 "Dishman to supply API for Janssen Pharma’s TB drug Sirturo")
Dishman Pharmaceuticals and Chemicals Ltd has bagged the license agreement from Janssen Pharmaceutica NV, one of the Janssen Pharmaceutical Companies of Johnson & Johnson Group to produce active pharmaceutical ingredient (API) for the drug Sirturo (bedaquiline), a medicine used in the treatment of Multi-Drug-Resistant Tuberculosis (MDR TB).
In 2008, Janssen had contracted Dishman to conduct full chemical synthesis of this API at its Bavla facility in Gujarat. Janssen subsequently registered Dishman as a manufacturer of API with the USFDA, European Medicines Agency and several other Asian regulatory authorities.
Dishman has recently started supplying the API to Janssen from its Bavla facility, where it has the capacity to make 5 tonnes of the API per month. At the moment, Janssen is procuring around 2-2.5 tonnes per year from Dishman. Janssen is expected to launch the drug across the globe very soon. Janssen has already registered the drug in 150 countries.
While the pricing of the drug is yet to be decided, market sources peg the price for the full course (of six months) ranging between $900-30,000 depending on the country. The price of the treatment would be more in developed nations, compared to that in emerging nations.
There are around 2.8 million cases of MDR TB worldwide, and India alone has around 64,000 cases.
In January 2015, Sirturo recevived approval from the Drugs Controller General of India for use in adults as part of combination therapy of pulmonary tuberculosis due to multidrug-resistant mycobacterium tuberculosis.
