Biotech M&A is rip­ping along now as IPOs surge and ven­ture cash flows. Who's the next big tar­get?

Over the course of the first three days of this week we’ve been treat­ed to two biotech buy­outs to­tal­ing $9.6 bil­lion — by it­self more than all the buy­out cash Eval­u­atePhar­ma ac­count­ed for dur­ing all of Q2 last year. And af­ter Q1 racked up close to $47 bil­lion in M&A work, there’s plen­ty of an­tic­i­pa­tion that more deals lie ahead in what could be a very busy 2018.

At the top of the to-buy list right now is Shire $SH­PG, which Take­da put in­to play with its move to flag a like­ly up­com­ing of­fer. That would be worth more than $50 bil­lion by it­self. Take­da’s in­ter­est came out of left field, but the com­pa­ny has been re­struc­tur­ing for the past two years, shed­ding R&D jobs and reeval­u­at­ing the pipeline.

Flem­ming Orn­skov

Since news of Take­da’s in­ter­est sur­faced, the re­views of Shire’s Flem­ming Orn­skov on the num­bers have been bru­tal. And if Take­da can’t fin­ish the deal, some­one else may well come along and do it. 

We still haven’t heard about any­thing big from Bio­gen $BI­IB, which most an­a­lysts would tell you needs to do some­thing im­pres­sive on the M&A front that would help spread the con­sid­er­able risk it faces on Alzheimer’s and some dis­tant cat­a­lysts for in­vestors to pon­der. And there’s been word that Cel­gene $CELG is back at it, hunt­ing new buy­outs af­ter scoop­ing up Juno in the first quar­ter, look­ing for an­oth­er deal that would help ease the con­cerns that have been grow­ing about its wob­bly per­for­mance of late.

Agios $AGIO has been one pos­si­ble tar­get men­tioned, but Cel­gene likes to roam far and wide in hunt­ing buy­out tar­gets.

This is one year when you might ex­pect the un­ex­pect­ed. No­var­tis set the tone for sur­pris­ing strate­gies with its $8.7 bil­lion deal to buy AveX­is $AVXS and its late-stage gene ther­a­py for SMA. (An­oth­er rea­son why Bio­gen, with its SMA ther­a­py Spin­raza now fac­ing an even big­ger threat, has to pull the trig­ger on some­thing im­pres­sive.) No­var­tis CEO Vas Narasimhan in­tends to make the phar­ma gi­ant a big leader in the cell and gene ther­a­py field, and he’s cut him­self free of the usu­al $2 bil­lion to $5 bil­lion bolt-on ac­qui­si­tions that had lim­it­ed their ear­li­er ac­tiv­i­ty.

You can al­so nev­er for­get Pfiz­er in these dis­cus­sions, the last of the big play­ers which still has an ap­petite for mega-merg­ers, even though they of­fer a ques­tion­able path to earn­ings growth. GSK’s new CEO Em­ma Walm­s­ley has done one con­sumer deal, and now you can ex­pect her to turn to the re­search side for new pacts. And what about Eli Lil­ly, where the new R&D chief has made it clear he’d like to do some pipeline build­ing?

M&A charts are usu­al­ly dom­i­nat­ed by sin­gle deals, as you can see in Eval­u­ate’s chart be­low. But this year the fo­cus is on a slate of multi­bil­lion-dol­lar deals more in the small to mid-range are­na. That trend will keep every­one look­ing for the next deal. And the next. And the next. 

It’s a sell­er’s mar­ket right now, with mon­ey pump­ing in­to the in­dus­try from every di­rec­tion. How long this can last is any­one’s guess.

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

Bris­tol-My­ers is clean­ing up the post-Cel­gene merg­er pipeline, and they’re sweep­ing out an ex­per­i­men­tal check­point in the process

Back during the lead up to the $74 billion buyout of Celgene, the big biotech’s leadership did a little housecleaning with a major pact it had forged with Jounce. Out went the $2.6 billion deal and a collaboration on ICOS and PD-1.

