In­vestors fret as new reg­u­la­to­ry probes spur fresh de­lays to Roche's $4.3B Spark buy­out

An­oth­er day, an­oth­er de­lay. On Mon­day, Roche re­vealed that in ad­di­tion to the US Fed­er­al Trade Com­mis­sion, the UK’s Com­pe­ti­tion and Mar­kets Au­thor­i­ty is prob­ing the Spark Ther­a­peu­tics takeover deal, trig­ger­ing an­oth­er de­lay of the $4.3 bil­lion ac­qui­si­tion an­nounced in Feb­ru­ary.

Spark share­hold­ers now have un­til Ju­ly 31 to ten­der their shares.

Since its last up­date in mid-May, the per­cent­age of shares al­ready sold inched up to 21.1% from 21%, low­er than 26.1% and 29.4% reg­is­tered on pre­vi­ous dead­lines. These num­bers are still a far cry from the 50% re­quired to con­sum­mate the deal, but Roche has main­tained it’s not un­usu­al for “a sig­nif­i­cant por­tion of share­hold­ers” to wait un­til the last days of the of­fer pe­ri­od.

“We think this is ap­pro­pri­ate dili­gence by FTC but there is un­like­ly any ma­jor is­sue and the deal will close smooth­ly,” Jef­feries an­a­lysts wrote in a note, not­ing that he­mo­phil­ia mar­ket is crowd­ed and that the way a gene ther­a­py is en­gi­neered to work is a stark con­trast to Roche’s ex­ist­ing Hem­li­bra he­mo­phil­ia drug.

“If any­thing, the reg­u­la­tors should see the nu­mer­ous com­peti­tors as pos­i­tive for the mar­ket dy­nam­ics where­by price could po­ten­tial­ly come way down over time and all the play­ers will have to bat­tle for pa­tients (sim­i­lar to Hep C mar­ket in that re­spect)…For these fun­da­men­tal im­por­tant rea­sons, we don’t see how this will be an an­ti-com­pet­i­tive merg­er and un­der­stand the reg­u­la­tors are think­ing about it in the long-term,” they wrote.

Roche’s orig­i­nal dead­line for the deal clos­ing was set for the first half of 2019. “(I)t is un­like­ly that the trans­ac­tion will close dur­ing the first half of 2019. The par­ties ex­pect the trans­ac­tion to close in 2019,” a Roche spokesper­son tells End­points News.

Mean­while the UK’s CMA has al­so opened an in­ves­ti­ga­tion in­to the pro­posed takeover to de­ter­mine whether the deal could hurt com­pe­ti­tion in the UK. Pend­ing the out­come of its in­ves­ti­ga­tion, the CMA has is­sued an in­ter­im en­force­ment or­der  which pre­cludes Roche from in­te­grat­ing Spark in­to the com­pa­ny, and stip­u­lates the two main­tain and op­er­ate the two busi­ness­es sep­a­rate­ly — for now. Both firms are co­op­er­at­ing with the CMA, they said on Mon­day.

“The is­suance of an IEO does not of it­self mean that the CMA has sub­stan­tive con­cerns about the ac­qui­si­tion nor that the CMA has the le­gal pow­er to in­ter­vene to im­pose con­di­tions to the ac­qui­si­tion pro­ceed­ing,” the spokesper­son added.

Spark’s in­vestors ex­pressed their frus­tra­tion with the lat­est de­lay, as the com­pa­ny’s shares $ONCE tum­bled about 9% to $99.80 in ear­ly morn­ing trad­ing.

In a Feb­ru­ary Q&A doc­u­ment in­tend­ed to pla­cate em­ploy­ees, Spark sug­gest­ed that Roche in­tend­ed to al­low the Philadel­phia-based com­pa­ny to op­er­ate as an au­tonomous gene ther­a­py spe­cial­ist, while pour­ing in the re­sources to build a whole unit around it.

Im­age: Spark CEO Jef­frey Mar­raz­zo at an End­points News break­fast pan­el at the 2019 JP Mor­gan con­fer­ence in San Fran­cis­co – pho­to by Jeff Ru­mans for End­points News

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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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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George Scangos / Credit: Cornell University

ARCH, Soft­Bank-backed Vir Biotech­nol­o­gy un­der­whelms with $143 mil­lion IPO

George Scangos went back to Wall Street, and came back 700 million pennies short.

Scangos’ vaunted startup Vir Biotechnology raised $143 million in an IPO they hoped would earn $150 million. Shares were priced at $20, the low-end of the $20-$22 target.

Launched with backing from ARCH Venture’s Robert Nelsen, Masayoshi Son’s SoftBank Vision Fund, and the Bill & Melinda Gates Foundation, the infectious disease startup was one of a new wave of well-resourced biotechs that emerged with deep enough coffers to pursue a full R&D line rather than slowly build their case by picking off a single lead program.