Where Te­va failed, Eli Lil­ly gained — mi­graine drug Em­gal­i­ty wins US ap­proval for episod­ic clus­ter headaches

It may be trail­ing be­hind its ri­vals in mi­graine sales, but Lil­ly’s Em­gal­i­ty has se­cured the FDA nod for episod­ic clus­ter headaches.

Em­gal­i­ty was the last in­jectable to win ap­proval for mi­graine pre­ven­tion last Sep­tem­ber, months af­ter Aimovig from Am­gen $AMGN  and No­var­tis $NVS, and Te­va’s {$TE­VA] Ajovy. All three form part of a fam­i­ly of drugs de­vel­oped to block cal­ci­tonin gene-re­lat­ed pep­tide (CGRP), a pro­tein as­so­ci­at­ed with the on­set of mi­graine pain. Each has demon­strat­ed a sig­nif­i­cant re­duc­tion in mi­graine fre­quen­cy in about half of pa­tients when test­ed in clin­i­cal stud­ies and is priced at $6,900 a year, or $575 per month. Tiny Alder’s $AL­DR CGRP is un­der FDA re­view.

In March, Em­gal­i­ty was grant­ed pri­or­i­ty re­view by the FDA for pre­ven­tion of episod­ic clus­ter headache in adults. The fol­low­ing month, Te­va aban­doned a late-stage tri­al test­ing Ajovy for episod­ic clus­ter headaches af­ter the drug failed to clear a fu­til­i­ty test, af­ter giv­ing up on a chron­ic clus­ter headache study last sum­mer. The Is­raeli drug­mak­er is still test­ing the drug for post-trau­mat­ic headaches.

Em­gal­i­ty was ap­proved on the ba­sis of da­ta from a 106-pa­tient place­bo-con­trolled study. In the tri­al, pa­tients on Em­gal­i­ty ex­pe­ri­enced an av­er­age of 8.7 few­er week­ly clus­ter headache at­tacks be­tween weeks 1 to 3 ver­sus 5.2 few­er week­ly at­tacks for pa­tients on place­bo (p=0.036). With Em­gal­i­ty, 71.4% of pa­tients had their week­ly clus­ter headache at­tacks cut in half or more from base­line at week 3 vs. 52.6% of pa­tients with place­bo (p=0.046).

“The op­por­tu­ni­ty in this pop­u­la­tion, which we es­ti­mate to be ~200,000 pa­tients in the US, could add to Lil­ly’s com­pet­i­tive ad­van­tage against Am­gen and Te­va,” Leerink an­a­lysts wrote in a note in April.

Af­flict­ed pa­tients ex­pe­ri­ence ex­cru­ci­at­ing headache at­tacks de­scribed some­times as “sui­cide headaches” be­tween 1-8 times per day, and these clus­ter cy­cles can last weeks or months and are usu­al­ly sep­a­rat­ed by headache-free re­mis­sion pe­ri­ods, which typ­i­cal­ly last months or years.

While the mi­graine dose is 120 mg, pa­tients pre­scribed Lil­ly’s $LLY Em­gal­i­ty for clus­ter headaches will be ad­min­is­tered a 300 mg dose at the on­set of a clus­ter pe­ri­od, fol­lowed by sub­cu­ta­neous in­jec­tions each month un­til the end of the pe­ri­od. The price per mg for Em­gal­i­ty re­mains the same, Lil­ly said.

In the first quar­ter of 2019, Aimovig gen­er­at­ed sales of $59 mil­lion, Ajovy brought in $20 mil­lion, while Em­gal­i­ty made $14 mil­lion.

The ap­proval comes as a wel­come re­lief for Lil­ly, which has suf­fered a string of set­backs in re­cent months — a late-stage fail­ure trig­gered the with­draw­al of its can­cer drug Lartru­vo, the US drug­mak­er rel­e­gat­ed two mid-stage drugs to the scrap heap, and Japan flagged safe­ty con­cerns as­so­ci­at­ed with its breast can­cer treat­ment, Verzenio.


