Pharmstandard Announces Registration of Sirturo® for MDR-TB
OREANDA-NEWS. Russia's leading pharmaceutical company Pharmstandard OJSC ("Pharmstandard" or the "Company") announces registration of the drug Sirturo® ("Sirturo" or the "Drug") in Russia. Intellectual property rights for the Drug belong to Janssen Pharmaceutica NV ("Janssen").
The Drug is produced in a tablet form with the main active ingredient being bedaquiline. The indication registered in Russia is for pulmonary multi-drug resistant tuberculosis ("MDR-TB"). This is the first TB drug registered in Russia with a new mechanism of action in nearly 40 years: it blocks the enzyme which gives energy for TB bacteria to survive.
Pharmstandard started the strategic partnership with Janssen in January 2013 when IT acquired license for production and commercialization of the Drug in Russia and selected current and former CIS countries. The company also holds responsibility for obtaining state registration and liaison with regulators and health authorities to ensure market access and availability of the drug.
Pharmstandard takes care of secondary packaging and quality control on one of its regional production facilities - OJSC Pharmstandard-UfaVita (Pharmstandard-UfaVita). The company is actively performing technical transfer to Pharmstandard-UfaVita for local manufacturing, in accordance with the Pharma 2020 strategy in Russia.
Additionally, Pharmstandard and Janssen have set up a joint expert committee to address legal, medical, production issues or those related to the supply of bedaquiline. The committee also oversees the responsible use of bedaquiline in the view of reducing potential risks of developing resistance to the new therapy.
"I am happy with the progress of the strategic partnership with Janssen", - comments Pharmstandard CEO Igor Krylov. "Sirturo is undoubtedly a breakthrough in the level and quality of multi-drug resistant tuberculosis therapy. Obtaining registration in Russia is a big achievement that will make modern therapy available for Russian patients."