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

5AM Ven­tures: Fu­el­ing the Next Gen­er­a­tion of In­no­va­tors

By RBC Capital Markets
With Andy Schwab, Co-Founder and Managing Partner at 5AM Ventures

Key Points

Prescription Digital Therapeutics, cell therapy technologies, and in silico medicines will be a vital part of future treatment modalities.
Unlocking the potential of the microbiome could be the missing link to better disease diagnosis.
Growing links between academia, industry, and venture capital are spinning out more innovative biotech companies.
Biotech is now seen by investors as a growth space as well as a safe haven, fuelling the recent IPO boom.

Hal Barron, GSK via YouTube

What does $29B buy you in Big Phar­ma? In Glax­o­SmithK­line’s case, a whole lot of un­com­fort­able ques­tions about the pipeline

Talk about your bad timing.

A little over a week ago, GSK R&D chief Hal Barron marked his third anniversary at the research helm by taking a turn at the virtual podium during JP Morgan to make the case that he and his team had built a valuable late-stage pipeline capable of churning out more than 10 blockbusters in the next 5 years.

And then, just days later, one of the cancer drugs he bet big on as a top prospect — bintrafusp, partnered with Merck KGaA — failed its first pivotal test in non-small cell lung cancer.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Eli Lil­ly's an­ti­body cuts risk of Covid-19 by up to 80% among the most vul­ner­a­ble — but will it have a place next to vac­cines?

Eli Lilly says bamlanivimab lowered the risk of contracting symptomatic Covid-19 in a first-of-its-kind trial involving nursing home residents and staff, paving the way for a new option to protect against the virus.

But how big of an impact it might have, and what role it will play, at a time vaccines are being rolled out to the exact population it is targeting still remains unclear.

Among 965 participants in the study — all of whom tested negative for the coronavirus at baseline — the number of symptomatic cases reported in the bamlanivimab arm was 57% lower than that in the placebo arm (odds ratio 0.43, p=0.00021). In addition to that primary endpoint, all secondary endpoints reached statistical significance.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 98,400+ biopharma pros reading Endpoints daily — and it's free.

Janet Woodcock (AP Images)

End­points poll: Janet Wood­cock takes the (in­ter­im) helm at the FDA. And a large ma­jor­i­ty of our read­ers want her to stay there

It’s official: Janet Woodcock is now the acting chief of the FDA.

And — according to an Endpoints poll — most industry readers would like her to stay there, although a significant minority is strongly opposed.

To recap: Joe Biden is reportedly choosing between Woodcock and former deputy FDA commissioner Joshua Sharfstein as his nominee for the permanent position. Given their respective track records, the decision is set to determine the agency’s lodestar for years to come.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 98,400+ biopharma pros reading Endpoints daily — and it's free.

An Endpoints Zoom meeting; and the email header employees will see if your company is a Premium subscriber

What’s next for End­points — and how to sup­port our in­de­pen­dent bio­phar­ma news mis­sion

The firehose of biopharma news is gushing these days.

That’s why broader and deeper is the theme for 2021 at Endpoints. You can expect new coverage outside our core R&D focus, with deeper reporting in some key areas. When John Carroll and I launched Endpoints nearly five years ago, we were wading in waist-high waters. Now we’re a team of 25 full-time staffers (and growing) with plans to cover the flood of biopharma news, Endpoints-style.

Charlie Fuchs, Roche and Genentech global head of product development for oncology and hematology (Yale Cancer Center)

Yale can­cer spe­cial­ist Char­lie Fuchs tapped as new glob­al de­vel­op­ment chief for Roche/Genen­tech

Roche and their big sub Genentech have just recruited a top cancer specialist at Yale to head up global product development in oncology and hematology.

I just got word that the pharma giant, which leads one of the most active cancer research operations in the world, recruited Charlie Fuchs, director of the Yale Cancer Center and physician-in-chief of Smilow Cancer Hospital. He’ll join the global operation March 1 and will be based in South San Francisco, where Genentech is based.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 98,400+ biopharma pros reading Endpoints daily — and it's free.

Jonathan Weissman (MIT)

Can a new CRISPR tech­nique un­lock the se­crets of how can­cer spreads?

Jonathan Weissman’s team watched the cancer cells spread across the doomed mouse. Engineered with a bioluminescent enzyme, they appeared in scans first as a small navy blue diamond lodged near the heart; a week later, as a triangle splayed across the mouse’s upper body, with streaks of green and two distinct bright red hubs of activity. By day 54, the mouse resembled a lava lamp.

The images would have been familiar to any cancer biologist, but they didn’t actually tell you much about what was going on: why the cancer was metastasizing or which cells were responsible. For that, Weissman’s team had designed a new tool. Inside the original navy blue diamond, they had engineered the microbiological equivalent of an airplane’s black box — a “molecular recorder” that, after the mouse’s death, could allow them to extract the cells and wind back intimate footage of a single cancer’s ascent.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 98,400+ biopharma pros reading Endpoints daily — and it's free.

Glax­o­SmithK­line scraps a LAG3 study, mark­ing an­oth­er fail­ure for the pipeline af­ter a crit­i­cal set­back

Another gap has appeared in GlaxoSmithKline’s pipeline.

Friday morning the Australian biotech Immutep put out word that Hal Barron’s R&D group at GSK had decided to scrap a Phase II proof-of-concept study in ulcerative colitis for their anti-LAG3 therapy GSK2831781. According to the biotech, the program didn’t survive an interim review.

The trial was stopped by GSK based on the assessment of clinical data as part of a planned interim analysis conducted in consultation with the trial’s Data Review Committee. GSK is conducting further reporting, assessment and analyses of the efficacy and safety data and evaluating the biology to determine next steps for the GSK2831781 development program.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 98,400+ biopharma pros reading Endpoints daily — and it's free.

Janet Woodcock and Joshua Sharfstein (AP, Images)

Poll: Should Joshua Sharf­stein or Janet Wood­cock lead the FDA from here?

It’s time for a new FDA commissioner to come on board, a rite of passage for Joe Biden’s administration that should help seal the new president’s rep on seeking out the experts to lead the government over the next 4 years.

As of now, the competition for the top job appears to have narrowed down to 2 people: The longtime CDER chief Janet Woodcock and Joshua Sharfstein, the former principal deputy at the FDA under Peggy Hamburg. Both were appointed by Barack Obama.