Forg­ing an In­no­v­a­tive Path in CNS Treat­ment

In 2019, SK Bio­phar­ma­ceu­ti­cal Co. Ltd., along­side its U.S. sub­sidiary SK Life Sci­ence, Inc., be­came the first South Ko­re­an com­pa­ny to in­de­pen­dent­ly bring a com­pound from dis­cov­ery to FDA ap­proval – a mo­ment that was 20 years in the mak­ing. On No­vem­ber 21, 2019, the FDA an­nounced its ap­proval of XCO­PRI® (cenoba­mate tablets) CV for the treat­ment of par­tial-on­set seizures in adults, for­ti­fy­ing the com­pa­ny to emerge as a glob­al phar­ma­ceu­ti­cal play­er. Two months lat­er, the world con­front­ed a dead­ly pan­dem­ic.

Every­thing sud­den­ly be­came un­cer­tain and ten­u­ous. Though there was buzz and ex­cite­ment about the new med­i­cine, a ma­jor de­ci­sion had to be made: launch now or wait? Lead­ers con­sid­ered pa­tient needs and de­cid­ed to forge ahead. In May 2020, SK life sci­ence adapt­ed to this new re­al­i­ty and launched XCO­PRI® with the vir­tu­al sup­port, ac­cess and re­sources that pa­tients, care­givers and health­care providers may need.

“Our team has al­ways been dri­ven to make a dif­fer­ence for those who live with cen­tral ner­vous sys­tem dis­or­ders no mat­ter what,” said Jeong Woo Cho, PhD, Pres­i­dent and CEO of SK Bio­phar­ma­ceu­ti­cals and SK life sci­ence. “The progress we have made so far would not have been pos­si­ble with­out the com­pa­ny’s long-stand­ing com­mit­ment to cre­at­ing eco­nom­ic and so­cial val­ue through in­no­va­tion, its ap­petite for tak­ing ap­pro­pri­ate risks, and dis­ci­pline to op­er­ate ef­fi­cient­ly.”

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This spir­it to adapt and take risks is not an anom­aly for SK Bio­phar­ma­ceu­ti­cals and SK life sci­ence nor their par­ent com­pa­ny, SK Group. Found­ed on an ethos of in­no­va­tion and col­lab­o­ra­tion, SK Group start­ed as a tex­tile en­ter­prise and rein­vent­ed it­self fol­low­ing the Ko­re­an War by ex­plor­ing, ac­quir­ing and lead­ing new ven­tures to be­come the third largest con­glom­er­ate in South Ko­rea. Af­ter achiev­ing suc­cess in oth­er ver­ti­cals – name­ly oil and gas – SK Group ven­tured in­to fine chem­i­cal as its new growth. Then, it as­signed a small team of sci­en­tists to ex­plore and in­vest in a new val­ue-added are­na: drug dis­cov­ery and de­vel­op­ment. SK Group de­cid­ed to fo­cus its ef­forts on dis­cov­er­ing com­pounds to treat cen­tral ner­vous sys­tem (CNS) dis­or­ders, an area where high un­met needs still ex­ist­ed, and be­gan its am­bi­tious jour­ney to un­der­stand and treat the mys­ter­ies of the hu­man brain.

Ap­prox­i­mate­ly three mil­lion adults¹ in the U.S. live with ac­tive epilep­sy and near­ly 60 per­cent have seizures, even while tak­ing an an­ti-seizure med­ica­tion (ASM)², demon­strat­ing a great un­met need for those liv­ing with the con­di­tion.

“Epilep­sy can be a chal­leng­ing con­di­tion to man­age giv­en it has sig­nif­i­cant phys­i­cal and men­tal ef­fects on pa­tients,” said Dr. Marc Kamin, Chief Med­ical Of­fi­cer at SK life sci­ence. “That is why de­liv­er­ing new treat­ment op­tions to the com­mu­ni­ty is such a crit­i­cal task.”