Im­age: Kristof­fer Trip­plaar for SIPA AP

Regeneron CEO Leonard Schleifer speaks at a meeting with President Donald Trump, members of the Coronavirus Task Force, and pharmaceutical executives in the Cabinet Room of the White House (AP Photo/Andrew Harnik)

OWS shifts spot­light to drugs to fight Covid-19, hand­ing Re­gen­eron $450M to be­gin large scale man­u­fac­tur­ing in the US

The US government is on a spending spree. And after committing billions to vaccines defense operations are now doling out more of the big bucks through Operation Warp Speed to back a rapid flip of a drug into the market to stop Covid-19 from ravaging patients — possibly inside of 2 months.

The beneficiary this morning is Regeneron, the big biotech engaged in a frenzied race to develop an antibody cocktail called REGN-COV2 that just started a late-stage program to prove its worth in fighting the virus. BARDA and the Department of Defense are awarding Regeneron a $450 million contract to cover bulk delivery of the cocktail starting as early as late summer, with money added for fill/finish and storage activities.

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Donald and Melania Trump watch the smoke of fireworks from the South Lawn of the White House on July 4, 2020 (via Getty)

Which drug de­vel­op­ers of­fer Trump a quick, game-chang­ing ‘so­lu­tion’ as the pan­dem­ic roars back? Eli Lil­ly and Ab­Cellera look to break out of the pack

We are unleashing our nation’s scientific brilliance and will likely have a therapeutic and/or vaccine solution long before the end of the year.

— Donald Trump, July 4

Next week administration officials plan to promote a new study they say shows promising results on therapeutics, the officials said. They wouldn’t describe the study in any further detail because, they said, its disclosure would be “market-moving.”

— NBC News, July 3

Something’s cooking. And it’s not just July 4 leftovers involving stale buns and uneaten hot dogs.

Over the long weekend observers picked up signs that the focus in the Trump administration may swiftly shift from the bright spotlight on vaccines being promised this fall, around the time of the election, to include drugs that could possibly keep patients out of the hospital and take the political sting out of the soaring Covid-19 numbers causing embarrassment in states that swiftly reopened — as Trump cheered along.

So far, Gilead has been the chief beneficiary of the drive on drugs, swiftly offering enough early data to get remdesivir an emergency authorization and into the hands of the US government. But their drug, while helpful in cutting stays, is known for a limited, modest effect. And that won’t tamp down on the hurricane of criticism that’s been tearing at the White House, and buffeting the president’s most stalwart core defenders as the economy suffers.

We’ve had positive early-stage vaccine data, most recently from Pfizer and BioNTech, playing catchup on an mRNA race led by Moderna — where every little sign of potential trouble is magnified into a lethal threat, just as every advance excites a frenzy of support. But that race still has months to play out, with more Phase I data due ahead of the mid-stage numbers looming ahead. A vaccine may not be available in large enough quantities until well into 2021, which is still wildly ambitious.

So what about a drug solution?

Trump’s initial support for a panacea focused on hydroxychloroquine. But that fizzled in the face of data underscoring its ineffectiveness — killing trials that aren’t likely to be restarted because of a recent population-based study offering some support. And there are a number of existing drugs being repurposed to see how they help hospitalized patients.

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David Hallal

AlloVir tests how much an an­tivi­ral biotech can reap in a pan­dem­ic stock mar­ket

The pandemic stock market has proven fruitful for virtually any type of biotech. Now a 7-year-old cell therapy startup will see how much it can yield for a company that specializes in fighting viruses.

AlloVir, a company that until 2019 largely lived off grant money, has filed for a $100 million IPO to back its line of off-the-shelf, virus-fighting T cells. Although in normal circumstances, $100 million could be a solid return for a biotech that got its first major round of funding only last year, we’ll have to wait to see how much the company ultimately earns. As Covid-19 has sent investor money scurrying to almost anyone in drug development, every single biotech to go public this year has prized above their midpoint or upsized their offering, according to Renaissance Capital, sometimes dramatically so.

