Eli Lil­ly posts promis­ing PhI­II mi­graine re­sults, but set­tles in­to the pack in the last leg of the race to the FDA

Eli Lil­ly $LLY is lin­ing up its ap­pli­ca­tion for its CGRP mi­graine drug gal­canezum­ab af­ter rack­ing up a slate of date from three Phase III stud­ies that puts it right along­side its many ri­vals. The head­line suc­cess was her­ald­ed weeks ago, with the de­tails un­veiled Sat­ur­day at the Amer­i­can Headache So­ci­ety an­nu­al sci­en­tif­ic meet­ing in Boston.

David Ricks

CGRP drugs look like a safe way to low­er the num­ber of mi­graine days per month among pa­tients with episod­ic and chron­ic mi­graine, the 120 mg and 240 mg dos­es of gal­canezum­ab cut the av­er­age num­ber of de­bil­i­tat­ing episodes by 4 and 3.8 days in one study for episod­ic mi­graine and 3.7 days and 3.6 days in an­oth­er — com­pared to a place­bo re­sponse that ran from 1.85 to 2.15 days.

In the Phase III for chron­ic mi­graine the 240 mg dose cut the rate of mi­graine days by 2.1 days over a place­bo.

What’s emerg­ing from the bat­tery of late-stage da­ta is a re­mark­ably sim­i­lar set of re­sults for drugs that tar­get CGRP. With the stan­dard caveat that cross-tri­al com­par­isons can be in­her­ent­ly un­re­li­able, based on a dif­fer­ing set of pa­tient pro­files and end­points, Lil­ly nev­er­the­less will be lin­ing up along­side the lead­ers, Am­gen/No­var­tis {$AMGN, $NVS}, as well as Te­va $TE­VA , which ear­li­er this week re­port­ed the sec­ond set of its promis­ing Phase III re­sults fre­manezum­ab (TEV-48125) that is al­so head­ed to reg­u­la­tors.

Lit­tle Alder $AL­DR is al­so plan­ning to wage a com­mer­cial war with their drug. And Al­ler­gan $AGN has a late-stage pro­gram un­der­way for an oral CGRP ther­a­py it in-li­censed from Mer­ck in 2015 with a $250 mil­lion up­front.

One con­clu­sion from all this da­ta seems in­escapable. The stan­dard for treat­ing mi­graine should change for the bet­ter. Who ac­tu­al­ly comes out on top, able to dif­fer­en­ti­ate them­selves from the main­stream with the right dose, treat­ment reg­i­men and re­tail price for pay­ers, has yet to be de­ter­mined. But it will be a ma­jor league matchup, with at least one David (Alder) among the Go­liaths.

An­a­lysts have been puz­zling out the late-stage ri­val­ry for months now, with lit­tle con­sen­sus on how this will all shake out. For Lil­ly, it’s rel­a­tive­ly good news, es­pe­cial­ly af­ter the de­ba­cle at the FDA with the re­cent, un­ex­plained re­jec­tion of baric­i­tinib.

5AM Ven­tures: Fu­el­ing the Next Gen­er­a­tion of In­no­va­tors

By RBC Capital Markets
With Andy Schwab, Co-Founder and Managing Partner at 5AM Ventures

Key Points

Prescription Digital Therapeutics, cell therapy technologies, and in silico medicines will be a vital part of future treatment modalities.
Unlocking the potential of the microbiome could be the missing link to better disease diagnosis.
Growing links between academia, industry, and venture capital are spinning out more innovative biotech companies.
Biotech is now seen by investors as a growth space as well as a safe haven, fuelling the recent IPO boom.

Biohaven CEO Vlad Coric (Photo Credit: Andrew Venditti)

Pssst: That big Bio­haven Alzheimer's study? It was a bust. Even the sub­group analy­sis ex­ecs tout­ed was a flop

You know it’s bad when a biopharma player plucks out a subgroup analysis for a positive take — even though it was way off the statistical mark for success, like everything else.

So it was for Biohaven $BHVN on MLK Monday, as the biotech reported on the holiday that their Phase II/III Alzheimer’s study for troriluzole flunked both co-primary endpoints as well as a key biomarker analysis.

The drug — a revised version of the ALS drug riluzole designed to regulate glutamate — did not “statistically differentiate” from placebo on the Alzheimer’s Disease Assessment Scale-Cognitive Subscale 11 (ADAS-cog) and the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB).  The “hippocampal volume” assessment by MRI also failed to distinguish itself from placebo for all patients fitting the mild-to-moderate disease profile they had established for the study.

