FDA opts to nail down REMS plan for Sage's land­mark post­par­tum de­pres­sion drug, de­lays fi­nal de­ci­sion

A month be­fore the FDA is sched­uled to hand down what many ex­pect to be an OK for Sage Ther­a­peu­tics’ land­mark drug for post­par­tum de­pres­sion, the agency says it needs some more time to re­view a new­ly sub­mit­ted risk eval­u­a­tion and mit­i­ga­tion strate­gies plan.

The un­ex­pect­ed de­lay push­es its PDU­FA date back three months to March 2019, while the com­mer­cial­iza­tion is now slat­ed to be­gin in June, Sage said in a state­ment, like­ly mean­ing that the REMS will be in place by the time the drug is rolled out.

Paul Mat­teis

Sage sub­mit­ted $SAGE the pro­posed REMS af­ter the re­cent ad­vi­so­ry com­mit­tee meet­ing, where a pan­el of 18 out­side ex­perts vot­ed over­whelm­ing­ly for brex­anolone’s ap­proval but voiced con­cerns over safe­ty pre­cau­tions. Specif­i­cal­ly, the ex­perts point­ed to un­pre­dictable episodes of un­con­scious­ness ob­served in 6 out of 140 pa­tients who have so far re­ceived the treat­ment as rea­son for de­mand­ing des­ig­nat­ed fa­cil­i­ties for ad­min­is­tra­tion and a 12-hour fol­low-up to the 60-hour in­fu­sion.

While the de­lay is sur­pris­ing, it’s not a shock for Stifel’s Paul Mat­teis, who notes that the FDA’s de­ci­sion — like the pan­el dis­cus­sion — was about “safe use” rather than ap­prov­abil­i­ty. The an­a­lyst not­ed:

From our dis­cus­sions with SAGE, we un­der­stand that ahead of the pan­el the com­pa­ny was un­cer­tain as to whether or not la­bel­ing alone would be enough to en­sure safe use of brex in the re­al world. Thus, im­me­di­ate­ly af­ter a pan­el that af­firmed that a REMS would be need­ed, SAGE worked to pro­pose a REMS to FDA as quick­ly as pos­si­ble. … SAGE be­lieves the rest of the NDA re­view is on track, and we don’t view the de­lay as im­pact­ing the high prob­a­bil­i­ty that the prod­uct is ap­proved.

The mar­ket, though, is less in­ter­est­ed in the strings put on this ap­proval than the un­der­stand­ing they can glean about the FDA’s ap­proach to their oral PPD drug SAGE-217. That drug is the key to un­lock­ing the block­buster mar­ket avail­able here. And so far, so good, with reg­u­la­tors gear­ing up to re­view a drug that has — so far — not been tied to the same safe­ty is­sues.

A batch of Phase III SAGE-217 da­ta will read out in Jan­u­ary — a keen­ly watched event as Sage con­tin­ues to jus­ti­fy its multi­bil­lion-dol­lar val­u­a­tion.

Jake Van Naarden, Josh Bilenker, Nisha Nanda (Credit: Loxo, Aisling Capital)

Josh Bilenker and his Loxo crew are tak­ing the reins on on­col­o­gy R&D at Eli Lil­ly, culling the weak and map­ping a new path

Josh Bilenker, Jake Van Naarden and Nisha Nanda came out of Eli Lilly’s $8 billion Loxo Oncology buyout with a bundle of cash and plenty of choices on what they could do next. Start a new company, go public. Live on the beach in 5-star luxury. Contemplate the stars — in their own observatory.

So what are they doing?

They formed a new executive team that is taking over the management of Eli Lilly’s hundreds-strong oncology R&D group — essentially using Loxo as a base for a bold new experiment in Big Pharma R&D in an attempt to create a true biotech environment with the deep pockets of a top-15 industry player. They’ve recruited David Hyman from Memorial Sloan Kettering to join the team as chief medical officer. And the mandate includes culling out the oncology pipeline, highlighting their star prospects and going after new programs wherever they can find the best prospects.

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J&J team shows off 'break­through' BC­MA CAR-T da­ta, and that could cause a big headache at blue­bird and Bris­tol-My­ers

Just hours after J&J’s oncology team bragged about scoring a breakthrough therapy designation for their BCMA CAR-T drug, they pulled the wraps off of the multiple myeloma data for JNJ-4528 that impressed the FDA. And it’s easy to see why they may well be on a short path to a landmark approval — which may well be making the rival team at bluebird/Bristol-Myers more than a little nervous.

