In FY 2017-18, the R&D expense for Wockhardt amounted to Rs 4.43 billion at 11 per cent of total sales. Building on the Intellectual Property (IP) base, the company has filed 133 patents this fiscal, and won 75 patents, taking cumulative patents filed to 3,037 and patents won to 628. Today Wockhardt has 5 breakthrough New Chemical Entities (NCEs) that have been accorded Qualified Infectious Disease Product (QIDP) status by US FDA, all of which have entered Phase III clinical stage. Being developed as novel antibiotics, all 5 drugs are expected to significantly help the global war against Antimicrobial Resistance
(AMR) in the near future.
Key Highlights – FY2018
Received approvals for its 6 US ANDAs from third party approved manufacturing facility during the year.
Filed for 1 new product (ANDAs) in US and 4 in UK.
NCE WCK 5222- Phase 3 study protocol finalized in consultation with US FDA, study to commence in second half of fiscal 2018-19.
NCE WCK 4282Phase 3 study protocol finalized
in consultation with US
FDA, study to commence in mid-2018-19. Phase 3 protocol submitted to EMA in January 2018.
NCE WCK 4873- Oral community acquired pneumonia Phase 2 study has been completed in the US and Europe. WCK 4873 IND has been filed with
USA only. The Company will be able utilize the current Phase 2 data for future EU application. Phase 3 study is expected to commence in India in 2nd half of fiscal 2018-19.
NCE WCK 771 & WCK 2349Phase 3 complicated skin and skin structure infections study progressing well in India and is expected to complete in fiscal 201819 and the company is planning to file for marketing authorisation in fiscal 2018-19.