A few key rea­sons why Bio­gen has now be­come a buzzed about takeover tar­get

Strug­gling with rev­enue and keep­ing in­vestors’ in­ter­est in its pipeline as its CEO heads for the ex­its, Bio­gen has drawn some in­ter­est from two big play­ers about a pos­si­ble takeover. The Wall Street Jour­nal re­port­ed Tues­day af­ter­noon that Al­ler­gan and Mer­ck have both made over­tures to Bio­gen to sound out their in­ter­est in a deal.

Bio­gen’s shares $BI­IB raced up 9%, adding bil­lions in mar­ket cap as the in­vest­ment com­mu­ni­ty looked to jump in­to a pos­si­ble deal in the mak­ing. But by ear­ly Tues­day evening CN­BC was fol­low­ing up with a re­port that Al­ler­gan, which may have had a hard time mak­ing a buy­out work un­der cur­rent tax rules, was un­like­ly to fol­low up.

The Jour­nal piece made it clear that there’s no bid on the ta­ble and may not be one. The over­tures were “in­for­mal and pre­lim­i­nary,” its re­port­ing team not­ed, not sig­ni­fy­ing much in­ter­est in a hos­tile move if nec­es­sary.

CEO George Scan­gos

The ru­mors come just days af­ter Bio­gen CEO George Scan­gos an­nounced plans to ex­it the com­pa­ny, plan­ning to hand over the reins to a new ex­ec­u­tive ready to tack­le the next phase. Scan­gos him­self has down­played any talk of a po­ten­tial takeover, and an­a­lysts have won­dered why he would be leav­ing if the com­pa­ny was about to go in­to an auc­tion, with big po­ten­tial pay­offs for the top team.

In many ways, Bio­gen would make a tempt­ing ac­qui­si­tion, with a mar­ket cap now sit­ting at about $75 bil­lion. It has sev­er­al fran­chise drugs on the mar­ket and a few close­ly-watched pro­grams in the clin­ic, in­clud­ing a new late-stage pro­gram part­nered with Io­n­is that just cleared a Phase III study for spinal mus­cu­lar at­ro­phy. But on­ly a hand­ful of play­ers in the in­dus­try could pull off a deal that size.

Com­pli­cat­ing any buy­out, Bio­gen’s R&D group has made a ma­jor in­vest­ment in fields like Alzheimer’s, where its drug ad­u­canum­ab rep­re­sents an­oth­er big swing at a po­ten­tial­ly enor­mous mar­ket. But it’s in the high­est risk are­na in biotech, mak­ing a val­u­a­tion dev­il­ish­ly hard to reach with­out a de­vice like a CVR, pay­ing off on mile­stones.

Bio­gen’s prob­lem, and the rea­son why it’s vul­ner­a­ble now, is that Scan­gos and his team sad­dled the com­pa­ny with an ul­tra high risk pipeline with few near-term cat­a­lysts able to whet Wall Street’s ap­petite as its Tec­fidera fran­chise fades. That forced the com­pa­ny to ex­e­cute a ma­jor re­or­ga­ni­za­tion last year to cut costs. And a re­cent set­back in its lat­est at­tempt to come up with a new drug that could po­ten­tial­ly re­verse the ef­fects of mul­ti­ple scle­ro­sis sim­ply high­light­ed the fix it is in now.

For many an­a­lysts, that weak­ened po­si­tion made it all the more like­ly that Bio­gen would have to pull off sev­er­al big deals of its own to re­plen­ish the pipeline. In the words of Baird’s Bri­an Sko­r­ney: “We think it’s time for Bio­gen to buy or be bought.”

Al­ler­gan is run by Brent Saud­ers, a deal-mak­ing CEO who just land­ed a big pay­off now that the Te­va gener­ics deal has gone through. And while Mer­ck has its new check­point drug Keytru­da to boast about, it al­so has plen­ty of rea­sons to find val­ue in a com­pa­ny like Bio­gen.

Every­one loves a ru­mored buy­out deal, so ex­pect lots of smoke as every­one tries to fig­ure out if there’s any fire at Bio­gen.

Hal Barron and Rick Klausner (GSK, Lyell)

Ex­clu­sive: GSK’s Hal Bar­ron al­lies with Rick Klaus­ner’s $600M cell ther­a­py start­up, look­ing to break new ground blitz­ing sol­id tu­mors

LONDON — Chances are, you’ve heard little or nothing about Rick Klausner’s startup Lyell. But that ends now.

Klausner, the former head of the National Cancer Institute, former executive director for global health at the Gates Foundation, co-founder at Juno and one of the leaders in the booming cell therapy field, has brought together one of the most prominent teams of scientists tackling cell therapy 2.0 — highlighted by a quest to bridge a daunting tech gap that separates some profound advances in blood cancers with solid tumors. And today he’s officially adding Hal Barron and GlaxoSmithKline as a major league collaborator which is pitching in a large portion of the $600 million he’s raised in the past year to make that vision a reality.