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J&J's Mathai Mammen at an Endpoints News event in Boston, June 2018 (Photo: Rob Tannenbaum for Endpoints News)

J&J fronts $750M cash to grab a failed can­cer drug that’s been re­pur­posed as a pow­er­ful an­ti-in­flam­ma­to­ry

J&J has stepped up with one of its blockbuster drug buys, agreeing to pay Austin-based XBiotech $XBIT $750 million in cash and up to $600 million more in milestones for their late stage-ready anti-inflammatory drug bermekimab — which some longtime biotech observers may recognize as a failed cancer therapy with a disaster-prone past.

The drug targets the IL-1a pathway. J&J $JNJ R&D chief Mathai Mammen is cutting a check for a drug that has produced positive mid-stage data in patients suffering from a skin condition called hidradenitis suppurativa with another mid-stage program underway for atopic dermatitis.

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One of Wall Street’s most high-pro­file hedge funds push­es Alex­ion's CEO to the auc­tion block — and he's not budg­ing

Fresh off buying Barnes & Noble and prodding AT&T with some heavy-handed criticism after picking up a $3.2 billion stake in the company, the activist — and supremely high profile — hedge fund Elliott Management has stepped up with some M&A advice for Alexion’s management team.
And the execs on the team $ALXN are giving them a polite — but very firm — stiff arm Friday morning.
In a release out early Friday, the big biotech said that the Elliott team had been in touch to encourage them to sell the company. But that’s not on the agenda.

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Un­lock the full End­points ex­pe­ri­ence for your com­pa­ny — and sup­port our mis­sion of in­de­pen­dent bio­phar­ma re­port­ing

I want to give readers a quick update on the most important part of our business model — premium subscriptions. We have some crucial financial goals we hope to achieve by the end of the year, and the team here in Lawrence is ready to ship some swag to kick off this limited December promotion.

We offer two premium plans — Enterprise for companies ($1,000/year, unlimited people), and Insider for individuals ($200/year). This month of December will be the last chance to enroll at the original rates — which have remained flat since we launched them in 2017.

Jasper Ther­a­peu­tics launch­es out of Stan­ford with new ap­proach to stem cell treat­ment

The first girl in the trial came in with chronic diarrhea and the immune system of an untreated HIV patient. Born with a rare genetic disease that impeded her ability to make B and T cells, she had once been given a stem cell transplant but it didn’t take.  Back in the hospital, she was injected with a new experimental antibody and then given a new stem cell transplant. Soon, she gained weight. The diarrhea stopped.

Ex-Cel­gene ex­ec Ter­rie Cur­ran puts her Phath­om team in place; Car­away taps Mar­tin Williams as CEO

→ Gastrointestinal disease-focused Phathom Pharmaceuticals has shaken up its leadership team. The company has tapped former Celgene exec Terrie Curran as CEO, succeeding David Socks, who is transitioning to interim CFO. Curran was president of Celgene’s global inflammation and immunology franchise — helping with the sale of Otezla for $13.4 billion to Amgen — and has held a previous stint at Merck. In addition to Curran, the company also welcomed former Omeros CMO Eckhard Leifke as CMO, ex-Celgene exec Joseph Hand as chief administrative officer, and former general counsel for Cyclerion Therapeutics Larry Miller as general counsel. They also replaced Chris Slavinsky on the board with Takeda exec Asit Parikh.

UCB buffs up in block­buster pso­ri­a­sis race as bimek­izum­ab beats Hu­mi­ra in head-to-head

Just weeks after boasting head-to-head victories over first placebo and then J&J’s IL-23 contender Stelara in clearing psoriasis, the results are in for UCB’s last Phase III trial, in which bimekizumab went up against the world’s best-selling drug.

Only topline results are provided for today’s readout of the BE SURE study, so we won’t find out just how superior bimekizumab proved against Humira on the co-primary endpoints — standard scores known as PASI90 and IGA measuring the impact and severity of the disease — until a scientific conference in 2020.

With EMA re­view in progress, No­var­tis un­veils more pos­i­tive da­ta on asth­ma ther­a­py

Having made its marketing pitch to the EU regulator, Novartis on Thursday unveiled positive pivotal study data supporting the use of its inhaled asthma treatment.

The therapy, QMF149, consists of the long-acting beta-agonist, or LABA, called indacaterol acetate and the corticosteroid mometasone furoate. In the 2,216-patient, 52-week PALLADIUM study, asthma patients either received a medium or high dose of the Novartis therapy (150/160 μg; 150/320 μg) or mometasone furoate (MF) alone.