‘‘Fer­ring will con­tinue to launch the global re­search prod­ucts in In­dia” Suresh Pat­tathil, Chief Ex­ec­u­tive Of­fi­cer (CEO), In­dia, Fer­ring Phar­ma­ceu­ti­cals

BioSpectrum (India) - - BIO CONTENT - Dr Man­beena Chawla man­beena.chawla@mmac­tiv.com

Fer­ring Phar­ma­ceu­ti­cals, a pharma ma­jor from Europe, re­cently laid the foun­da­tion stone for their state- of-the art R&D lab­o­ra­tory and man­u­fac­tur­ing fa­cil­ity in Hy­der­abad. The com­pany had es­tab­lished its In­dian sub­sidiary in 1997 and has thus far es­tab­lished a man­u­fac­tur­ing fa­cil­ity, an R&D cen­tre and com­mer­cial op­er­a­tions in Ma­ha­rash­tra. The 2 bil­lion Euro re­search-driven spe­cialty bio­phar­ma­ceu­ti­cal group is a leader in re­pro­duc­tive medicine and women’s health. In line with this, the com­pany is all set to re­lease its heat-sta­ble car­be­tocin drug in the In­dia that is as ef­fec­tive as oxy­tocin in pre­vent­ing post­par­tum haem­or­rhage (PPH). The drug is ex­pected to hit the shelves in In­dia in a year’s time af­ter ob­tain­ing the ap­proval from the Cen­tral Drugs Stan­dard Con­trol Or­gan­i­sa­tion (CD­SCO). Suresh Pat­tathil, Chief Ex­ec­u­tive Of­fi­cer (CEO), In­dia, Fer­ring Phar­ma­ceu­ti­cals in­ter­acted with BioSpec­trum re­cently and shared de­tails of these re­cent de­vel­op­ments. Edited ex­cerpts;

What would be the core fo­cus of the new R&D fa­cil­ity in Hy­der­abad? What are the plans re­gard­ing the re­cruit­ment at the new fa­cil­ity?

The Hy­der­abad project will con­sist of an R&D Cen­tre, Pi­lot Plant, and Man­u­fac­tur­ing fa­cil­ity. The cur­rent R&D fa­cil­ity based in Mum­bai will be shifted to Hy­der­abad and the fo­cus will be on for­mu­la­tion de­vel­op­ment which will pro­vide more con­ve­nience and ef­fi­cacy. The cap­i­tal in­vest­ment planned is around 235 crores for this project. Af­ter we have com­pleted all the phases of the project we es­ti­mate around 245 peo­ple work­ing at the fa­cil­ity.

What are the com­pany’s plans re­gard­ing the launch of car­be­tocin in In­dia? Af­ter car­be­tocin, what more is in store at Fer­ring?

Car­be­tocin Heat Sta­ble is in­di­cated for pre­vent­ing Post­par­tum Haem­or­rhage (PPH) which is one of the ma­jor causes of ma­ter­nal mor­tal­ity and we are in the process of sub­mit­ting the ap­pli­ca­tion with the clin­i­cal re­sults to the DCGI for reg­u­la­tory ap­proval.

The CHAM­PION (Car­be­tocin He­m­or­rhage Preven­tion) trial is the largest clin­i­cal trial in the preven­tion of PPH. It was a Phase III, ran­domised, multi­na­tional, mul­ti­cen­tric, dou­ble blind, non-in­fe­ri­or­ity trial com­par­ing Car­be­tocin Heat Sta­ble with Oxy­tocin that in­cluded 30,000 women in 10 coun­tries. Re­cently, the re­sults of this trial have been pub­lished in the New Eng­land Jour­nal of Medicine. The data shows that Car­be­tocin Heat Sta­ble is as ef­fec­tive as Oxy­tocin with­out the need to keep it in tem­per­a­ture-con­trolled stor­age. Oxy­tocin, the cur­rent stan­dard of care in pre­vent­ing ex­ces­sive bleed­ing fol­low­ing vagi­nal birth needs to be stored be­tween 2–8°cel­sius and any de­vi­a­tion in tem­per­a­ture can lower its ef­fi­cacy. On the other hand, Car­be­tocin Heat Sta­ble can be used with­out wor­ry­ing about loss of ef­fi­cacy due to tem­per­a­ture ex­cur­sion.

Fer­ring will con­tinue to launch the global re­search prod­ucts in In­dia. Some of them are Cor­ti­ment MMX for ul­cer­a­tive col­i­tis and Rekovelle for IVF treat­ment.

How does the com­pany plan to ad­dress the health­care chal­lenges in In­dia?

Fer­ring is a spe­cialty pharma com­pany and we will con­tinue to ad­dress the un­met med­i­cal needs by fo­cus­ing on the pa­tient. We want to work on en­hanc­ing the di­ag­no­sis and treat­ment ad­her­ence of spe­cific disease like ul­cer­a­tive col­i­tis in which Fer­ring has a lead­er­ship role.

Is the com­pany plan­ning any col­lab­o­ra­tion or ac­qui­si­tion in the com­ing years for new prod­ucts?

If the op­por­tu­nity arises Fer­ring will work with part­ners or ac­quire to en­able syn­ergy and a strong ‘go to mar­ket’ strat­egy for our key prod­ucts.

What are your views on the chang­ing clin­i­cal tri­als trend in In­dia?

The clin­i­cal trial reg­u­la­tory frame­work is very ro­bust now and has made the ap­proval process quicker, pre­dictable, and in-line with global prac­tices. I be­lieve that we have good qual­ity sys­tems in place in In­dia to en­sure con­duct of clin­i­cal tri­als as per global stan­dards. The In­dia ad­van­tage will be the abil­ity to pro­vide suf­fi­cient pa­tient num­bers, sim­pler pro­cesses, and lower rel­a­tive cost of con­duct­ing a trial com­pared to other coun­tries.

Chief Ex­ec­u­tive Of­fi­cer (CEO), In­dia, Fer­ring Phar­ma­ceu­ti­calsSuresh Pat­tathil,

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