Vlad Coric, Biohaven CEO

Vlad Coric charts course for new Bio­haven with neu­ro­science push and Big Phar­ma vets on board

What’s Bio­haven with­out its CGRP port­fo­lio? That’s what CEO Vlad Coric is tasked with de­cid­ing as he maps out the new Bio­haven post-Pfiz­er takeover.

Pfiz­er of­fi­cial­ly scooped up Bio­haven’s CGRP as­sets on Mon­day, in­clud­ing block­buster mi­graine drug Nurtec and the in­ves­ti­ga­tion­al za­veg­epant, for $11.6 bil­lion. As a re­sult, Coric spun the broad­er pipeline in­to an in­de­pen­dent com­pa­ny on Tues­day — with the same R&D team be­hind Nurtec but about 1,000 few­er staffers and a re­newed fo­cus on neu­ro­science and rare dis­ease.

Shares $BHVN were up 13% on Tues­day af­ter­noon, pric­ing in around $7.91 apiece.

“A lot of large phar­ma left that area and it’s cre­at­ed sig­nif­i­cant op­por­tu­ni­ty,” Coric said of the neu­ro space. “A sea­soned R&D team like ours, we’ve proven you can be suc­cess­ful in neu­ro­science.”

Bruce Car

He’s al­so bring­ing in a cou­ple more ex­perts, in­clud­ing Bris­tol My­ers Squibb and Agios vet Bruce Car as CSO and Al­ny­lam, Sanofi and Bris­tol My­ers alum Tanya Fis­ch­er as chief de­vel­op­ment of­fi­cer and head of trans­la­tion­al med­i­cine.

Right now it’s full steam ahead on a Kv7 ion chan­nel mod­u­la­tor in adult fo­cal epilep­sy, as the com­pa­ny de­pri­or­i­tizes two sep­a­rate ALS and Alzheimer’s pro­grams in the wake of re­cent fail­ures. Verdiper­stat flunked an arm of an ALS plat­form tri­al led by Mass­a­chu­setts Gen­er­al Hos­pi­tal, Bio­haven re­vealed last week. And its ver­sion of rilu­zole — one of the two drugs ap­proved for ALS — failed an Alzheimer’s tri­al sev­er­al months ear­li­er.

Tanya Fis­ch­er

“We’ll meet with the ex­perts and de­cide on whether it makes sense to look at oth­er neu­rode­gen­er­a­tive dis­or­ders,” Coric said. “Haven’t ruled those out yet, but they cer­tain­ly will be de­pri­or­i­tized be­hind Kv7 and tro­r­ilu­zole.”

Deficits in Kv7, a potas­si­um-gat­ed ion chan­nel, re­sult in hy­per­ex­citable neu­rons, which can then lead to seizure in those with epilep­sy, Coric ex­plained. Bio­haven is look­ing to nor­mal­ize those hy­per­ac­tive neu­rons, thus re­duc­ing seizures with min­i­mal side ef­fects.

Xenon Phar­ma­ceu­ti­cals re­leased topline da­ta on its own Kv7 can­di­date in adult fo­cal epilep­sy last year, demon­strat­ing that treat­ment with XEN1101 led to a sig­nif­i­cant re­duc­tion from base­line in month­ly seizure fre­quen­cy com­pared to place­bo (p<0.001).

“There was da­ta out last year from Xenon demon­strat­ing in­creased ef­fi­ca­cy com­pared to the old­er an­ti­con­vul­sants and a bet­ter safe­ty pro­file, and so we be­lieve the Kv7 mech­a­nism has been de-risked,” he said.

Coric isn’t wor­ried about the com­pe­ti­tion, though. He’s plan­ning on launch­ing two par­al­lel Phase II/III tri­als next year, com­par­ing the sit­u­a­tion to Ubrelvy, which beat Nurtec to mar­ket as an acute mi­graine treat­ment.

“It’s kind of like when you look back to what we did with Nurtec,” he said. “We know Ubrelvy was a lit­tle bit ahead of us at Al­ler­gan/Ab­b­Vie. We ran three par­al­lel tri­als so if they were pos­i­tive we could file, and then we end­ed up launch­ing around the same time.”

There’s al­so talde­f­grobep al­fa, Bio­haven’s Phase III SMA com­pound from Bris­tol My­ers. The com­pa­ny’s hop­ing to fin­ish en­roll­ment by next year and read out da­ta by the fol­low­ing year.

“I think af­ter Kv7, the next fo­cus will be our glu­ta­mate mod­u­la­tors. And then we have a whole host of oth­er as­sets. We have myo­statin as­sets for spinal mus­cu­lar at­ro­phy and then a de­grad­er pro­gram,” Coric said. “So quite a broad ar­ray of as­sets, and start­ing off with a good amount of mon­ey from the Pfiz­er trans­ac­tion, $258 (mil­lion) cash and no debt and re­al­ly ex­cit­ed about next year.”

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.

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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.

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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!

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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.

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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.

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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.

Rachael Rollins (Charles Krupa/AP Images)

US seeks jail time for co-CEO of New Eng­land com­pound­ing cen­ter af­ter dead­ly 2012 fun­gal out­break

The US attorney for the district of Massachusetts late last week called on the state’s district court to sentence the former co-owner of the now-defunct New England Compounding Center to 18 months of jail time for his role in the center’s quality deviations that led to more than 100 people dead from a fungal meningitis outbreak.

Gregory Conigliaro was convicted of conspiring with more than a dozen others at NECC to deceive the FDA and misrepresent the fact that the center was only dispensing drugs pursuant to patient-specific prescriptions.