Al­ler­gan goes on a buy­ing spree for NASH drugs, adding Akar­na in M&A dou­ble head­er

Brent Saun­ders, Al­ler­gan

Al­ler­gan $AGN is pulling out all the stops in ramp­ing up its own NASH pipeline in record time. Just hours af­ter an­nounc­ing plans to bag To­bi­ra $TBRA for a jaw-drop­ping pre­mi­um in a $1.7 bil­lion deal, the fast-grow­ing phar­ma bagged the fledg­ling UK biotech Akar­na for $50 mil­lion up­front and an un­spec­i­fied set of mile­stones.

This new deal adds Akar­na’s lead ther­a­py, one of its non-bile acid FXR ag­o­nists dubbed AKN-083. And there are more pre­clin­i­cal FXR ther­a­pies in the works that will now be fed in­to Al­ler­gan’s overnight R&D ex­pan­sion. Akar­na an­nounced a mod­est $15 mil­lion B round back in Feb­ru­ary.

Akar­na is fo­cused on a nu­clear hor­mone re­cep­tor ex­pressed in the liv­er, which many be­lieve is the kind of mas­ter reg­u­la­tor that can be used to treat NASH, a fat­ty liv­er dis­ease that’s grow­ing rapid­ly. In­ter­cept’s $ICPT Ocali­va, ap­proved in the US, tar­gets FXR. Gilead’s $GILD ex­per­i­men­tal GS-9674 is al­so a play­er. Al­ler­gan will now set out to try and beat them both in up­com­ing clin­i­cal stud­ies.

Al­ler­gan an­nounced this morn­ing that it had agreed to pay To­bi­ra’s in­vestors six times what their stock was worth at the close of busi­ness on Mon­day. That deal de­liv­ered two drugs, in­clud­ing ceni­crivi­roc, which flunked a Phase IIb study for NASH in Ju­ly. The South San Fran­cis­co-based biotech, though, said it got enough pos­i­tive da­ta on a sec­ondary end­point to war­rant a move in­to a piv­otal Phase III pro­gram.

Al­ler­gan CEO Brent Saun­ders has said he plans a se­ries of step­ping stone deals to beef up the pipeline, with new deals rang­ing from Phase I through late-stage de­vel­op­ment. He’s not wait­ing around to sa­vor each one, in­stead choos­ing to leap from one to the next. Al­ler­gan ac­quired Vi­tae just a few days ago, and more deals are clear­ly in the works.

David Nichol­son, Chief Re­search & De­vel­op­ment Of­fi­cer, Al­ler­gan, had this to say about deal num­ber two:

“AKN-083 is a high­ly dif­fer­en­ti­at­ed, se­lec­tive FXR ag­o­nist which is a strong­ly val­i­dat­ed ther­a­peu­tic mech­a­nism for the treat­ment of NASH. In ad­di­tion, AKN-083 is a non-bile acid FXR ag­o­nist that in pre­clin­i­cal stud­ies has shown high affin­i­ty, po­ten­cy and se­lec­tiv­i­ty with a bet­ter tol­er­a­bil­i­ty pro­file. These char­ac­ter­is­tics make AKN-083 a great ad­di­tion to our port­fo­lio of as­sets for the treat­ment of NASH.”

Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

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Covid-19 roundup: BAR­DA sup­ports Op­er­a­tion Warp Speed with big $628M con­tract to ser­vice Amer­i­ca's vac­cine pro­duc­tion needs

Another BARDA contract designed to service America’s Covid-19 vaccine needs has been deployed.

The White House-led initiative designed to bankroll development to bring a vaccine to the American public by this fall — Operation Warp Speed — has via BARDA handed a meaty contract to the maker of an FDA-licensed anthrax vaccine to open up its manufacturing apparatus to shore up production of Covid-19 vaccines.

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FDA de­lays de­ci­sion on No­var­tis’ po­ten­tial block­buster MS drug, wip­ing away pri­or­i­ty re­view

So much for a speedy review.

