Roche, Bio­gen hand­ing over $470M in cash to bag two drug pro­grams from Bris­tol-My­ers Squibb

Bris­tol-My­ers Squibb has forged a pair of sep­a­rate pacts with Roche and Bio­gen to out­li­cense two drugs, grab­bing a whop­ping $470 mil­lion up­front for the deals.

Bio­gen gets con­trol of BMS-986168, an an­ti-eTau com­pound in clin­i­cal de­vel­op­ment for Pro­gres­sive Supranu­clear Pal­sy, for $300 mil­lion up­front and $410 mil­lion in mile­stones. And Roche gets BMS-986089, an an­ti-myo­statin Ad­nectin in de­vel­op­ment for Duchenne mus­cu­lar dy­s­tro­phy. Roche is pay­ing $170 mil­lion plus $205 mil­lion in mile­stones.

Thomas Lynch, BMS

Bio­gen is al­so as­sum­ing the oblig­a­tions Bris­tol-My­ers took on when it ac­quired iP­ier­ian in 2014 for $175 mil­lion in cash and $550 mil­lion in mile­stones. That deal fo­cused heav­i­ly on the tau pro­gram, along with Bris­tol’s in­ter­est in pur­su­ing it as a com­bo for Alzheimer’s — which odd­ly ar­rived months af­ter Bris­tol’s de­ci­sion to re­treat from neu­ro­sciences work in 2013. But in re­cent years Bris­tol’s in­ter­est in Alzheimer’s has fad­ed, while Bio­gen has been ex­cit­ing the in­dus­try with ear­ly-stage da­ta on ad­u­canum­ab, an amy­loid ther­a­py.

The deals to­tal about $1.1 bil­lion, plus prospec­tive roy­al­ties.

Roche is get­ting its myo­statin drug in Phase I, ac­cord­ing to a spokesper­son at Bris­tol-My­ers.Bris­tol orig­i­nal­ly ac­quired it way back in 2007 with the $505 mil­lion deal to buy Ad­nexus, which orig­i­nal­ly de­vel­oped Ad­nectins.

Bio­gen says it will now launch the Phase II stud­ies for its drug in both Alzheimer’s dis­ease as well as PSP. Notes Baird’s Bri­an Sko­r­ney:

Ad­di­tion of BMS-986168 ex­pands Bio­gen’s port­fo­lio in Alzheimer’s, which al­ready in­cludes an­ti-tau and an­ti-Aβ (ad­u­canum­ab, BAN2401 with Ei­sai) pro­grams and BACE in­hibitor E2609, through a col­lab­o­ra­tion with Ei­sai.

“Bio­gen aims to be a leader in Alzheimer’s dis­ease and we are build­ing a pipeline with mul­ti­ple ap­proach­es to ad­dress the com­plex, dev­as­tat­ing process of neu­rode­gen­er­a­tion,” said Michael Ehlers, ex­ec­u­tive vice pres­i­dent, re­search & de­vel­op­ment. “Based on en­cour­ag­ing safe­ty and ef­fi­ca­cy da­ta, we be­lieve BMS-986168 is a promis­ing an­ti-tau can­di­date that may rep­re­sent the next wave of med­i­cines for Alzheimer’s dis­ease as well as the first re­al an­swer for pro­gres­sive supranu­clear pal­sy.”

Bio­gen has been un­der in­tense pres­sure to add new drugs to its pipeline, which is con­cen­trat­ed on neu­ro­log­i­cal con­di­tions. Roche, though, has been com­ing through with a va­ri­ety of ma­jor league ap­provals, in­clud­ing the re­cent OK for Ocre­vus, and has been choosy about what it wants to add to the pipeline.

Bris­tol-My­ers, mean­while, has been shak­ing up its R&D group in re­cent months, af­ter the fi­as­co with the check­point Op­di­vo as it slipped be­hind Mer­ck’s Keytru­da on non-small cell lung can­cer. Bris­tol-My­ers brought in a new R&D chief, Thomas Lynch, and has been se­lec­tive­ly look­ing for ways to econ­o­mize as it looks to make a come­back in a field that it helped to pi­o­neer.


“Li­cens­ing these as­sets to Bio­gen and Roche will en­able Bris­tol-My­ers Squibb to pri­or­i­tize the oth­er promis­ing op­por­tu­ni­ties for as­set de­vel­op­ment that have ad­vanced across our di­ver­si­fied port­fo­lio,” said Mike Burgess, head of Car­dio­vas­cu­lar, Fi­bro­sis and Im­muno­science De­vel­op­ment, Bris­tol-My­ers Squibb. “We rec­og­nize the sig­nif­i­cant un­met med­ical needs for pa­tients with PSP and with DMD, and are pleased to put the fu­ture de­vel­op­ment of these com­pounds in­to the hands of Bio­gen and Roche, who both have strong ca­pa­bil­i­ties, fo­cus and lead­er­ship in neu­rode­gen­er­a­tive and rare dis­eases.”

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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Hal Barron. GSK

GSK's Hal Bar­ron her­alds their sec­ond pos­i­tive PhI­II 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.

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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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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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

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.