J&J, GSK stum­ble com­ing out of the gate with mixed PhI­II rheuma­toid arthri­tis da­ta for sirukum­ab

This is a big week­end for the wave of late-stage drugs lin­ing up for a slice of the multi­bil­lion-dol­lar rheuma­toid arthri­tis mar­ket. And J&J and Glax­o­SmithK­line got things start­ed by spelling out the da­ta in a less-than-stel­lar matchup against Ab­b­Vie’s Hu­mi­ra.

In­ves­ti­ga­tors turned up at the an­nu­al Amer­i­can Col­lege of Rheuma­tol­ogy meet­ing in Wash­ing­ton DC to re­port a hit and a miss in a Phase III head-to-head be­tween sirukum­ab — a top rheuma­toid arthri­tis drug in both J&J’s as well as GSK’s late-stage pipeline — and Hu­mi­ra.

Pa­tients tak­ing 50 mg of sirukum­ab dosed every 4 weeks and 100 mg dosed every two weeks achieved some­what bet­ter re­spons­es — a 2.58 and 2.96 drop from base­line on the dis­ease ac­tiv­i­ty score —  than the 2.19 drop for pa­tients tak­ing a low­er 40 mg dose of Hu­mi­ra every two weeks. That was a sta­tis­ti­cal­ly sig­nif­i­cant re­sponse.

That Hu­mi­ra reg­i­men, though, beat the 50 mg sirukum­ab dose on hit­ting ACR50, a min­i­mum 50% im­prove­ment in signs and symp­toms of the dis­ease, and bare­ly missed match­ing the 100 mg dose, miss­ing the sec­ond pri­ma­ry end­point in the study. The 50 mg and 100 mg sirukum­ab num­bers hit 27% and 35% on ACR50 com­pared to 32% of the Hu­mi­ra group.

The high dose of sirukum­ab al­so reg­is­tered a high­er rate of se­ri­ous ad­verse events in the 50 mg group, with 7% re­port­ing a se­ri­ous AE com­pared to 3% in the 100 mg group and 4% tak­ing Hu­mi­ra.

In the sec­ond Phase III study among pa­tients re­sis­tant to an­ti-TNF drugs, like Hu­mi­ra, the ACR20 scores were 40% and 45% for the 50 mg and 100 mg sirukum­ab dos­es and 24% in the place­bo arm.

None of that spells dis­as­ter for this drug. But it’s just one of sev­er­al new con­tenders for the mar­ket crown and pay­ers will be de­vot­ing par­tic­u­lar­ly close at­ten­tion to the head-to-head num­bers for Hu­mi­ra, as biosim­i­lars are lin­ing up to dec­i­mate the $14 bil­lion fran­chise — soon­er or lat­er.

J&J has re­peat­ed­ly tapped sirukum­ab as a key part of its Phase III ef­fort to line up ma­jor new prod­ucts for the mar­ket­ing group. GSK, mean­while, has been try­ing to over­come per­sis­tent crit­i­cism that its pipeline lacks piz­zazz. In their deal on sirukum­ab, GSK gained com­mer­cial rights in the US and the West­ern Hemi­sphere, while J&J lined up Eu­rope and the rest of the world.

Still to come this week­end: New da­ta on Eli Lil­ly’s baric­i­tinib, an oral ri­val in-li­censed from In­cyte. Sanofi and Re­gen­eron are grap­pling with a re­cent re­jec­tion for their IL-6 con­tender sar­ilum­ab, stiff-armed by the FDA due to man­u­fac­tur­ing con­cerns, which al­so post­ed a su­pe­ri­or pro­file to Hu­mi­ra for rheuma­toid arthri­tis.

And fur­ther back in the pipeline are even more big drugs that will look to grab best-in-class sta­tus.

A few weeks ago Ab­b­Vie turned its back on Abl­ynx’s Phase III-ready IL-6 drug vo­bar­il­izum­ab, shrug­ging off its $175 mil­lion up­front buy-in, af­ter that drug al­so turned in an unim­pres­sive per­for­mance com­pared to Roche’s Actem­ra. Ab­b­Vie is look­ing to its own in-house pro­gram for ABT-494 to pro­duce the best new drug in the field. Gilead stepped in af­ter Ab­b­Vie al­so spurned its part­ner­ship with Gala­pa­gos on fil­go­tinib, pay­ing $725 mil­lion to ac­quire rights to the JAK1 drug.

Op­ti­miz­ing Cell and Gene Ther­a­py De­vel­op­ment and Pro­duc­tion: How Tech­nol­o­gy Providers Like Corn­ing Life Sci­ences are Spurring In­no­va­tion

Remarkable advances in cell and gene therapy over the last decade offer unprecedented therapeutic promise and bring new hope for many patients facing diseases once thought incurable. However, for cell and gene therapies to reach their full potential, researchers, manufacturers, life science companies, and academics will need to work together to solve the significant challenges facing the industry.

