Orchid Pharma Signs USD 178 Million Russia Licensing Deal for Antibiotic Exblifep
New Delhi: Orchid Pharma Ltd. has entered into an exclusive licensing and supply agreement with Russia's Pharmasyntez JSC for the registration and commercialization of its novel antibiotic Exblifep (cefepime/enmetazobactam) in Russia, subject to regulatory approval from the Ministry of Health of the Russian Federation.
Under the agreement, Pharmasyntez will hold exclusive rights to register and commercialize Exblifep in the Russian market, while Orchid Pharma will supply the finished dosage form of the product.
According to the company, the partnership represents a potential commercial opportunity of approximately USD 178 million over the first 10 years, reflecting the unmet need for effective treatments against multidrug-resistant Gram-negative bacterial infections and the scale of hospital procurement in Russia.
Exblifep is a carbapenem-sparing antibiotic indicated 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. The antibiotic has been developed to address infections caused by extended-spectrum beta-lactamase (ESBL)-producing bacteria.
The drug has received approvals from both the U.S. Food and Drug Administration (USFDA) and the European Medicines Agency (EMA) and is included in treatment guidelines issued by the Infectious Diseases Society of America (IDSA) and the European Committee on Antimicrobial Susceptibility Testing (EUCAST). Orchid Pharma said Exblifep is the first new chemical entity originating from an Indian pharmaceutical company to secure approvals from both the USFDA and EMA.
Commenting on the partnership, Manish Dhanuka, Managing Director, Orchid Pharma, said the collaboration with Pharmasyntez would help expand patient access to Exblifep in Russia by leveraging the company's strong presence in the country's hospital procurement network.
Natalia Malykh, Vice President of Business Development at Pharmasyntez Group, said antimicrobial resistance remains one of the biggest challenges in modern medicine and that the agreement would enable Russian patients to access an innovative antibacterial therapy.