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Hal Barron, GSK R&D chief (GSK via YouTube)

Glax­o­SmithK­line's $4B bis­pe­cif­ic can­cer drug al­liance with Mer­ck KGaA hit by big set­back with a PhI­II fail­ure on NSCLC

Close to 2 years ago, GSK’s R&D team eagerly agreed to pay up to $4 billion-plus to ally itself with Merck KGaA on a mid-stage bispecific called bintrafusp alfa, which intrigued them with the combination of a TGF-β trap with the anti-PD-L1 mechanism in one fusion protein.

But today the German pharma company says that their lead study on lung cancer was a bust, as independent monitors said there was no reason to believe that the experimental drug — targeting PD-L1/TGF-Beta — could beat Keytruda.

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News brief­ing: Ve­rastem CMO ex­its two weeks af­ter join­ing com­pa­ny; Ther­mo Fish­er inks $550M M&A deal

Two weeks after joining Verastem Oncology as chief medical officer, Frank Neumann is leaving the company for another job.

Neumann had joined Verastem after leaving bluebird bio, which surprisingly split into two companies last week, one in oncology and one in rare diseases. It’s not yet clear to where Neumann is headed next, but he noted in a statement that Verastem’s data and strategy were “truly exciting.”

FDA hits the brakes on His­to­gen's knee car­ti­lage ther­a­py, ask­ing for more in­fo on man­u­fac­tur­ing process

A month after filing the IND application for its human extracellular matrix designed to regenerate knee cartilage, Histogen has hit a roadblock.

The FDA on Tuesday verbally notified the San Diego-based biotech that it was placing a clinical hold on the planned Phase I/II clinical trial of HST-003 due to pending CMC information and additional questions needed to complete their review.

Histogen had planned to test the safety and efficacy of implanting hECM within microfracture interstices and related cartilage defects to regenerate that cartilage in conjunction with a microfracture procedure. The company said in a press release that it expects to receive written notice of the clinical hold from the FDA by Feb 12.

Andrew Allen, Gritstone CEO (Gritstone via website)

Grit­stone con­tin­ues Covid-19 push with deal to de­vel­op 'self-am­pli­fy­ing RNA' vac­cines, as shares con­tin­ue bal­loon­ing

Gritstone Oncology has had a big week, and it’s only Wednesday.

On Tuesday, the biotech revealed plans to start clinical testing of an experimental Covid-19 vaccine — in tandem with NIAID — that can also target other coronaviruses, with the goal of preventing future pandemics should SARS-CoV-2 prove difficult to cure with current vaccines. Then, on Wednesday morning, Gritstone licensed lipid nanoparticle technology from Genevant Sciences to develop what it’s calling “self-amplifying RNA vaccines” against Covid-19.

Janet Woodcock and Joshua Sharfstein (AP, Images)

Poll: Should Joshua Sharf­stein or Janet Wood­cock lead the FDA from here?

It’s time for a new FDA commissioner to come on board, a rite of passage for Joe Biden’s administration that should help seal the new president’s rep on seeking out the experts to lead the government over the next 4 years.

As of now, the competition for the top job appears to have narrowed down to 2 people: The longtime CDER chief Janet Woodcock and Joshua Sharfstein, the former principal deputy at the FDA under Peggy Hamburg. Both were appointed by Barack Obama.

Bris­tol My­ers Squibb gets re­view date for Op­di­vo com­bo in gas­tric can­cer, look­ing to over­turn Keytru­da's 3-year lead

The past two months have been tough for Bristol Myers Squibb and its checkpoint inhibitor Opdivo after setbacks in lung and brain cancers. But in the battle against Merck’s Keytruda, any success matters — and now Bristol could be looking at a quick approval for Opdivo in an unmatched indication.

The FDA will launch a speedy review of a combination of Bristol Myers Squibb’s Opdivo and chemotherapy to treat first-line patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer or esophageal adenocarcinoma, the drugmaker said Wednesday. The agency set an action date of May 25 for the application.

Covid-19 claims an­oth­er PDU­FA vic­tim as Glax­o­SmithK­line push­es back planned PD-1 roll­out

Bristol Myers Squibb isn’t the only pharma giant that’s been standing in the FDA’s waiting line for site inspections.

GlaxoSmithKline is telling us today that their H2 2020 PDUFA deadline for the PD-1 drug dostarlimab — picked up in its Tesaro buyout — was pushed back due to a delay in the manufacturing site inspection needed for a regulatory decision. And that is forcing the company to revise its timeline.

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