Sage shrugs off po­ten­tial com­pe­ti­tion in post­par­tum de­pres­sion, as­serts plan to re­main in­de­pen­dent

Post­par­tum de­pres­sion (PPD), a so-far un­tapped mar­ket, is large enough for mul­ti­ple play­ers with 1 in 7 women di­ag­nosed with the con­di­tion that has no spe­cif­ic ther­a­pies ap­proved by the FDA. But Sage $SAGE, which re­port­ed im­pres­sive late-stage da­ta on its pill in se­vere PPD pa­tients on Mon­day, is not wor­ried about po­ten­tial com­pe­ti­tion.

An­a­lysts have drawn cau­tious com­par­isons with Mar­i­nus $MRNS, whose drug ganax­olone is al­so un­der eval­u­a­tion for PPD. An IV for­mu­la­tion of ganax­olone is cur­rent­ly in a Phase II study in se­vere PPD pa­tients, while mid-stage da­ta from an oral for­mu­la­tion of ganax­olone in mod­er­ate PPD pa­tients is ex­pect­ed in the first half of this year.

Steve Kanes

Sage, mean­while, is clear­ly ahead. The FDA is ex­pect­ed to make a de­ci­sion on the ap­prov­abil­i­ty of its IV PPD drug, brex­anolone, by March 19, af­ter a set­back de­layed the de­ci­sion by three months. The com­pa­ny’s oral PPD drug — SAGE-217 — re­port­ed stel­lar Phase III da­ta on Mon­day, and Sage in­tends to wait for da­ta from a piv­otal study on the pill in pa­tients with ma­jor de­pres­sive dis­or­der (ex­pect­ed in 2020) — be­fore it sub­mits a mar­ket­ing ap­pli­ca­tion. The oral drug has se­cured the agency’s break­through ther­a­py des­ig­na­tion.

“I think we’re in two very dif­fer­ent worlds, both sci­en­tif­i­cal­ly at this point and strate­gi­cal­ly as well,” Sage chief med­ical of­fi­cer Steve Kanes said in an in­ter­view with End­points News, when asked about the Mar­i­nus com­pound.

But Can­tor Fitzger­ald an­a­lysts pre­dict the two com­pa­nies may end up with equal mar­ket share con­sid­er­ing the size of the large­ly un­tapped mar­ket — if both man­age to take their re­spec­tive drugs across the fin­ish line.

“We mod­el ~572,000 women per year in the U.S. are af­fect­ed with PPD and be­lieve both Sage and Mar­i­nus (we mod­el 30% peak mar­ket pen­e­tra­tion) could have fair mar­ket share ver­sus ex­ist­ing ther­a­pies that take too long to work and are not ef­fi­ca­cious for a ma­jor­i­ty of pa­tients,” they wrote in a note.

Sage de­clined to pro­vide de­tail on their ex­pect­ed time­line to­ward ap­proval for SAGE-217 and sug­gest­ed it was too ear­ly to talk about pric­ing.

When asked about whether the com­pa­ny would be open to takeover dis­cus­sions, Kanes re­it­er­at­ed their plan was al­ways to grow and de­vel­op and in­de­pen­dent com­pa­ny — from dis­cov­ery all the way to com­mer­cial­iza­tion.

“The kinds of op­por­tu­ni­ties we look for are ones that ac­cel­er­ate treat­ment for pa­tients — a good ex­am­ple of that is our part­ner­ship Shino­gi in Japan,” Kanes said.

Japan’s Sh­iono­gi last June agreed to an up $575 mil­lion deal to bag lim­it­ed Asian rights to the SAGE-2017 — with $90 mil­lion in as cash up­front, a day af­ter the Cam­bridge, Mass­a­chu­setts-based com­pa­ny se­cured break­through ther­a­py sta­tus from the reg­u­la­tor.

But when pressed on whether a takeover was off the ta­ble, Kanes did not di­rect­ly com­ment, elect­ing in­stead to say that op­er­at­ing as an in­de­pen­dent en­ti­ty has al­ways been their po­si­tion.

Sage’s SAGE-217 re­sults on Mon­day morn­ing cat­a­pult­ed the stock up about 44% to $140.66 in mid­day trad­ing.

“We had thought that a pos­i­tive study would fun­da­men­tal­ly add in the $15-20 range. How­ev­er, that fore­cast was way off giv­en the $50-55 pos­i­tive move this morn­ing, much of which we would at­tribute to ex­cite­ment re­gard­ing M&A in the biotech space, and since SAGE has been viewed as a po­ten­tial take out can­di­date,” Leerink an­a­lysts wrote in a note.

Janet Woodcock (Greg Nash/Pool via AP Images)

'I re­al­ly don’t look back': Janet Wood­cock on her tran­si­tion away from drugs

Janet Woodcock may have one of the most historically long and drug-intense tenures in FDA history, but her new role is outside of all things pharma and the once-acting FDA commissioner isn’t looking back.

“No I really don’t look back,” Woodcock told Endpoints News via email on Monday morning. “Yes I will be transitioning. Longer discussion on infrastructure needed.”