Celgene, though, also added a $530 million deal — $50 million up front — to get the worldwide rights to JTX-8064, a drug that targets the LILRB2 receptor on macrophages.

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President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

UP­DAT­ED: White House names fi­nal­ists for Op­er­a­tion Warp Speed — with 5 ex­pect­ed names and one no­table omis­sion

A month after word first broke of the Trump Administration’s plan to rapidly accelerate the development and production of a Covid-19 vaccine, the White House has selected the five vaccine candidates they consider most likely to succeed, The New York Times reported.

Most of the names in the plan, known as Operation Warp Speed, will come as little surprise to those who have watched the last four months of vaccine developments: Moderna, which was the first vaccine to reach humans and is now the furthest along of any US effort; J&J, which has not gone into trials but received around $500 million in funding from BARDA earlier this year; the joint AstraZeneca-Oxford venture which was granted $1.2 billion from BARDA two weeks ago; Pfizer, which has been working with the mRNA biotech BioNTech; and Merck, which just entered the race and expects to put their two vaccine candidates into humans later this year.

GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.

José Basel­ga finds promise in new class of RNA-mod­i­fy­ing can­cer tar­gets, lock­ing in 3 pre­clin­i­cal pro­grams with $55M

Having dived early into some of the RNA breakthroughs of the last decades — betting on Moderna’s mRNA tech and teaming up with Silence on the siRNA front — AstraZeneca is jumping into a new arena: going after proteins that modify RNA.

Their partner of choice is Accent Therapeutics, which is receiving $55 million in upfront payment to steer a selected preclinical program through to the end of Phase I. After AstraZeneca takes over, the Lexington, MA-based startup has the option to co-develop and co-commercialize in the US — and collect up to $1.1 billion in milestones in the long run. The deal also covers two other potential drug candidates.

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Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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Leen Kawas, Athira CEO (Athira)

Can a small biotech suc­cess­ful­ly tack­le an Ever­est climb like Alzheimer’s? Athi­ra has $85M and some in­flu­en­tial back­ers ready to give it a shot

There haven’t been a lot of big venture rounds for biotech companies looking to run a Phase II study in Alzheimer’s.

The field has been a disaster over the past decade. Amyloid didn’t pan out as a target — going down in a litany of Phase III failures — and is now making its last stand at Biogen. Tau is a comer, but when you look around and all you see is destruction, the idea of backing a startup trying to find complex cocktails to swing the course of this devilishly complicated memory-wasting disease would daunt the pluckiest investors.

Covid-19 roundup: Mod­er­na read­ies to en­ter PhI­II in Ju­ly, As­traZeneca not far be­hind; EU ready to ne­go­ti­ate vac­cine ac­cess with $2.7B fund

Moderna may soon add another first to the Covid-19 vaccine race.

In March, the mRNA biotech was the first company to put a Covid-19 vaccine into humans. Next month, they may become the first company to put their vaccine into the large, late-stage trials that are needed to prove whether the vaccine is effective.

In an interview with JAMA editor Howard Bauchner, NIAID chief Anthony Fauci said that a 30,000-person, Phase III trial for Moderna’s vaccine could start in July. The news comes a week after Moderna began a Phase II study that will enroll several hundred people.

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Gilead bol­sters its case for block­buster hope­ful fil­go­tinib as FDA pon­ders its de­ci­sion

Before remdesivir soaked up the spotlight amid the coronavirus crisis, Gilead’s filgotinib was the star experimental drug tapped to rake in billions competing with other JAK inhibitors made by rivals including AbbVie and Eli Lilly.

Now, long term data on the drug — discovered by Gilead’s partners at Galapagos and posted as part of a virtual medical conference — have solidified the durability and safety of filgotinib in patients with rheumatoid arthritis, spanning data from three late-stage trials. An FDA decision on the drug is expected this year.