Ther­a­peu­tic­sMD wins FDA nod for hor­mone ther­a­py, cap­ping off drug­mak­er's pro­lif­ic year

The FDA has ap­proved Ther­a­peu­tic­sMD’s $TXMD hor­mone ther­a­py for hot flash­es as­so­ci­at­ed with menopause, mark­ing the women’s health drug­mak­er’s third ap­proval this year.

Bi­ju­va, which was ap­proved with a boxed warn­ing of car­dio­vas­cu­lar dis­or­ders, prob­a­ble de­men­tia as well as breast and en­dome­tri­al can­cer, is an oral treat­ment that con­tains mol­e­c­u­lar­ly iden­ti­cal (bio-iden­ti­cal) ver­sions of the hor­mones estra­di­ol and prog­es­terone for menopausal women with a uterus ex­pe­ri­enc­ing mod­er­ate-to-se­vere va­so­mo­tor symp­toms. The drug will be made avail­able in the sec­ond quar­ter of next year, the com­pa­ny said on Mon­day.

There are rough­ly 43 mil­lion women in the Unit­ed States of menopausal age (45-64 years). As their ovaries cease hor­mone pro­duc­tion, lev­els of cir­cu­lat­ing es­tro­gen fall, of­ten caus­ing va­so­mo­tor symp­toms — hot flash­es or flush­es — in ad­di­tion to sleep and mood dis­tur­bances. Hot flash­es oc­cur in up to to 80% of women, and can last for years.

Women have ac­cess to a range of op­tions to deal with these symp­toms: FDA-ap­proved syn­thet­ic (non-bio-iden­ti­cal) hor­mones; sep­a­rate FDA-ap­proved bio-iden­ti­cal es­tro­gen and prog­es­terone prod­ucts that are used to­geth­er but are not sanc­tioned for com­bi­na­tion use; or com­pound­ing phar­ma­cies that com­bine the two bio-iden­ti­cal ther­a­pies if re­quest­ed by pa­tients, but whose prod­ucts are not reg­u­lat­ed by the FDA. Al­to­geth­er, some 15 to 20 mil­lion an­nu­al pre­scrip­tions are writ­ten for this slate of prod­ucts, the com­pa­ny said.

Robert Finizio

“The com­bi­na­tion of these mar­kets are a mul­ti-bil­lion dol­lar op­por­tu­ni­ty which we be­lieve we can ob­tain sig­nif­i­cant share,” Ther­a­peu­tic­sMD chief and co-founder Robert Finizio told End­points News.

Bi­ju­va is there­fore poised to be a po­ten­tial block­buster prod­uct as the con­ve­nient, FDA-reg­u­lat­ed op­tion for a com­bi­na­tion bio-med­ical hor­mone ther­a­py, ac­cord­ing to Cowen an­a­lysts as cit­ed re­cent­ly by Reuters — al­though Ther­a­peu­tic­sMD ac­knowl­edges there is no ev­i­dence that sug­gests bio-iden­ti­cal hor­mones are safer or more ef­fec­tive than syn­thet­ic hor­mones.

The com­pa­ny has not fi­nal­ized a price for the drug, Finizio said, but ex­pects the prod­uct will be priced at par­i­ty to ex­ist­ing treat­ments.

The drug was cleared for ap­proval on the ba­sis of a place­bo-con­trolled late-stage study that showed Bi­ju­va in­duced a sta­tis­ti­cal­ly sig­nif­i­cant re­duc­tion in hot flash­es, while di­min­ish­ing the risks to the en­dometri­um.

The ap­proval marks a fe­cund year for the drug­mak­er, which in re­cent months has se­cured the ap­proval of two oth­er prod­ucts — a con­tra­cep­tive de­vice and a treat­ment for vagi­nal pain as­so­ci­at­ed with sex­u­al ac­tiv­i­ty — from the FDA.

Ab­b­Vie wins an ap­proval in uter­ine fi­broid-as­so­ci­at­ed heavy bleed­ing. Are ri­vals My­ovant and Ob­sE­va far be­hind?

Women expel on average about 2 to 3 tablespoons of blood during their time of the month. But with uterine fibroids, heavy bleeding is typical — a third of a cup or more. Drugmakers have been working on oral therapies to try and stem the flow, and as expected, AbbVie and their partners at Neurocrine Biosciences are the first to make it across the finish line.

Known chemically as elagolix, the drug is already approved as a treatment for endometriosis under the brand name Orilissa. It targets the GnRH receptor to decrease the production of estrogen and progesterone.

Pablo Legorreta, founder and CEO of Royalty Pharma AG, speaks at the annual Milken Institute Global Conference in Beverly Hills, California (Patrick T. Fallon/Bloomberg via Getty Images)

Cap­i­tal­iz­ing Pablo: The world’s biggest drug roy­al­ty buy­er is go­ing pub­lic. And the low-key CEO di­vulges a few se­crets along the way

Pablo Legorreta is one of the most influential players in biopharma you likely never heard of.

Over the last 24 years, Legorreta’s Royalty Pharma group has become, by its own reckoning, the biggest buyer of drug royalties in the world. The CEO and founder has bought up a stake in a lengthy list of the world’s biggest drug franchises, spending $18 billion in the process — $2.2 billion last year alone. And he’s become one of the best-paid execs in the industry, reaping $28 million from the cash flow last year while reserving 20% of the cash flow, less expenses, for himself.

