Shire blasts Roche over its 'mis­lead­ing' case for trail­blaz­ing he­mo­phil­ia drug emi­cizum­ab, scor­ing in­junc­tion

Over the past year, Shire $SH­PG has seen its shares buf­fet­ed re­peat­ed­ly as Roche moved steadi­ly ahead with its late-stage pro­gram for its close­ly-watched he­mo­phil­ia A drug emi­cizum­ab (ACE910). Now it’s fight­ing back, tak­ing Roche to court over the week­end, ahead of any reg­u­la­to­ry de­ci­sion for a se­ries of what it claims are dam­ag­ing and mis­lead­ing com­ments about the drug’s rel­a­tive safe­ty and ef­fi­ca­cy. But Roche im­me­di­ate­ly fired back Mon­day morn­ing with more Phase III da­ta, with no sign that Shire’s as­sault had in­flu­enced its lat­est up­date.

One day be­fore Roche was slat­ed to re­lease new da­ta at a sci­en­tif­ic con­fer­ence in Berlin, Shire an­nounced on Sun­day that it ob­tained a pre­lim­i­nary in­junc­tion from a court in Ham­burg, Ger­many against Roche aimed at the way it’s po­si­tioned the da­ta and shunt­ed blame for throm­bot­ic events – blood clot­ting – away from emi­cizum­ab and on­to by­pass­ing agents, in­clud­ing one from Shire.

Flem­ming Orn­skov

While it’s com­mon for drug mak­ers to wran­gle over in­tel­lec­tu­al prop­er­ty among ri­val ther­a­pies, IP has noth­ing to do with this le­gal coun­ter­at­tack. Shire is ar­gu­ing that Roche has been mak­ing “in­ac­cu­rate and mis­lead­ing” state­ments about the se­ri­ous ad­verse events tracked in its Phase III – events which have con­spired to keep this would-be block­buster un­der a cloud.

Shire claims that Roche has been mis­lead­ing­ly of­fer­ing a look at “treat­ed bleeds” — a sec­ondary end­point — in­stead of the “num­ber of bleeds over time,” orig­i­nal­ly laid out as the pri­ma­ry end­point in HAVEN 1. And by blam­ing throm­bot­ic in­ci­dents on its by­pass­ing agent, Shire adds, it’s been dam­aged.

Roche isn’t say­ing any­thing in di­rect re­sponse and de­clined to re­spond to my ques­tion of how the pre­lim­i­nary in­junc­tion could af­fect to­day’s pre­sen­ta­tion. In a state­ment to End­points News, the Basel com­pa­ny not­ed:

We are not com­ment­ing on press re­leas­es from oth­er com­pa­nies.

We stand be­hind the emi­cizum­ab da­ta, our clin­i­cal tri­al pro­to­col, in­ves­ti­ga­tors and the he­mo­phil­ia com­mu­ni­ty.
We are ex­cit­ed to be here at the In­ter­na­tion­al So­ci­ety on Throm­bo­sis and Haemosta­sis (ISTH) Con­gress to be a part of the sci­en­tif­ic dis­cus­sion around the emi­cizum­ab Phase III HAVEN 1 da­ta. Our de­ci­sions and ac­tions are al­ways based on do­ing what is right for pa­tients. 

As promised, Roche rolled out HAVEN 1 da­ta bright and ear­ly on Mon­day. Emi­cizum­ab, they say, not on­ly re­duced the rate of treat­ed bleeds by 87%, hit­ting the pri­ma­ry end­point, the drug al­so hand­i­ly outscored by­pass­ing agents like Shire’s. Their ther­a­py slashed “on-de­mand BPAs across all bleed mea­sure­ments, in­clud­ing ze­ro treat­ed bleeds (62.9 per­cent vs. 5.6 per­cent), ze­ro treat­ed spon­ta­neous bleeds (68.6 per­cent vs. 11.1 per­cent), ze­ro treat­ed joint bleeds (85.7 per­cent vs. 50.0 per­cent), ze­ro treat­ed tar­get joint bleeds (94.3 per­cent vs. 50.0 per­cent) and ze­ro bleeds over­all, which in­cludes all treat­ed and non-treat­ed bleeds (37.1 per­cent vs. 5.6 per­cent).”

Roche, though, has al­so ac­knowl­edged that there were 2 cas­es of throm­boem­bol­ic events and 3 in­stances of throm­bot­ic mi­croan­giopa­thy, ac­cord­ing to re­searchers en­gaged in the late-stage pro­gram. Back in Feb­ru­ary Roche rat­tled its most bull­ish fol­low­ers on this drug with the re­port that a pa­tient died from a rec­tal he­m­or­rhage af­ter be­ing treat­ed with emi­cizum­ab and a by­pass­ing agent dur­ing a break­through bleed­ing episode. The in­ci­dents were at­trib­uted to the BPAs.

As a re­sult of the ad­verse events, an­a­lysts back­ing Shire and No­vo Nordisk – both of which have he­mo­phil­ia fran­chis­es threat­ened by Roche’s drug – have been spec­u­lat­ing about a pos­si­ble di­rect tie to the Roche drug. While Roche would ap­pear to have the in­side track among pa­tients who had de­vel­oped in­hibitors to stan­dard drugs, it could face re­sis­tance to its use among oth­ers with­out in­hibitors, re­strict­ing its use and lim­it­ing its com­mer­cial ap­peal.

Shire made it clear that it’s been rat­tling its le­gal sword be­hind the scenes, to no avail.

From Shire’s state­ment:

Based on Roche’s pub­licly avail­able in­for­ma­tion to date (as of 7 Ju­ly 2017), physi­cians, pa­tients and care­givers may be mis­in­formed about the ap­pro­pri­ate man­age­ment of break­through bleeds un­con­trolled by emi­cizum­ab. In ad­di­tion, through these ac­tions, Shire be­lieves Roche has un­law­ful­ly dis­par­aged Shire’s proven by­pass­ing agent, FEI­BA (An­ti-In­hibitor Co­ag­u­lant Com­plex). Shire has is­sued mul­ti­ple un­heed­ed re­quests to Roche in an ef­fort to re­solve these con­cerns in an ap­pro­pri­ate man­ner. As a re­sult, Shire made the de­ci­sion to seek court in­ter­ven­tion.

There’s a lot at stake here for these com­pa­nies. Roche bad­ly needs to push through a slate of ma­jor new prod­uct ap­provals as biosim­i­lar com­pe­ti­tion to its fran­chise drugs starts to carve in­to its rev­enue flow. An­a­lysts have of­fered a va­ri­ety of es­ti­mates on peak sales for emi­cizum­ab, in­clud­ing one of $1.5 bil­lion by 2022, if Roche can es­tab­lish this as a new stan­dard of ther­a­py for he­mo­phil­ia.

Roche is slat­ed to of­fer a new pre­sen­ta­tion on its drug on Mon­day at the 26th In­ter­na­tion­al So­ci­ety on Throm­bo­sis and Haemosta­sis (ISTH) Meet­ing in Berlin, Ger­many. The phar­ma gi­ant did not im­me­di­ate­ly re­spond to a query from End­points News on Sun­day.

Shire CEO Flem­ming Orn­skov got in­to the he­mo­phil­ia mar­ket in a big way with its ac­qui­si­tion of Bax­al­ta. But it’s al­so been af­flict­ed with wa­ver­ing sales, which has hit the bot­tom line.

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