Play­ing catch-up, Eli Lil­ly is hus­tling pos­i­tive PhI­II CGRP mi­graine da­ta to the FDA as late-stage ri­val­ry heats up

Eli Lil­ly is hus­tling up a bi­o­log­ics ap­pli­ca­tion for its close­ly-watched mi­graine drug gal­canezum­ab af­ter post­ing some re­mark­ably con­sis­tent and pos­i­tive late-stage da­ta from three Phase III stud­ies.

The top-line da­ta from the Lil­ly $LLY study demon­strat­ed that the 120 and 240 mg dos­es re­duced the av­er­age num­ber of mi­graine days by 4.3 to 4.8 days and 4.2 to 4.6 days a month. The place­bo arm had a 2.3 to 2.8 day month­ly drop in mi­graine days, on av­er­age, leav­ing the drug with a con­sis­tent two-day ad­van­tage that will like­ly do fair­ly well in the mar­ket­ing bat­tle to come as Te­va, Alder and the pow­er­house duo of No­var­tis $NVS and Am­gen $AMGN hus­tle their com­pet­ing CGRP drugs to the mar­ket.

No­var­tis and Am­gen — cred­it­ed as the fron­trun­ners in the race to the first OK — were the first to come up with pos­i­tive Phase III da­ta for erenum­ab (AMG 334) last fall, when a 70 mg dose scored an av­er­age 1.1 day per month drop in mi­graine episodes. Then their STRIVE study de­liv­ered an av­er­age re­duc­tion of 3.2 and 3.7 days from base­line in month­ly mi­graine days for the 70 mg and 140 mg dos­es, re­spec­tive­ly, as com­pared to a 1.8-day re­duc­tion in the place­bo arm. The da­ta so far have all in­di­cat­ed that these drugs can con­sis­tent­ly re­duce mi­graine days by one or two days, as an­a­lysts try to make com­par­isons with dif­fer­ent pa­tient pop­u­la­tions and a va­ri­ety of base­line scores to start with.

De­spite the num­ber of CGRP drugs an­gling for the lead here, Bio­haven $BHVN re­cent­ly in-li­censed a sim­i­lar drug from Bris­tol-My­ers Squibb and scored a very suc­cess­ful IPO with it just a few days ago.

“The ro­bust re­sults from these three stud­ies bring us one step clos­er to help­ing peo­ple ex­pe­ri­ence more mi­graine-free days, an im­por­tant treat­ment goal for those liv­ing with this se­ri­ous dis­ease,” said Christi Shaw, pres­i­dent of Lil­ly Bio-Med­i­cines. “The im­pact of mi­graine is un­der­es­ti­mat­ed, with peo­ple who ex­pe­ri­ence mi­graine at­tacks of­ten miss­ing work, fam­i­ly ac­tiv­i­ties or so­cial en­gage­ments. For pa­tients with as few as one mi­graine headache day per week, this can mean more than 50 days of lost pro­duc­tiv­i­ty a year.”

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.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

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.

Dan Skovronsky, Eli Lilly CSO (Lilly via Facebook)

Eli Lil­ly tees up dis­cov­ery pact worth more than $1.6B with Merus for T cell-fo­cused bis­pe­cif­ic an­ti­bod­ies

Under science chief Dan Skovronsky, Eli Lilly has taken some big swings at next-gen therapies, including trying to find the next big thing in oncology. Now, after one early failure in the field, Lilly is going back to the bispecific antibody well with a new deal with a Dutch biotech.

Lilly will pay $40 million upfront with an additional $20 million equity stake in Merus NV to identify and develop three bispecific antibodies looking to engage the CD3 antigen on T cells and redirect immune cells, the Indianapolis pharma giant said Tuesday.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 98,100+ biopharma pros reading Endpoints daily — and it's free.

Andrew Allen (Gritstone)

As coro­n­avirus vari­ants trig­ger new alarms, the NIH is putting an un­der-the-radar ‘next-gen’ vac­cine in­to PhI

Over the past year, the world has been transfixed by the development of new vaccines to fight SARS-CoV-2. In a frenzy of activity, the new mRNA approach has delivered pioneering emergency approvals in record time. And with some setbacks, the more traditional big players are coming along with added jabs as the most affluent nations in the world begin to vaccinate large portions of their populations.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

The IPO queue adds 5 more biotechs hop­ing to ring in 2021 by blitz­ing Nas­daq

Following a record year for IPOs — in terms of both proceeds and count — there’s already a long lineup of biotechs ready to jump onto Nasdaq in the new year. The companies are likely looking for much higher raises than they initially projected on their S-1s. Now it’s time to see if investors are still hungry for another round of biotech stocks.

Sana helped set the pace early on, as its founders look to divvy up a fortune from their IPO. And late last week 5 more biotechs crowded in, looking to pick up the pace where 2020 left off. Here they are:

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 98,100+ biopharma pros reading Endpoints daily — and it's free.

News brief­ing: Beam bags a $260M pri­vate place­ment; mi­Ra­gen re­brands to Virid­i­an Ther­a­peu­tics

Agios vet John Evans has demonstrated how to raise big money for a little biotech.

The Beam Therapeutics CEO — and ARCH partner — has pieced together a $260 million private placement from a group of backers that includes Perceptive Advisors, Farallon Capital, Casdin Capital, Redmile Group and Cormorant Asset Management. And there are 3 main goals they’ll pursue with it: clinical development, strategic partnerships and general corporate purposes.

As­traZeneca keeps the ball rolling on Dai­ichi-part­nered En­her­tu, pick­ing up 2nd in­di­ca­tion in gas­tric can­cer

AstraZeneca’s big gamble on Daiichi Sankyo’s antibody-drug conjugate Enhertu has already paid off with a big approval in breast cancer more than a year ago. But the partners have big plans for their blockbuster in the making, and a new nod in gastric cancer will raise their spirits even higher.

The FDA on Friday approved Enhertu to treat locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma in patients who have previously undergone at least one round of treatment with a Herceptin-based regimen, AstraZeneca said in a release.

Ox­ford gets £100M to seize a 'break­through mo­men­t' in fight­ing su­per­bugs

Close to 70 years after Oxford scientists purified penicillin and confirmed its effect as an antibacterial drug, the university is establishing a new research institute at the forefront of combating antimicrobial resistance.

The Ineos Oxford Institute for AMR Research will initially be powered by a $136 million (£100 million) donation from Ineos, the UK-based chemicals giant founded by billionaire Jim Ratcliffe, that also plays a hand in manufacturing medical and pharma products.