In February, Novartis announced that an application for their much-touted multiple sclerosis drug ofatumumab had been accepted and, with the drug company cashing in on one of their priority review vouchers, the agency was due for a decision by June.

But with June less than 48 hours old, Novartis announced the agency has extended their review, pushing back the timeline for approval or rejection to September. The Swiss pharma filed the application in December, meaning their new schedule will be nearly in line with the standard 10-month window period had they not used the priority voucher.

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Adam Keeney (NodThera)

As NL­RP3 play­ers head for first clin­i­cal face off, No­vo, Sanofi fu­el trans-At­lantic con­tender with $55M

In the relative short history of inflammasome research, Adam Keeney sees two time points marking major breakthroughs: The early 2000s, when the role of inflammasomes as a major innate immunity node was elucidated; and 2015, when Pfizer found out a compound it thought was targeting IL-1 actually blocks NLRP3. Keeney’s biotech, NodThera, was founded the year after alongside several others to create its own superior small molecule drugs.

Cana­da’s drug price re­forms de­layed to 2021

Amendments to Canada’s Patented Medicines Regulations will now be put in place 1 January 2021, delaying implementation of the sweeping drug pricing reforms by six months.

The new timeline represents a further adjustment from the schedule laid out in 2017, when Health Canada first proposed overhauling its drug pricing review process.

Draft pricing guidelines promulgated by the government of Canada’s Patent Medicine Prices Review Board (PMPRB) have been available for stakeholder and public consultation since November 2019. Based on this feedback, the PMPRB will release a final set of revised guidelines the week of 15 June 2020, with a 30-day period of public written consultation to follow.

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Why Mer­ck wait­ed, and what they now bring to the Covid-19 fight

Nicholas Kartsonis had been running clinical infectious disease research at Merck for almost 2 years when, in mid-January, he got a new assignment: searching the pharma giant’s vast libraries for something that could treat the novel coronavirus.

The outbreak was barely two weeks old when Kartsonis and a few dozen others got to work, first in small teams and then in a larger task force that sucked in more and more parts of the sprawling company as Covid-19 infected more and more of the globe. By late February, the group began formally searching for vaccine and antiviral candidates to license. Still, while other companies jumped out to announce their programs and, eventually and sometimes controversially, early glimpses at human data, Merck remained silent. They made only a brief announcement about a data collection partnership in April and mentioned vaguely a vaccine and antiviral search in their April 28 earnings call.

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Mark Genovese (Stanford via Twitter)

Gilead woos fil­go­tinib clin­i­cal in­ves­ti­ga­tor from Stan­ford to lead the charge on NASH, in­flam­ma­to­ry dis­eases

With an FDA OK for the use of filgotinib in rheumatoid arthritis expected to drop any day now, Gilead has recruited a new leader from academia to lead its foray into inflammatory diseases.

Mark Genovese — a longtime Stanford professor and most recently the clinical chief in the division of immunology and rheumatology — was the principal investigator in FINCH 2, one of three studies that supported Gilead’s NDA filing. In his new role as SVP, inflammation, he will oversee the clinical development of the entire portfolio.

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Stephen Isaacs, Aduro president and CEO (Aduro)

Once a high fly­er, a stag­ger­ing Aduro is auc­tion­ing off most of the pipeline as CEO Stephen Isaacs hands off the shell to new own­ers

After a drumbeat of failure, setbacks and reorganizations over the last few years, Aduro CEO Stephen Isaacs is handing over his largely gutted-out shell of a public company to another biotech company and putting up some questionable assets in a going-out-of-business sale.

Isaacs —who forged a string of high-profile Big Pharma deals along the way — has wrapped a 13-year run at the biotech with one program for kidney disease going to the new owners at Chinook Therapeutics. A host of once-heralded assets like their STING agonist program partnered with Novartis (which dumped their work on ADU-S100 after looking over weak clinical results), the Lilly-allied cGAS-STING inhibitor program and the anti-CD27 program out-licensed to Merck will all be posted for auction under a strategic review process.

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