Falling be­hind gi­ant mi­graine drug ri­vals, Alder ousts founder Randy Schatz­man — could a buy­out be next?

Ran­dall Schatz­man

Af­ter 14 years at the helm of Alder Bio­Phar­ma­ceu­ti­cals $AL­DR, com­pa­ny co-founder Randy Schatz­man is out in what the com­pa­ny calls a “mu­tu­al de­ci­sion” with the board that it’s time for new lead­er­ship — just ahead of its first mar­ket­ing ap­pli­ca­tion.

Schatz­man will be tem­porar­i­ly re­placed by Paul Cleve­land, who was CEO at the gene ther­a­py com­pa­ny Cel­ladon be­fore it crashed and burned in 2015, even­tu­al­ly serv­ing as a shell for a re­verse merg­er. Ear­li­er he had been an ex­ec­u­tive at Aragon (apa­lu­tamide), ac­quired by J&J, which is what Alder prefers to fo­cus on.

Paul Cleve­land

All niceties aside, Schatz­man was bumped off the ex­ec­u­tive ros­ter at a time that there have been some grow­ing con­cerns about the biotech’s com­pet­i­tive stance. Alder is close to fil­ing a li­cens­ing ap­pli­ca­tion for its CGRP mi­graine drug as it com­pletes piv­otal re­search work.

In­vestors weren’t pleased by the jit­tery move, though. Alder’s stock dropped more than 10% this morn­ing.

Lit­tle Alder is well be­hind the two gi­ants lead­ing the CGRP mi­graine race: No­var­tis and Am­gen, with Aimovig now un­der re­view. Ear­li­er this year, Eli Lil­ly $LLY cel­e­brat­ed its Phase III re­sults for gal­canezum­ab, with a con­sis­tent 2-day re­duc­tion in month­ly mi­graines. Te­va is a play­er, but may be de­layed by man­u­fac­tur­ing is­sues. And Al­ler­gan $AGN has a late-stage pro­gram un­der­way for an oral CGRP ther­a­py it in-li­censed from Mer­ck in 2015 with a $250 mil­lion up­front.

Leerink’s Ge­of­frey Porges not­ed that the move to oust Schatz­man comes af­ter grow­ing “frus­tra­tion with the pace of progress, rel­a­tive com­pet­i­tive po­si­tion, and ex­ter­nal dis­clo­sure at Alder, par­tic­u­lar­ly in the last 12-18 months.”

He added:

This lead­er­ship tran­si­tion may have been planned for a while but not pub­licly dis­closed due to the po­ten­tial share­hold­er con­cerns over a CEO leav­ing a com­pa­ny ahead of piv­otal tri­al da­ta. To us, this tim­ing and dis­clo­sure, which ob­vi­ous­ly came di­rect­ly from the board of di­rec­tors, means that the com­pa­ny is free to open­ly re­cruit a leader with the req­ui­site skills and ex­pe­ri­ence or to se­cure the sale of the com­pa­ny.

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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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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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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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.

BeiGene and Mus­tang nail down spe­cial FDA sta­tus for top drugs; Roche bags added cov­er­age for Hem­li­bra

→ BeiGene $BGNE is getting a boost in its drive to field a rival to Imbruvica. The FDA has offered an accelerated review to zanubrutinib, a BTK inhibitor that has posted positive results for mantle cell lymphoma. The PDUFA date lands on February 27, 2020. The drug scored breakthrough status at the beginning of the year.

→ BeiGene isn’t the only biopharma company to gain special regulatory status today. Mustang Bio $MBIO and St. Jude Children’s Research Hospital announced that MB-107, a lentiviral gene therapy for the treatment of X-linked severe combined immunodeficiency, also known as bubble boy disease, has been granted Regenerative Medicine Advanced Therapy status.

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

UP­DAT­ED: 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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