As­traZeneca teams with Chi­na-owned fund to launch a new bio­phar­ma drug de­vel­op­ment com­pa­ny

As­traZeneca is part­ner­ing up with a gov­ern­ment-owned pri­vate eq­ui­ty group in Chi­na to cre­ate a new joint ven­ture bio­phar­ma that will be charged with de­vel­op­ing new drugs for the boom­ing Asian mar­ket.

For its part, the Lon­don-based gi­ant has of­fered jobs to all staffers at its In­no­va­tion Cen­ter Chi­na in Shang­hai, with pre­vi­ous ICC head Xi­aolin Zhang tak­ing over the new ven­ture — dubbed Dizal Phar­ma­ceu­ti­cal. As of now the JV has 90 staffers, a spokesper­son for As­traZeneca tells me, with the “vast ma­jor­i­ty” of the ICC em­ploy­ees sign­ing up for the new ven­ture.

The Chi­nese Fu­ture In­dus­try In­vest­ment Fund man­aged by the Chi­na State De­vel­op­ment & In­vest­ment Cor­po­ra­tion will fund the joint ven­ture, which starts out with de­vel­op­ment rights to three pre­clin­i­cal pro­grams with plans to add more ex­per­i­men­tal meds to the mix.

Pas­cal So­ri­ot

That’s a small ini­tial pipeline for a com­pa­ny that has been op­er­at­ing in Chi­na since 1993, build­ing an or­ga­ni­za­tion cov­er­ing R&D, man­u­fac­tur­ing and sales with 11,000 staffers. But Dizal has big plans as Chi­na’s com­mu­nist gov­ern­ment re­vamps its drug de­vel­op­ment rules with an eye to ramp­ing up in­dus­try ac­tiv­i­ties. Chi­na rep­re­sents one of the big growth mar­kets glob­al­ly for As­traZeneca, and CEO Pas­cal So­ri­ot is gam­bling that a lo­cal­ly backed out­fit can make faster head­way.

Just a few weeks ago So­ri­ot boast­ed about the dou­ble-dig­it sales growth the com­pa­ny has been see­ing in Chi­na, which he ex­pects can be sus­tained for sev­er­al years to come.

The new move al­so re­moves some of the burn rate for As­traZeneca’s R&D group at a time the phar­ma gi­ant has been push­ing ahead on sev­er­al fronts, with no­table suc­cess­es on the can­cer side of the busi­ness.

So­ri­ot had this to say in a pre­pared state­ment:

As­traZeneca has a long-stand­ing and strong com­mit­ment to Chi­na, which we are re­in­forc­ing to­day with this ground-break­ing joint ven­ture. By join­ing forces with the FI­IF, we aim to ac­cel­er­ate the lo­cal dis­cov­ery and de­vel­op­ment of in­no­v­a­tive, af­ford­able med­i­cines for pa­tients in Chi­na and around the world.

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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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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Stéphane Bancel, CEO of Moderna

Mod­er­na re­fused to dis­close mR­NA vac­cine tech­nol­o­gy to Chi­na — re­port

Moderna has been protective of the intellectual property surrounding its vaccine, including being willing to go to court and accusing other companies of patent infringement. Now the most recent update puts a magnifying glass on Moderna’s dealings with China.

Per a report from the Financial Times over the weekend, China asked Moderna to hand over the intellectual property behind its megablockbuster vaccine known as Spikevax. Citing people “familiar with the matter,” the report notes that the mRNA biotech was in negotiations with China in 2020 and 2021 to sell its product in the world’s most populous country.

Marc Dunoyer, Alexion CEO (AstraZeneca via YouTube)

Up­dat­ed: As­traZeneca nabs a small rare dis­ease gene ther­a­py play­er for 667% pre­mi­um

AstraZeneca is kicking off the fourth quarter with a little M&A Monday for a gene editing player recently overcoming a second clinical hold to its only program in human studies.

The Big Pharma and its subsidiary Alexion are buying out little LogicBio for $2.07 per share. That’s good for a massive 667% premium over its Friday closing price, when it headed into the weekend at 27 cents and just weeks after Nasdaq said LogicBio would have to delist, which has been put on hold as the biotech requests a hearing. It’s one of two biotech deals to commence October, alongside the news of Incyte buying a vitiligo-focused biotech.

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Land­mark Amy­lyx OK spurs de­bate; Some... pos­i­tive? Alzheimer's da­ta; Can­cer tri­al bot­tle­neck; Sanofi's CRISPR bet; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

After brief stops in Paris and Boston, John Carroll and the Endpoints crew are staying on the road in October with their return for a live/streaming EUBIO22 in London. The hybrid event fireside chats and panels on mRNA, oncology and the crazy public market. We hope you can join him there.

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