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As­traZeneca trum­pets the 'mo­men­tous' da­ta they found for Tagris­so in an ad­ju­vant set­ting for NSCLC — but many of the ex­perts aren’t cheer­ing along

AstraZeneca is rolling out the big guns this evening to provide a salute to their ADAURA data on Tagrisso at ASCO.

Cancer R&D chief José Baselga calls the disease-free survival data for their drug in an adjuvant setting of early stage, epidermal growth factor receptor-mutated NSCLC patients following surgery “momentous.” Roy Herbst, the principal investigator out of Yale, calls it “transformative.”

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David Chang, Allogene CEO (Jeff Rumans)

Head­ed to PhII: Al­lo­gene CEO David Chang com­pletes a pos­i­tive ear­ly snap­shot of their off-the-shelf CAR-T pi­o­neer

Allogene CEO David Chang has completed the upbeat first portrait of the biotech’s off-the-shelf CAR-T contender ALLO-501 at virtual ASCO today, keeping all eyes on a drug that will now try to go on to replace the first-wave personalized pioneers he helped create.

The overall response rate outlined in Allogene’s abstract for treatment-resistant patients with non-Hodgkin lymphoma slipped a little from the leadup, but if you narrow the patient profile to treatment-naïve patients — removing the 3 who had previous CAR-T therapy who didn’t respond, leaving 16 — the ORR lands at 75% with a 44% complete response rate. And 9 of the 12 responders remained in response at the data cutoff, offering a glimpse on durability that still has a long way to go before it can be completely nailed down.

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Pfiz­er, Mer­ck KGaA ce­ment Baven­cio blad­der can­cer win with OS da­ta — while carv­ing an­oth­er niche in rare can­cer

Pfizer and Merck KGaA have detailed the Phase III data that inspired FDA regulators to designate Bavencio a “breakthrough” for first-line advanced bladder cancer and offered an early glance at how the PD-L1 can help patients with a rare gynecological cancer — carving out niches in the checkpoint space for itself after being shut out of numerous others.

In JAVELIN Bladder 100, Bavencio led to a 31% reduction in risk of death compared to standard care alone. It also extended median survival by more than seven months — a historic feat in this setting, according to investigators at Queen Mary University of London.

Sanofi brings in 4 new ex­ec­u­tives in con­tin­ued shake-up, as vac­cines and con­sumer health chief head out the door

In the middle of Sanofi’s multi-pronged race to develop a Covid-19 vaccine, David Loew, the head of their sprawling vaccines unit, is leaving – part of the final flurry of moves in the French giant’ months-long corporate shuffle that will give them new-look leadership under new CEO Paul Hudson.

The company also said today that Alan Main, the head of their consumer healthcare unit, is out, and they named 4 executives to fill new or newly vacated positions, 3 of whom come from both outside both Sanofi and from Pharma.

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Fabrice Chouraqui, Cellarity CEO-partner (LinkedIn)

Drug de­vel­op­er, Big Phar­ma com­mer­cial ex­ec, now an up­start biotech chief — Fab­rice Chouraqui is ready to try some­thing new as a ‘CEO-part­ner’ at Flag­ship

Fabrice Chouraqui’s career has taken some big twists along his life journey. He got his PharmD at Université Paris Descartes and jumped into the drug development game for a bit. Then he took a sharp turn and went back to school to get his MBA at Insead before returning to pharma on the commercial side.

Twenty years later, after steadily rising through the ranks and journeying the globe to nab a top job as president of US pharma for the Basel-based Novartis, Chouraqui exited in another career switch. And now he’s headed into a hybrid position as a CEO-partner at Flagship, where he’ll take a shot at leading Cellarity — one of the VC’s latest paradigm-changing companies of the groundbreaking model that aspires to deliver a new platform to the world of drug R&D.

Dan O'Day, Gilead CEO (Andrew Harnik, AP Images)

UP­DAT­ED: Gilead leas­es part­ner rights to TIG­IT, PD-1 in a $2B deal with Ar­cus. Now comes the hard part

Gilead CEO Dan O’Day has brokered his way to a PD-1 and lined up a front row seat in the TIGIT arena, inking a deal worth close to $2 billion to align the big biotech closely with Terry Rosen’s Arcus. And $375 million of that comes upfront, with cash for the buy-in plus equity, along with $400 million for R&D and $1.22 billion in reserve to cover opt-in payments and milestones..

Hotly rumored for weeks, the 2 players have formalized a 10-year alliance that starts with rights to the PD-1, zimberelimab. O’Day also has first dibs on TIGIT and 2 other leading programs, agreeing to an opt-in fee ranging from $200 million to $275 million on each. There’s $500 million in potential TIGIT milestones on US regulatory events — likely capped by an approval — if Gilead partners on it and the stars align on the data. And there’s another $150 million opt-in payments for the rest of the Arcus pipeline.

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Paul Hudson, Sanofi CEO (Getty Images)

Sanofi CEO Paul Hud­son has $23B burn­ing a hole in his pock­et. And here are some hints on how he plans to spend that

Sanofi has reaped $11.1 billion after selling off a big chunk of its Regeneron stock at $515 a share. And now everyone on the M&A side of the business is focused on how CEO Paul Hudson plans to spend it.

After getting stung in France for some awkward politicking — suggesting the US was in the front of the line for Sanofi’s vaccines given American financial support for their work, versus little help from European powers — Hudson now has the much more popular task of managing a major cash cache to pull off something in the order of a big bolt-on. Or two.

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