Neu­ro­crine bags an FDA OK for tar­dive dysk­i­ne­sia, trump­ing Te­va as it preps first com­mer­cial launch

Kevin Gor­man, CEO of Neu­ro­crine Bio­sciences, presents at a Jef­feries in­vestor con­fer­ence in 2013. Bloomberg/via Get­ty Im­ages


The FDA has fol­lowed through with an ap­proval for Neu­ro­crine Bio­science’s In­grez­za (val­be­nazine) for tar­dive dysk­i­ne­sia, set­ting up a po­ten­tial show­down just a week af­ter Te­va scored with their ri­val ther­a­py, now ap­proved for Hunt­ing­ton’s chorea.

Un­like Te­va, Neu­ro­crine’s la­bel has come through with­out a black box warn­ing on de­pres­sion and sui­ci­dal ideation, giv­ing it a dis­tinct edge in any mar­ket­ing con­fronta­tion to come as Te­va waits for the FDA to de­cide on its own ap­pli­ca­tion to hit the TD mar­ket. Neu­ro­crine shares jumped 28% on the news, though some an­a­lysts had fret­ted about the la­bel.

The ap­proval marks a sea change for San Diego-based Neu­ro­crine $NBIX, which has been build­ing up a sales force for its first com­mer­cial launch. An­a­lysts next want to see late-stage Tourette syn­drome da­ta on In­grez­za and NDAs for elagolix — part­nered with Ab­b­Vie — in en­dometrio­sis and uter­ine fi­broids as the biotech jour­neys through a trans­for­ma­tive year.

Bar­clays, for one, has of­fered Neu­ro­crine’s drug its stamp of block­buster-wor­thi­ness, es­ti­mat­ing peak sales at more than $1 bil­lion for tar­dive dysk­i­ne­sia alone. Eval­u­atePhar­ma has al­so tracked a block­buster fu­ture for this drug as well, de­signed to treat in­vol­un­tary move­ments spurred by the pro­longed use of an­tipsy­chotics. Hunt­ing­ton’s chorea is a re­lat­ed con­di­tion in­volv­ing in­vol­un­tary twist­ing and writhing.

“This is a mo­men­tous oc­ca­sion for us,” said CEO Kevin Gor­man in a Tues­day evening call with an­a­lysts. Few com­pa­nies can say they dis­cov­ered a drug in their lab, de­vel­oped it and grabbed an FDA ap­proval, he added. This is the first drug ap­proved for TD.

What Gor­man and his team didn’t say, though, was how much the drug will cost. Like a grow­ing num­ber of com­pa­nies, Neu­ro­crine wants a clean shot at cel­e­brat­ing the ap­proval with­out hav­ing to ex­plain the cost — a sen­si­tive top­ic with man­u­fac­tur­ers and pay­ers. That will come with the launch, slat­ed for May 1.

The lat­est ap­proval came through af­ter Neu­ro­crine pub­lished the full set of da­ta in its fa­vor, in­clud­ing a note that its drug scored for 40% of the pa­tients in the drug arm who reg­is­tered at least a 50% im­prove­ment in the AIMS dysk­i­ne­sia score, com­pared to 8.7% of those on place­bo.

“Un­til now, one of the few op­tions for physi­cians, when man­ag­ing TD, was to stop, change or low­er the dose of an­tipsy­chot­ic med­ica­tion, po­ten­tial­ly jeop­ar­diz­ing pa­tients’ psy­chi­atric sta­bil­i­ty,” said Christoph U. Cor­rell, MD, Pro­fes­sor, Psy­chi­a­try and Mol­e­c­u­lar Med­i­cine, Hof­s­tra North­well School of Med­i­cine. “In clin­i­cal tri­als, IN­GREZ­ZA sig­nif­i­cant­ly and rapid­ly im­proved TD symp­toms com­pared to place­bo, re­duc­ing in­vol­un­tary move­ments acute­ly and through 48 weeks of treat­ment with­out com­pro­mis­ing un­der­ly­ing psy­chi­atric care. These re­sults, com­bined with con­ve­nient once-dai­ly dos­ing, rep­re­sent a tremen­dous break­through for pa­tients suf­fer­ing from TD.”

Last fall Te­va in­cit­ed a con­sid­er­able amount of spec­u­la­tion about how it could one day ri­val Neu­ro­crine in tar­dive dysk­i­ne­sia with Auste­do (SD-809, deutetra­benazine). But their mixed re­sults al­so sparked more than a lit­tle kick­back from an­a­lysts who pre­fer In­grez­za. The FDA hand­ed Te­va’s drug — ac­quired 2 years ago in a $3.5 bil­lion Aus­pex buy­out — a pri­or­i­ty re­view for TD in Feb­ru­ary and as­sign­ing them an Au­gust 30 PDU­FA date.

In­ves­ti­ga­tors for Te­va say that a high and mid-range dose of their drug hit the pri­ma­ry end­point on the move­ment scale rat­ing for a “mod­i­fied in­tent to treat” group in their sec­ond late-stage study. The low dose failed to sep­a­rate sig­nif­i­cant­ly from the place­bo. But the high dose, mean­while, missed beat­ing the place­bo based on in­ves­ti­ga­tors’ as­sess­ment of how their pa­tients were do­ing.

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