Orchid Pharma Limited has entered into a licensing and supply agreement with Pharmasyntez JSC, Russia for Exblifep® (cefepime/enmetazobactam), a novel combination antibiotic. The disclosure was made pursuant to Regulation 30 read with Part A of Schedule III of SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015.

Agreement Details

The agreement grants Pharmasyntez exclusive rights to register and commercialize Exblifep in Russia, subject to regulatory approval by the Ministry of Health of the Russian Federation. Orchid Pharma will supply the finished dosage form to Pharmasyntez.

Financial Impact

The partnership represents a potential opportunity of approximately USD 178 million over the first 10 years, reflecting the scale of unmet clinical need and significant hospital procurement volumes in the Russian market.

Product Information

Exblifep is indicated for the treatment of:

  • Complicated urinary tract infections (cUTI)
  • Hospital-acquired and ventilator-associated bacterial pneumonia (HAP/VAP) caused by Gram-negative bacterial pathogens

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

Management Commentary

Manish Dhanuka, Managing Director of Orchid Pharma Ltd., stated: "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."

Natalia Malykh, Vice President of Business Development at Pharmasyntez group, commented: "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."

Company Background

Orchid Pharma Limited is a fully vertically integrated pharmaceutical company with end-to-end capabilities from Key Starting Materials (KSMs) to Active Pharmaceutical Ingredients (APIs) and Finished Dosage Forms (FDFs), focused on complex injectable antibiotics. The company operates globally approved manufacturing facilities compliant with USFDA and EU-GMP standards.

Pharmasyntez Group is one of the leading Russian biopharmaceutical companies engaged in research, manufacturing, and distribution of socially significant pharmaceuticals. The Group operates eight manufacturing facilities across Russia, with annual production exceeding 100 million packages and 2025 consolidated revenue of 50.5 billion rubles. Their portfolio includes over 320 products, with over 77% on Russia's List of Vital and Essential Drugs.

Advisory Role

Sathguru Management Consultants acted as exclusive advisor to Orchid Pharma on the transaction.