitable antibiotics area is one many big drugmakers have left behind over the years. GSK is one of the few that continues to invest in the area. The British pharma touts one of the “largest and most diverse” infectious disease pipeline in the industry. Still, it’s a difficult area to innovate in, Melanie Paff, Ph.D., head of GSK’s hepatitis B program, told Fierce Biotech in 2023. The Eagle trial wins from Blujepa specifically were “hard fought,” Paff said.The Blujepa nod is the second that GSK can check off its list of the five expected approvals it aims to pick up this year. Next up are hopeful expansions for its antibody-drug conjugate Blenrep and asthma med Nucala, plus a new launch for biologic depemokimab. All five should help the company achieve its recently increased 2031 sales goal of more than 40 billion pounds sterling ($50 billion).