|
Orchid Pharma Ltd. and Pharmasyntez JSC 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 Gramnegative 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 US 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.
"Our partnership with Pharmasyntez marks an important step in making Exblifep available to patients in Russia. Pharmasyntez's deep reach into the Russian hospital procurement system makes them the right partner to ensure this medicine gets to the clinicians and patients who need it." — Manish Dhanuka, managing director, Orchid Pharma Ltd.
“Antimicrobial resistance is one of the most significant challenges facing modern medicine, making the development of new antibiotics critical. Orchid Pharma has met this challenge by developing the novel antibiotic Exblifep (cefepime/enmetazobactam). This licensing agreement with Pharmasyntez enables Russian patients to gain access to modern antibacterial therapy” said Natalia Malykh, vice president of business development at the Pharmasyntez group.
|