Vlad Coric, Biohaven CEO (Jordan Sirek/Bloomberg via Getty Images)

Bio­haven earns pre­ven­ta­tive nod for mi­graine med Nurtec, snar­ing a much-need­ed leg up over Ab­b­Vie

Bio­haven had a rough start to the year with fail­ing da­ta in Alzheimer’s that sent in­vestor in­ter­est spin­ning out. But the drug­mak­er still had a lot of rea­son to be­lieve in CGRP mi­graine med Nurtec de­spite a big chal­lenge from Ab­b­Vie — and now that be­lief is con­tin­u­ing to pay off.

The FDA on Thurs­day ap­proved Bio­haven’s CGRP drug Nurtec ODT as a pre­ven­ta­tive treat­ment for mi­graine, mak­ing the drug the first and on­ly op­tion for both acute mi­graine care and pre­ven­tion, the drug­mak­er said in a re­lease.

With the ap­proval in hand, Bio­haven says its oral drug cov­ers about 95% of avail­able mi­graine pa­tients, and it’s a need­ed boost, too: The CGRP mar­ket is grow­ing fast and in­cludes se­ri­ous chal­lengers like Ab­b­Vie’s Ubrelvy, which launched just a cou­ple months be­fore Nurtec’s cur­tain draw in ear­ly 2020.

The agency based its re­view on Phase III da­ta show­ing Nurtec cut pa­tients’ av­er­age mi­graine days by 4.3 per month com­pared with place­bo and sliced the num­ber of mod­er­ate-to-se­vere mi­graines per month by more than 50%.

De­spite be­ing the sec­ond-to-mar­ket oral CGRP and one of a group of drugs that have launched in the field on the whole in the last two years, Bio­haven has dif­fer­en­ti­at­ed Nurtec through its fast-act­ing for­mu­la­tion and durable ef­fi­ca­cy over 48 hours, CEO Vlad Coric told End­points News in De­cem­ber.

“Tim­ing in the mar­ket is very im­por­tant, (but) a cou­ple months is some­thing you can han­dle if you have a bet­ter prod­uct,” Coric said at the time. “We have a best-in-class pro­file prod­uct.”

The pre­ven­tion ap­proval is just the first step in Bio­haven’s plan for Nurtec, which will in­clude a po­ten­tial first-in-class nasal de­liv­ery ap­proval, but al­so added in­di­ca­tions out­side of mi­graine where CGRP drugs have shown some ear­ly promise.

An­oth­er win for Nurtec is good news for Bio­haven, which has seen at least one big set­back in the rest of its pipeline. In Jan­u­ary, the drug­mak­er rolled out da­ta for its Phase II/III Alzheimer’s study for tro­r­ilu­zole, which flopped 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.

That news sent shares plum­met­ing, but $BHVN has since most­ly re­cov­ered. Since a re­cent low of $66.05 ear­li­er this month, the drug­mak­er’s shares opened at $84.73 on Fri­day.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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When ef­fi­ca­cy is bor­der­line: FDA needs to get more con­sis­tent on close-call drug ap­provals, agency-fund­ed re­search finds

In the exceedingly rare instances in which clinical efficacy is the only barrier to a new drug’s approval, new FDA-funded research from FDA and Stanford found that the agency does not have a consistent standard for defining “substantial evidence” when flexible criteria are used for an approval.

The research comes as the FDA is at a crossroads with its expedited-review pathways. The accelerated approval pathway is under fire as the agency recently signed off on a controversial new Alzheimer’s drug, with little precedent to explain its decision. Meanwhile, top officials like Rick Pazdur have called for a major push to simplify and clarify all of the various expedited pathways, which have grown to be must-haves for sponsors of nearly every newly approved drug.

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Vicente Anido (University of West Virginia via YouTube)

Aerie fires CEO af­ter lead pro­gram flop, com­ments about pri­ma­ry end­points be­ing 'not re­quired'

Aerie Pharmaceuticals CEO Vicente Anido has left the company less than a week after trying to chart a Phase III study in the wake of a serious Phase IIb flop.

Anido’s last day at Aerie was Friday, the biotech announced in a news release Tuesday morning, and Benjamin McGraw is taking his place in an interim role. The now former CEO was terminated without cause, according to an SEC filing.

The board has started looking for a full-time chief to take his place.

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FDA hands ac­cel­er­at­ed nod to Seagen, Gen­mab's so­lo ADC in cer­vi­cal can­cer, but com­bo stud­ies look even more promis­ing

Biopharma’s resident antibody-drug conjugate expert Seagen has scored a clutch of oncology approvals in recent years, finding gold in what are known as “third-gen” ADCs. Now, another of their partnered conjugates is ready for prime time.

The FDA on Monday handed an accelerated approval to Seagen and Genmab’s Tivdak (tisotumab vedotin-tftv, or “TV”) in second-line patients with recurrent or metastatic cervical cancer who previously progressed after chemotherapy rather than PD-(L)1 systemic therapy, the companies said in a release.

Take­da snaps up the Japan­ese rights to an old Shire cast-off; Boehringer In­gel­heim ac­quires Abexxa Bi­o­log­ics

A week before the FDA is set to decide on Mirum Pharmaceuticals’ lead liver disease drug — an old Shire cast-off called maralixibat — Takeda is swooping in to secure the rights in Japan.

Maralixibat’s roots trace back to Lumena, which was snapped up by Shire for $260 million-plus back in 2014. While the candidate had failed mid-stage studies at Shire, Mirum believes better trial design and patient selection will deliver the wins it needs. The drug is currently in development for Alagille syndrome (a condition called ALGS in which bile builds up in the liver), progressive familial intrahepatic cholestasis (PFIC, which causes progressive liver disease) and biliary atresia (a blockage in the ducts that carry bile from the liver to the gallbladder).

Jay Bradner (Jeff Rumans for Endpoints News)

Div­ing deep­er in­to in­her­it­ed reti­nal dis­or­ders, No­var­tis gob­bles up an­oth­er bite-sized op­to­ge­net­ics biotech

Right about a year ago, a Novartis team led by Jay Bradner and Cynthia Grosskreutz at NIBR swooped in to scoop up a Cambridge, MA-based opthalmology gene therapy company called Vedere. Their focus was on a specific market niche: inherited retinal dystrophies that include a wide range of genetic retinal disorders marked by the loss of photoreceptor cells and progressive vision loss.

But that was just the first deal that whet their appetite.

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