Lynn Seely, Myovant CEO (Myovant)

In ground­break­ing move, FDA ap­proves My­ovan­t's re­l­u­golix as the first once-a-day pill for ad­vanced prostate can­cer

My­ovant Sci­ences $MY­OV won’t be get­ting coal in their stock­ing this Christ­mas.

The Swiss biotech, for­mer­ly part of the Vivek Ra­maswamy fam­i­ly of Vants, won FDA ap­proval of its re­l­u­golix drug on Fri­day af­ter­noon for the treat­ment of ad­vanced prostate can­cer. It’s the first oral hor­mone ther­a­py ap­proved for the in­di­ca­tion, reg­u­la­tors said, and the drug will be mar­ket­ed as Or­govyx. PDU­FA ac­tion had been sched­uled for Dec. 20.

Or­govyx will be priced at $2,300 per month, CEO Lynn Seely told End­points News on Mon­day.

In­vestors briefly cheered the green light, send­ing shares up rough­ly 7% im­me­di­ate­ly af­ter the ap­proval. But My­ovant’s stock slid back to its pre­vi­ous lev­els and sat down about 5% lat­er Fri­day.

With the risk im­muno­sup­pressed can­cer pa­tients face in the wake of the Covid-19 pan­dem­ic, the agency high­light­ed pa­tients’ abil­i­ty to take Or­govyx at home as a ben­e­fit for the drug. The stan­dard of care in this field, Ab­b­Vie’s Lupron, needs to be in­ject­ed once every three months, and oth­er treat­ments typ­i­cal­ly are placed as im­plants un­der the skin.

Richard Paz­dur

Or­govyx al­so “may elim­i­nate some pa­tients’ need to vis­it the clin­ic for treat­ments that re­quire ad­min­is­tra­tion by a health­care provider,” FDA on­col­o­gy chief Richard Paz­dur said in a state­ment.

Seely said, how­ev­er, that she be­lieved the ben­e­fits can help the drug stand out on its own, with or with­out a pan­dem­ic.

“We know from our re­search that the ma­jor­i­ty of men pre­fer an oral treat­ment to an in­jec­tion,” Seely said. “Now, all that be­ing said, with the Covid-19 pan­dem­ic, there is a rec­om­men­da­tion from the Na­tion­al Com­pre­hen­sive Can­cer Net­work for pa­tients with can­cer to avoid hos­pi­tals and clin­ics as much as pos­si­ble. It’s, we be­lieve, one of the rea­sons we were grant­ed pri­or­i­ty re­view by the FDA.”

Fri­day’s ap­proval came on the ba­sis of a Phase III study from back in No­vem­ber 2019, which pit­ted Or­govyx head-to-head with Lupron in men with prostate can­cer. The idea be­hind the pro­gram is cen­tered around testos­terone pro­duc­tion — be­cause prostate can­cer is fu­eled by the hor­mone, My­ovant had sought to cut testos­terone lev­els to a point that would qual­i­fy as med­ical cas­tra­tion.

The pri­ma­ry end­point in that study showed 96.7% of men treat­ed with Or­govyx achieved sus­tained testos­terone sup­pres­sion over 48 weeks, com­pared to 88.8% on Lupron. Reg­u­la­tors had set a bench­mark of at least 90% clear­ance, CEO Lynn Seely told End­points News at the time.

Ap­proval came de­spite Or­govyx whiff­ing bad­ly on a key sec­ondary end­point when fur­ther da­ta came out in Sep­tem­ber, as the drug fared nu­mer­i­cal­ly worse in cas­tra­tion re­sis­tance-free sur­vival af­ter 48 weeks than Lupron. In the sub­group of men with metasta­t­ic prostate can­cer, 74% of those treat­ed with Or­govyx were alive and cas­tra­tion-re­sis­tance free through 48 weeks, com­pared to 75% on Lupron.

The p-val­ue of the end­point was p=0.84, and My­ovant shares were crushed by 25% at the time.