“We’ve being staying stealth,” Klausner tells me, then adding with a chuckle: “and going back to stealth after this.”

“Cell therapy has a lot of challenges,” notes Barron, the R&D chief at GSK, ticking off the resistance put up by solid tumors to cell therapies, the vein-to-vein time involved in taking immune cells out of patients, engineering them to attack cancer cells, and getting them back in, and more. “Over the years Rick and I talked about how it would be wonderful to take that on as a mission.”

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First place fin­ish: Eli Lil­ly just moved to fran­chise leader with their sec­ond mi­graine drug OK in 1 year

In a rare twist for Eli Lilly’s historically slow-moving R&D group, the pharma giant has seized bragging rights to a first-in-class new drug approval. And all signs point to an aggressive marketing followup as they look to outclass some major franchise rivals hobbled by internal dissension.

The FDA came through with an OK for lasmiditan on Friday evening, branding it as Reyvow and lining it up — once a substance classification comes through from the DEA — for a major market release. The oral drug binds to 5-HT1F receptors and is designed to stop an acute migraine after it starts. That makes it a complementary therapy to their CGRP drug Emgality, which has a statistically significant impact on preventing attacks.

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Pfizer, South San Francisco — Jeff Rumans for Endpoints News

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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Allogene HQ Open House on September 17, 2019 in South San Francisco. (Jeff Rumans, Endpoints News)

The next 10 years: Where is biotech head­ed?

The last 10 years have seen a revolution in drug development. Timelines have shortened, particularly in oncology. Regulators have opened up. Investment has skyrocketed. China became a player. Biotechs have multiplied as gene and cell therapy has exploded — offering major new advances in the way diseases are treated, and sometimes cured.

So where are we headed from here? I journeyed out to San Francisco in September to discuss the answer to that question at Allogene’s open house. If the last 10 years have been an eye-opener, what does the next decade hold in store?

Patrick Mahaffy, Getty Images

Court green-lights Clo­vis case af­ter de­tail­ing ev­i­dence the board ‘ig­nored red flags’ on false safe­ty and ef­fi­ca­cy da­ta

Clovis investors have cleared a major hurdle in their long-running case against the board of directors, with a Delaware court making a rare finding that they had a strong enough case against the board to proceed with the action.

In a detailed ruling at the beginning of the month that’s been getting careful scrutiny at firms specializing in biotech and corporate governance, the Delaware Court of Chancery found that the attorneys for the investors had made a careful case that the board — a collection of experts that includes high-profile biotech entrepreneurs, a Harvard professor and well-known investigator as well as Clovis CEO Patrick Mahaffy — repeatedly ignored obvious warnings that Mahaffy’s executive crew was touting inflated, unconfirmed data for their big drug Roci. Serious safety issues were also reportedly overlooked while the company continued a fundraising campaign that brought in more than a half-billion dollars. And that leaves the board open to claims related to their role in the fiasco.

The bottom line:

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Bill Gates backs Gink­go Biowork­s' $350M raise to fu­el the buzzy syn­thet­ic bi­ol­o­gy 'rev­o­lu­tion'

If you want to understand Ginkgo Bioworks, the name should suffice: Bioworks, a spin off “ironworks,” that old industrial linchpin devoted to leveraging scale as a wellspring for vast new industries capable of remaking society. Ginkgo wants to be the ironworks for the revolution it’s heralded with as much fanfare as they can, playing off of one of the buzziest technologies in biotech.

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UCB bags a ri­val to Soliris in $2.1B buy­out deal — but will an in­creas­ing­ly vig­i­lant FTC sign off?

UCB is buying out Ra Pharma $RARX, announcing an acquisition deal that rings up at $48 a share, or $2.1 billion net of cash, and puts them toe-to-toe with Alexion on a clinical showdown.

Ra shares closed at $22.70 on Wednesday.

There’s a small pipeline in play at Ra, but UCB is going for the lead drug — a C5 inhibitor called zilucoplan in Phase III for myasthenia gravis (MG) looking to play rival to Alexion’s Soliris. Soliris has the market advantage, though, with a much earlier approval in MG in late 2017 that UCB feels confident in challenging.

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A new play­er is tak­ing the field in a push for a he­mo­phil­ia A gene ther­a­py, and it’s a big one

BioMarin, the execs at Spark (and buyer-to-be Roche) as well as the Sangamo/Pfizer team have a new rival striding onto the hemophilia block. And it’s a big one.

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Stuck with a PhI­II gene ther­a­py fail­ure at 96 weeks, Gen­Sight prefers the up­beat as­sess­ment

Two years after treatment, the best thing that GenSight Biologics $SIGHT can say about their gene therapy for vision-destroying cases of Leber Hereditary Optic Neuropathy is that it’s just a bit better than a placebo — just maybe because one treatment can cover both eyes.

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