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Orchid Pharma Ltd on Tuesday (July 7) said it has signed a licensing and supply agreement with Pharmasyntez JSC, Russia, for the commercialisation of Exblifep (cefepime/enmetazobactam) in the Russian market. The agreement is subject to regulatory approval from the Ministry of Health of the Russian Federation.
Exblifep is a novel combination 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.
According to the company, Exblifep is a carbapenem-sparing antibiotic developed to treat serious hospital infections caused by ESBL-producing Gram-negative bacteria.
ALSO READ | Orchid Pharma raises Rs 400 crore via QIP — MIT, Societe Generale among those allotted shares
The product has received approvals from the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). It is also included in the IDSA and EUCAST treatment guidelines.
Orchid Pharma said Exblifep is the first new chemical entity originating from an Indian pharmaceutical company to receive approvals from both the US FDA and the EMA.
Under the agreement, Pharmasyntez will hold the exclusive rights to register and commercialise Exblifep in Russia, with Orchid supplying the finished dosage form. The partnership represents a potential opportunity of approximately $178 million over the first 10 years, reflecting the scale of unmet clinical need and the significant hospital procurement volumes in the Russian market.
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Manish Dhanuka, Managing Director, Orchid Pharma Ltd, said, "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 the Pharmasyntez group, said, "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."
ALSO READ | Orchid Pharma stock has doubled in 2024—MD outlines future growth plans
Shares of Orchid Pharma Ltd ended at ₹926.05, down by ₹6.55, or 0.70%, on the BSE.
Exblifep is a novel combination 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.
According to the company, Exblifep is a carbapenem-sparing antibiotic developed to treat serious hospital infections caused by ESBL-producing Gram-negative bacteria.
ALSO READ | Orchid Pharma raises Rs 400 crore via QIP — MIT, Societe Generale among those allotted shares
The product has received approvals from the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). It is also included in the IDSA and EUCAST treatment guidelines.
Orchid Pharma said Exblifep is the first new chemical entity originating from an Indian pharmaceutical company to receive approvals from both the US FDA and the EMA.
Under the agreement, Pharmasyntez will hold the exclusive rights to register and commercialise Exblifep in Russia, with Orchid supplying the finished dosage form. The partnership represents a potential opportunity of approximately $178 million over the first 10 years, reflecting the scale of unmet clinical need and the significant hospital procurement volumes in the Russian market.
ALSO READ | Orchid Pharma gains over 8% on DCGI approval for drug to treat complicated UTI
Manish Dhanuka, Managing Director, Orchid Pharma Ltd, said, "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 the Pharmasyntez group, said, "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."
ALSO READ | Orchid Pharma stock has doubled in 2024—MD outlines future growth plans
Shares of Orchid Pharma Ltd ended at ₹926.05, down by ₹6.55, or 0.70%, on the BSE.
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