An NYU surgeon transplants an engineered pig kidney into the outside of a brain-dead patient (Joe Carrotta/NYU Langone Health)

'Xeno­trans­plan­ta­tion is com­ing': New NE­JM pa­per gives de­tailed look in­to 2 pig-to-hu­man kid­ney trans­plant cas­es

The thymokidney is a curious organ, if you could call it that. It’s a sort of Frankensteinian creation — a system of pig thymus embedded underneath the outer layer of a pig’s kidney, made for human transplantation.

In the first case of pig-to-human xenotransplantation of a kidney into a brain-dead patient, the thymokidney quietly featured front and center.

In that experiment, which took place in September of last year, NYU researchers led by Robert Montgomery sutured a pig thymokidney onto the leg of a brain-dead 66-year-old woman. That case was widely reported on by a horde of major media outlets, including the New York Times, the BBC, and an in-depth feature by USA Today.

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Vlad Coric, Biohaven CEO

UP­DAT­ED: Fresh off $11.6B sale to Pfiz­er, New Bio­haven hits Phase III set­back just weeks af­ter Vlad Coric chalked up promise

When Pfizer bought up Biohaven’s migraine portfolio in the largest M&A deal of the year earlier this month, Biohaven CEO Vlad Coric promised the rest of the pipeline, which will live on under the umbrella of New Biohaven, still has a lot to offer. But that vision took a dent Monday as the drugmaker revealed it’s once again flopped on troriluzole.

The glutamate regulator failed to meet the primary endpoint on a Phase III study in patients with spinocerebellar ataxia, an inherited disorder that impairs a person’s ability to walk, speak and swallow. SCA can also lead to premature death.

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Bay­er sounds re­treat from a $670 mil­lion CAR-T pact in the wake of a pa­tient death

Two months after Atara Biotherapeutics hit the hold button on its lead CAR-T 2.0 therapy following a patient death, putting the company under the watchful eye of the FDA, its Big Pharma partners at Bayer are bowing out of a $670 million global alliance. And the move is forcing a revamp of Atara’s pipeline plans, even as research execs vow to continue work on the two drugs allied with Bayer 18 months ago, which delivered a $60 million cash upfront.

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Co­pay coupons gone wrong, again: Pfiz­er pays al­most $300K to set­tle com­plaints in four states

Pfizer has agreed to pay $290,000 to settle allegations of questionable copay coupon practices in Arizona, Colorado, Kansas, and Vermont from 2014 to 2018.

While the company has not admitted any wrongdoing as part of the settlement, Pfizer has agreed to issue restitution checks to about 5,000 consumers.

A Pfizer spokesperson said the company has “enhanced its co-pay coupons to alleviate the concerns raised by states and agreed to a $30,000 payment to each.”

Delaware court rules against Gilead and Astel­las in years-long patent case

A judge in Delaware has ruled against Astellas Pharma and Gilead in a long-running patent case over Pfizer-onwed Hospira’s generic version of Lexiscan.

The case kicked off in 2018, after Hospira submitted an Abbreviated New Drug Application (ANDA) for approval to market a generic version of Gilead’s Lexiscan. The drug is used in myocardial perfusion imaging (MPI), a type of nuclear stress test.

Taye Diggs (courtesy Idorsia)

Idor­sia inks an­oth­er celebri­ty en­dors­er deal with ac­tor and dad Taye Dig­gs as Qu­viviq in­som­nia am­bas­sador

Idorsia’s latest Quviviq insomnia campaign details the relatable dad story of a well-known celebrity — actor and Broadway star Taye Diggs.

Diggs stopped sleeping well after the birth of his son, now more than 10 years ago. Switching mom-and-dad nightly shifts to take care of a baby interrupted his sleep patterns and led to insomnia.

“When you’re lucky enough to be living out your dream and doing what you want, but because of something as simple as a lack of sleep, you’re unable to do that, it felt absolutely — it was treacherous,” he says in an interview-style video on the Quviviq website.

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Belén Garijo, Merck KGaA CEO (Kevin Wolf/AP Images for EMD Serono)

Mer­ck KGaA pumps €440M in­to ex­pand­ing and con­struct­ing Irish man­u­fac­tur­ing fa­cil­i­ties

The area of Ireland famous for Blarney Castle and its cliffsides along the Atlantic Ocean is seeing Merck KGaA expand its commitment there.

The German drug manufacturer is expanding its membrane and filtration manufacturing capabilities in Ireland. The company will invest approximately €440 million ($470 million) to increase membrane manufacturing capacity in Carrigtwohill, Ireland, and build a new manufacturing facility at Blarney Business Park, in County Cork, Ireland.

Rep. Katie Porter (D-CA) (Michael Brochstein/Sipa USA/Sipa via AP Images)

House Dems to Sen­ate lead­er­ship: Quick­ly move a rec­on­cil­i­a­tion bill with drug price ne­go­ti­a­tion re­forms

Twenty House Democrats, including Reps. Katie Porter of California and Susan Wild of Pennsylvania, are calling on Senate leaders to move quickly with a reconciliation bill (meaning they only need a simple majority for passage) with prescription drug pricing reforms, and to include adding new authority for Medicare to negotiate drug prices.

They also called on the Senate to specifically follow suit with the House passage of a $35 per month insulin cap (as Senate Majority Leader Chuck Schumer’s deadline for a vote on that provision has come and gone), and to cap Medicare Part D costs at $2,000 per year for seniors.