The Russian Federation Health Ministry has granted approval to Theravance Biopharma‘s Vibativ (telavancin) to treat Gram-positive complicated skin and soft tissue infections.
Vibativ is a once-daily, injectable lipoglycopeptide antibiotic with in-vitro potency and a dual mechanism of action against difficult-to-treat pathogens such as methicillin-resistance Staphylococcus aureus (MRSA).
As part of a development and commercialisation agreement signed in 2012, the approval will allow R-Pharm to market and sell Theravance’s Vibativ in Russia. The antibiotic is expected to be commercially available in September.
The clearance also results in a milestone payment to Theravance, including potential future contingent payments and a royalty on net sales.
Theravance Biopharma development and operations senior vice-president Frank Pasqualone said: “We are pleased that healthcare practitioners in Russia will now be able to add vibativ to their antibiotic choices, especially for those difficult-to-treat Gram-positive bacteria, such as MRSA, against which the drug has been shown to be an effective treatment.
“At the same time, this is another key achievement for Theravance Biopharma, highlighting the value of strategic collaborations with partners, such as R-Pharm, in our efforts to build the global brand and expand the commercial reach of vibativ into target markets outside the US.”
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In the US, vibativ for injection is approved to treat hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Staphylococcus aureus when alternative treatments are not suitable.
In addition, the drug is approved for treatment of adult patients with complicated skin and skin structure infections (cSSSI) caused by susceptible isolates of Gram-positive bacteria, including Staphylococcus aureus, both methicillin-susceptible (MSSA) and MRSA strains.
Outside the US, vibativ is currently being sold in Europe, Canada, Middle East, North Africa, Israel, and Russia.