Orchid Pharma has entered into an exclusive licensing and supply agreement with Pharmasyntez JSC for the commercialisation of Exblifep (cefepime/enmetazobactam) in Russia, subject to approval from the Ministry of Health of the Russian Federation.

The agreement grants Pharmasyntez exclusive rights to register and market Exblifep in Russia, while Orchid Pharma will manufacture and supply the finished dosage form. The collaboration is expected to generate an estimated USD 178 million over the first ten years, highlighting the significant demand for advanced antibacterial therapies in the Russian hospital market.

Exblifep is a novel carbapenem-sparing antibiotic developed to treat complicated Urinary Tract Infections (cUTI) and hospital-acquired and ventilator-associated bacterial pneumonia (HAP/VAP) caused by Gram-negative bacterial pathogens, including Extended-Spectrum Beta-Lactamase (ESBL)-producing organisms.

The antibiotic has received approval from both the US Food and Drug Administration (FDA) 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). It is also the first new chemical entity developed by an Indian pharmaceutical company to secure approvals from both the FDA and EMA.

Commenting on the partnership, Manish Dhanuka, Managing Director of Orchid Pharma, said the agreement represents an important milestone in expanding patient access to Exblifep in Russia. He noted that Pharmasyntez's extensive reach within the country's hospital procurement system makes it well positioned to deliver the therapy to healthcare providers and patients.

Natalia Malykh, Vice President of Business Development at the Pharmasyntez Group, emphasised that antimicrobial resistance remains one of the most pressing challenges in modern healthcare. She added that the collaboration will enable Russian patients to benefit from an innovative antibacterial therapy designed to combat resistant Gram-negative infections.

The partnership further strengthens Orchid Pharma's global strategy of expanding access to innovative anti-infective therapies while addressing the growing global burden of antimicrobial resistance.