Sam­sung to make drug for US firm

The Korea Times - - BUSINESS - By Nam Hyun-woo [email protected]­re­atimes.co.kr

Sam­sung BioLog­ics said Tues­day it had signed a con­tract with a U.S. biotech firm to ex­pand the man­u­fac­ture of a drug to com­bat atopic der­mati­tis that is un­der­go­ing clin­i­cal tri­als.

Since the con­tract also guar­an­tees com­mer­cial man­u­fac­ture, Sam­sung BioLog­ics ex­pects it will lead to greater op­por­tu­ni­ties in the lu­cra­tive atopic der­mati­tis drug mar­ket.

The com­pany said it had signed a long-term agree­ment with Ich­nos Sci­ences to man­u­fac­ture the lat­ter’s ISB 830 atopic der­mati­tis drug for phase three clin­i­cal tri­als.

With the con­tract, Sam­sung BioLog­ics will man­u­fac­ture at least $15.1 mil­lion worth of the drug, up from an ex­ist­ing deal of $8.62 mil­lion, which was signed in June 2018.

ISB 830 is an anti-OX40 mon­o­clonal an­ti­body, be­lieved to have the po­ten­tial to treat a range of au­toim­mune dis­eases be­yond atopic der­mati­tis. A ran­dom­ized placebo-con­trolled phase two study was com­pleted re­cently.

Ad­di­tion­ally, the new deal also guar­an­tees Sam­sung the drug’s com­mer­cial man­u­fac­tur­ing worth $66.44 mil­lion, if Ich­nos Sci­ences wins reg­u­la­tory ap­proval at the con­clu­sion of phase three tri­als next year.

Ich­nos Sci­ences is a biotech spinoff from the global phar­ma­ceu­ti­cal com­pany Glen­mark, and has five can­di­date drugs in the pipe­line — treat­ments for breast can­cer, myeloma, os­teoarthri­tis, neu­ro­pathic pain and atopic der­mati­tis. Of them, the two for atopic der­mati­tis and neu­ro­pathic pain are on the fastest track, as they are both in phase three tri­als.

Sam­sung BioLog­ics and Ich­nos Sci­ences formed their first part­ner­ship in 2017 with a Master Ser­vice Agree­ment for the Korean firm to pro­vide the U.S. com­pany with process op­ti­miza­tion and man­u­fac­tur­ing ser­vices.

Com­mer­cial man­u­fac­tur­ing of the drug will de­pend on mar­ket de­mand, and Sam­sung Biolog­ics is con­sid­er­ing pro­duc­ing it at its In­cheon Plant 3, which is the world’s largest sin­gle bio man­u­fac­tur­ing plant.

“We are ex­tremely proud to ad­vance our on­go­ing re­la­tion­ship with Ich­nos and truly ap­pre­ci­ate the trust they have placed in Sam­sung Biolog­ics to en­sure de­liv­ery of a high-qual­ity ISB 830 drug sup­ply for clin­i­cal stud­ies and for po­ten­tial fu­ture com­mer­cial pro­duc­tion,” Sam­sung BioLog­ics CEO Kim Tae­han said.

“Client sat­is­fac­tion is our high­est pri­or­ity, and we look for­ward to gen­er­at­ing fu­ture value for Ich­nos via our con­tin­ued col­lab­o­ra­tion.”

The con­tract is ex­pected to ex­pand Sam­sung BioLog­ics pres­ence in the global atopic der­mati­tis mar­ket.

Ac­cord­ing to mar­ket tracker Global Data, the seven largest mar­kets for the con­di­tion world­wide are the U.S., France, Ger­many, Italy, Spain, the U.K. and Ja­pan - and th­ese are grow­ing by an av­er­age 11.1 per­cent an­nu­ally with their value an­tic­i­pated to reach $18.3 bil­lion by 2027.

“As we progress our pipe­line of clin­i­cal stage as­sets, in­clud­ing our most ad­vanced bi­o­logic ISB 830, we are pleased to con­tinue to work with Sam­sung Biolog­ics to en­sure a con­tin­ued drug sub­stance sup­ply for ISB 830,” Ich­nos Sci­ences CEO Alessan­dro Riva said.

“We look for­ward to a mu­tu­ally ben­e­fi­cial col­lab­o­ra­tion as we con­tinue de­vel­op­ing ISB 830 for au­toim­mune dis­eases, in­clud­ing atopic der­mati­tis.”

Cour­tesy of Sam­sung BioLog­ics

Sam­sung BioLog­ics Plant 3 in In­cheon

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