In­ves­tiga­tive re­port calls for re­newed scruti­ny on Aca­dia drug; Im­bru­vi­ca fails in front­line DL­B­CL PhI­II

→ The spot­light on Aca­dia Phar­ma­ceu­ti­cals’ $ACAD Parkin­son’s drug has turned more in­tense as in­ves­tiga­tive jour­nal­ist Rod­dy Boyd (you might re­mem­ber his re­port­ing on Valeant) drops an ex­posé on the com­pa­ny. Fol­low­ing a se­ries of re­ports from CNN and ProP­ub­li­ca high­light­ing Nu­plazid’s dan­gers, Boyd’s ac­count pound­ed on both the con­tro­ver­sial his­to­ry of its ap­proval and its spot­ty safe­ty record since then.

Boyd, writ­ing on the South­ern In­ves­tiga­tive Re­port­ing Foun­da­tion, al­so ques­tioned the mar­ket­ing tac­tics of Aca­dia’s sales team, many of whom had been scooped from an­oth­er scan­dal-prone com­pa­ny, Avanir: “For 2017, Aca­dia paid more than $8.6 mil­lion to 7,051 physi­cians, with 62 doc­tors re­ceiv­ing more than $50,000 apiece, and 26 re­ceiv­ing at least $100,000 each.” And there ap­pears to be an over­lap be­tween fre­quent pre­scribers of the drug and those who re­ceived con­sult­ing fees.

The at­ten­tion on safe­ty is­sues has pushed a steep drop in Aca­dia shares, which have lost more than half their val­ue over the past months. Nu­plazid — des­ig­nat­ed a “break­through” drug — is now un­der re­view again at the FDA.

→ Re­searchers at Ab­b­Vie say that Im­bru­vi­ca failed as a front­line ther­a­py for dif­fuse large B-cell lym­phoma. Their drug in com­bi­na­tion with oth­er agents was un­able to beat the stan­dard of care — R CHOP — for treat­ing the dis­ease. They did, though, add that their drug ap­par­ent­ly worked in a sub­set of pa­tients and plan to fol­low up with more re­search.

Em­ma Walm­s­ley’s re­make of the ex­ec­u­tive round­table at GSK is near­ing com­ple­tion. To­day the phar­ma gi­ant not­ed that gen­er­al coun­sel Dan Troy is leav­ing the com­pa­ny af­ter 10 years. He’s be­ing re­placed by James Ford, cur­rent­ly SVP and gen­er­al coun­sel for Glob­al Phar­ma.

→ France’s Antabio has added €5.2 mil­lion to their Se­ries A, bring­ing the to­tal to €12.5 mil­lion. The biotech is work­ing on a in­hibitor of bac­te­r­i­al met­al­lo ß-lac­ta­mases for drug re­sis­tant cas­es. Omnes, BNP Paribas Développe­ment, and Sham In­no­va­tion San­té (Turenne Cap­i­tal) stepped in, with ex­ist­ing share­hold­er Galia Ges­tion.

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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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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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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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.

FDA asks why No­var­tis took two months to launch for­mal in­ter­nal probe, af­ter AveX­is flagged da­ta ma­nip­u­la­tion

And the plot thickens. Novartis $NVS officials are reportedly now scrambling to explain to the FDA why it took them two months to open an internal investigation into data discrepancies for their $2.1 million gene-therapy for spinal muscular dystrophy — the world’s most expensive drug.

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Build­ing on suc­cess­ful PD-1 pact, Eli Lil­ly li­cens­es di­a­betes drug to Chi­nese part­ners at In­novent

Eli Lilly is expanding its partnership with China’s Innovent in a deal involving a diabetes drug sitting in its Phase I reserves.

The two companies had jointly developed one of China’s first homegrown PD-1 agents, scoring an approval for Tyvyt (sintilimab) late last year for relapsed/refractory classical Hodgkin’s lymphoma. This time around, Lilly is out-licensing a piece of its diabetes pipeline, a leading franchise that has historically produced the top-selling Trulicity and Humalog.

Am­gen, Al­ler­gan biosim­i­lar of Roche's block­buster Rit­ux­an clears an­oth­er US piv­otal study 

Novartis $NVS may have given up, but Amgen $AMGN and Allergan $AGN are plowing ahead with their knockoff of Roche’s blockbuster biologic Rituxan in the United States.

Their copycat, ABP 798, was found to have a clinically equivalent impact as Rituxan — meeting the main goal of the study involving CD20-positive B-cell non-Hodgkin’s lymphoma patients. This is the second trial supporting the profile of the biosimilar. In January, it came through with positive PK results in patients with rheumatoid arthritis.

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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