Eli Lil­ly touts some mixed PhI­II re­sults for clus­ter headaches as Am­gen, No­var­tis prep a mar­ket-bust­ing move in mi­graine

With Am­gen and No­var­tis ea­ger­ly await­ing their PDU­FA date for the lead­ing CGRP mi­graine drug Aimovig lat­er this week, Eli Lil­ly is step­ping up with some mixed Phase III re­sults for its own con­tender in the field.

Christi Shaw

In a hit and a miss, Lil­ly re­searchers say that gal­canezum­ab scored on the pri­ma­ry end­point in a Phase III study of pa­tients suf­fer­ing from episod­ic, week­ly clus­ter headaches. Placed up against a place­bo, their drug achieved a sta­tis­ti­cal­ly sig­nif­i­cant re­duc­tion in clus­ter at­tacks — though the p val­ue of 0.036 was a long way from a stand­out grade. 

Lil­ly al­so not­ed that an­oth­er Phase III for chron­ic clus­ter headaches failed — though you can be sure the phar­ma gi­ant was far more ea­ger to high­light the pos­i­tive re­sults in its re­lease. And now Lil­ly ex­ecs are set­ting up talks with reg­u­la­tors about the way for­ward to the mar­ket.

Lil­ly has al­ready post­ed its pos­i­tive late-stage da­ta for this drug in suc­cess­ful­ly re­duc­ing mi­graines. CGRP drugs are wide­ly viewed as the up­com­ing stan­dard of care for this cat­e­go­ry of dis­ease, and Am­gen and No­var­tis aim to push hard to cap­i­tal­ize on their fron­trun­ner sta­tus — pro­vid­ed the FDA comes through as ex­pect­ed with an ap­proval with­in a cou­ple of days.

An­a­lysts have of­fered a $1.2 bil­lion peak sales es­ti­mate for Aimovig — mak­ing it a top-12 drug for this year — which il­lus­trates just how im­por­tant a ground­break­ing po­si­tion can be in drug de­vel­op­ment.

Lil­ly is in a fa­mil­iar po­si­tion fur­ther back in the field, as it awaits an FDA de­ci­sion some­time in the third quar­ter. But they should be next in line be­hind the Am­gen/No­var­tis team. Te­va’s ri­val fre­manezum­ab had been in line for a June de­ci­sion, then ear­li­er this month con­ced­ed that man­u­fac­tur­ing prob­lems would tem­porar­i­ly de­rail its pro­gram and push any ap­proval and mar­ket­ing launch fur­ther back in the year. And in March lit­tle Alder, which al­so has a con­tender in the mix, oust­ed its CEO and be­gan to re­struc­ture af­ter falling be­hind the lead­ers.

Eli Lil­ly has been scram­bling to beef up its on­col­o­gy pipeline with bolt-on deals this year. The phar­ma gi­ant has gained a num­ber of new ap­provals in re­cent years, but was se­ri­ous­ly de­layed on baric­i­tinib last year, be­fore the FDA abrupt­ly de­cid­ed to al­low their mar­ket­ing pitch to move through a re­view with­out a re­quired safe­ty tri­al.

“Clus­ter headache can be dif­fi­cult to eval­u­ate in clin­i­cal stud­ies, which has con­tributed to few avail­able treat­ment op­tions for clus­ter headache, of­ten con­sid­ered the most se­vere pain one can ex­pe­ri­ence,” said Christi Shaw, pres­i­dent of Lil­ly Bio-Med­i­cines. “The pos­i­tive re­sults in episod­ic clus­ter headache are tru­ly a land­mark mo­ment—both for peo­ple liv­ing with clus­ter headache and for our re­searchers at Lil­ly, many of whom have spent more than two decades re­search­ing and de­vel­op­ing in­no­v­a­tive, non-opi­oid treat­ment op­tions for dis­eases like mi­graine and clus­ter headache.”

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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Michael Corbo, Pfizer CDO of inflammation & immunology

UP­DAT­ED: Plan­ning ahead for crowd­ed ul­cer­a­tive col­i­tis mar­ket, Pfiz­er spells out PhI­II da­ta on $6.7B Are­na drug

Pfizer has laid out the detailed results behind its boast that etrasimod — the S1P receptor modulator at the center of its $6.7 billion buyout of Arena Pharma — is the winner of the class, potentially leapfrogging an earlier entrant from Bristol Myers Squibb.

Pivotal data from the ELEVATE program in ulcerative colitis — which consists of two Phase III trials, one lasting 52 weeks and the other just 12 weeks — illustrate an “encouraging balance of efficacy and safety,” according to Michael Corbo, chief development officer of inflammation & immunology at Pfizer. The company is presenting the results as a late breaker at Digestive Disease Week.

