The United Nations Food and Drug Administration (UFSDA) on October 16 approved of Abiraterone Acetate tablets, used to treat prostate cancer which is produced by Glenmark Pharmaceuticals. The Indian Pharmaceutical company has reportedly produced a generic version of Zytiga tablets, 250 mg, of Janssen Biotech which is used to cure the same disease. Janssen Pharmaceutical Companies of Johnson & Johnson is a biotechnology company that was founded in Philadelphia in 1979 with an initial goal of developing new diagnostic assays using monoclonal antibody technology. Glenmark at the same time is a pharmaceutical company headquartered in Mumbai, India that was founded in 1977 by Gracias Saldanha as a generic drug and active pharmaceutical ingredient manufacturer.
“Glenmark Pharmaceuticals Inc., USA has been granted final approval by the United States Food & Drug Administration (USFDA) for Abiraterone Acetate tablets USP, 250 mg,” Glenmark said in a regulatory filing.
As per a Press Release by Janssen Pharmaceuticals, they studied the effect of Zytiga tablet on once daily in combination with prednisone 5 mg once daily in patients with newly diagnosed, metastatic high-risk CSPC, who had not received prior cytotoxic chemotherapy. The results showed that Zytiga in combination with prednisone reduced the risk of death by 38 percent compared to another treatment by placebo. Additional data demonstrated the statistically significant delay in time to initiation of chemotherapy for patients in the Zytiga arm as compared to the placebo. As mentioned in the Press Release, Metastatic prostate cancer is cancer that has spread to another part of the body. Metastatic castration-sensitive prostate cancer (CSPC), also referred to as metastatic hormone-sensitive prostate cancer (HSPC), refers to prostate cancer that still responds to testosterone suppression therapy.
The Zytiga tablets, 250 mg market achieved annual sales of approximately USD 794.1 million, said Glenmark quoting IQVIA sales data for the 12 month period ending August 2019. The Indian Pharmaceutical giant's current portfolio consists of 162 products authorised for distribution in the US marketplace. As per BSE indices, shares of Glenmark Pharma were trading 0.15 percent higher at Rs 286.00 apiece.