No sur­prise: Ab­b­Vie turns cold shoul­der to a messy rheuma­toid arthri­tis part­ner­ship with Abl­ynx

Ab­b­Vie is punt­ing yet an­oth­er high-pro­file rheuma­toid arthri­tis de­vel­op­ment part­ner­ship. The phar­ma out­fit is tak­ing a pass on Abl­ynx’s Phase III-ready drug vo­bar­il­izum­ab and shrug­ging off its $175 mil­lion up­front buy-in.

The de­ci­sion will come as no sur­prise to any care­ful ob­serv­er of RA. The an­ti-IL-6R re­cent­ly failed to pass muster in a Phase IIb tri­al, de­spite Abl­ynx’s best ef­forts to get an­a­lysts to look past the fail­ure on the pri­ma­ry end­point and on to more up­beat re­sults in the study. And Ab­b­Vie al­ready has an in-house ri­val that it’s been much more pumped about.

I wrote up that IIb da­ta back in Au­gust, not­ing that the Bel­gian biotech had plen­ty of ex­plain­ing to do. Not on­ly did the treat­ment flop on the ACR20 goal, it al­so failed on a score of im­proved phys­i­cal func­tion when com­bined with methotrex­ate against methotrex­ate alone. Eli Lil­ly and In­cyte (baric­i­tinib), GSK and J&J (sirukum­ab) and Re­gen­eron/Sanofi (sar­ilum­ab), mean­while, have been tack­ling Hu­mi­ra in head-to-head stud­ies for their drugs.

The lat­est da­ta set ar­rived just one month af­ter Abl­ynx al­so demon­strat­ed that their drug was at best a matchup against Roche’s Actem­ra (ap­proved in 2010) on the key ACR scores, though it did bet­ter on dis­ease ac­tiv­i­ty scores.

Last year, Ab­b­Vie al­so left Gala­pa­gos at the al­tar with their drug fil­go­tinib. But Gilead im­me­di­ate­ly stepped in, pay­ing $725 mil­lion to ac­quire part­ner­ship rights. Now Abl­ynx will face the task of find­ing some­one will­ing to step in­to Ab­b­Vie’s shoes as well, try­ing to lure in part­ners with its pos­i­tive ACR50 and ACR70 scores as well as up­beat re­sults for low dis­ease ac­tiv­i­ty. But it will face some harsh com­par­isons.

Ab­b­Vie, mean­while, seems con­tent to stay fo­cused on ABT-494, which it be­lieves has a sol­id shot at emerg­ing from this com­pet­i­tive field as a best-in-class ther­a­py. And Abl­ynx CEO Ed­win Moses says he’s ready to march in­to a big late-stage study.

“We are ob­vi­ous­ly dis­ap­point­ed that Ab­b­Vie has de­cid­ed at this time not to ex­er­cise its right to li­cense vo­bar­il­izum­ab in RA. The strong Phase IIb re­sults in RA demon­strat­ed that vo­bar­il­izum­ab is not just an­oth­er an­ti­body but a mem­ber of a new ther­a­peu­tic class with unique dif­fer­en­ti­at­ing fea­tures re­sult­ing in a su­pe­ri­or ef­fi­ca­cy and safe­ty pro­file as com­pared to oth­er bi­o­log­i­cals. We are ab­solute­ly com­mit­ted to pro­gress­ing this pro­gram and will there­fore start the prepa­ra­tions for the Phase III study with the first pa­tients ex­pect­ed to be en­rolled by the end of 2017.”

Com­mu­ni­cat­ing the val­ue of pre­ci­sion med­i­cine

By Natasha Cowan, Content Marketing Manager at Blue Latitude Health.
Many stakeholders are confused by novel precision medicines, including patients and healthcare professionals. So, how can industry help them to navigate this complexity?

Precision medicine represents a new paradigm in healthcare. It embodies the shift from treating many patients with the same therapy, to having the tools to identify the best treatment for every patient.

FDA pan­el large­ly op­pos­es ex­pand­ing use of Lil­ly, Boehringer's SGLT2 in­hibitor to type I di­a­bet­ics

Last week, Eli Lilly and partner Boehringer Ingelheim rejigged the terms of their 2011 diabetes pact that nurtured the development of their blockbuster Jardiance franchise. Akin to manufacturers of rival SGLT2 drugs, the companies are working to expanding the use of their type II diabetes drug to reach a broader group of patients. On Wednesday, an expert panel to the FDA resisted that effort by largely voting against their quest to market the drug in type I diabetics.