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An NYU surgeon transplants an engineered pig kidney into the outside of a brain-dead patient (Joe Carrotta/NYU Langone Health)

'Xeno­trans­plan­ta­tion is com­ing': New NE­JM pa­per gives de­tailed look in­to 2 pig-to-hu­man kid­ney trans­plant cas­es

The thymokidney is a curious organ, if you could call it that. It’s a sort of Frankensteinian creation — a system of pig thymus embedded underneath the outer layer of a pig’s kidney, made for human transplantation.

In the first case of pig-to-human xenotransplantation of a kidney into a brain-dead patient, the thymokidney quietly featured front and center.

In that experiment, which took place in September of last year, NYU researchers led by Robert Montgomery sutured a pig thymokidney onto the leg of a brain-dead 66-year-old woman. That case was widely reported on by a horde of major media outlets, including the New York Times, the BBC, and an in-depth feature by USA Today.

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Vlad Coric, Biohaven CEO

UP­DAT­ED: Fresh off $11.6B sale to Pfiz­er, New Bio­haven hits Phase III set­back just weeks af­ter Vlad Coric chalked up promise

When Pfizer bought up Biohaven’s migraine portfolio in the largest M&A deal of the year earlier this month, Biohaven CEO Vlad Coric promised the rest of the pipeline, which will live on under the umbrella of New Biohaven, still has a lot to offer. But that vision took a dent Monday as the drugmaker revealed it’s once again flopped on troriluzole.

The glutamate regulator failed to meet the primary endpoint on a Phase III study in patients with spinocerebellar ataxia, an inherited disorder that impairs a person’s ability to walk, speak and swallow. SCA can also lead to premature death.

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Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Phar­ma com­pa­ny con­tin­ues its FDA law­suit spree, this time af­ter agency de­nies fast-track des­ig­na­tion

Vanda Pharmaceuticals is making a name for itself, at least in terms of suing the FDA.

The DC-headquartered firm on Monday filed its latest suit against the agency, with the company raising concerns over the FDA’s failure to grant a fast track designation for Vanda’s potential chronic digestive disorder drug tradipitant, which is a neurokinin 1 receptor antagonist.

Specifically, Vanda said FDA’s “essential point” in its one-page denial letter on the designation pointed to “the lack of necessary safety data,” which was “inconsistent with the criteria for … Fast Track designation.”

Mod­er­na seeks to dis­miss Al­ny­lam suit over Covid-19 vac­cine com­po­nent, claim­ing wrong venue

RNAi therapeutics juggernaut Alnylam Pharmaceuticals made a splash in March when it sued and sought money from both Pfizer and Moderna regarding their use of Alnylam’s biodegradable lipids, which Alnylam claims have been integral to the way both companies’ mRNA-based Covid-19 vaccines work.

But now, Moderna lawyers are firing back, telling the same Delaware district court that Alnylam’s claims can only proceed against the US government in the Court of Federal Claims because of the way the company’s contract is set up with the US government. The US has spent almost $10 billion on Moderna’s Covid-19 vaccine so far.

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Cracks in the fa­cade: Is phar­ma's pan­dem­ic ‘feel good fac­tor’ wan­ing?

The discordant effects of the Covid-19 pandemic on pharma reputation continues. While the overall industry still retains a respectable halo from its Covid-19 quick response and leadership, a new patient group study reveals a different story emerging in the details.

On one hand, US patient advocacy groups rated the industry higher-than-ever overall. More than two-thirds (67%) of groups gave the industry a thumbs up for 2021, a whopping 10 percentage point increase over the year before, according to the PatientView annual study, now in its 9th year.

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Saqib Islam, SpringWorks CEO

Pfiz­er spin­out Spring­Works will ship its first drug to the FDA be­fore year’s end with PhI­II win

SpringWorks Therapeutics thinks it has cemented the backbone for its first “pipeline-in-a-product” oncology treatment and will send it to the FDA before the clock strikes 2023 with a Phase III win on Tuesday.

The oral gamma secretase inhibitor, dubbed nirogacestat, beat placebo on the primary goal of progression-free survival in adults with progressing desmoid tumors.

The soft-tissue tumors can lead to long-lasting pain, disfigurement and amputation, and there are currently no approved meds for the rare oncology indication. The tumors typically impact patients aged 20 to 44 years old and disproportionately affect women at rates 2 to 3 times higher, with up to a total of 1,650 new cases diagnosed in the US annually, according to SpringWorks.

Robert Califf (Michael Brochstein/Sipa USA via AP Images)

House Re­pub­li­cans at­tack Chi­na-on­ly da­ta in FDA sub­mis­sions, seek new in­ves­ti­ga­tion in­to re­search in­spec­tions

Three Republican representatives are calling on the FDA to take a closer look at the applications including only clinical data from China.

The letter to FDA commissioner Rob Califf late last week comes as the agency recently rejected Eli Lilly’s anti-PD-1 antibody, which attempted to bring China-only data but ran into a bruising adcomm that may crush the hopes of any other companies looking to bring cheaper follow-ons based only on Chinese data.

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