Dave Marek, Myovant CEO

Pfiz­er and My­ovant’s en­dometrio­sis pain drug Myfem­bree gets an­oth­er FDA nod

Af­ter months of de­lay in its de­ci­sion, the FDA has giv­en a green light to Pfiz­er and My­ovant’s drug Myfem­bree for pain re­lat­ed en­dometrio­sis, a gy­ne­co­log­i­cal con­di­tion as­so­ci­at­ed with mod­er­ate to se­vere pain, mak­ing it the drug’s sec­ond in­di­ca­tion ap­proval.

The FDA had ear­li­er de­layed its de­ci­sion to re­view ad­di­tion­al da­ta it had re­quest­ed from the com­pa­nies re­gard­ing bone min­er­al den­si­ty. The reg­u­la­tors had “iden­ti­fied de­fi­cien­cies that pre­clude dis­cus­sion of la­bel­ing and/or post-mar­ket­ing re­quire­ments and com­mit­ment at this time,” the com­pa­nies had said.

The ap­proval comes af­ter reg­u­la­tors not­ed da­ta from two tri­als — SPIR­IT 1 and SPIR­IT 2 — which had more than 1,200 par­tic­i­pants. Ad­di­tion­al­ly, there was a 28-week open-la­bel study to an­a­lyze the drug’s longer-term use.

Both SPIR­IT 1 and 2 met their co-pri­ma­ry end­points with 75% of women in the Myfem­bree group in both stud­ies achiev­ing a clin­i­cal­ly mean­ing­ful re­duc­tion in men­stru­al cramps, com­pared with 27% and 30% of women in the place­bo groups at Week 24, re­spec­tive­ly (both p <0.0001), the com­pa­nies said in a press state­ment.

For non-men­stru­al pelvic pain, treat­ment demon­strat­ed a clin­i­cal­ly mean­ing­ful re­duc­tion in pain in 59% and 66% of women, com­pared with 40% and 43% of women in the place­bo groups (p < 0.0001), the com­pa­nies added.

How­ev­er, the im­prove­ments in pain were not free of side ef­fects in some women. Ad­verse re­ac­tions oc­cur­ring in at least 3% of women treat­ed with Myfem­bree and greater than place­bo were: headache, va­so­mo­tor symp­toms, mood dis­or­ders, ab­nor­mal uter­ine bleed­ing, nau­sea, toothache, back pain, de­creased sex­u­al de­sire and arousal, arthral­gia, fa­tigue and dizzi­ness, the com­pa­nies said.

Women who had com­plet­ed par­tic­i­pa­tion on SPIR­IT 1 or 2 were el­i­gi­ble for the open-la­bel ex­ten­sion study. The da­ta showed bone min­er­al den­si­ty loss of less than 1% from base­line through one year of treat­ment, while 19.7% of pa­tients had loss­es >3%.

The com­pa­nies said the drug would be im­me­di­ate­ly avail­able to pa­tients with pre­scrip­tions from their health­care providers.

The drug, which is a com­bi­na­tion of re­l­u­golix 40 mg, estra­di­ol 1 mg and norethin­drone ac­etate 0.5 mg, is a one-pill, once-a-day ther­a­py, to be tak­en for up to a year.

The drug, which was first ap­proved in May 2021 to treat heavy men­stru­al bleed­ing as­so­ci­at­ed with uter­ine fi­broids, reeled in $4 mil­lion in net prod­uct rev­enues in the Swiss bio­phar­ma’s most re­cent quar­ter, the com­pa­ny said last month, not­ing 2,400 new pa­tients be­gan tak­ing the treat­ment in the past three months.

In 2018, the FDA had ap­proved Ab­b­Vie and Neu­ro­crine Bio­sciences’ drug Orilis­sa (elagolix) for women with mod­er­ate to se­vere en­dometrio­sis pain. The drug reeled in $145 mil­lion in net rev­enue for all of 2021, Ab­b­Vie re­port­ed ear­li­er this year.

En­dometrio­sis is a con­di­tion where tis­sue lin­ing the in­ner side of the uterus grows on oth­er parts of the body, some­times re­sult­ing in se­vere pain. The con­di­tion af­fects an es­ti­mat­ed 2-10% per­cent of Amer­i­can women of child­bear­ing age, ac­cord­ing to Johns Hop­kins Med­i­cine.

An FDA nod means My­ovant will re­ceive a $100 mil­lion reg­u­la­to­ry mile­stone from its part­ner Pfiz­er.

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Justin Klee (L) and Joshua Cohen, Amylyx co-CEOs (Cody O'Loughlin/The New York Times; courtesy Amylyx)

Ad­vo­cates, ex­perts cry foul over Amy­lyx's new ALS drug, cit­ing is­sues with price, PhI­II com­mit­ment

Not 24 hours after earning the first ALS drug approval in five years, Amylyx Pharmaceuticals’ Relyvrio is already drawing scrutiny. And it’s coming from multiple fronts.

