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.

Vac­cine doc­u­ments, young lead­ers and mar­ket tur­moil: End­points' 10 biggest sto­ries of 2022

It’s been a volatile year in the world of biopharma. Market declines reset M&A valuations, and may be beginning to tempt bigger buyers back into dealmaking. Russia’s war in Ukraine disrupted drug sales and clinical trials. A new generation of young biotech leaders emerged in the Endpoints 20(+1) Under 40. And as capital runs dry in a tough environment for raising new funds, companies big and small are taking a look at their headcounts and operations for ways to make it through lean times.

Endpoints Premium

Premium subscription required

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

Tom Riga, Spectrum Pharmaceuticals CEO

Spec­trum im­plodes af­ter a harsh pub­lic slap­down and now a CRL from Richard Paz­dur

The FDA has gone out of its way several times to flatten any expectations for Spectrum’s lung cancer drug poziotinib, including slamming the regulatory door in the biotech’s face four years ago when the their executive crew came calling for a breakthrough drug designation and encouragement from the oncology wing of the FDA.

That stinging early rebuke pointed straight down the path to a corrosive in-house agency review of Spectrum’s attempt to land an accelerated approval for the oral EGFR TKI and a public whipping that included a classic takedown by none other than Richard Pazdur, who slammed the company for “poor drug development” that led to confusion over the dose needed for a slice of NSCLC patients harboring HER2 exon 20 insertion mutations.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 153,900+ biopharma pros reading Endpoints daily — and it's free.

Big Phar­ma's Twit­ter ex­o­dus; Mer­ck wa­gers $1.35B on buy­out; $3.5M gene ther­a­py; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

As you start planning for #JPM23, we hope you will consider joining Endpoints News for our live and virtual events. For those who are celebrating Thanksgiving, we hope you are enjoying the long weekend with loved ones. And if you’re not — we’ll see you next week!

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 153,900+ biopharma pros reading Endpoints daily — and it's free.

Robert Califf, FDA commissioner (Jose Luis Magana/AP Images)

Fourth ac­cel­er­at­ed ap­proval in Duchenne? Sarep­ta gets pri­or­i­ty re­view for gene ther­a­py amid FDA scruti­ny

Sarepta is once again on the accelerated approval path for a Duchenne drug, picking up a priority review Monday morning.

The FDA granted the accelerated review to SRP-9001, Sarepta announced Monday, which would become the biotech’s fourth Duchenne drug if approved. Much like SRP-9001 will do, each of the previous three therapies went through the accelerated approval pathway. But unlike the others, SRP-9001 is a gene therapy.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 153,900+ biopharma pros reading Endpoints daily — and it's free.

Sanofi's new headquarters, La Maison Sanofi, in Paris (Credit: Luc Boegly)

Sanofi wel­comes 500 staffers to new Paris HQ af­ter €30M ren­o­va­tion

When Paul Hudson took the helm at Sanofi back in 2019, he promised to reinvent the pharma giant — including its Paris headquarters. This week, the company set up shop in new “state-of-the-art” digs.

La Maison Sanofi, as the new HQ is called, is officially open for business, Hudson announced on Monday. The 9,000-square-meter (just under 97,000-square-foot) space accommodates 500 employees across the company’s government and global support functions teams, including finance, HR, legal and corporate affairs — and it was built with environmental sustainability and hybrid work in mind.

Albert Bourla, Pfizer CEO (John Thys/POOL/AFP via Getty Images)

Pfiz­er CEO un­der fire from UK watch­dog over vac­cine com­ments — re­port

Pfizer CEO Albert Bourla told the BBC last December that he had “no doubt in my mind that the benefits, completely, are in favor” of vaccinating 5- to 11-year-olds for Covid-19. Almost a year later, those comments have reportedly landed him in trouble with a UK pharma watchdog.

Children’s advocacy group UsForThem filed a complaint with the UK’s Prescription Medicines Code of Practice Authority (PMCPA) last year accusing Bourla of making “disgracefully misleading” statements during the BBC interview, including one that “Covid in schools is thriving.” At the time, UK regulators had not yet cleared the vaccine for the 5 to 11 age group, though the vaccine did have a positive opinion from the EMA’s human medicines committee.

FDA tells Catal­ent to fix is­sues at two man­u­fac­tur­ing sites on its own

The CDMO Catalent will have to fix issues at two manufacturing plants in the US and Europe that were subject to inspections by the FDA this summer, giving the company room to correct the issues without facing further regulatory action.

The FDA gave Catalent a “voluntary action indicated” response to two inspections at the contract manufacturer’s site in Bloomington, IN, and Brussels, Belgium. Fixing the issues on its own is a preferable outcome to facing an “official action indicated” response, meaning that an official warning would be sent out or a sit-down with the FDA would be required.

Endpoints Premium

Premium subscription required

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

Merck targets vaccine-hesitant parents in its latest 'Why Vaccines' campaign. (Image: Shutterstock)

Mer­ck­'s lat­est 'Why Vac­ci­nes' cam­paign seeks to bet­ter in­form vac­cine-hes­i­tant moms

From Hollywood couple endorsements to targeted equity efforts, Merck has been pushing the value of vaccinations, especially since the Covid-19 pandemic disruption. Now the pharma is turning to a new target — vaccine-hesitant parents, and moms in particular.

Merck’s “Why Vaccines” latest social media and digital campaign spotlights real-life new moms who have questions about vaccinating their children.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 153,900+ biopharma pros reading Endpoints daily — and it's free.

Sta­da to place $50M+ in­vest­ment in a new fa­cil­i­ty in Ro­ma­nia

While Romania may conjure up images of vast mountain ranges and tales of medieval kings, one generic manufacturer has broken ground on a new facility there.

German pharma company Stada said Monday that it has placed a €50 million ($51.9 million) investment into a 100,000 square-meter (1.08 million square-foot) site in Turda, Romania, a city in the Southeast of the country. According to a Stada spokesperson in an email to Endpoints News, the company has developed only 281,500 square feet of the site so far.