Dr Reddy's may file two new drugs with FDA by 2019

Drug maker Dr Reddy's Laboratories Limited has said that it is currently working on 16 new drug applications and out of which a drug to treat migraines has completed Phase-3 trials and another anti-cancer biologic agent is currently under Phase-3 trials. 

According to filing with the US Securities and Exchange Commission, the city-based pharma company is expected to file the New Drug Application (NDA) with US Food and Drug Administration with regard the migraine drug in 2018 while it  is expected to submit license application for the cancer drug, it may approach the drug regulator in 2019. 

"As of March 31, 2017, we had 16 active product development programs in our pipeline (for DFN-02- the drug to treat acute treatment of migraines, with or without aura in adults) Phase 3 is completed. Submission of NDA to USFDA is planned for 2018," it said. 

Another (E7777-Treatment of Cutaneous T Cell Lymphoma) is an anti-cancer biologic agent in-licensed from EISAI limited...Phase 3 is in process. Submission of a biologics license application to the USFDA is planned for 2019," the company said. 

It however, said the timelines for expected filing may change due to various factors including outcome of Phase 3 studies, completion of Integrated Summary of Safety/Integrated Summary of effectiveness outcome of stability data and internal reprioritization of portfolio. 

The company's principal research and development facilities are located in Telangana-India, Cambridge-United Kingdom and Leiden- the Netherlands while the principal manufacturing facilities are located in Telangana, Andhra Pradesh and Himachal Pradesh in India, Cuernavaca-Cuautla, Mexico, Mirfield, United Kingdom, Louisiana and Tennessee, United States. 

The research and development expenses of the drugmaker were at Rs 1955 crore for the year ended March 31, 2017, an increase of 10 per cent as compared to Rs 1783.4 crore during FY 16. 

"This increase was in accordance with our strategy to expand our research and development efforts in complex formulations, differentiated formulations and bio-similar compounds," the company said in the filing.



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