Noubar Afeyan, Flagship CEO and Tessera chairman (Victor Boyko/Getty Images)

Flag­ship ex­ecs take a les­son from na­ture to mas­ter ‘gene writ­ing,’ launch­ing a star-stud­ded biotech with big am­bi­tions to cure dis­ease

Flagship Pioneering has opened up its deep pockets to fund a biotech upstart out to revolutionize the whole gene therapy/gene editing field — before gene editing has even made it to the market. And they’ve surrounded themselves with some marquee scientists and execs who have crowded around to help shepherd the technology ahead.

The lead player here is Flagship general partner Geoff von Maltzahn, an MIT-trained synthetic biologist who set out in 2018 to do CRISPR — a widely used gene editing tool — and other rival technologies one or two better. Von Maltzahn has been working with Sana co-founder Jake Rubens, another synthetic biology player out of MIT who he describes as his “superstar,” who’s taken the CSO role.

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Covid-19 roundup: Squab­bles with gov­ern­ment de­lay Mod­er­na’s PhI­II — re­ports; No­vavax se­cures largest Warp Speed deal yet: $1.6B

A much-anticipated Phase III trial for Moderna’s Covid-19 vaccine is being held up as the company delayed submitting trial protocols and sparred with government scientists on how to run the study and even what the benchmark for success should be, Reuters reported.

Moderna, the first US company to put their vaccine into human testing, was supposed to enter a 30,000-person study this month in partnership with the NIH to determine whether it can prevent infection. STAT reported last week that the trial was facing delays over the protocol, but that a July start was still possible. Neither the NIH nor Moderna ever disclosed a specific date the trial should start, but Reuters reported that the agency had hoped to begin on July 10.

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Boehringer In­gel­heim ties the knot with Num­ab on new an­ti­bod­ies; Ca­balet­ta inks pact with Ar­ti­san

→ Switzerland’s Numab Therapeutics has added Boehringer Ingelheim to its roster of collaborators. And they will start with two projects aiming at developing new drugs for difficult-to-treat lung and gastrointestinal cancers and patients with geographic atrophy. “Numab’s technology platform fits well with our internal antibody discovery and engineering capabilities and will enhance our efforts to deliver transformative antibody-based therapeutics to patients,” said Paige Mahaney, an SVP at Boehringer Ingelheim.

Take­da’s post-merg­er deals con­tin­ue as OTC sub­sidiary is pre­pared for sale

Takeda has been burdened under mountains of debt since acquiring Shire for $62 billion 18 months ago, but one of the company’s biggest moves yet to relieve the stress could be on the horizon.

The Japanese pharma is preparing a bidding war for its $3.7 billion over-the-counter subsidiary, a sale that would dwarf previous spinoffs. Any transaction would be the latest in what’s been a long string of sell-offs, as Takeda marches unflinchingly toward its ultimate goal of shedding $10 billion in assets.

Cel­lec­tis slammed af­ter pa­tient dies and FDA slaps a hold on their tri­al for an off-the-shelf CAR-T for mul­ti­ple myelo­ma

Cellectis was slammed after the market close on Monday as the biotech reported that the FDA demanded it hit the brakes on their MELANI-01 trial for their off-the-shelf cell therapy UCARTCS1A after one of the patients in the study died of treatment-related cardiac arrest.

The multiple myeloma patient had previously been treated unsuccessfully with various therapies, noted the biotech, and had been given dose level two (DL2) of their allogeneic CAR-T.

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Jean-Paul Clozel, Idorsia CEO (Patrick Straub/Keystone via AP Images)

Sec­ond PhI­II study for Idor­si­a's sleep drug re­turns pos­i­tive re­sults, but al­so rais­es new ques­tions

Following a successful Phase III study in April showcasing the safety and potential of its new sleep drug, Idorsia posted some mixed news in the second Phase III study, but that won’t stop a planned filing aimed at regulatory approval.

The drug, a dual orexin receptor antagonist (DORA) called daridorexant, was found to significantly improve sleep maintenance and subjective total sleep time in 25 mg doses, replicating results from the first Phase III study. However, improvements in sleep onset and daytime functioning narrowly missed statistical significance, despite numerical consistency with the April study.