GSK li­cens­es Ion­is' ex­per­i­men­tal hep B treat­ments in up to $262M deal

GSK $GSK may have walked away from two of Io­n­is’ $IONS an­ti­sense drugs (in­clud­ing the now-ap­proved Tegse­di) in 2017 — but the British drug­mak­er held on as a part­ner to the biotech­nol­o­gy com­pa­ny’s ex­per­i­men­tal he­pati­tis B treat­ments.

On Tues­day, GSK ex­er­cised its op­tion to li­cense Io­n­is’ drugs — IO­N­IS-HBVRx and IO­N­IS-HBV-LRx — fol­low­ing pos­i­tive mid-stage da­ta. In re­turn, Io­n­is re­ceives up to $262 mil­lion in mile­stone pay­ments, in­clud­ing a $25 mil­lion li­cense fee. In ad­di­tion, Io­n­is is al­so el­i­gi­ble to re­ceive tiered roy­al­ties on net sales. Now, GSK is re­spon­si­ble for all de­vel­op­ment, reg­u­la­to­ry and com­mer­cial­iza­tion ac­tiv­i­ties and costs for the two drugs.

Hep B is trans­mit­ted through con­tact with blood and bod­i­ly flu­ids of an in­fect­ed per­son and is a high­ly in­fec­tious virus, 50 to 100 times more in­fec­tious than HIV — even slight laps­es in in­fec­tion con­trol can re­sult in pa­tient-to-pa­tient trans­mis­sion. The chron­ic in­fec­tion, which af­fects more than 200 mil­lion glob­al­ly, can lead to life-threat­en­ing health con­di­tions, in­clud­ing cir­rho­sis, liv­er fail­ure and liv­er can­cer. Cur­rent treat­ments that are ef­fec­tive in re­duc­ing cir­cu­lat­ing virus in the blood, do not ef­fi­cient­ly in­hib­it anti­gen pro­duc­tion and se­cre­tion, which are as­so­ci­at­ed with poor prog­no­sis.

The an­ti­sense drugs are en­gi­neered to ad­dress the root cause of the dis­ease — by re­duc­ing the pro­duc­tion of vi­ral pro­teins as­so­ci­at­ed with hep B in­fec­tion and repli­ca­tion, in­clud­ing hep B sur­face anti­gen, which is found in both acute and chron­ic in­fec­tions. Mean­while, GSK al­ready sells a hep B vac­cine called En­ger­ix-B.

Io­n­is has a myr­i­ad of big phar­ma part­ner­ships un­der its belt, in­clud­ing Roche, Bio­gen, Bay­er and As­traZeneca. Un­der chief Stan­ley Crooke, who found­ed the com­pa­ny about thir­ty years ago, Io­n­is has honed a mod­el in which it de­vel­ops an­ti­sense prod­ucts for a pletho­ra of in­di­ca­tions, de-risks them in the clin­ic and then se­cures a phar­ma part­ner to con­duct piv­otal tri­als and com­mer­cial­ize. In re­turn, the com­pa­ny prof­its from a steady stream of up­front and mile­stone pay­ments, as well as roy­al­ties. Last De­cem­ber, Crooke dis­closed plans to tran­si­tion to the role of ex­ec­u­tive chair­man in 2020.

Hal Bar­ron

Un­der re­search chief Hal Bar­ron, GSK has been work­ing on con­jur­ing up some ex­cite­ment for its pipeline by large­ly fo­cus­ing on on­col­o­gy, al­though oth­er ar­eas that are un­der­served are al­so of in­ter­est. In an in­ter­view with the Fi­nan­cial Times in Ju­ly, he said that tak­ing “smart risks” in R&D is how he sees the once glacial gi­ant trans­form­ing its re­search work. “(O)nce you start fear­ing fail­ure, you be­come so con­ser­v­a­tive that you end up ba­si­cal­ly mov­ing to­wards things that are ob­vi­ous­ly go­ing to work and there­fore like­ly to be not very in­no­v­a­tive . . . And, ul­ti­mate­ly, it’s a death spi­ral.”

So­cial im­age: GSK, AP Im­ages

 

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