Up­dat­ed: Eli Lil­ly blames Biden's IRA for can­cer drug dis­con­tin­u­a­tion as the new phar­ma play­book takes shape

Eli Lil­ly laid blame Tues­day af­ter­noon on Pres­i­dent Joe Biden’s In­fla­tion Re­duc­tion Act as the rea­son it scrapped a $40 mil­lion can­cer drug.

As part of its third quar­ter up­date ear­li­er Tues­day morn­ing, the Big Phar­ma re­vealed it had re­moved a Phase I drug li­censed from Fo­s­un Phar­ma, a BCL2 in­hibitor that had been un­der­go­ing stud­ies for a va­ri­ety of blood can­cers. Though the rea­son­ing had been ini­tial­ly un­clear, an Eli Lil­ly spokesper­son told End­points News in an email that “in light of the In­fla­tion Re­duc­tion Act, this pro­gram no longer met our thresh­old for con­tin­ued in­vest­ment.”

Asked to ex­plain how the IRA im­pact­ed this spe­cif­ic drug, the spokesper­son high­light­ed the law’s im­pact on small mol­e­cule R&D.

“The IRA changes many dy­nam­ics for small mol­e­cules in on­col­o­gy and when we in­te­grat­ed those changes with this pro­gram and its com­pet­i­tive land­scape, the pro­gram’s fu­ture in­vest­ment no longer met our thresh­old,” the spokesper­son told End­points in a fol­low-up email.

The In­fla­tion Re­duc­tion Act, which Biden signed in­to law over the sum­mer, con­tains pro­vi­sions al­low­ing Medicare to ne­go­ti­ate prices for cer­tain high-cost drugs. Start­ing in 2026, the HHS sec­re­tary will se­lect drugs from a list of the high­est-sell­ing Medicare Part D and, lat­er on, Part B med­i­cines for which the agency will be al­lowed to set a “max­i­mum fair price.”

For small mol­e­cules, the gov­ern­ment can be­gin ne­go­ti­at­ing prices af­ter the drugs have been on the mar­ket for at least nine years. The drugs would al­so have to be among the top ther­a­pies Medicare pays for. Crit­ics of the law have said be­gin­ning ne­go­ti­a­tions at the nine-year mark will ham­per in­no­va­tion, be­cause phar­ma com­pa­nies ob­tain 13 years of mar­ket ex­clu­siv­i­ty — a thresh­old which re­mains in place with the IRA.

Lil­ly’s de­ci­sion comes a few days af­ter Al­ny­lam not­ed the IRA in a press re­lease, ty­ing it to the leg­is­la­tion to a de­ci­sion end­ing Phase III plans for vutrisir­an in the rare Star­gardt dis­ease. In this in­stance, Al­ny­lam em­pha­sized the or­phan drug ex­emp­tion for the IRA’s drug price caps, in which ther­a­pies are ex­empt from Medicare ne­go­ti­a­tions if ap­proved for on­ly one des­ig­na­tion.

Ear­li­er this year, the FDA ap­proved vutrisir­an, brand­ed as Amvut­tra, to treat hered­i­tary transthyretin-me­di­at­ed (hAT­TR) amy­loi­do­sis. Al­ny­lam lists the price at $463,500 per pa­tient per year, and the drug pulled in about $25 mil­lion in its first quar­ter on the mar­ket.

The Lil­ly drug, dubbed LOXO-338, was far from any reg­u­la­to­ry de­ci­sion. Re­searchers were test­ing it as a monother­a­py in Phase I stud­ies and it would have pro­gressed to a com­bi­na­tion co­hort had safe­ty and ef­fi­ca­cy been con­firmed, ac­cord­ing to the fed­er­al gov­ern­ment’s clin­i­cal tri­als data­base.

Lil­ly ex­pect­ed to en­roll more than 300 pa­tients, as of the tri­al’s most re­cent up­date on Oct. 12. Start­ed in Au­gust 2021, the study was sup­posed to ob­serve pa­tients’ re­sponse rates over the course of two years and re­port da­ta in 2024. But with Lil­ly drop­ping the pro­gram, it’s not clear what will hap­pen to pa­tients who have al­ready tak­en the ex­per­i­men­tal drug.

Lil­ly li­censed LOXO-338 from Fo­s­un Phar­ma in Oc­to­ber 2020, nab­bing the rights to the drug every­where but Chi­na for $40 mil­lion. On top of that, Fo­s­un had been el­i­gi­ble for up to $400 mil­lion in mile­stones and mid-to-high sin­gle-dig­it roy­al­ty pay­ments on any ap­provals.

