Sun Gets a Shot in the Arm as USFDA Gives Nod to Eye Drug

Ap­proval for non-steroidal anti-in­flam­ma­tory BromSite opens up ac­cess to a $400-m mar­ket in the US

The Economic Times - - Companies - Vikas.Dan­dekar@ times­group.com

Mum­bai: Sun Phar­ma­ceu­ti­cal In­dus­tries has re­ceived the US Food and Drug Ad­min­is­tra­tion (USFDA) ap­proval for BromSite, used to re­lieve post-op­er­a­tive in­flam­ma­tion and pre­ven­tion of eye pain in pa­tients un­der­go­ing cataract surgery, a sig­nif­i­cant boost to the com­pany’s strat­egy of step­ping up its spe­cialty branded drugs play in the world’s big­gest pharmaceuticals mar­ket. It’s the first non-steroidal anti-in­flam­ma­tory drug (NSAID) ap­proved for such con­di­tions, the com­pany said. Sun Pharma said the ap­proval opens ac­cess to a $400-mil­lion mar­ket grow­ing at 8% as of Jan­uary, ac­cord­ing to data from re­search provider IMS, based on the mov­ing an­nual to­tal (MAT). BromSite was de­vel­oped by In­Site Vi­sion, a US com­pany that the In­dian drug maker ac­quired in Novem­ber.

The prod­uct will be com­mer­cialised through New Jersey-based Sun Oph­thalmics, a di­vi­sion that Sun formed re­cently to route its spe­cialty branded of­fer­ings in eye care. The com­pany said in a re­lease that it aims to pro­vide

used to treat post-op­er­a­tive in­flam­ma­tion and pre­ven­tion of oc­u­lar pain af­ter cataract surgery

to start mar­ket­ing the drug in sec­ond half of 2016

Sun’s JV with In­trexon will give edge through tar­get­ted bi­o­logic ther­a­pies for eye care

prod­ucts that en­hance treat­ment op­tions and de­liver them through a concierge-level ap­proach to cus­tomer care.

With BromSite’s ap­proval and ad­di­tional late-stage can­di­dates in its pipe­line, Sun Oph­thalmics is po­si­tioned to of­fer a range of ben­e­fi­cial prod­ucts, the com­pany said.

Sun’s other pipe­line can­di­dates in the area of eye care in­clude Xel­pros, which is latanoprost oph­thalmic solu- play in­cludes der­ma­tol­ogy brands; progress of Phase III trial data for MK3222 be­ing watched closely

spend was in FY15, six-fold jump over

tion that seeks to treat re­duc­tion of el­e­vated in­traoc­u­lar pres­sure in pa­tients with open an­gle glau­coma or oc­u­lar hy­per­ten­sion. Dex­aSite is a dex­am­etha­sone that’s be­ing ex­plored for the treat­ment of ble­phar­i­tis. Of to­tal sales of $4.5 bil­lion in 2015, Sun Pharma’s US oper­a­tions con­trib­uted $2.2 bil­lion. Sun spends more than 7% of its sales on R&D, which amounted to .₹ 1,960 crore last year, a six-fold jump from .₹ 330 crore in 2009.

In 2013, Sun formed a JV with In­trexon, a lead­ing US drug maker in the area of syn­thetic biotech­nol­ogy, for de­vel­op­ing gene-based novel ther­a­pies for oc­u­lar dis­eases. Among the ar­eas of re­search, the ven­ture is work­ing on plat­form tech­nol­ogy RheoSwitch Ther­a­peu­tic Sys­tem that, when com­mer­cialised, will help pa­tients re­ceive a tar­geted bi­o­logic ther­apy with­out hav­ing to en­dure long-term use of in­jec­tions. The joint ven­ture had planned an ex­pan­sion of the pipe­line to tar­get oc­u­lar dis­eases that in­clude wet AMD (age-re­lated mac­u­lar de­gen­er­a­tion), mac­u­lar edema, non-in­fec­tious uveitis and di­a­betic retinopa­thy.

Be­sides eye care, Sun is ramp­ing up its pipe­line of der­ma­tol­ogy drugs in the US, where it is ranked third among branded com­pa­nies in the seg­ment, helped by a port­fo­lio of prod­ucts from Taro and DUSA, the sec­ond of which it ac­quired in 2012 to broaden its pres­ence in the skin-re­lated seg­ment. The progress of Sun’s late-stage com­pound MK-3222 (in-li­censed from US drug maker Merck) to treat chronic plaque pso­ri­a­sis is be­ing watched closely by in­vestors.

Sun’s R&D

1,960 crore

330 crore

BromSite: Sun Gets USFDA Nod

Only NSAID

Sun Oph­thalmics

More Aces:

Sun’s spe­cialty

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