Bio­con gets ap­proval for generic Crestor in Europe

The Pak Banker - - COMPANIES/BOSS -

Bio­phar­ma­ceu­ti­cals firm Bio­con Ltd on Mon­day said it has got ap­proval to sell the generic equiv­a­lent of As­trazenaca Plc's choles­terol-low­er­ing pill Crestor in the Euro­pean Union (EU). The ap­proval is for the 5 mil­ligram (mg), 10 mg, 20 mg and 40 mg dosage forms of the drug.

Crestor, gener­i­cally called ro­su­vas­tatin cal­cium, is Bio­con's first-ever generic for­mu­la­tion ap­proval in a reg­u­lated mar­ket. "(It) marks an im­por­tant mile­stone in Bio­con's small mol­e­cules strat­egy of for­ward in­te­gra­tion from APIs to fin­ished dosages," Bio­con said in a state­ment. "The ap­proval for ro­su­vas­tatin cal­cium, through de­cen­tral­ized pro­ce­dure, will open the doors for Bio­con to over 15 Euro­pean coun­tries and will en­able the com­pany to ad­dress $1.2 bil­lion op­por­tu­nity, start­ing FY17," the com­pany said.

Bio­con said it be­come the first generic com­pany to re­ceive a cer­tifi­cate of suit­abil­ity (CEP) for ro­su­vas­tatin cal­cium ac­tive phar­ma­ceu­ti­cal in­gre­di­ent from the Euro­pean Di­rec­torate for the Qual­ity of Medicines (EDQM). CEP cer­ti­fi­ca­tion in­di­cates that an API is suit­able for use in medic­i­nal prod­ucts in the EU.

"This is in­deed a proud mo­ment for Bio­con's small mol­e­cules busi­ness," said Ki­ran Mazum­dar-Shaw, Bio­con chair­per­son and man­ag­ing di­rec­tor. "We plan to col­lab­o­rate with re­gional part­ners in the near term to pro­vide ac­cess to this af­ford­able generic and thus help pa­tients and gov­ern­ments to bring down their health­care spends," Ma­jum­dar-Shaw said.

Bio­con said it aims to boost its generic for­mu­la­tions busi­ness with a pipe­line of 20-25 fil­ings over the next few years tar­get­ing reg­u­lated mar­kets such as the US and the EU. The com­pany is build­ing a new oral solid dosage for­mu­la­tions fa­cil­ity in Ben­galuru to en­able its ex­pan­sion in the gener­ics space.

Bio­con said it had filed an ini­tial set of mar­ket­ing au­tho­riza­tion ap­pli­ca­tions in the EU and ab­bre­vi­ated new drug ap­pli­ca­tions ( AN­DAs) in the US in FY15 in ad­di­tion to work­ing on dossiers to in­tro­duce th­ese for­mu­la­tions in emerg­ing mar­kets where reg­u­la­tory clear­ances are pri- mar­ily based on ap­provals given by reg­u­la­tors in the US and the EU. An­a­lysts say Bio­con, which sells APIs, the key sub­stances that lend drugs their heal­ing prop­erty to pharma firms abroad, is try­ing to move up the value chain to higher mar­gin for­mu­la­tion or fin­ished dosages busi­ness, as biosim­i­lars, the com­pany's flag­ship prod­ucts, are ex­pected to take at least two- three years to start con­tribut­ing mean­ing­fully to the com­pany.

"Generic Crestor is a small mol­e­cule, and there will be sig­nif­i­cant com­pe­ti­tion from es­tab­lished generic play­ers, it needs to be seen how Bio­con will play in this space," said Afzaal Mo­hammed, pharma ex­pert at Karvy Stock Broking Ltd.

Bio­con is con­fi­dent. "In small mol­e­cules our strength is in statins and im­muno-sup­pres­sants, we are one of the largest global sup­plier of th­ese com­plex APIs, so we are start­ing with statin as our first generic prod­uct," said a Bio­con spokesper­son. Shares of Bio­con Ltd gained 4.57% to Rs.464.30 at 12pm on BSE, while the bench­mark Sen­sex gained 2.29% to 23,512.91 points.

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