Kolon’s ‘in­no­va­tive drug com­pany’ sta­tus to be re­voked

The Korea Times - - NATIONAL - By Bahk Eun-ji [email protected]­re­atimes.co.kr

The Min­istry of Health and Wel­fare said Wed­nes­day that it is con­sid­er­ing re­vok­ing Kolon Life Science’s cer­tifi­cate as an “in­no­va­tive drug com­pany” for its mis­la­bel­ing and false re­port­ing of a key in­gre­di­ent in its gene ther­apy drug In­vossa.

In­vossa, the os­teoarthri­tis gene ther­apy drug for pa­tients with de­gen­er­a­tive joint dis­ease, was ap­proved by the Min­istry of Food and Drug Safety (MFDS) in 2017, based on the fact that the drug used car­ti­lage-orig­i­nated cells. How­ever, the drug man­u­fac­turer in­stead pro­duced and sold the drug made with a dif­fer­ent ma­te­rial — cells orig­i­nat­ing from the kid­ney.

The cer­tifi­cate is given to a com­pany which has had sig­nif­i­cant suc­cess in de­vel­op­ing new drugs and ex­pand­ing ex­ports, in a gov­ern­ment ef­fort to boost the global com­pet­i­tive­ness of lo­cal phar­ma­ceu­ti­cal firms. Such com­pa­nies are pro­vided with var­i­ous ad­min­is­tra­tive and fi­nan­cial sup­port.

Un­der the rel­e­vant law, the health min­istry is able to re­voke the cer­ti­fi­ca­tion af­ter hold­ing a hear­ing if a drug man­u­fac­turer re­ceived the cer­tifi­cate via false and other il­le­gal meth­ods.

The min­istry also said it plans to re­trieve the 8.2 bil­lion won ($7.02 mil­lion) in re­search and de­vel­op­ment sub­si­dies jointly pro­vided to Kolon Life Science by the health min­istry and the Min­istry of Science and ICT for three years since Oc­to­ber 2015 when the com­pany was se­lected for the gov­ern­ment’s project for high­tech bio­med­i­cine de­vel­op­ment.

Ear­lier this year, an in­ves­ti­ga­tion re­vealed the com­pany falsely re­ported the in­gre­di­ents and in­ten­tion­ally did not dis­close ad­di­tional data on the prob­lem to the health au­thor­i­ties be­fore the drug’s ap­proval.

Upon fi­nal dis­clo­sure, the MFDS forced the com­pany to stop man­u­fac­tur­ing and selling the drug in March, and can­celled the li­cense for the drug later.

More than 300 cases of In­vossa side ef­fects have been re­ported among about 3,000 peo­ple who had the drug ad­min­is­tered to help with knee prob­lems, ac­cord­ing to data sub­mit­ted to Rep. Jung Choun-sook of the rul­ing Demo­cratic Party of Korea by the health min­istry.

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