Play­ing catch-up, Eli Lil­ly swoops in with $1.6B cash deal for Ar­mo Bio and its promis­ing PhI­II can­cer drug

Eli Lil­ly’s BD team is on the march, and as promised they’re stay­ing care­ful­ly fo­cused on on­col­o­gy.

This morn­ing Lil­ly $LLY an­nounced that it has ac­quired Ar­mo Bio­Sciences $AR­MO for $1.6 bil­lion in cash — just a few months af­ter their suc­cess­ful IPO de­but on Nas­daq. This is a biotech that in­de­pen­dent in­vestor Brad Lon­car re­cent­ly dubbed as the “next Nek­tar,” com­par­ing Ar­mo to one of the dar­lings in im­muno-on­col­o­gy which al­so has a strat­e­gy in­volv­ing cy­tokine im­muno-stim­u­la­to­ry ther­a­pies.

Levi Gar­raway

Lil­ly is pay­ing $50 a share, which im­me­di­ate­ly trig­gered a 67% spike on the stock this morn­ing as in­vestors rushed in to take ad­van­tage of the lat­est bolt-on deal.

The jew­el in the crown for Lil­ly here is pegilode­cakin, a PE­Gy­lat­ed IL-10 that is now in a piv­otal study af­ter demon­strat­ing ear­ly-stage suc­cess in sev­er­al tu­mor types. The Phase III is for pan­cre­at­ic can­cer, with tri­als un­der­way for lung and re­nal cell can­cer, melanoma and oth­er sol­id tu­mor types. Lil­ly al­so high­light­ed some pre­clin­i­cal can­di­dates it’s pick­ing up.

The big idea here falls right in the sweet spot of the cur­rent I/O rave. The lead drug is de­signed to spur the pro­lif­er­a­tion of CD8+ T cells in pa­tients, im­prov­ing prog­no­sis and length­en­ing the sur­vival of can­cer pa­tients. 

An­a­lysts fol­low­ing Lil­ly have been track­ing the ex­ec­u­tive team’s keen in­ter­est in plung­ing di­rect­ly in­to I/O af­ter get­ting left be­hind by lead­ers like Mer­ck and Bris­tol-My­ers Squibb. Just a few days ago the com­pa­ny added to the grow­ing ev­i­dence of a break­out move by re­cruit­ing Leena Gand­hi, an in­ves­ti­ga­tor at the Perl­mut­ter Can­cer Cen­ter at NYU Lan­gone Health and a Dana-Far­ber vet, to head up its im­muno-on­col­o­gy re­search work. Gand­hi played a big role in one re­cent Keytru­da pro­gram and she’ll now be putting her know-how to use for Lil­ly.

Lil­ly could eas­i­ly af­ford a string of these bolt-on deals, adding to a string of M&A pacts topped by Take­da’s $62 bil­lion Shire buy­out. Af­ter a lengthy drought of deals, big play­ers are clear­ly will­ing to fork over ma­jor pre­mi­ums to beef up their pipelines and add cat­a­lysts to their cal­en­dars.

And Lil­ly sig­naled it’s on­ly be­gun to wheel and deal.

“As we de­vel­op our im­muno-on­col­o­gy port­fo­lio, Lil­ly will pur­sue med­i­cines that use the body’s im­mune sys­tem in new ways to treat can­cer,” added Levi Gar­raway, se­nior vice pres­i­dent, glob­al de­vel­op­ment and med­ical af­fairs, Lil­ly On­col­o­gy. “We be­lieve that pegilode­cakin has a unique im­muno­log­ic mech­a­nism of ac­tion that could even­tu­al­ly al­low physi­cians to of­fer new hope for many can­cer pa­tients.”


Im­age: SHUT­TER­STOCK

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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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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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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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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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

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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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.