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.

UP­DAT­ED: Mer­ck pulls Keytru­da in SCLC af­ter ac­cel­er­at­ed nod. Is the FDA get­ting tough on drug­mak­ers that don't hit their marks?

In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders?

Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday.

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Michael Shpigelmacher

Khosla joins bet on un­con­ven­tion­al start­up look­ing to send drug de­liv­er­ing ro­bots in­to the brain

When Michael Shpigelmacher started the project, he knew he’d have to fund it himself. Every other effort of its kind was academic, rejected as too risky by investors.

Shpigelmacher, a robotics geek and entrepeneur who had drifted into consulting for pharma, wanted to build the real-life equivalent of technology from the 1960s film Fantastic Voyage, the one where a submarine crew is shrunk to “about the size of a microbe” and sent on a mission to repair a scientist’s brain. He scanned the literature, found the lab that was working on the most advanced project — at the Max Planck Institute in Germany, it turned out — and started funding them with money from his own account, along with some seed cash from friends and family.

Paul Sekhri

The next big biotech su­per­star? Paul Sekhri has some thoughts on that

It occasionally occurs to Paul Sekhri that if they pull this off, his company will be on the front page of the New York Times and a lead story in just about every major news outlet on the planet. He tries not to dwell on it, though.

“I just want to be laser-focused on getting to that point,” Sekhri says, before acknowledging, “Yes, it absolutely crossed my mind.”

Sekhri, a longtime biopharma executive with tenures at Sanofi and Novartis, is now entering year three as CEO of eGenesis, the biotech that George Church protégé Luhan Yang founded to genetically alter pigs so that they can be used for organ transplants. He led them through one megaround and has just closed another, raising $125 million from 17 different investors to push the first-ever (humanized) pig to human transplants into the clinic.

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Amit Munshi, Arena

One of Are­na's top drugs flops in a PhI­Ib study for IBS pain. But re­searchers tease out a pos­si­ble path for­ward as CEO ex­plores 's­trate­gic op­tion­s'

Four years ago, when Arena CEO Amit Munshi cut its ties to a troubled weight drug and doubled down on the pipeline, a cannabinoid receptor 2 agonist figured prominently in the biotech’s future. On Tuesday evening, however, Munshi’s high hopes for the drug took a nasty hit after it failed a Phase IIb study for patients with irritable bowel syndrome pain.

Put through a randomized pace with 273 patients, researchers said it flat failed the primary endpoint among the large group with abdominal pain. But they quickly went on to highlight subgroup data, always a tricky and controversial ploy, where they spotlighted a positive p value for patients with moderate to severe pain who received the high dose of the drug — one of 3 provided in the study.

Bob Nelsen (Photo by Michael Kovac/Getty Images)

With stars aligned and cash in re­serve, Bob Nelsen's Re­silience plans a makeover at 2 new fa­cil­i­ty ad­di­tions to its drug man­u­fac­tur­ing up­start

Bob Nelsen’s new, state-of-the-art drug manufacturing initiative is taking shape.

Just 3 months after gathering $800 million of launch money, a dream team board and a plan to shake up a field where he found too many bottlenecks and inefficiencies for the era of Covid-19, Resilience has snapped up a pair of facilities now in line for a retooling.

The company has acquired a 310,000-square-foot plant in Boston from Sanofi along with a 136,000-square-foot plant in Ontario to add to a network which CEO Rahul Singhvi says is just getting started on building his company’s operations up. The Sanofi deal comes with a contract to continue manufacturing one of its drugs.

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CEO Marco Taglietti (Scynexis)

'N­ev­er been more ur­gent:' Scynex­is looks to tack­le su­per­bug cri­sis with late-stage read­out for an­ti­fun­gal hope­ful

As the superbug crisis heats up around the world, Scynexis says it has new data from two interim analyses that prove its antifungal has the potential to treat a broad range of infections.

“The need for new anti-infectives capable of fighting the most resistant pathogens has never been more urgent as we confront the ongoing COVID-19 global pandemic,” CEO Marco Taglietti said in a statement.

A spot­light schiz­o­phre­nia drug in Neu­ro­crine's $2B Take­da deal flunks its first ma­jor test. But it's not giv­ing up yet

When Takeda spun out a pipeline of experimental psychiatry drugs to Neurocrine in a $2 billion deal amid a post-merger shakeout, R&D chief Andy Plump described the therapies as “very interesting but still difficult.”

On Tuesday, we got some idea of how difficult.

San Diego-based Neurocrine revealed that one of the three spotlight clinical programs they’d acquired failed the primary endpoint in a Phase II trial for schizophrenia, registering a negative outcome on the change from baseline in the positive and negative syndrome scale/negative symptom factor score (PANSS NSFS).

Af­ter bail­ing on Covid-19 vac­cines, Mer­ck will team up with J&J to pro­duce its shot as part of un­usu­al Big Phar­ma pact

Merck took a big gamble when it opted to jump into the Covid-19 vaccine race late, and made an equally momentous decision to back out in late January. Now, looking to chip in on the effort, Merck reportedly agreed to team up with one of the companies that has already crossed the finish line.

President Joe Biden on Tuesday is expected to announce a partnership between drugmakers Merck and Johnson & Johnson to jointly produce J&J’s recombinant protein Covid-19 vaccine that received the FDA’s emergency use authorization Saturday, the Washington Post reported.

Ab­b­Vie tees up a biotech buy­out af­ter siz­ing up their Parkin­son's drug spun out of Ke­van Shokat's lab

AbbVie has teed up a small but intriguing biotech buyout after looking over the preclinical work it’s been doing in Parkinson’s disease.

The company is called Mitokinin, a Bay Area biotech spun out of the lab of UCSF’s Kevan Shokat, whose scientific explorations have formed the academic basis of a slew of startups in the biotech hub. One of Shokat’s PhD students in the lab, Nicholas Hertz, co-founded Mitokinin using their lab work on PINK1 suggesting that amping up its activity could play an important role in regulating the mitochondrial dysfunction contributing to Parkinson’s disease pathogenesis and progression.

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