Orchid Pharma and Pharmasyntez sign licensing and supply agreement for Exblifep?

Orchid Pharma (Orchid) and Pharmasyntez JSC (Pharmasyntez) have entered into a licensing and supply agreement for Exblifep? (cefepime/enmetazobactam), a novel combination antibiotic for the treatment of complicated urinary tract infections (cUTI) and hospital-acquired and ventilator-associated bacterial pneumonia (HAP/VAP) caused by Gram negative bacterial pathogens, subject to regulatory approval by the Ministry of Health of the Russian Federation.

Exblifep is a carbapenem-sparing antibiotic developed to address the growing clinical challenge posed by ESBL-producing Gram-negative bacteria in serious hospital infections. The product is approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), is included in IDSA and EUCAST treatment guidelines, and is the first new chemical entity originating from an Indian pharmaceutical company to receive both approvals.

Under the agreement, Pharmasyntez will hold the exclusive rights to register and commercialize Exblifep in Russia, with Orchid supplying the finished dosage form. The partnership represents a potential opportunity of approximately USD 178 million over the first 10 years, reflecting the scale of unmet clinical need and the significant hospital procurement volumes in the Russian market.