Te­va turns the last cor­ner in the CGRP mi­graine drug race with its 2nd round of promis­ing PhI­II da­ta

Te­va has brought in its sec­ond suc­cess­ful Phase III study of its CGRP mi­graine drug fre­manezum­ab (TEV-48125), rack­ing up a fresh slate of promis­ing da­ta across all end­points that will soon be pack­aged and de­liv­ered in­to the hands of reg­u­la­tors.

Te­va re­cruit­ed a heav­i­ly af­flict­ed group of pa­tients for this episod­ic study with a mean num­ber of 9.1 mi­graine days per month go­ing in. Their $TE­VA core da­ta boils down to this: a 1.5-day ad­van­tage in re­duced mi­graine days for the drug arm, putting it in the mix of around 2 days im­prove­ment across a full slate of CGRP ri­vals test­ed in a wide va­ri­ety of mid- and late-stage stud­ies.

Umer Raf­fat at Ever­cor­eISI has been fol­low­ing the num­bers, and high­light­ed this point:

(I)n to­day’s da­ta, there is an­oth­er impt tid­bit:  Te­va prospec­tive­ly ran­dom­ized a sub­group of pa­tients in this episod­ic tri­al on sta­ble pro­phy meds … and in this sub­group, Te­va showed a 1.7-2 day stat sig mi­graine day re­duc­tion (both for quar­ter­ly and month­ly dos­es).  This may al­so help from la­bel­ing per­spec­tive.

Raf­fat de­clined to com­pare these new num­bers for episod­ic mi­graine with Am­gen or Lil­ly, not­ing the dif­fer­ence in tri­al length that makes it im­pos­si­ble to line up the stats.

The de­tails:

Fre­manezum­ab giv­en month­ly im­proved the av­er­age num­ber of mi­graine days, rel­a­tive to base­line, by 41.6% for the du­ra­tion of the tri­al (-3.7 days vs. -2.2 days for place­bo, p < 0.0001). Num­ber of days with dis­abil­i­ty were de­creased by 64.7% (p =0.0021) and med­ica­tion con­sump­tion was de­creased by 39.0%( p < 0.0001). The quar­ter­ly SC dose, which was unique­ly test­ed in this pro­gram, al­so yield­ed high­ly sig­nif­i­cant re­sults for de­crease in mi­graine days (-3.4 days or 37.0%, p < 0.0001) and for all oth­er com­par­isons. Al­so unique to this de­vel­op­ment, both dose reg­i­mens high­ly sig­nif­i­cant­ly im­proved mi­graine in sub­jects on sta­ble dos­es of oth­er pro­phy­lac­tic med­ica­tions (-4.0 days for month­ly dose vs -2.0 days for place­bo, p = 0.001; -3.7 days for quar­ter­ly dose, p = 0.006).

It all looks good enough for an ap­proval, with de­cent odds that this drug will ap­pear on the mar­ket along­side a slate of ri­vals next year. Te­va, though, is hop­ing that its month­ly and quar­ter­ly dos­ing reg­i­mens will help dif­fer­en­ti­ate it from the com­pe­ti­tion to come.

Michael Hay­den, Te­va

“Te­va’s HA­LO tri­als are the on­ly Phase III an­ti-CGRP stud­ies to demon­strate ef­fi­ca­cy with both month­ly and quar­ter­ly dos­ing for chron­ic and episod­ic pa­tients and in pa­tients al­ready re­ceiv­ing pre­ven­tion ther­a­pies. This is a ma­jor ad­vance on ex­ist­ing da­ta. The ef­fi­ca­cy and rapid on­set, as both add-on and monother­a­py, quar­ter­ly dos­ing, and ef­fect on dis­abil­i­ty and qual­i­ty of life in­di­cate that this ther­a­py has the po­ten­tial to set new and dif­fer­ent bench­marks in the re­lief of mi­graine suf­fer­ing,” said Te­va R&D chief Michael Hay­den in a state­ment. “We are im­mense­ly proud to be able to bring to the mi­graine com­mu­ni­ty the hope that they might soon have a new op­tion that could pro­vide a mean­ing­ful re­duc­tion in the mi­graine bur­den pa­tients ha­bit­u­al­ly suf­fer.”

A few weeks ago it was Eli Lil­ly’s $LLY turn to cel­e­brate its Phase III re­sults for gal­canezum­ab, with a con­sis­tent 2-day re­duc­tion in month­ly mi­graines. 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. No­var­tis $NVS and Am­gen $AMGN — 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.

Paul Hudson, Sanofi CEO (Getty Images)

Sanofi CEO Paul Hud­son has $23B burn­ing a hole in his pock­et. And here are some hints on how he plans to spend that

Sanofi has reaped $11.1 billion after selling off a big chunk of its Regeneron stock at $515 a share. And now everyone on the M&A side of the business is focused on how CEO Paul Hudson plans to spend it.

After getting stung in France for some awkward politicking — suggesting the US was in the front of the line for Sanofi’s vaccines given American financial support for their work, versus little help from European powers — Hudson now has the much more popular task of managing a major cash cache to pull off something in the order of a big bolt-on. Or two.

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The Advance Clinical leadership team: CEO Yvonne Lungershausen, Sandrien Louwaars - Director Business Development Operations, Gabriel Kremmidiotis - Chief Scientific Officer, Ben Edwards - Chief Strategy Officer

How Aus­tralia De­liv­ers Rapid Start-up and 43.5% Re­bate for Ear­ly Phase On­col­o­gy Tri­als

About Avance Clinical

Avance Clinical is an Australian owned Contract Research Organisation that has been providing high-quality clinical research services to the local and international drug development industry for 20 years. They specialise in working with biotech companies to execute Phase 1 and Phase 2 clinical trials to deliver high-quality outcomes fit for global regulatory standards.

