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

Mi­no­ryx and Sper­o­genix ink an ex­clu­sive li­cense agree­ment to de­vel­op and com­mer­cial­ize lerigli­ta­zone in Chi­na

September 23, 2020 – Hong Kong, Beijing, Shanghai (China) and Mataró, Barcelona (Spain)  

Minoryx will receive an upfront and milestone payments of up to $78 million, as well as double digit royalties on annual net sales 

Sperogenix will receive exclusive rights to develop and commercialize leriglitazone for the treatment of X-linked adrenoleukodystrophy (X-ALD), a rare life-threatening neurological condition

Daniel O'Day, Gilead CEO (Kevin Dietsch/UPI/Bloomberg via Getty Images)

Play-by-play of Gilead­'s $21B Im­munomedics buy­out de­tails a fren­zied push — and mints a new biotech bil­lion­aire

Immunomedics had not really been looking for a buyout when the year began. Excited by its BLA for Trodelvy, submitted to the FDA in late 2019, executive chairman Behzad Aghazadeh started off looking for potential licensing deals and zeroed in on four potential partners, including Gilead, following January’s JP Morgan Healthcare Conference in San Francisco. Such talks advanced throughout the year, with discussions advancing to the second round in mid-August.

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FDA chief Stephen Hahn on Capitol Hill earlier this week (Getty Images)

As FDA buck­les un­der the strain of a pan­dem­ic work­load, Trump again ac­cus­es the agency of a po­lit­i­cal hit job

Peter Marks appeared before a virtual SVB Leerink audience yesterday and said that his staff at FDA’s CBER is on the verge of working around the clock. Manufacturing inspections, policy work and sponsor communications have all been pushed down the to-do list so that they can be responsive to Covid-related interactions. And the agency’s objective right now? “To save as many lives as we can,” Marks said, likening the mortality on the current outbreak as equivalent to “a nuclear bomb on a small city.”

The win­dow is wide open as four more biotechs join the go-go IPO class of 2020

It’s another day of hauling cash in the biopharma world as four more IPOs priced Friday and a fifth filed its initial paperwork.

The biggest offering comes from PMV Pharma, an oncology biotech focusing on p53 mutations, which raised $211.8 million after pricing shares at $18 apiece. Prelude Therapeutics, developing PRMT5 inhibitors for rare cancers, was next with a $158 million raise, pricing shares at $19 each. Graybug Vision raised $90 million after pricing at $16 per share for its wet AMD candidates, and breast cancer biotech Greenwich Lifesciences brought up the rear with a small, $7 million raise after pricing shares at $5.75.

J&J of­fers PhI/IIa da­ta show­ing its sin­gle-dose vac­cine can stir up suf­fi­cient im­mune re­sponse

Days after J&J dosed the first participants of its Phase III ENSEMBLE trial, the pharma giant has detailed the early-stage data that gave them confidence in a single-dose regimen.

Testing two dose levels either as a single dose or in a two-dose schedule spaced by 56 days in, the scientists from Janssen, the J&J subsidiary developing its vaccine, reported that the low dose induced a similar immune response as the high dose. The interim Phase I/IIa results were posted in a preprint on medRxiv.

President Donald Trump reacts after signing an executive order following his remarks on his healthcare policies yesterday in Charlotte, North Carolina (Getty Images)

Op-ed: Will phar­ma re­al­ly pay for Trump’s lat­est law­less promise to 33 mil­lion Medicare ben­e­fi­cia­ries? Not like­ly

Sitting atop the executive branch, President Donald Trump is the ultimate authority at the FDA. He can fast track any vaccine to approval himself. If it came to that, of course.

What he can’t do is unilaterally order the legislative branch to loosen the Treasury’s coffers for $6.6 billion. Nor can he command pharmaceutical companies to pay for $200 vouchers sent to 33 million Medicare beneficiaries for prescription drugs before the election.

New York governor Andrew Cuomo (AP Images)

An­drew Cuo­mo says New York will un­der­take its own vac­cine re­view process, and wouldn’t rec­om­mend trust­ing the fed­er­al gov­ern­ment

The concerns keep mounting over President Donald Trump’s politicization of the FDA and other federal agencies guiding the development of a safe and effective vaccine. And today, the telegenic New York governor Andrew Cuomo appeared to introduce even more politics into the matter — latest in an ongoing series of incidents that have cast the proudly independent FDA in starkly political terms.

During his daily press conference Cuomo said that the state will review any coronavirus vaccines approved by the federal government, citing a lack of trust in the Trump administration. The announcement comes one day after Trump accused the FDA of making an “extremely political” move in proposing stricter vaccine guidance.

President Trump walks past HHS secretary Alex Azar (Getty Images)

Azar falls in line un­der Trump again. Ex­perts say he's re­in­forc­ing a dark sig­nal sent to the FDA

In the latest incident where Alex Azar has steadfastly taken the side of President Donald Trump over that of the FDA, the HHS secretary was noncommittal this morning when asked if he supports the attempt by his subordinates at the FDA to strengthen guidelines for a vaccine EUA.

Appearing on NBC’s Today Show, the HHS secretary muddied the waters, stating that the guidance that matters is the one that is “actually already out there.”

Covid-19 roundup: Op­er­a­tion Warp Speed's 7th vac­cine is live at­ten­u­at­ed; Small biotech touts big suc­cess where gi­ants have failed

Operation Warp Speed is stacking its vaccine portfolio with a “TBD” new candidate: a live attenuated vaccine that can be administered in a single dose, potentially as an oral formulation rather than an injection.

Sound familiar?

That could be because the unannounced candidate appears to match the profile of an inoculation being developed by Merck, according to Bloomberg, which first reported the development based on a presentation by Moncef Slaoui.

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