BioSpectrum (India) - - COVER STORY -

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.

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