In ad­di­tion to de­liv­er­ing treat­ment, SK life sci­ence has strength­ened its foot­print in the U.S. by work­ing with the epilep­sy com­mu­ni­ty to raise aware­ness, col­lab­o­rat­ing on new ideas and of­fer­ing new re­sources. The pan­dem­ic had up­end­ed the nor­mal course of in-per­son health­care provider vis­its, med­ical con­fer­ences and pa­tient care, but SK life sci­ence moved for­ward us­ing dig­i­tal re­sources at its dis­pos­al to help with their needs.

Last year, SK life sci­ence de­buted a new vir­tu­al ex­pe­ri­ence at the Amer­i­can Epilep­sy So­ci­ety (AES) an­nu­al meet­ing to bring health­care providers in­to the lives of pa­tients and show­case the clin­i­cal pro­file of XCO­PRI® (cenoba­mate tablets) CV. Pre­vi­ous­ly, the com­pa­ny al­so spon­sored the “Seize the Truth About Epilep­sy Per­cep­tions” (STEP) Sur­vey to un­der­stand the cur­rent state of epilep­sy in the Unit­ed States and fos­ter bet­ter com­mu­ni­ca­tion be­tween pa­tients and their care team.

“In the midst of this pan­dem­ic, we knew there were pa­tients and health­care providers who were wait­ing for this op­tion,” said Seb­by Bor­riel­lo, Vice Pres­i­dent and Chief Com­mer­cial Of­fi­cer at SK life sci­ence. “We lis­tened to clin­i­cians and adopt­ed dig­i­tal com­mu­ni­ca­tion prac­tices to help them through the process of on­board­ing new pa­tients in a vir­tu­al en­vi­ron­ment. This was a marathon, not a sprint, and we want epilep­sy stake­hold­ers to know that they should re­ly on us for con­sis­tent sup­port as we work to ful­fill our com­pa­ny vi­sion of be­com­ing a leader with­in the CNS com­mu­ni­ty.”

Around the world, the com­pa­ny has forged strate­gic ties to de­vel­op and com­mer­cial­ize cenoba­mate. SK Bio­phar­ma­ceu­ti­cals forged li­cens­ing agree­ments with Arvelle Ther­a­peu­tics GmbH (re­cent­ly ac­quired by An­geli­ni Phar­ma) in Eu­rope and Ono Phar­ma­ceu­ti­cal Co., Ltd. in Japan.

“We can­not ap­ply a one-size ap­proach to all mar­kets. We must be flex­i­ble and strate­gic in our com­mer­cial op­er­a­tions in or­der to grow and de­liv­er on our promise,” said Dr. Cho. “Giv­en the U.S. phar­ma­ceu­ti­cal mar­ket­place and reg­u­la­to­ry land­scape, we are op­ti­mistic about lay­ing a strong foun­da­tion for the fu­ture, and we look for­ward to build­ing part­ner­ships glob­al­ly that will pro­vide an ef­fec­tive, in­no­v­a­tive treat­ment to pa­tients.”

In 2021 and be­yond, SK Bio­phar­ma­ceu­ti­cals and SK life sci­ence are poised to in­vest and de­vel­op a pipeline of po­ten­tial new treat­ments for CNS dis­or­ders, as part of ef­forts to ex­pand its busi­ness port­fo­lio for fu­ture growth.

“Our mis­sion is sim­ple. We con­nect health and hap­pi­ness to of­fer hope for a bet­ter life.” said Dr. Cho. “Our team is dri­ven to make a dif­fer­ence by de­vel­op­ing and pro­vid­ing new CNS med­i­cines, and our suc­cess is de­fined by those who are pos­i­tive­ly im­pact­ed by the treat­ment and sup­port we pro­vide.”

