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.

Martin Shkreli [via Getty]

Pris­on­er #87850-053 does not get to add drug de­vel­op­er to his list of cred­its

Just days after Retrophin shed its last ties to founder Martin Shkreli, the biotech is reporting that the lead drug he co-invented flopped in a pivotal trial. Fosmetpantotenate flunked both the primary and key secondary endpoints in a placebo-controlled trial for a rare disease called pantothenate kinase-associated neurodegeneration, or PKAN.

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We­bi­nar: Re­al World End­points — the brave new world com­ing in build­ing fran­chise ther­a­pies

Several biopharma companies have been working on expanding drug labels through the use of real world endpoints, combing through the data to find evidence of a drug’s efficacy for particular indications. But we’ve just begun. Real World Evidence is becoming an important part of every clinical development plan, in the soup-through-nuts approach used in building franchises.

I’ve recruited a panel of 3 top experts in the field — the first in a series of premium webinars — to look at the practical realities governing what can be done today, and where this is headed over the next few years, at the prodding of the FDA.

ZHEN SU — Merck Serono’s Senior Vice President and Global Head of Oncology
ELLIOTT LEVY — Amgen’s Senior Vice President of Global Development
CHRIS BOSHOFF — Pfizer Oncology’s Chief Development Officer

A premium subscription to Endpoints News is required to attend this webinar. Please upgrade to either an Insider or Enterprise plan for access. Already have Endpoints Premium? Please sign-in below. You can contact our Subscriptions team at help@endpointsnews.com with any issues.

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Brian Kaspar. AveXis via Twitter

AveX­is sci­en­tif­ic founder fires back at No­var­tis CEO Vas Narasimhan, 'cat­e­gor­i­cal­ly de­nies any wrong­do­ing'

Brian Kaspar’s head was among the first to roll at Novartis after company execs became aware of the fact that manipulated data had been included in its application for Zolgensma, now the world’s most expensive therapy.

But in his first public response, the scientific founder at AveXis — acquired by Novartis for $8.7 billion — is firing back. And he says that not only was he not involved in any wrongdoing, he’s ready to defend his name as needed.

I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

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Hal Barron. GSK

GSK's Hal Bar­ron her­alds their sec­ond pos­i­tive piv­otal for cru­cial an­ti-BC­MA ther­a­py, point­ing to a push for quick OKs in a crowd­ed field

Hal Barron has his second positive round of Phase III data in hand for his anti-BCMA antibody drug conjugate belantamab mafodotin (GSK2857916). And GSK’s research chief says the data paves the way for their drive in search of an FDA approval for treating multiple myeloma.

It’s hard to overestimate the importance of this drug for GSK, a cornerstone of Barron’s campaign to make a dramatic impact on the oncology market and provide some long-lost excitement for the pharma giant’s pipeline. They’re putting this BCMA program at the front of that charge — looking to lead a host of rivals all aimed at the same target.

We don’t know what the data are yet, but DREAMM-2 falls on the heels of a promising set of data delivered 5 months ago for DREAMM-1. There investigators noted that complete responses among treatment-resistant patients rose to 15% in the extra year’s worth of data to look over, with a median progression-free survival rate of 12 months, up from 7.9 months reported earlier. The median duration of response was 14.3 months.

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UP­DAT­ED: An em­bold­ened As­traZeneca splurges $95M on a pri­or­i­ty re­view vouch­er. Where do they need the FDA to hus­tle up?

AstraZeneca is in a hurry.

We learned this morning that the pharma giant — not known as a big spender, until recently — forked over $95 million to get its hands on a priority review voucher from Sobi, otherwise known as Swedish Orphan Biovitrum.

That marks another step down on price for a PRV, which allows the holder to slash 4 months off of any FDA review time.

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Bob Smith, Pfizer

Pfiz­er is mak­ing a $500M state­ment to­day: Here’s how you be­come a lead play­er in the boom­ing gene ther­a­py sec­tor

Three years ago, Pfizer anted up $150 million in cash to buy Bamboo Therapeutics in Chapel Hill, NC as it cautiously stuck a toe in the small gene therapy pool of research and development.

Company execs followed up a year later with a $100 million expansion of the manufacturing operations they picked up in that deal for the UNC spinout, which came with $495 million in milestones.

And now they’re really going for it.

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Video: Putting the AI in R&D — with Badhri Srini­vasan, Tony Wood, Rosana Kapeller, Hugo Ceule­mans, Saurabh Sa­ha and Shoibal Dat­ta

During BIO this year, I had a chance to moderate a panel among some of the top tech experts in biopharma on their real-world use of artificial intelligence in R&D. There’s been a lot said about the potential of AI, but I wanted to explore more about what some of the larger players are actually doing with this technology today, and how they see it advancing in the future. It was a fascinating exchange, which you can see here. The transcript has been edited for brevity and clarity. — John Carroll

As­traZeneca’s Imfinzi/treme com­bo strikes out — again — in lung can­cer. Is it time for last rites?

AstraZeneca bet big on the future of their PD-L1 Imfinzi combined with the experimental CTLA-4 drug tremelimumab. But once again it’s gone down to defeat in a major Phase III study — while adding damage to the theory involving targeting cancer with a high tumor mutational burden.

Early Wednesday the pharma giant announced that their NEPTUNE study had failed, with the combination unable to beat standard chemo at overall survival in high TMB cases of advanced non-small cell lung cancer. We won’t get hard data until later in the year, but the drumbeat of failures will call into question what — if any — future this combination can have left.

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Why would Am­gen want to buy Alex­ion? An­a­lysts call hot­ly ru­mored takeover un­like­ly, but seize the mo­ment

A rumor that Amgen is closing in on buyout deal for Alexion has sparked a guessing game on just what kind of M&A strategy Amgen is pursuing and how much Alexion is worth.

Mizuho analyst Salim Syed first lent credence to the report out of the Spanish news outlet Intereconomía, which said Amgen is bidding as much as $200 per share. While the source may be questionable, “the concept of this happening doesn’t sound too crazy to me,” he wrote.