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.

Bio­gen shares spike as ex­ecs com­plete a de­layed pitch for their con­tro­ver­sial Alzheimer's drug — the next move be­longs to the FDA

Biogen is stepping out onto the high wire today, reporting that the team working on the controversial Alzheimer’s drug aducanumab has now completed their submission to the FDA. And they want the agency to bless it with a priority review that would cut the agency’s decision-making time to a mere 6 months.

The news drove a 10% spike in Biogen’s stock $BIIB ahead of the bell.

Part of that spike can be attributed to a relief rally. Biogen execs rattled backers and a host of analysts earlier in the year when they unexpectedly delayed their filing to the third quarter. That delay provoked all manner of speculation after CEO Michel Vounatsos and R&D chief Al Sandrock failed to persuade influential observers that the pandemic and other factors had slowed the timeline for filing. Actually making the pitch at least satisfies skeptics that the FDA was not likely pushing back as Biogen was pushing in. From the start, Biogen execs claimed that they were doing everything in cooperation with the FDA, saying that regulators had signaled their interest in reviewing the submission.

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Nick Galakatos, Blackstone global head of life sciences

Nick Galakatos and the Black­stone team now have a record $4.6B to in­vest in bio­phar­ma, with a big fo­cus on push­ing com­pa­nies over the top

Nick Galakatos and his team at Blackstone Life Sciences have seen their biggest opportunities swell up in mostly established players who don’t have all the money they need to accomplish everything on the to-do list. And right now, with the industry booming, that’s a long list with some hefty needs.

The Blackstone team has neatly tied up the largest private fund ever raised in life sciences for making big dreams come true in biopharma. Late Thursday, Blackstone put out word that they had closed their highly anticipated fund with the projected $4.6 billion all in.

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Regeneron CEO Leonard Schleifer speaks at a meeting with President Donald Trump, members of the Coronavirus Task Force, and pharmaceutical executives in the Cabinet Room of the White House (AP Photo/Andrew Harnik)

OWS shifts spot­light to drugs to fight Covid-19, hand­ing Re­gen­eron $450M to be­gin large scale man­u­fac­tur­ing in the US

The US government is on a spending spree. And after committing billions to vaccines defense operations are now doling out more of the big bucks through Operation Warp Speed to back a rapid flip of a drug into the market to stop Covid-19 from ravaging patients — possibly inside of 2 months.

The beneficiary this morning is Regeneron, the big biotech engaged in a frenzied race to develop an antibody cocktail called REGN-COV2 that just started a late-stage program to prove its worth in fighting the virus. BARDA and the Department of Defense are awarding Regeneron a $450 million contract to cover bulk delivery of the cocktail starting as early as late summer, with money added for fill/finish and storage activities.

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Gilead boasts of pos­i­tive remde­sivir da­ta on mor­tal­i­ty — but their analy­sis pro­vokes the skep­tics

Gilead is surging again off data that suggest its antiviral remdesivir might improve survival.

The new data come from an analysis Gilead conducted comparing the death rate and recovery time of patients in one of its remdesivir trials to a group of 800 patients “with similar baseline characteristics and disease severity” who received only standard-of-care around the same time. The result, they said, suggested that patients who received remdesivir had a 62% better chance at surviving than those who did not.

Andrew Kruegel, Kures president and co-founder (Columbia Tech Ventures via Vimeo)

Af­ter psilo­cy­bin and ke­t­a­mine, a new biotech comes along de­vel­op­ing a drug Scott Got­tlieb fought

Andrew Kruegel was six years into his chemistry work at Columbia University, when, one day in August 2016, he learned he might have only 30 days before the government made him destroy his research.

Kruegel had been studying kratom, a leaf long used in Southeast Asia as a stimulant or for pain. It had opioid-like properties, he found, but seemed to offer pain relief without the addictive potential or respiratory side effects of traditional opioids — a riddle that might help illuminate how human opioid receptors work.

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The home run count: The $100M+ mega-round boom in biotech in­spired a $7.3B feed­ing fren­zy — so far this year

Over the last 6 months there’s been a blizzard of money piling up drifts of the green stuff through the biotech landscape. And the forecast calls for more cash windfalls ahead.

Even as a global pandemic has killed more than half a million people, blighted economies and divided nations over the proper response, it’s also helped ignite an unprecedented burst of big-time investing. And not just in Covid-19 deals, as we’ve looked at before.

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Atul Deshpande, Harbour BioMed chief strategy officer & head, US operations (Harbour BioMed)

An­oth­er biotech IPO set-up? Multi­na­tion­al biotech leaps from round to round, scoop­ing up cash at a blis­ter­ing pace

A short four months after announcing a $75 million haul in Series B+ fundraising, the multinational biotech Harbour BioMed pulled in another round of investments and eclipsed the nine-digit mark in the process.

Harbour completed its Series C financing, the company announced Thursday morning, raising $102.8 million and bringing its total investment sum to over $300 million since its founding in late 2016. The biotech plans to use the money to transition early-stage candidates from the discovery phase, fund candidates already in the clinic, and prep late-stage candidates for commercialization.

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Daniel O'Day, Gilead CEO (Kevin Dietsch/UPI/Bloomberg via Getty Images)

A new study points to $6.5B in pub­lic sup­port build­ing the sci­en­tif­ic foun­da­tion of Gilead­'s remde­sivir. Should that be re­flect­ed in the price?

By drug R&D standards, Gilead’s move to repurpose remdesivir for Covid-19 and grab an emergency use authorization was a remarkably easy, low-cost layup that required modest efficacy and a clean safety profile from just a small group of patients.

The drug OK also arrived after Gilead had paid much of the freight on getting it positioned to move fast.

In a study by Fred Ledley, director of the Center for Integration of Science and Industry at Bentley University in Waltham, MA, researchers concluded that the NIH had invested only $46.5 million in the research devoted to the drug ahead of the pandemic, a small sum compared to the more than $1 billion Gilead expected to spend getting it out this year, all on top of what it had already cost in R&D expenses.

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Hal Barron, GSK

Win or lose on the mar­ket­ing OK, the FDA just gunned down GSK’s bright hopes for their BC­MA ther­a­py

The FDA’s ODAC — the Oncologic Drugs Advisory Committee — has a well-known bias in favor of adding new cancer drugs to the market, even if efficacy is at best marginal and serious safety issues demand careful management.

Doctors want as many arrows in their quiver as they can get. And when patients are dying after failing multiple drugs, why not give it a go one more time?

GlaxoSmithKline, though, is about to test out how their new BCMA antibody drug conjugate belantamab mafodotin can do after being mauled in an in-house FDA review, ahead of the Tuesday expert panel discussion. Even if the agency goes ahead with an expected green light, this drug will likely be constrained to a small niche — icing any plans they may have for making waves in oncology anytime soon.

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