¹Cen­ters for Dis­ease Con­trol and Pre­ven­tion. Epilep­sy. https://www.cdc.gov/epilep­sy/ about/fast-facts.htm. Ac­cessed Jan­u­ary 21, 2021

²Tian N, Bor­ing M, Kobau R, Za­ck MM, Croft JB. Ac­tive epilep­sy and seizure con­trol in adults — Unit­ed States, 2013 and 2015. MMWR Morb Mor­tal Wk­ly Rep 2018; 67(15): 437–442. Ac­cessed Jan­u­ary 21, 2021

IM­POR­TANT SAFE­TY IN­FOR­MA­TION AND IN­DI­CA­TION FOR XCO­PRI® (cenoba­mate tablets) CV

DO NOT TAKE XCO­PRI IF YOU:

• Are al­ler­gic to cenoba­mate or any of the oth­er in­gre­di­ents in XCO­PRI.
• Have a ge­net­ic prob­lem (called Fa­mil­ial Short QT syn­drome) that af­fects the elec­tri­cal sys­tem of the heart.

XCO­PRI CAN CAUSE SE­RI­OUS SIDE EF­FECTS, IN­CLUD­ING:

Al­ler­gic re­ac­tions: XCO­PRI can cause se­ri­ous skin rash or oth­er se­ri­ous al­ler­gic re­ac­tions which may af­fect or­gans and oth­er parts of your body like the liv­er or blood cells. You may or may not have a rash with these types of re­ac­tions. Call your health­care provider right away and go to the near­est emer­gency room if you have any of the fol­low­ing: swelling of your face, eyes, lips, or tongue, trou­ble swal­low­ing or breath­ing, a skin rash, hives, fever, swollen glands, or sore throat that does not go away or comes and goes, painful sores in the mouth or around your eyes, yel­low­ing of your skin or eyes, un­usu­al bruis­ing or bleed­ing, se­vere fa­tigue or weak­ness, se­vere mus­cle pain, fre­quent in­fec­tions, or in­fec­tions that do not go away. Take XCO­PRI ex­act­ly as your health­care provider tells you to take it. It is very im­por­tant to in­crease your dose of XCO­PRI slow­ly, as in­struct­ed by your health­care provider.

QT short­en­ing: XCO­PRI may cause prob­lems with the elec­tri­cal sys­tem of the heart (QT short­en­ing). Call your health­care provider if you have symp­toms of QT short­en­ing in­clud­ing fast heart­beat (heart pal­pi­ta­tions) that last a long time or faint­ing.

Sui­ci­dal be­hav­ior and ideation: Antiepilep­tic drugs, in­clud­ing XCO­PRI, may cause sui­ci­dal thoughts or ac­tions in a very small num­ber of peo­ple, about 1 in 500. Call your health care provider right away if you have any of the fol­low­ing symp­toms, es­pe­cial­ly if they are new, worse, or wor­ry you: thoughts about sui­cide or dy­ing; at­tempt­ing to com­mit sui­cide; new or worse de­pres­sion, anx­i­ety, or ir­ri­tabil­i­ty; feel­ing ag­i­tat­ed or rest­less; pan­ic at­tacks; trou­ble sleep­ing (in­som­nia); act­ing ag­gres­sive; be­ing an­gry or vi­o­lent; act­ing on dan­ger­ous im­puls­es; an ex­treme in­crease in ac­tiv­i­ty and talk­ing (ma­nia); or oth­er un­usu­al changes in be­hav­ior or mood.

Ner­vous sys­tem prob­lems: XCO­PRI may cause prob­lems that af­fect your ner­vous sys­tem. Symp­toms of ner­vous sys­tem prob­lems in­clude: dizzi­ness, trou­ble walk­ing or with co­or­di­na­tion, feel­ing sleepy and tired, trou­ble con­cen­trat­ing, re­mem­ber­ing, and think­ing clear­ly, and vi­sion prob­lems. Do not dri­ve, op­er­ate heavy ma­chin­ery, or do oth­er dan­ger­ous ac­tiv­i­ties un­til you know how XCO­PRI af­fects you.