Ad­di­tion­al­ly, Lil­ly aban­doned an­oth­er pipeline pro­gram Tues­day, a PACAP38-tar­get­ing an­ti­body known as LY3451838. Ac­cord­ing to pre­vi­ous SEC fil­ings, re­searchers had been test­ing the drug in a Phase II study for chron­ic pain since No­vem­ber 2020. But in Au­gust, Lil­ly up­dat­ed the in­di­ca­tion to mi­graines.

Per the tri­al data­base, the Phase II tri­al was com­plet­ed this past Sep­tem­ber. A press re­lease from Lil­ly Neu­ro­science said the study “did not meet pre-spec­i­fied crit­i­cal suc­cess fac­tors.”

With earn­ings sea­son in full swing, Lil­ly isn’t the on­ly Big Phar­ma com­pa­ny to cull pro­grams from its pipeline. Last month, Roche chopped a Phase II eye dis­ease can­di­date af­ter a biotech tossed a sim­i­lar drug the day be­fore, and No­var­tis in­def­i­nite­ly post­poned plans to sub­mit an FDA pitch for its PD-1 drug. GSK made a broad re­treat from NY-ESO as a can­cer tar­get when it pulled out of two cell ther­a­py 2.0 al­liances, while Ab­b­Vie dis­card­ed an au­toim­mune drug, the prod­uct of a 10-year dis­cov­ery part­ner­ship.

Lei Lei Wu con­tributed re­port­ing. 

Ed­i­tor’s note: This ar­ti­cle and head­line have been up­dat­ed to re­flect com­ments from an Eli Lil­ly spokesper­son. 

Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; 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.

I hope your weekend is off to a nice start, wherever you are reading this email. As for me, I’m trying to catch the tail of the Lunar New Year festivities.

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Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

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Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

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CBER Director Peter Marks (Susan Walsh/AP Images)

FDA ad­vi­so­ry com­mit­tee votes unan­i­mous­ly in fa­vor of bi­va­lent Covid shots re­plac­ing pri­ma­ry se­ries

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

FDA ap­proves an­oth­er in­di­ca­tion for Keytru­da, this time in the ad­ju­vant NSCLC set­ting

Merck’s blockbuster cancer treatment Keytruda has been handed another indication by the FDA.

The US regulator announced on Thursday that it has approved Keytruda to serve as an adjuvant treatment for non-small cell lung cancer (NSCLC), which is its fifth indication in NSCLC and 34th indication overall.

According to a Merck release, the approval is based on data from a Phase III trial, dubbed Keynote-091, which measured disease-free survival in patients who received chemotherapy following surgery. The data from Merck displayed that Keytruda cut down on the risk of disease recurrence or death by 27% versus placebo.

No­var­tis' ap­proved sick­le cell dis­ease drug fails to beat place­bo in PhI­II

Novartis’ sickle cell drug, approved in 2019 and branded as Adakveo, has failed an ongoing Phase III, according to preliminary results.

The Swiss pharma giant unveiled early data from the ongoing STAND Phase III study on Friday, saying that crizanlizumab showed no statistically significant difference between the drug at two different dose levels compared to placebo in annualized rates of vaso-occlusive crises that lead to a healthcare visit over the first year since being randomized into the trial.

Post-hoc analy­sis: EMA's CHMP re­jects Ipsen's po­ten­tial drug for rare ge­net­ic dis­ease

The European Medicines Agency’s Committee for Medicinal Products for Human Use on Friday rejected Ipsen Pharma’s potential treatment for a rare genetic disease known as fibrodysplasia ossificans progressiva (FOP), which causes extra bone to form outside the skeleton.

The EMA said on its website that it could not draw any firm conclusions on the benefits of the French biopharma’s Sohonos (palovarotene), which selectively targets the retinoic-acid receptor gamma (RARγ), “as the applicant’s conclusion was based on a post-hoc analysis which was neither scientifically nor clinically justified and pre-specified study objectives were not met.”

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Steve Harr, Sana Biotechnology CEO

Four years in, Sana gets first FDA go-ahead to bring can­cer treat­ment in­to the clin­ic

Sana Biotechnology is finally headed to the clinic.

Thursday afternoon, the biotech announced the FDA had cleared its application to start a clinical trial for its allogeneic, or “off-the-shelf,” CAR-T cell therapy targeting the antigen CD19 for patients with B-cell lymphomas and leukemias. Sana said its therapy, dubbed SC291, was designed to evade the immune system, which could help cell therapy produce a more durable response in patients, a concern that has followed such off-the-shelf therapies that use donor cells as opposed to a patient’s own cells.

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