No­tably, how­ev­er, Or­govyx man­aged to beat out Lupron on ma­jor car­dio­vas­cu­lar events, show­ing a 2.9% rate against the Ab­b­Vie drug’s 6.2% rate. The su­pe­ri­or­i­ty in these safe­ty events is a big rea­son why SVB Leerink an­a­lyst Ami Fa­dia says My­ovant can po­si­tion Or­govyx as a more ap­peal­ing op­tion to physi­cians.

As a go­nadotropin-re­leas­ing hor­mone (GnRH) an­tag­o­nist, Or­govyx works by block­ing the re­cep­tor, an ap­proach that con­trasts with Lupron. The Ab­b­Vie drug de­sen­si­tizes the re­cep­tor by hit­ting it re­peat­ed­ly.

Prostate can­cer is one of three in­di­ca­tions in which My­ovant has prepped ap­proval pack­ages for both the FDA and EMA. The oth­er fields are uter­ine fi­broids, with a PDU­FA date set for next June 1, and en­dometrio­sis, where the com­pa­ny is plan­ning NDA and Eu­ro­pean sub­mis­sions for the drug lat­er in 2021. Or­govyx us­es the same path­way to low­er testos­terone in men as it does to low­er es­tro­gen and prog­es­terone in women.

Ab­b­Vie isn’t con­tent to let by­gones be by­gones, how­ev­er, as it’s been prep­ping a Lupron suc­ces­sor for some time. Back in May, the FDA ap­proved the com­pa­ny’s elagolix in com­bi­na­tion with two hor­mone drugs, estra­di­ol and norethin­drone ac­etate, for uter­ine fi­broids. My­ovant is look­ing at us­ing Or­govyx in com­bi­na­tion with ABT in that field, and saw 50% or more re­duc­tion in blood loss in two Phase III stud­ies, sim­i­lar to Ab­b­Vie’s ap­proach.

My­ovant com­pa­ny is al­so ex­pect­ed to ap­proach Eu­ro­pean reg­u­la­tors for ap­proval in prostate can­cer in the first half of next year.

Spe­cial re­port: Meet 20 ex­tra­or­di­nary women who are su­per­charg­ing bio­phar­ma R&D

Even though many biopharma leaders have come together in recent years to address its gender gap, the consensus is clear: We still have a long way to go.

Companies this year were 2.5 times more likely than last year to have a diversity and inclusion program in place, according to a recent BIO survey, but women are still largely absent from executive roles. Getting women to enter the industry isn’t the problem — studies show that they represent just under half of all biotech employees around the world. But climbing through the ranks can be challenging, as women still report facing stereotypes, and, unfortunately, harassment.

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Op­ti­miz­ing Oral Drug De­liv­ery us­ing Zy­dis® Oral­ly Dis­in­te­grat­ing Tablet Tech­nol­o­gy to Ad­dress Pa­tient Chal­lenges

KEY POINTS

Patients prefer oral dosing, but swallowing tablets can be a challenge for many patients.
The Zydis® orally disintegrating tablet (ODT) platform addresses challenges associated with oral dosing, expanding benefits for patients and options for healthcare providers.
A strong growth trajectory is expected for ODTs given therapeutic innovation and continued technology development.

Many patients prefer conventional tablets for the administration of medications, but some geriatric and pediatric patients and those with altered mental status and physical impairments find swallowing tablets to be difficult. Orally disintegrating tablets (ODTs), which dissolve completely without chewing or sucking, offer a patient-friendly dosage form for the administration of small-molecule drugs, peptides and proteins. With the potential for multiple sites of drug absorption, often faster onset action for the active pharmaceutical ingredient (API), and potentially greater bioavailability, ODTs are an attractive option for drug developers considering first-to-market formulations or product line extensions of existing drugs with compatible API. In this report, we look at how innovation in the industry-leading Zydis ODT platform is expanding oral formulation options and bringing benefits to patients.

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Geoffrey Porges (SVB Leerink)

The 2022 wave com­ing? Top an­a­lyst says Big Phar­ma will have more than $1T avail­able to sat­is­fy its grow­ing ap­petite for biotech M&A

All through this year you could practically feel the frustration of the biotech investor class as M&A activity continued to drag behind expectations — or desires. Buyouts of public companies provide the essential juice for keeping stocks lively, and there’s been a notable lack of juice in 2021.