Amid mon­key­pox fears, biotechs spring to ac­tion; Mod­er­na’s CFO trou­ble; Cuts, cuts every­where; Craft­ing the right pro­teins; 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.

It’s always a bittersweet moment saying goodbye, but as Josh Sullivan goes off to new adventures we are grateful for the way he’s built up the Endpoints Manufacturing section — which the rest of the team will now carry forward. If you’re not already, this may be a good time to sign up for your weekly dose of drug manufacturing news. Thank you for reading and wish you a restful weekend.

Bay­er sounds re­treat from a $670 mil­lion CAR-T pact in the wake of a pa­tient death

Two months after Atara Biotherapeutics hit the hold button on its lead CAR-T 2.0 therapy following a patient death, putting the company under the watchful eye of the FDA, its Big Pharma partners at Bayer are bowing out of a $670 million global alliance. And the move is forcing a revamp of Atara’s pipeline plans, even as research execs vow to continue work on the two drugs allied with Bayer 18 months ago, which delivered a $60 million cash upfront.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,600+ biopharma pros reading Endpoints daily — and it's free.

Try­ing to shake up the Parkin­son's par­a­digm, Ab­b­Vie sub­mits NDA for con­tin­u­ous, 24-hour in­fu­sion ther­a­py

AbbVie is approaching the FDA with a new therapy to potentially treat Parkinson’s disease, using prodrugs of two medications commonly used for the condition.

The Big Pharma submitted its NDA for ABBV-951, a solution of levodopa and carbidopa prodrugs being evaluated in advanced Parkinson’s patients who don’t respond well to oral therapy, AbbVie announced Friday morning. Researchers are hoping a positive Phase III study that reads out in late October will help move things along quickly at the agency.

Sanofi and Re­gen­eron clear the fin­ish line in an in­flam­ma­to­ry esoph­a­gus dis­ease, leav­ing Take­da in the dust

With atopic dermatitis rivals breathing down Dupixent’s neck, Sanofi and Regeneron on Friday secured a first win in new territory in what Sanofi’s head of immunology and inflammation Naimish Patel called the fastest approval he’s ever seen.

The FDA approved Dupixent on Friday to treat patients 12 years and older with eosinophilic esophagitis (EoE), an inflammatory condition that causes swelling and scarring of the esophagus. The approval came just a couple months after regulators granted Dupixent priority review, and months ahead of its PDUFA date on Aug. 3.

Fu­ji­film con­tin­ues its biotech build­ing spree with new fa­cil­i­ty in Chi­na

A Japanese conglomerate is making a big play in China with the opening of a new facility, as it continues to expand.

Fujifilm Irvine Scientific has opened its new Innovation and Collaboration Center in Suzhou New District, China, an area in Jiangsu province specifically designated for technological and industrial development.

According to Fujifilm, the 12,000-square-foot site will be responsible for the company’s cell culture media optimization, analysis and design services. Cell culture media itself often requires customization of formulas and protocols to achieve the desired quantity and quality of therapeutic desired. Fujifilm Irvine Scientific is offering these services from its headquarters in California and Japan to its customers globally, as well as in China now.

Emer Cooke, EMA director (AP Photo/Geert Vanden Wijngaert)

Ahead of FDA, EMA rec­om­mends au­tho­riz­ing new gene ther­a­py treat­ment for ul­tra-rare dis­ease

Aromatic amino acid decarboxylase (AADC) deficiency is an ultra-rare genetic disease that leaves patients unable to produce certain hormones in the brain, such as dopamine and serotonin, usually leading to developmental delays, weak muscle tone and inability to control the movement of the limbs. It can also lead to multiple organ failure.

To date, there have been no treatments approved for AADC deficiency, which has been identified in less than 150 patients.

Ather­sys tries to post-hoc-an­a­lyze its way out of an­oth­er tri­al fail for stroke stem cell ther­a­py

Athersys’ stem cell therapy has failed yet again.

In a 206-person trial conducted in Japan, Athersys’ stem cell therapy for stroke failed its primary endpoint of “excellent outcome,” a combined measure of three stroke recovery scores.

While a greater percentage of patients in the treatment group reached the primary endpoint compared to placebo, that difference was not statistically significant.

Siddhartha Mukherjee (Brian Ach/Getty Images for The New Yorker)

All Blue's $733M bid to ac­quire Zymeworks turns hos­tile as board bat­tles back — af­ter a biotech celebri­ty jumps in

Yesterday, the team at All Blue Capital — bent on the takeover of a badly battered Zymeworks — brought in celebrated oncologist, Pulitzer prize-winning writer and biotech exec Siddhartha Mukherjee to add some glitz to their proposed board. But they’re still not winning over any converts.

This morning, Zymeworks’ board officially turned this acquisition offer into a hostile showdown, rejecting the unsolicited offer and marshaling its forces to prevent a buyout at $10.50 per share.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,600+ biopharma pros reading Endpoints daily — and it's free.