In an investor call Friday morning, Amylyx revealed that it would charge about $158,000 per year, a price point that immediately drew backlash from ALS advocates and some outside observers. The cost reveal had been highly anticipated in the immediate hours after Thursday evening’s approval, though Amylyx only teased Relyvrio would cost less than previously approved drugs.

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Dave Marek, Myovant CEO

My­ovant board balks as ma­jor­i­ty own­er Sum­it­o­mo swoops in with a $2.5B deal to buy them out

Three years after Sumitomo scooped up Roivant’s 46% stake in the publicly traded Myovant $MYOV as part of a 5-company, $3 billion deal, they’re coming back for the whole thing.

But these other investors at Myovant want more than what the Japanese pharma company is currently offering to pay at this stage.

Sumitomo is bidding $22.75 a share for the outstanding stock, which now represents 48% of the company after Sumitomo bumped its ownership since the original deal with Roivant. Myovant, however, created a special committee on the board, and they’re shaking their heads over the offer.

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Big Phar­ma heavy­weights seek tweaks to FDA's clin­i­cal out­come as­sess­ment guid­ance

Pfizer, GSK, Janssen, Regeneron, Boehringer Ingelheim and at least a half dozen other companies are calling on the FDA to provide significantly more clarity in its draft guidance from this summer on clinical outcome assessments, which are a type of patient experience.

The draft is the third in a series of four patient-focused drug development guidance documents that the FDA had to create as part of the 21st Century Cures Act, and they describe how stakeholders (patients, caregivers, researchers, medical product developers and others) can collect and submit patient experience data and other relevant information for medical product development and regulatory decision-making.

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Albert Bourla, Pfizer CEO (Gian Ehrenzeller/Keystone via AP)

Can a smart­phone app de­tect Covid? Pfiz­er throws down $116M to find out

What can a cough say about a patient’s illness? Quite a bit, according to ResApp Health — and Pfizer’s listening.

The pharma giant is shelling out about $116 million ($179 million AUD) to scoop up the University of Queensland spinout and its smartphone technology that promises to diagnose Covid and other respiratory illnesses based on cough and breathing sounds, the university announced last week.

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An­oth­er warn­ing let­ter for Lupin as FDA iden­ti­fies de­fi­cien­cies at In­dia-based site

With few new details of what needs fixing, Lupin disclosed last week that the FDA recently sent a warning letter to its Tarapur, India-based site.

After an inspection from March 22 to April 4, Lupin disclosed in an April stock filing that it received a Form 483 with four observations, but it didn’t offer any details on the observations.

Similar to comments made in April, the company said last week it does not believe the FDA slap will disrupt its drug supplies or the existing revenues from operations of this facility.

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Will Lewis, Insmed CEO

In­smed plots up­com­ing med launch­es built on its first drug lessons and con­sumer play­book mar­ket­ing strate­gies

With its first drug launch in the books, Insmed is now focusing on building out a road map for upcoming products – with an eye on consumer marketing strategies.

For CEO Will Lewis, that means tapping consumer insights as early as possible and developing products and packaging that are intuitive and easy to use. It also means translating those patient experiences into creative and atypical biopharma marketing, and in both cases, taking a page from consumer marketers’ playbooks.

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Severin Schwan, outgoing Roche CEO (via Getty Images)

Roche hires new di­ag­nos­tics chief from with­in, ahead of C-suite shake-up

More than two months after Severin Schwan announced he’s leaving Roche and handing the reins to diagnostics chief Thomas Schinecker, the pharma giant has revealed who’s taking Schinecker’s place.

Matt Sause, who currently leads Roche’s North American diagnostics business, is popping the cork on the big global promotion to take effect on March 15. The 20-year Roche veteran has served a handful of roles across the company’s diagnostics and pharma units, including a stint at Genentech where he was lifecycle leader for blockbuster Tecentriq’s head and neck cancer programs.

FTC chair Lina Khan with National Community Pharmacists Association CEO Douglas Hoey (NCPA via Twitter)

FTC chair Lina Khan pledges to use all tools to in­ves­ti­gate PBMs

KANSAS CITY, Mo. — Pharmacy benefit managers have become a thorn in the side of the pharma and insurance industries in recent years, and just a couple of months after the Federal Trade Commission signaled it would investigate unlawful PBM practices, FTC chair Lina Khan is looking to turn up the heat even more.

Khan sat down with National Community Pharmacists Association CEO Douglas Hoey on Monday morning at the NCPA’s annual convention, with a fireside chat in the heart of the Midwest.

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