So is all that about to change, big time?

SVB Leerink’s Geoffrey Porges, a longtime student of biotech M&A, thinks so. In a lengthy analysis he put out last week, Porges totted up the cash flow of the major pharmas and determined that there was a good long list of industry buyers who would have around a half trillion dollars of cash to play with in 2022. Leverage that up with added debt and you could get that deal cache to $1.6 trillion.

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Warren Huff, Reata CEO

FDA slams Reata's kid­ney drug as in­ef­fec­tive ahead of ad­comm meet­ing

The FDA on Monday offered an overwhelmingly negative opinion on Reata Pharmaceuticals’ potential drug to slow the loss of kidney function in those with the rare disease Alport syndrome, according to briefing documents released ahead of an advisory committee meeting Wednesday.

The agency’s review team said it “does not believe the submitted data demonstrate that bardoxolone is effective in slowing the loss of kidney function in patients with AS and reducing the risk of progression to kidney failure.” Originally developed as a cancer drug, bardoxolone was later scuttled by Reata almost a decade ago as a chronic kidney disease drug due to deaths in a Phase III trial.

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No­var­tis pe­ti­tions FDA to block 18 gener­ic com­peti­tors for its megablock­buster heart drug un­til 2024

Novartis is looking to milk one of its most prized possessions a little while longer without any generic competition, mostly because of a newly approved use that the Big Pharma won earlier this year for its megablockbuster heart drug Entresto.

In addition to battling (and winning) litigation last month to block a handful of Indian generics from entering the market early alongside Entresto, the company last week petitioned the FDA to try to stop a total of 18 Entresto generics from launching before 2024 at the earliest.

Mar­ket­ingRx Matchup: How Ab­b­Vie and Bio­haven ads rank in head-to-head mi­graine chal­lenge

Are you ready to rumble? DTC brands that is. MarketingRx is launching a new monthly feature today called MarketingRx Matchup. We’re pitting two pharma brands’ DTC advertising in the same therapeutic category against each other to find out what consumers and patients really think.

Market research company Leger is handling the polling and analysis each month, and I’ll be writing up the results — along with my own take — inside MRx on the first Tuesday of the month.

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Wendy Lund, Organon chief communications officer

Q&A: Organon chief com­mu­ni­ca­tions of­fi­cer Wendy Lund talks about the Mer­ck spin­off, women’s health and why it mat­ters

One of Wendy Lund’s earliest jobs was head of marketing at Planned Parenthood. As the youngest person on its management team, she introduced them to emerging new technologies, and in return, she learned the importance of fighting for what you believe in.

Now as chief communications officer at Organon, the women’s health company recently spun off by Merck, Lund is keeping that point top of mind. That’s in part because women’s health hasn’t been a spotlight therapy area for Big Pharma in years. Several companies have spun off, sold or at least considered selling women’s health assets to focus on “core” products.

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Mar­ket­ingRx roundup: Pfiz­er re-ups pneu­mo­nia ads as Mer­ck threat looms; Re­al Chem­istry founder CEO Jim Weiss steps back

Every autumn, leaves fall from the trees and people start holiday shopping – and for the last few years Pfizer debuts a new “Know Pneumonia” awareness TV ad. This year the commercial, launched a week ago, features different people who talk about why they got vaccinated against pneumococcal pneumonia. Actors portray a young female firefighter with asthma, a mechanic with heart disease and an older woman with her grandchild. A Pfizer spokesperson declined comment on the latest iteration of the long-running campaign.

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Mer­ck pumps the brakes on two more PhI­II tri­als for its lead an­ti-HIV drug

After trial investigators flagged a drop in immune cell counts that an external committee determined was related to treatment last month, Merck has been pausing HIV-related Phase II and III trials ever since.

On Monday, the biopharma company announced it’s pausing enrollment in two of its Phase III trials evaluating its leading anti-HIV drug candidate, which is the once-monthly, oral islatravir.

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