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.

From left to right: Lilian Kim, Associate Director Business Development; John Moller, CEO; Yooni Kim, Executive Director, Asia Operations; Michelle Park, Director South Korea Operations.

Novotech CRO sees 26% growth in Asia tri­al ac­tiv­i­ty from biotechs, but still plen­ty of ca­pac­i­ty

As the Asia-Pacific clinical trials sector continues to grow rapidly, Novotech the Asia-Pacific-based CRO is seeing biotech clinical activity up by 26%. But says there is still plenty of capacity in the region that features advanced medical facilities, supportive regulatory environments, and more than 2.3 billion people, largely treatment naïve, living in urban areas.

China, South Korea and Australia have the most studies registered as recruiting or about to recruit according to ClinicalTrials.Gov.

Pfizer, South San Francisco — Jeff Rumans for Endpoints News

UP­DAT­ED: Pfiz­er takes aim at a flag­ship fran­chise at Sanofi and Re­gen­eron — and scores a few di­rect hits

Count Pfizer in as a top player in the blockbuster game of JAK1 inhibitors.

Over the weekend the pharma giant posted some stellar Phase III efficacy data for their heavyweight contender abrocitinib in atopic dermatitis (eczema) that lines up ahead of a booming Dupixent (dupilumab), a blockbuster in the portfolios of Regeneron and Sanofi. And they put some real distance ahead of Eli Lilly’s trailing Olumiant, which made a delayed initial arrival on the market for rheumatoid arthritis after the FDA hobbled it with some additional hurdles on safety concerns.

JADE-MONO-1 scores well for Pfizer, teeing up what will be an intensely followed breakdown of the JADE MONO-2 data, which the pharma giant recently top-lined as “similar” to the first Phase III when tested against a placebo — a control group that has been easily outclassed by all the drugs in this market niche.

As of now, Pfizer looks to be equipped to run into the review stage — advantaged by a breakthrough therapy designation that is intended to speed up the regulatory process.

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A preda­tor's world? Top an­a­lyst sees the 'haves' and the 'haven't­s' di­verge as biotech bub­bles form — and col­lapse

Josh Schimmer

We’ve all seen the deluge of cash that’s been pouring into biotech from every angle: VCs, IPOs and follow-ons have generated billions in capital for new and emerging drug developers with ready access to some powerful new tech. But Evercore ISI’s Josh Schimmer is asking where we’re headed from here.

His answer is neither apocalyptic nor universally blissful, but if he’s right — and this is a discussion we’re hearing much, much more about at a time of growing economic and industry uncertainty — we may well be at a crossroads that could affect valuations, M&A and the entire global industry that has formed over the past 5 years.

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US mulls tar­iffs on Swiss drug ex­ports, weigh­ing on No­var­tis and Roche –  re­port

The leading Swiss newspaper has reported that the US is considering placing tariffs on pharmaceuticals from Switzerland. Roche and Novartis stock each fell 1% after the news broke.

Neue Zürcher Zeitung reported that US Trade Representative Robert Lighthizer told pharmaceutical representatives the Trump administration was considering the move. Tariffs do not appear to be in the immediate offing, but they would potentially affect Swiss giants Novartis and Roche along with other companies that manufacture in Switzerland, including Merck KGaA and US biotech Biogen, which is currently constructing a new facility in the country.

Neil Kumar, Endpoints

Bridge­Bio drops bid to re­claim Ei­dos af­ter di­rec­tors spurn 3 of­fers

A couple of months ago a newly public BridgeBio turned some heads by disclosing that it had made a bid for subsidiary Eidos Therapeutics in hopes of gobbling up the 34% stake that it doesn’t already own. Two offers later, the parties are calling it off.

A special committee of independent directors at the smaller biotech led by RA Capital’s Rajeev Shah and ex-Portola CEO William Lis first rejected the parent company’s initial offer — which would swap 1.3 BridgeBio shares for each Eidos share — on September 12. In the latest announcement, BridgeBio revealed that it eventually raised the offer to 1.5 shares and made $110 million available for all-cash or mixed consideration options, but Eidos still wasn’t interested.

Mark Foley, Revance

HR vi­o­la­tion push­es Re­vance co-founder out, vault­ing for­mer Zel­tiq chief to the helm

Months after Revance amended the terms of its Botox biosimilar collaboration with Mylan, the Newark, California-based drug developer disclosed its co-founder Dan Browne is stepping down, in what appears to be mysterious circumstances.

The company — which is also developing a rival to Allergan’s formidable Botox franchise — on Monday said Browne is departing “due to misjudgment in handling an employee matter,” that has also culminated in his resignation from Revance’s board of directors.

In-house FDA re­view flags a sus­pi­cious im­bal­ance in deaths as Sh­iono­gi hunts an OK for an­tibi­ot­ic

Shionogi has some big questions to answer if they plan to win an FDA panel’s backing for their new antibiotic.

While investigators have provided positive efficacy data for their new product to treat cases of complex urinary tract infections, an FDA review has flagged an imbalance of deaths between the antibiotic and a control arm. And they want the agency’s outside advisers to take a good hard look at that when they meet on Wednesday.

Cell ther­a­py start­up rais­es $16 mil­lion to fund its quest for the Holy Grail in re­gen­er­a­tive med­i­cine

In 2006, Shinya Yamanaka shook stem cell research with his discovery that mature cells can be converted into stem cells, relieving a longstanding political-ethical blockage and throwing open medical research on everything from curbing eye degeneration to organ printing.

But that process still has pitfalls, including in risk and scalability, and some researchers are exploring another way first hinted at years ago: new technology to convert mature cells directly into other mature cells without the complex and time-consuming process of first making them into stem cells.

Eye­ing $86M, Galera leads a pack of three mod­est biotech IPOs push­ing past high pro­file stum­bles

Exactly one year after kicking off a pivotal Phase III study for its lead drug — a companion for cancer patients receiving radiotherapy — Galera is looking to the Nasdaq for some new cash to complete the clinical work and fuel its commercial drive.

CEO Mel Sorensen has penciled in an $86 million ask, which was filed on the same day as liver disease company 89bio and rare disease diagnostics shop Centogene. The trio marks the first batch of IPO filings in the wake of two highly anticipated but ultimately disappointing public debuts by BioNTech and Vir, signaling dwindling biotech fervor on Wall Street. 89bio and Centogene are seeking $70 million and $69 million, respectively.