Pharmstandard to produce Janssen's anti-TB drugs in Russia; Nyuvak deal

JSC Pharmstandard (PHST: MM), one of Russia's largest pharmaceutical producers, has signed an agreement with Janssen Pharmaceutica, a subsidiary of US health care giant Johnson & Johnson (JNJ) on the licensing, production and promotion of bedaquiline, a drug for the treatment of multidrug-resistant TB, in Russia, according to Naira Adamian, general director of Janssen Russia and the CIS.

Bedaquiline is expected to be the first antitubercular drug of its type to be registered and produced in Russia for the last 40 years. The new drug is expected to be officially launched in the Russian market by the end of the current year. Pricing of the product has not yet been disclosed.

Bedaquiline recently received backing for accelerated approval from a US Food and Drug Administration advisory panel as a treatment of pulmonary multi-drug resistant tuberculosis (MDR-TB) as part of combination therapy in adults (The Pharma Letter November 29, 2012). The drug is also under review at the European Medicines Agency.