Do not drink al­co­hol or take oth­er med­i­cines that can make you sleepy or dizzy while tak­ing XCO­PRI with­out first talk­ing to your health­care provider.

DIS­CON­TIN­U­A­TION:

Do not stop tak­ing XCO­PRI with­out first talk­ing to your health­care provider. Stop­ping XCO­PRI sud­den­ly can cause se­ri­ous prob­lems. Stop­ping seizure med­i­cine sud­den­ly in a pa­tient who has epilep­sy can cause seizures that will not stop (sta­tus epilep­ti­cus).

DRUG IN­TER­AC­TIONS:

XCO­PRI may af­fect the way oth­er med­i­cines work, and oth­er med­i­cines may af­fect how XCO­PRI works. Do not start or stop oth­er med­i­cines with­out talk­ing to your health­care provider. Tell health­care providers about all the med­i­cines you take, in­clud­ing pre­scrip­tion and over-the-counter med­i­cines, vi­t­a­mins and herbal sup­ple­ments.

PREG­NAN­CY AND LAC­TA­TION:

XCO­PRI may cause your birth con­trol med­i­cine to be less ef­fec­tive. Talk to your health care provider about the best birth con­trol method to use.

Talk to your health care provider if you are preg­nant or plan to be­come preg­nant. It is not known if XCO­PRI will harm your un­born ba­by. Tell your health­care provider right away if you be­come preg­nant while tak­ing XCO­PRI. You and your health­care provider will de­cide if you should take XCO­PRI while you are preg­nant. If you be­come preg­nant while tak­ing XCO­PRI, talk to your health­care provider about reg­is­ter­ing with the North Amer­i­can Antiepilep­tic Drug (NAAED) Preg­nan­cy Reg­istry. The pur­pose of this reg­istry is to col­lect in­for­ma­tion about the safe­ty of antiepilep­tic med­i­cine dur­ing preg­nan­cy. You can en­roll in this reg­istry by call­ing 1-888-233-2334 or go to www.aed­preg­nan­cyreg­istry.org.

Talk to your health care provider if you are breast­feed­ing or plan to breast­feed. It is not known if XCO­PRI pass­es in­to breast­milk. Talk to your health­care provider about the best way to feed your ba­by while tak­ing XCO­PRI.

COM­MON SIDE EF­FECTS:

The most com­mon side ef­fects in pa­tients tak­ing XCO­PRI in­clude dizzi­ness, sleepi­ness, headache, dou­ble vi­sion, and feel­ing tired.

These are not all the pos­si­ble side ef­fects of XCO­PRI. Tell your health­care provider if you have any side ef­fect that both­ers you or that does not go away. For more in­for­ma­tion, ask your health­care provider or phar­ma­cist.  Call your doc­tor for med­ical ad­vice about side ef­fects. You may re­port side ef­fects to FDA at 1-800-FDA-1088 or at www.fda.gov/med­watch.  

DRUG ABUSE:

XCO­PRI is a fed­er­al­ly con­trolled sub­stance (CV) be­cause it can be abused or lead to de­pen­dence. Keep XCO­PRI in a safe place to pre­vent mis­use and abuse. Sell­ing or giv­ing away XCO­PRI may harm oth­ers and is against the law.

IN­DI­CA­TION:

XCO­PRI is a pre­scrip­tion med­i­cine used to treat par­tial-on­set seizures in adults 18 years of age and old­er. It is not known if XCO­PRI is safe and ef­fec­tive in chil­dren un­der 18 years of age.

Please see ad­di­tion­al pa­tient in­for­ma­tion in the Med­ica­tion Guide. This in­for­ma­tion does not take the place of talk­ing with your health­care provider about your con­di­tion or your treat­ment.

Please see full Pre­scrib­ing In­for­ma­tion.

XCO­PRI® is a reg­is­tered trade­mark of SK Bio­phar­ma­ceu­ti­cals Co., Ltd.