Dr Reddy’s Labs
With 18 manufacturing units, 4 R&D units, 2 technology development centres in India, the R&D expenses for Dr Reddy’s Labs during FY2018 were Rs 18.265 billion, or 12.9 per cent of revenue versus 13.9 per cent in FY2017. According to Dr Reddy’s, the absolute and proportional decrease in R&D spends is in line with the continued focus on cost optimization, productivity improvement, and prioritization of projects, which have been executed in a manner that does not impinge on the company’s focus on building the pipeline of complex generics, biosimilars, and differentiated products.
Key Highlights – FY2018 Focus on advancing the development of the 2 in-licensed assets- a) XP-23829 acquired from XenoPort, which is a clinical stage new oral entity that has the potential for the treatment of plaque psoriasis and may even be developed for relapsing forms of multiple sclerosis; and b) E7777, from Eisai, which is an anti-cancer agent. Developing some internal pipeline products that involve dermatological and neurological assets, which are in midto-late stage development.
Launched 15 new products in North America – the major ones being Liposomal Doxorubicin, EzetimibeSimvastatin, Sevelamer, Palonosetron injection and Bivalrudin injection.
Filed 19 new US ANDAs and 1 New Drug Application (NDA).
110 generic filings pending approval from the USFDA, comprising 107 ANDAs and three NDAs filed under the 505(b)(2) route of the US Federal Food, Drug and Cosmetic Act. Of the 107 ANDAs, 63 are Para IV applications, of which 30 have ‘First to File’ status.