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. 

Image courtesy of The Janssen Pharmaceutical Companies of Johnson & Johnson.

Pro­tect­ing the glob­al phar­ma­ceu­ti­cal in­no­va­tion ecosys­tem – what’s at stake?

We are living in a new era of healthcare that is rapidly advancing progress impacting patient outcomes and experiences. We’ve seen a remarkable pace of transformational innovation, applied research, and advanced clinical development over the last decade.

Despite this tremendous progress, there is much more work to be done, and patients are counting on us – now more than ever – to continue that momentum. At the heart of our industry is a focus on developing and delivering medicines for some of the world’s most challenging diseases, including those that have few or no effective treatments today.

FDA lifts hold on Mol­e­c­u­lar Tem­plates’ mul­ti­ple myelo­ma tri­al af­ter less than two months

The FDA has lifted a partial clinical hold on Molecular Templates’ early-stage trial for a multiple myeloma drug, the biotech company announced Thursday morning.

Regulators had put the trial on partial hold in early April, pausing patient enrollment, following two adverse heart-related events in patients who received the highest dose of Molecular Templates’ treatment MT-0169 last year. One patient had asymptomatic grade 2 myocarditis, or heart muscle inflammation, while the other had a grade 3 cardiomyopathy. Both recovered within two months.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 170,400+ biopharma pros reading Endpoints daily — and it's free.

Albert Bourla, Pfizer CEO (Michel Euler/AP Images, Pool)

FDA ap­proves Pfiz­er’s RSV shot for old­er adults, tee­ing up a com­pet­i­tive $17B vac­cine mar­ket

The FDA approved Pfizer’s RSV vaccine called Abrysvo for older adults on Wednesday, placing another Big Pharma onto the commercial stage ahead of the next RSV season.

Pfizer’s approval comes weeks after GSK won approval for its rival shot, Arexvy. Those two vaccines are both approved for use in adults 60 years and older and will be reviewed by a CDC panel in June before they’re expected to commercially launch this fall. Wall Street analysts see RSV as the next multibillion-dollar vaccine market, with Jefferies analysts recently forecasting the RSV market will grow to $17 billion over the next decade.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 170,400+ biopharma pros reading Endpoints daily — and it's free.

Richard Pazdur, FDA's OCE director (Flatiron Health via YouTube)

FDA's can­cer chief weighs in on com­mon chemo short­ages — re­port

Richard Pazdur, director of the FDA’s Oncology Center of Excellence, attributes the current shortage of two cancer drugs to drug companies that haven’t invested in building out their production capacity.

In an interview with The Cancer Letter, a weekly cancer publication, Pazdur said that the current shortages of cisplatin and carboplatin, a pair of drugs used to treat a wide range of cancer patients, are the result of two problems: manufacturers not investing in enhancing production capacity, and drug companies being dependent on one supplier of raw ingredients. The cisplatin shortage followed an inspection that revealed quality issues at a manufacturing facility, which then led to the shutdown of production. This led to a surge in carboplatin demand, creating a secondary shortage.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 170,400+ biopharma pros reading Endpoints daily — and it's free.

Photo: Ida Marie Odgaard/Ritzau Scanpix/Sipa USA/Sipa via AP Images

FDA warns about com­pound­ed semaglu­tide-based drugs

The FDA has warned the public that compounded versions of popular GLP-1 drugs Ozempic and Wegovy may not include the same ingredients as the prescription medications, and that has raised questions about their safety and effectiveness.

The regulator said Tuesday it has received reports of adverse events related to compounded versions of semaglutide, the active ingredient in Ozempic and Wegovy. Some products being marketed as semaglutide contain the salt formation of semaglutide, which is not considered safe or effective.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 170,400+ biopharma pros reading Endpoints daily — and it's free.

Denny Lanfear, Coherus BioSciences CEO

FDA in­spec­tion of Chi­na-based site mak­ing Co­herus' po­ten­tial new can­cer drug ends with three ob­ser­va­tions

After Covid-related delays that forced the FDA to delay its China-based inspections, Coherus BioSciences said today that its China-based partner Junshi Biosciences has now successfully completed the required pre-approval inspection for its PD-1 toripalimab, which is being made at a site in China, with three observations.

“The Company believes that the three observations received at the close of the FDA inspection are readily addressable and, together with Junshi Biosciences, plans to submit the response to the FDA in early June,” Coherus said in an SEC filing. The company did not disclose the observations, but Coherus’ stock price $CHRS fell by almost 8% on Wednesday.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 170,400+ biopharma pros reading Endpoints daily — and it's free.

Eu­ro­pean Par­lia­ment calls mem­ber states to ac­tion on an­timi­cro­bial re­sis­tance

Members of the European Parliament have called on EU countries to develop national action plans against antimicrobial resistance (AMR), calling it a top-three priority health threat.

Parliament on Thursday announced recommendations for the fight against AMR, including national action plans that must be updated at least every two years, an EU-level database tracking AMR and antimicrobial use and increased partnership between the pharma industry, patient groups and academia.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 170,400+ biopharma pros reading Endpoints daily — and it's free.

Andrey Zarur, GreenLight Biosciences CEO

Green­Light Bio­sciences se­cures merg­er as it looks to go pri­vate

GreenLight Bioscience, the developer and manufacturer of RNA vaccines and therapeutics, is set to be acquired.

The company announced earlier this week that it would be acquired by a group of buyers led by Fall Line Capital in a cash deal valuing GreenLight at around $45.5 million. According to a release, Fall Line and the group agreed to acquire all of the shares of the company for $0.30 per share. The deal is expected to close sometime in the third quarter of this year.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 170,400+ biopharma pros reading Endpoints daily — and it's free.

Roche plans to di­vest from lega­cy Genen­tech man­u­fac­tur­ing fa­cil­i­ty in Cal­i­for­nia

Roche is planning to make some changes to its subsidiary’s manufacturing network in California.

The Swiss pharma announced Wednesday that it plans to divest from Genentech’s manufacturing facility in Vacaville, CA, around 58 miles northeast of San Francisco. According to a statement from Roche, the move is part of a “broader strategy” to bring its manufacturing capabilities in line with its future pipeline. Roche is starting the process of finding a buyer for the site but has not named any candidates yet.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 170,400+ biopharma pros reading Endpoints daily — and it's free.