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.

2019 Trin­i­ty Drug In­dex Eval­u­ates Ac­tu­al Com­mer­cial Per­for­mance of Nov­el Drugs Ap­proved in 2016

Fewer Approvals, but Neurology Rivals Oncology and Sees Major Innovations

This report, the fourth in our Trinity Drug Index series, outlines key themes and emerging trends in the industry as we progress towards a new world of targeted and innovative products. It provides a comprehensive evaluation of the performance of novel drugs approved by the FDA in 2016, scoring each on its commercial performance, therapeutic value, and R&D investment (Table 1: Drug ranking – Ratings on a 1-5 scale).

How to cap­i­talise on a lean launch

For start-up biotechnology companies and resource stretched pharmaceutical organisations, launching a novel product can be challenging. Lean teams can make setting a launch strategy and achieving your commercial goals seem like a colossal undertaking, but can these barriers be transformed into opportunities that work to your brand’s advantage?
We spoke to Managing Consultant Frances Hendry to find out how Blue Latitude Health partnered with a fledgling subsidiary of a pharmaceutical organisation to launch an innovative product in a
complex market.
What does the launch environment look like for this product?
FH: We started working on the product at Phase II and now we’re going into Phase III trials. There is a significant unmet need in this disease area, and everyone is excited about the launch. However, the organisation is still evolving and the team is quite small – naturally this causes a little turbulence.

Aymeric Le Chatelier, Ipsen

A $1B-plus drug stum­bles in­to an­oth­er big PhI­II set­back -- this time flunk­ing fu­til­i­ty test -- as FDA hold re­mains in ef­fect for Ipsen

David Meek

At the time Ipsen stepped up last year with more than a billion dollars in cash to buy Clementia and a late-stage program for a rare bone disease that afflicts children, then CEO David Meek was confident that he had put the French biotech on a short path to a mid-2020 launch.

Instead of prepping a launch, though, the company was hit with a hold on the FDA’s concerns that a therapy designed to prevent overgrowth of bone for cases of fibrodysplasia ossificans progressiva might actually stunt children’s growth. So they ordered a halt to any treatments for kids 14 and under. Meek left soon after to run a startup in Boston. And today the Paris-based biotech is grappling with the independent monitoring committee’s decision that their Phase III had failed a futility test.

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Roche's check­point play­er Tecen­triq flops in an­oth­er blad­der can­cer sub­set

Just weeks after Merck’s star checkpoint inhibitor Keytruda secured FDA approval for a subset of bladder cancer patients, Swiss competitor Roche’s Tecentriq has failed in a pivotal bladder cancer study.

The 809-patient trial — IMvigor010 — tested the PD-L1 drug in patients with muscle-invasive urothelial cancer (MIUC) who had undergone surgery, and were at high risk for recurrence.

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UP­DAT­ED: Eli Lil­ly’s $1.6B can­cer drug failed to spark even the slight­est pos­i­tive gain for pa­tients in its 1st PhI­II

Eli Lilly had high hopes for its pegylated IL-10 drug pegilodecakin when it bought Armo last year for $1.6 billion in cash. But after reporting a few months ago that it had failed a Phase III in pancreatic cancer, without the data, its likely value has plunged. And now we’re getting some exact data that underscore just how little positive effect it had.

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Ku­ra co-founder heads to Asian mul­ti-na­tion­al as biotech eyes the goal posts for lead drug

Six years after Kura Oncology snagged a farnesyl transferase inhibitor from J&J and leapt straight into clinical development, one of the biotech’s founders is leaving to start a new chapter in his career.

CMO and development chief Antonio Gualberto is exiting the company, and Kura — led by longtime biotech entrepreneur Troy Wilson — is on the hunt for a replacement. Wilson credited the CMO for some key biomarker work, including the discovery of the CXCL12 pathway as a target of their lead drug tipifarnib. Those biomarkers are being relied on to define the patient population most likely to benefit from the drug.

FDA waves Epizyme's $186K rare can­cer drug through to mar­ket — now get ready for the sec­ond act

After winning the hearts of the expert panel convened by the FDA despite a bleak in-house review and a checkered development history, Robert Bazemore has steered Epizyme to its first-ever OK for a rare cancer drug.

The approval in epithelioid sarcoma sets tazemetostat, now Tazverik, up nicely for a quick expansion to follicular lymphoma — a much bigger indication for which the biotech has just submitted an NDA.

2019 a 'trans­for­ma­tive year' for phar­ma M&A. Is that a good thing?

Big Pharma keeps getting bigger.

Fueled by the mega-mergers between Bristol-Myers Squibb and Celgene and between Allergan and AbbVie, the industry last year saw $350 billion worth of M&A, according to the new year-end report from the consultants at PwC.  That’s a more than 50% increase on 2018.

“I kind of look at 2019 as a transformational year,” report author Glen Hunzinger told Endpoints News. 

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UP­DAT­ED: FDA’s golodirsen CRL: Sarep­ta’s Duchenne drugs are dan­ger­ous to pa­tients, of­fer­ing on­ly a small ben­e­fit. And where's that con­fir­ma­to­ry tri­al?

Back last summer, Sarepta CEO Doug Ingram told Duchenne MD families and investors that the FDA’s shock rejection of their second Duchenne MD drug golodirsen was due to some concerns regulators raised about the risk of infection and the possibility of kidney toxicity. But when pressed to release the letter for all to see, he declined, according to a report from BioPharmaDive, saying that kind of move “might not look like we’re being as respectful as we’d like to be.”

He went on to assure everyone that he hadn’t misrepresented the CRL.

But Ingram’s public remarks didn’t include everything in the letter, which — following the FDA’s surprise about-face and unexplained approval — has now been posted on the FDA’s website and broadly circulated on Twitter early Wednesday.

The CRL raises plenty of fresh questions about why the FDA abruptly decided to reverse itself and hand out an OK for a drug a senior regulator at the FDA believed — 5 months ago, when he wrote the letter — is dangerous to patients. It also puts the spotlight back on Sarepta $SRPT, which failed to launch a confirmatory study of eteplirsen, which was only approved after a heated internal controversy at the FDA. Ellis Unger, director of CDER’s Office of Drug Evaluation I, notes that study could have clarified quite a lot about the benefit and risks associated with their drugs — which can cost as much as a million dollars per patient per year, depending on weight.

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