Ex­pan­sive So­sei lays out a $534M ac­qui­si­tion plan for the am­bi­tious saR­NA biotech Mi­NA

Af­ter swoop­ing in to buy Hep­tares a cou­ple of years ago in a $400 mil­lion deal, So­sei has put a new ac­qui­si­tion play in mo­tion. This morn­ing CEO Pe­ter Bains at So­sei took the first step to­ward a new buy­out, snag­ging 25.6% of the eq­ui­ty of Mi­NA Ther­a­peu­tics and an ex­clu­sive op­tion to ac­quire the com­pa­ny for $45 mil­lion in cash.

Right now Mi­NA is putting its small ac­ti­vat­ing RNA (saR­NA) tech­nol­o­gy to a Phase I/IIa test in liv­er can­cer. If the tri­al works, fol­low­ing an es­tab­lished sched­ule of mile­stones, So­sei can com­plete the deal for an­oth­er $180 mil­lion in cash plus $309 mil­lion more in mile­stones — for a to­tal of $534 mil­lion.

The way Bains ex­plains the deal, So­sei is tak­ing an­oth­er step to­ward cre­at­ing a glob­al com­pa­ny, based in Japan and pur­su­ing biotechs with a glob­al reach of their own.

Robert Habib, Mi­NA CEO

Just af­ter Al­ler­gan and Pfiz­er went their sep­a­rate ways in ear­ly 2016, for ex­am­ple, Al­ler­gan chose to seed an am­bi­tious de­vel­op­ment pact with Hep­tares on new drugs to ad­dress the cog­ni­tive de­cline and be­hav­ioral is­sues as­so­ci­at­ed with Alzheimer’s. Then Hep­tares swooped in to buy GPCR tech in an ac­qui­si­tion of Switzer­land’s G7 ear­li­er this year, which was quick­ly re­ward­ed with a pact from Dai­ichi Sankyo.

Now So­sei wants to take a step-by-step ap­proach to find­ing out if Mi­NA can boost its pipeline with a new slate of its saR­NA ther­a­peu­tics, which adopts a new ap­proach to kick­ing mes­sen­ger RNA in­to ac­tion to cre­ate new drugs — pro­teins — us­ing the body’s cells as a man­u­fac­tur­ing cen­ter. But it’s not just div­ing in all at once. Bains wants to see some da­ta be­fore com­ing back for the whole thing.

Mi­NA brought to­geth­er a group of in­ves­ti­ga­tors like Long-Chen Li, Har­vard’s David Corey and Nagy Habib at Im­pe­r­i­al who have been de­vel­op­ing their RNA tech to trig­ger pro­tein pro­duc­tion to ad­dress spe­cif­ic ail­ments. And their first clin­i­cal en­deav­or for MTL-CEB­PA marks a shot at treat­ment-re­sis­tant liv­er can­cer — an am­bi­tious tar­get.

Mes­sen­ger RNA is a nascent field, but it’s grow­ing fast. Mod­er­na raised a whop­ping $1.9 bil­lion for its work, be­fore see­ing the first snap­shot of hu­man da­ta. Ger­many’s Cure­Vac is al­so hot on the trail.

Says Bains:

We be­lieve MTL-CEB­PA could al­low us to ad­vance our pipeline strat­e­gy with a nov­el clin­i­cal as­set that could be de­vel­oped and ul­ti­mate­ly com­mer­cial­ized by So­sei. We rec­og­nize that this as­set is ear­ly stage and that more ro­bust da­ta will be avail­able in the near term; these con­sid­er­a­tions have in­flu­enced the pru­dent and phased deal struc­ture. We al­so be­lieve that Mi­NA’s RNA ac­ti­va­tion plat­form can be ap­plied to oth­er gene tar­gets, pro­vid­ing the op­por­tu­ni­ty to cre­ate a pipeline of in­no­v­a­tive prod­ucts.

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Dave Marek, Myovant CEO

My­ovant board balks as ma­jor­i­ty own­er Sum­it­o­mo swoops in with a $2.5B deal to buy them out

Three years after Sumitomo scooped up Roivant’s 46% stake in the publicly traded Myovant $MYOV as part of a 5-company, $3 billion deal, they’re coming back for the whole thing.

But these other investors at Myovant want more than what the Japanese pharma company is currently offering to pay at this stage.

Sumitomo is bidding $22.75 a share for the outstanding stock, which now represents 48% of the company after Sumitomo bumped its ownership since the original deal with Roivant. Myovant, however, created a special committee on the board, and they’re shaking their heads over the offer.