As oncology sponsors look internationally to speed-up trials after unprecedented COVID-19 suspensions and delays, Australia, which has led the world in minimizing the pandemic’s impact, stands out as an attractive destination for early phase trials. This in combination with the streamlined regulatory system and the financial benefits including a very favourable exchange rate and the R & D cash rebate makes Australia the perfect location for accelerating biotech clinical programs.

Dan O'Day, Gilead CEO (Andrew Harnik, AP Images)

UP­DAT­ED: Gilead leas­es part­ner rights to TIG­IT, PD-1 in a $2B deal with Ar­cus. Now comes the hard part

Gilead CEO Dan O’Day has brokered his way to a PD-1 and lined up a front row seat in the TIGIT arena, inking a deal worth close to $2 billion to align the big biotech closely with Terry Rosen’s Arcus. And $375 million of that comes upfront, with cash for the buy-in plus equity, along with $400 million for R&D and $1.22 billion in reserve to cover opt-in payments and milestones..

Hotly rumored for weeks, the 2 players have formalized a 10-year alliance that starts with rights to the PD-1, zimberelimab. O’Day also has first dibs on TIGIT and 2 other leading programs, agreeing to an opt-in fee ranging from $200 million to $275 million on each. There’s $500 million in potential TIGIT milestones on US regulatory events — likely capped by an approval — if Gilead partners on it and the stars align on the data. And there’s another $150 million opt-in payments for the rest of the Arcus pipeline.

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Covid-19 roundup: Roche pairs Actem­ra with remde­sivir in new PhI­II; GSK makes its own 1B vac­cine man­u­fac­tur­ing plan

A month after a small study in France suggested that Roche’s IL-6 inhibitor Actemra helped Covid-19 patients do better — even as Sanofi and Regeneron found somewhat disappointing results with their rival drug — Roche is doubling down on the strategy.

The Swiss pharma giant is kicking off a second Phase III global placebo-controlled study involving Actemra. But rather than testing it as a monotherapy, they will add Gilead’s remdesivir to the regimen.

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Roger Perlmutter, Merck R&D chief (YouTube)

UP­DAT­ED: Backed by BAR­DA, Mer­ck jumps in­to Covid-19: buy­ing out a vac­cine, part­ner­ing on an­oth­er and adding an­tivi­ral to the mix

Merck execs are making a triple play in a sudden leap into the R&D campaign against Covid-19. And they have more BARDA cash backing them up on the move.

Tuesday morning the pharma giant simultaneously announced plans to buy an Austrian biotech that has been working on a preclinical vaccine candidate, added a collaboration on another vaccine with the nonprofit IAVI and inked a deal with Ridgeback Biotherapeutics on an early-stage antiviral.

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Bryan Roberts, Venrock

Ven­rock sur­vey shows grow­ing recog­ni­tion of coro­n­avirus toll, wan­ing con­fi­dence in ar­rival of vac­cines and treat­ments

When Venrock partner Bryan Roberts went to check the results from their annual survey of healthcare leaders, what he found was an imprint of the pandemic’s slow arrival in America.

The venture firm had sent their form out to hundreds of insurance and health tech executives, investors, officials and academics on February 24 and gave them two weeks to fill it out. No Americans had died at that point but the coronavirus had become enough of a global crisis that they included two questions about the virus, including “Total U.S. deaths in 2020 from the novel coronavirus will be:”.

Fabrice Chouraqui, Cellarity CEO-partner (LinkedIn)

Drug de­vel­op­er, Big Phar­ma com­mer­cial ex­ec, now an up­start biotech chief — Fab­rice Chouraqui is ready to try some­thing new as a ‘CEO-part­ner’ at Flag­ship

Fabrice Chouraqui’s career has taken some big twists along his life journey. He got his PharmD at Université Paris Descartes and jumped into the drug development game for a bit. Then he took a sharp turn and went back to school to get his MBA at Insead before returning to pharma on the commercial side.

Twenty years later, after steadily rising through the ranks and journeying the globe to nab a top job as president of US pharma for the Basel-based Novartis, Chouraqui exited in another career switch. And now he’s headed into a hybrid position as a CEO-partner at Flagship, where he’ll take a shot at leading Cellarity — one of the VC’s latest paradigm-changing companies of the groundbreaking model that aspires to deliver a new platform to the world of drug R&D.

Al­ny­lam nabs speedy re­view, set­ting up 3rd pos­si­ble ap­proval in 3 years

After nearly two decades in the haze of preclinical and clinical development, things seem to be coming into focus for Alnylam Pharmaceuticals.

Two years ago the company landed the first approved drug for RNA interference (RNAi), a Nobel Prize-winning technique discovered in plants and pioneered around the turn of the century. Then last year, they landed another approval. Now, fresh off a massive investment from Blackstone, they’ve received an FDA priority review designation for a third therapy, setting them up to potentially nab three different approvals in three consecutive years.

FDA ex­plains im­pact of Covid-19 on ap­pli­ca­tions, for­mal meet­ings

The FDA on Tuesday issued immediately effective guidance explaining how the coronavirus disease public health emergency is impacting the conduct of formal meetings and its review of certain user fee-funded applications.

The guidance features 11 questions and answers on how the agency intends to handle disruptions affecting meetings and goals under its user fee programs established by the Prescription Drug User Fee Act (PDUFA), Biosimilar User Fee Act (BSUFA) and the Generic Drug User Fee Amendments (GDUFA).