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.

It’s fi­nal­ly over: Bio­gen, Ei­sai scrap big Alzheimer’s PhI­I­Is af­ter a pre­dictable BACE cat­a­stro­phe rais­es safe­ty fears

Months after analysts and investors called on Biogen and Eisai to scrap their BACE drug for Alzheimer’s and move on in the wake of a string of late-stage failures and rising safety fears, the partners have called it quits. And they said they were dropping the drug — elenbecestat — after the independent monitoring board raised concerns about…safety.

We don’t know exactly what researchers found in this latest catastrophe, but the companies noted in their release that investigators had determined that the drug was flunking the risk/benefit analysis.

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It's not per­fect, but it's a good start: FDA pan­elists large­ly en­dorse Aim­mune's peanut al­ler­gy ther­a­py

Two days after a fairly benign review from FDA staff, an independent panel of experts largely endorsed the efficacy and safety of Aimmune’s peanut allergy therapy, laying the groundwork for approval with a risk evaluation and mitigation strategy (REMS).

Traditionally, peanut allergies are managed by avoidance, but the threat of accidental exposure cannot be nullified. Some allergists have devised a way to dose patients off-label with peanut protein derived from supermarket products to wean them off their allergies. But the idea behind Aimmune’s product was to standardize the peanut protein, and track the process of desensitization — so when accidental exposure in the real world invariably occurs, patients are less likely to experience a life-threatening allergic reaction.

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Lisa M. DeAngelis, MSKCC

MSK picks brain can­cer ex­pert Lisa DeAn­ge­lis as its next CMO — fol­low­ing José Basel­ga’s con­tro­ver­sial ex­it

It’s official. Memorial Sloan Kettering has picked a brain cancer expert as its new physician-in-chief and CMO, replacing José Baselga, who left under a cloud after being singled out by The New York Times and ProPublica for failing to properly air his lucrative industry ties.

His replacement, who now will be in charge of MSK’s cutting-edge research work as well as the cancer care delivered by hundreds of practitioners, is Lisa M. DeAngelis. DeAngelis had been chair of the neurology department and co-founder of MSK’s brain tumor center and was moved in to the acting CMO role in the wake of Baselga’s departure.

Penn team adapts CAR-T tech, reengi­neer­ing mouse cells to treat car­diac fi­bro­sis

After establishing itself as one of the pioneer research centers in the world for CAR-T cancer therapies, creating new attack vehicles to eradicate cancer cells, a team at Penn Medicine has begun the tricky transition of using the basic technology for heart repair work.

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Tal Zaks. Moderna

The mR­NA uni­corn Mod­er­na has more ear­ly-stage hu­man da­ta it wants to show off — reach­ing new peaks in prov­ing the po­ten­tial

The whole messenger RNA field has attracted billions of dollars in public and private investor cash gambled on the prospect of getting in on the ground floor. And this morning Boston-based Moderna, one of the leaders in the field, wants to show off a few more of the cards it has to play to prove to you that they’re really in the game.

The whole hand, of course, has yet to be dealt. And there’s no telling who gets to walk with a share of the pot. But any cards on display at this point — especially after being accused of keeping its deck under lock and key — will attract plenty of attention from some very wary, and wired, observers.

“In terms of the complexity and unmet need,” says Tal Zaks, the chief medical officer, “this is peak for what we’ve accomplished.”

Moderna has two Phase I studies it wants to talk about now.

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Sanofi takes a $260M hit to ex­tri­cate it­self from a dis­as­trous al­liance with Lex­i­con

Sanofi spent $300 million in cash to get into a $1.7 billion alliance with Lexicon on their SGLT1/2 diabetes drug sotagliflozin. And now that the drug has been spurned by the FDA after burning through a program that provided mixed late-stage data and a late shot at a last-place finish, the French pharma giant is forking over another $260 million to get out of the deal.

Sanofi’s unhappiness was already apparent when the company — now under new CEO Paul Hudson — posted a statement back in July that they were dropping the deal. But it wasn’t that simple. 

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Rit­ter bombs fi­nal PhI­II for sole lac­tose in­tol­er­ance drug — shares plum­met

More than two years ago Ritter Pharmaceuticals managed to find enough silver lining in its Phase IIb/III study — after missing the top-line mark — to propel its lactose intolerance toward a confirmatory trial. But as it turned out, the enthusiasm only set the biotech and its investors up to be sorely disappointed.

This time around there’s little left to salvage. Not only did RP-G28 fail to beat placebo in reducing lactose intolerance symptoms, patients in the treatment group actually averaged a smaller improvement. On a composite score measuring symptoms like abdominal pain, cramping, bloating and gas, patients given the drug had a mean reduction of 3.159 while the placebo cohort saw a 3.420 drop on average (one-sided p-value = 0.0106).

Ear­ly snap­shot of Ad­verum's eye gene ther­a­py sparks con­cern about vi­sion loss

An early-stage update on Adverum Biotechnologies’ intravitreal gene therapy has triggered investor concern, after patients with wet age-related macular degeneration (AMD) saw their vision deteriorate, despite signs that the treatment is improving retinal anatomy.

Adverum, on Wednesday, unveiled 24-week data from the OPTIC trial of its experimental therapy, ADVM-022, in six patients who have been administered with one dose of the therapy. On average, patients in the trial had severe disease with an average of 6.2 anti-VEGF injections in the eight months prior to screening and an average annualized injection frequency of 9.3 injections.

Alex Ar­faei trades his an­a­lyst's post for a new role as biotech VC; Sanofi vet heads to Vi­for

Too often, Alex Arfaei arrived too late. 

An analyst at BMO Capital Markets, he’d meet with biotech or pharmaceutical heads for their IPO or secondary funding and his brain, trained on a biology degree and six years at Merck and Endo, would spring with questions: Why this biomarker? Why this design? Why not this endpoint? Not that he could do anything about it. These execs were coming for clinical money; their decisions had been made and finalized long ago.