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Justin Klee (L) and Joshua Cohen, Amylyx co-CEOs (Cody O'Loughlin/The New York Times; courtesy Amylyx)

Ad­vo­cates, ex­perts cry foul over Amy­lyx's new ALS drug, cit­ing is­sues with price, PhI­II com­mit­ment

Not 24 hours after earning the first ALS drug approval in five years, Amylyx Pharmaceuticals’ Relyvrio is already drawing scrutiny. And it’s coming from multiple fronts.

In an investor call Friday morning, Amylyx revealed that it would charge about $158,000 per year, a price point that immediately drew backlash from ALS advocates and some outside observers. The cost reveal had been highly anticipated in the immediate hours after Thursday evening’s approval, though Amylyx only teased Relyvrio would cost less than previously approved drugs.

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Albert Bourla, Pfizer CEO (Gian Ehrenzeller/Keystone via AP)

Can a smart­phone app de­tect Covid? Pfiz­er throws down $116M to find out

What can a cough say about a patient’s illness? Quite a bit, according to ResApp Health — and Pfizer’s listening.

The pharma giant is shelling out about $116 million ($179 million AUD) to scoop up the University of Queensland spinout and its smartphone technology that promises to diagnose Covid and other respiratory illnesses based on cough and breathing sounds, the university announced last week.

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Big Phar­ma heavy­weights seek tweaks to FDA's clin­i­cal out­come as­sess­ment guid­ance

Pfizer, GSK, Janssen, Regeneron, Boehringer Ingelheim and at least a half dozen other companies are calling on the FDA to provide significantly more clarity in its draft guidance from this summer on clinical outcome assessments, which are a type of patient experience.

The draft is the third in a series of four patient-focused drug development guidance documents that the FDA had to create as part of the 21st Century Cures Act, and they describe how stakeholders (patients, caregivers, researchers, medical product developers and others) can collect and submit patient experience data and other relevant information for medical product development and regulatory decision-making.

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Will Lewis, Insmed CEO

In­smed plots up­com­ing med launch­es built on its first drug lessons and con­sumer play­book mar­ket­ing strate­gies

With its first drug launch in the books, Insmed is now focusing on building out a road map for upcoming products – with an eye on consumer marketing strategies.

For CEO Will Lewis, that means tapping consumer insights as early as possible and developing products and packaging that are intuitive and easy to use. It also means translating those patient experiences into creative and atypical biopharma marketing, and in both cases, taking a page from consumer marketers’ playbooks.

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Severin Schwan, outgoing Roche CEO (via Getty Images)

Roche hires new di­ag­nos­tics chief from with­in, ahead of C-suite shake-up

More than two months after Severin Schwan announced he’s leaving Roche and handing the reins to diagnostics chief Thomas Schinecker, the pharma giant has revealed who’s taking Schinecker’s place.

Matt Sause, who currently leads Roche’s North American diagnostics business, is popping the cork on the big global promotion to take effect on March 15. The 20-year Roche veteran has served a handful of roles across the company’s diagnostics and pharma units, including a stint at Genentech where he was lifecycle leader for blockbuster Tecentriq’s head and neck cancer programs.

FTC chair Lina Khan with National Community Pharmacists Association CEO Douglas Hoey (NCPA via Twitter)

FTC chair Lina Khan pledges to use all tools to in­ves­ti­gate PBMs

KANSAS CITY, Mo. — Pharmacy benefit managers have become a thorn in the side of the pharma and insurance industries in recent years, and just a couple of months after the Federal Trade Commission signaled it would investigate unlawful PBM practices, FTC chair Lina Khan is looking to turn up the heat even more.

Khan sat down with National Community Pharmacists Association CEO Douglas Hoey on Monday morning at the NCPA’s annual convention, with a fireside chat in the heart of the Midwest.

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Rob Etherington, Clene CEO

Star­tup's gold nanocrys­tal ALS drug flops a PhII tri­al, a re­minder of the dis­ease's ob­sta­cles de­spite Amy­lyx OK

Despite the FDA approving an ALS drug for the first time in five years last week, the disease continues to fluster researchers, and another biotech is feeling the pain of a mid-stage failure.

Clene Nanomedicine reported early Monday that its ALS program, which uses gold nanocrystals to try to catalyze intracellular reactions, did not achieve its Phase II primary or secondary endpoints. And in a press release, the company noted for the first time that it’s speaking with “potential strategic partners” about the program — language that typically indicates a biotech is preparing to sell off an asset.

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