With Gilenya gener­ics loom­ing, No­var­tis’ sipon­i­mod team buffs up the MS da­ta pack­age be­ing prepped for the FDA

Re­searchers for No­var­tis $NVS turned up at the 70th Amer­i­can Acad­e­my of Neu­rol­o­gy an­nu­al meet­ing in LA Fri­day to pol­ish up their piv­otal da­ta pack­age for their would-be MS block­buster sipon­i­mod.

Bruce Cree

In the lat­est up­date on Phase III re­sults, they not­ed that while there was no ben­e­fit in mem­o­ry, pa­tients in the drug arm did get a sig­nif­i­cant boost on cog­ni­tive pro­cess­ing speed com­pared to place­bo (p=0.0004). And they have da­ta to demon­strate that there’s a sig­nif­i­cant re­duc­tion in risk of dis­ease pro­gres­sion among non-re­lapse pa­tients that grows from a sus­tained lev­el of 14%-to-20% at three months to 29%-to-33% at six months.

Why is that im­por­tant?

“Sipon­i­mod’s ben­e­fi­cial ef­fect on pre­vent­ing dis­abil­i­ty pro­gres­sion, in­de­pen­dent from its re­duc­tion in re­lapse fre­quen­cy, demon­strates that pa­tients with sec­ondary pro­gres­sive MS could ben­e­fit from this treat­ment,” said study steer­ing com­mit­tee mem­ber Bruce Cree. “This is very ex­cit­ing be­cause many peo­ple di­ag­nosed with re­laps­ing-re­mit­ting MS, the most com­mon form of the dis­ease, will ul­ti­mate­ly tran­si­tion to SPMS, where with­out ef­fec­tive new ther­a­pies, they ex­pe­ri­ence grad­ual wors­en­ing of dis­abil­i­ty de­spite in­fre­quent re­laps­es.”

Dan­ny Bar-Zo­har

A month ago we were told in­ves­ti­ga­tors tracked a sig­nif­i­cant 21% re­duc­tion in the risk of dis­ease pro­gres­sion among pa­tients tak­ing sipon­i­mod (BAF312) af­ter three months, mak­ing the pri­ma­ry goal of the study. The full re­sults pub­lished in The Lancet pro­vid­ed a more com­plete por­trait. 

Sec­on­daries in the study demon­strat­ed the ther­a­py:

  • Slowed the rate of brain vol­ume loss by 23%.
  • Lim­it­ed the in­crease of T2 le­sion vol­ume by a mean of about 80%.
  • Re­duced the an­nu­al re­lapse rate by 55%.
  • And raised the bar on re­duc­ing dis­ease pro­gres­sion to 26% at month 6.

“This is pret­ty much the first and on­ly study in sec­ondary pro­gres­sive MS that showed mean­ing­ful re­sults,” No­var­tis’ Dan­ny Bar-Zo­har, the glob­al head of neu­ro­science de­vel­op­ment at No­var­tis, told me last month. The drug works by bind­ing to the S1P1 sub-re­cep­tor on lym­pho­cytes, which pre­vents them from pen­e­trat­ing the cen­tral ner­vous sys­tem.

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.