Amir Nashat, World Medical Innovation Forum via Youtube

Bay­er bets up to $100M on ex­plor­ing new bio­mol­e­c­u­lar con­den­sate ter­rain with a biotech up­start

In the Indiana Jones warehouse of genomic oddities, the millions of units of so-called “junk DNA” that create nothing but play a hand in tons of things have grabbed most of the attention. But there are other arks and Templar crosses out there.

Among them: the code for intrinsically disordered regions. Floating like boundless clumps of boiling spaghetti throughout the cell, these regions first appeared in scientific sketches at the turn of the century before vanishing from most cell diagrams, such as those in a high school textbook. Most organelles were neatly bound in membranes. These loose molecules resisted characterization. Scientists largely ignored them.

“I’m honestly embarrassed I didn’t notice them,” Phil Sharp, a Nobel Prize-biologist at MIT who co-discovered RNA splicing, told Endpoints News. 

In 2009, two researchers at the Max Planck Institute re-sparked interest in these regions and their code with a Science paper identifying them as “condensates.” They started a chain of discoveries that began to show them as using a concept called phase transition and playing a vital role in gene transcription and a host of cell functions. Cell diseases too. Derek Lowe got interested. So did Merck’s Jason Imbriglio. Now the most prominent biotech trying to leverage the still-young research for research, Dewpoint Therapeutics, is getting a deal worth up to $100 million to collaborate with Bayer.

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In­vestors could emerge from Neil Wood­ford de­ba­cle with £1B loss, in­ter­nal analy­sis re­veals

When Link Fund Solutions announced that it is closing Woodford Equity Income Fund permanently and kicking out Neil Woodford, it was implied that investors probably won’t get back everything they entrusted to the fund manager. But nobody knew just how much they would lose.

An internal analysis commissioned by Link suggested that the collective loss could amount to £1 billion — out of a fund last valued at £3.1 billion — Citywire has revealed.

Mer­ck buys a fledg­ling neu­rode­gen­er­a­tive biotech spawned by an old GSK dis­cov­ery al­liance. What’s up with that?

Avalon Ventures chief Jay Lichter has a well-known yen for drug development programs picked up in academia. And what he found in Haoxing Xu’s lab at the University of Michigan pricked his interest enough to launch one of his umbrella biotechs in San Diego.
Xu’s work laid the foundation for Avalon to launch Calporta, which has been working on finding small molecule agonists of TRPML1 (transient receptor potential cation channel, mucolipin subfamily, member 1) for lysosomal storage disorders. And that pathway, they believe, points to new approaches on major market neurodegenerative diseases like Parkinson’s, ALS and Alzheimer’s.

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GSK's asth­ma bi­o­log­ic Nu­cala scores in rare blood dis­or­der study

GlaxoSmithKline’s asthma drug Nucala, which received a resounding FDA rejection for use in chronic obstructive pulmonary disease (COPD) last year, has shown promise in a rare blood disorder.

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Spe­cial re­port: Twen­ty ex­tra­or­di­nary women in bio­phar­ma R&D who worked their way to the top

What differentiates a woman leader in biopharma R&D from a man?

Not much, except there are fewer of them in senior posts. Data suggest women are not more risk-averse, family-oriented or less confident than their male counterparts — indeed the differences between the two sexes are negligible. But a glance at the top R&D positions in Big Pharma leaves little doubt that upward migration in the executive ranks of biopharma R&D is tough.

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FDA Vas­cepa re­view spot­lights new safe­ty sig­nals, pos­si­ble min­er­al oil spoil­er as Amarin hunts a block­buster ap­proval

An in-house FDA review of Amarin’s Vascepa raises a set of hurdles the biotech will have to clear if the biotech expects to get the long-awaited FDA approval that could set it on a path to superstar status. But it appears that Amarin has survived another potential setback without introducing a major new threat to its prospects.

The stakes don’t get much higher, with analysts saying a win this week for Amarin could lead to billions in new sales — provided the agency stamps it with an OK. And investors liked what they say in the FDA review this morning, bumping the stock $AMRN 17%.

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FDA slaps a hold on an AML tri­al as Mark­er scraps a fail­ing ovar­i­an can­cer pro­gram, sink­ing shares

The FDA has placed a hold on a Phase II AML trial from the small immuno-oncology biotech Marker Therapeutics. Marker disclosed the issue two weeks after responding to FDA concerns, adding it to the Q3 release Tuesday. The company also announced it was scrapping a Phase II ovarian cancer program it determined was unlikely to succeed.

The agency’s concern centers around two reagents used in manufacturing for their trial for acute myeloid leukemia patients who have received a stem cell transplant. The reagents are from third parties and not present in the final product, Marker said.