Orchid Pharma Limited has entered into an exclusive licensing and supply agreement with Pharmasyntez JSC for the registration and commercialization of Exblifep® (cefepime/enmetazobactam) in Russia. The agreement is subject to regulatory approval by the Ministry of Health of the Russian Federation and marks a significant step in expanding access to the novel antibiotic in an important international market.
Under the terms of the agreement, Pharmasyntez will hold the exclusive rights to register, market and commercialize Exblifep® across Russia, while Orchid Pharma will manufacture and supply the finished dosage form. The collaboration is expected to unlock a market opportunity of approximately USD 178 million over the first 10 years, driven by the high incidence of serious hospital-acquired infections and growing demand for advanced antibacterial therapies.
Exblifep® is a next-generation combination antibiotic developed 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. Designed as a carbapenem-sparing therapy, the antibiotic addresses the increasing threat of infections caused by extended-spectrum beta-lactamase (ESBL)-producing Gram-negative bacteria, a major contributor to antimicrobial resistance worldwide.
The medicine has received approval from both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) and is recommended in treatment guidelines issued by the Infectious Diseases Society of America (IDSA) and the European Committee on Antimicrobial Susceptibility Testing (EUCAST). Exblifep® is also the first new chemical entity discovered by an Indian pharmaceutical company to secure approvals in both the United States and Europe.
Commenting on the partnership, Manish Dhanuka, Managing Director of Orchid Pharma Limited, said, “Our collaboration with Pharmasyntez represents an important milestone in expanding the global reach of Exblifep®. With its strong presence in the Russian hospital procurement ecosystem, Pharmasyntez is well positioned to ensure that this innovative antibiotic reaches healthcare professionals and patients who require effective treatment options against difficult-to-treat bacterial infections.”
Natalia Malykh, Vice President of Business Development at the Pharmasyntez Group, said, “Antimicrobial resistance remains one of the most pressing healthcare challenges globally, creating an urgent need for innovative antibacterial medicines. Through this partnership with Orchid Pharma, we aim to provide Russian patients with access to an advanced treatment option that addresses serious infections caused by resistant Gram-negative pathogens.”
Orchid Pharma Limited is a fully integrated pharmaceutical company with capabilities spanning key starting materials, active pharmaceutical ingredients and finished dosage formulations. The company specializes in complex injectable antibiotics and operates globally approved manufacturing facilities compliant with USFDA and EU-GMP standards. With Exblifep®, Orchid continues to strengthen its position as an innovator in anti-infective therapies while expanding its international footprint through strategic partnerships.
