My­ovan­t's uter­ine fi­broid drug looks com­pet­i­tive in PhI­II — but can they van­quish mighty Ab­b­Vie?

Vivek Ra­maswamy’s My­ovant $MY­OV has close­ly matched its pos­i­tive first round of Phase III da­ta for their uter­ine fi­broid drug re­l­u­golix, set­ting up a head-to-head ri­val­ry with phar­ma gi­ant Ab­b­Vie as the lit­tle biotech steers to the mar­ket with a planned fil­ing in Q4.

Vivek Ra­maswamy

Here’s how My­ovant plans to pre­vail over the Ab­b­Vie $AB­BV em­pire.

In the study, 71.2% of women re­ceiv­ing once-dai­ly re­l­u­golix com­bi­na­tion ther­a­py achieved the clin­i­cal re­sponse they were look­ing for, com­pared to on­ly 14.7% in the con­trol arm. The da­ta com­fort­ably re­flect­ed the same out­comes in the first Phase III — 73.4% of women re­ceiv­ing once-dai­ly oral re­l­u­golix com­bi­na­tion ther­a­py achieved the re­spon­der cri­te­ria com­pared with 18.9% of women re­ceiv­ing place­bo — which will re­as­sure reg­u­la­tors that they are get­ting the care­ful­ly ran­dom­ized da­ta that qual­i­fies for the FDA’s gold stan­dard for suc­cess.

The suc­cess here, though, has to be com­pared with Ab­b­Vie’s elagolix, ap­proved last year for en­dometrio­sis and al­so on track for a date with the FDA on uter­ine fi­bro­sis — a con­di­tion that caus­es heavy men­stru­al bleed­ing among a por­tion of the pa­tients who have fi­broids. Ab­b­Vie’s Phase II­Is pro­duced clin­i­cal im­prove­ments for 76% and 68.5% of pa­tients.

Charles As­ch­er-Walsh Mount Sinai

A cou­ple of months ago, re­searchers pro­vid­ed an out­line of elagolix side ef­fects, though, that gave ex­perts in the field cau­tion about just how wide­ly sought af­ter the drug may be. In ad­di­tion to the loss of bone den­si­ty, the side ef­fects al­so in­clud­ed a pro­file sim­i­lar to menopause, with hot flash­es and night sweat. That could per­suade all but the most se­ri­ous cas­es to avoid the go­nadotropin-re­leas­ing hor­mone (GnRH) an­tag­o­nist.

“Women are will­ing to put up with [fi­broids] for years, so the idea of tak­ing a med­ica­tion that will have sig­nif­i­cant side ef­fects I don’t think is of­ten that pop­u­lar. [Symp­toms] are not as dra­mat­ic as the de­bil­i­tat­ing pain from en­dometrio­sis,” Charles As­ch­er-Walsh of Ic­ahn School of Med­i­cine at Mount Sinai told Med­Page To­day.

My­ovant, mean­while, said that there were no sig­nif­i­cant dif­fer­ences in terms of bone min­er­al den­si­ty with a sim­i­lar ef­fect in terms of hot flash­es — 5.6% for the drug ver­sus 3.9% for the place­bo.

Cowen’s Phil Nadeau sized it up and likes My­ovant’s chances of carv­ing out a block­buster fran­chise:

We think that to­day’s da­ta from LIB­ER­TY 2 cor­rob­o­rates the LIB­ER­TY 1 re­sults and con­firms that re­l­u­golix+add-back ther­a­py has a com­pet­i­tive pro­file with sim­i­lar ef­fi­ca­cy, some­what bet­ter tol­er­a­bil­i­ty, and im­proved con­ve­nience com­pared to Ab­b­Vie’s Orilis­sa. There­fore we con­tin­ue to be­lieve that re­l­u­golix has $1B+ sales po­ten­tial in uter­ine fi­borids.

Draw­ing dis­tinc­tions be­tween the two could be tough in this mar­ket for a com­pa­ny that doesn’t have near the same kind of com­mer­cial punch as Ab­b­Vie. But My­ovant has a com­pet­i­tive pro­file. In­vestors bid their shares up 10% this morn­ing in some­thing less than an en­thu­si­as­tic em­brace for the ri­val­ry ahead — then saw that melt away to a 1% drop in the ear­ly af­ter­noon.

So­cial im­age: Vivek Ra­maswamy at the US-Chi­na Bio­phar­ma In­no­va­tion and In­vest­ment Sum­mit in Shang­hai on Oc­to­ber 23, 2018; Cred­it: End­points News, Pharm­Cube

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President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

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