Covid-19 roundup: Pfizer lands massive $5B+ deal with US for potential pill; Boosters for all adults are incoming

President Joe Biden listens as Pfizer CEO Albert Bourla speaks (Patrick Semansky/AP Images)

Pfiz­er’s pill to treat Covid-19 is out­pac­ing its top ri­val from Mer­ck not on­ly in terms of ef­fi­ca­cy da­ta but now in the size of its US gov­ern­ment con­tract, too.

The US on Thurs­day an­nounced it will pay $5.29 bil­lion for 10 mil­lion cours­es of Pfiz­er’s po­ten­tial treat­ment, which is the largest sin­gle pro­cure­ment of any ther­a­peu­tic or vac­cine since the pan­dem­ic be­gan. And at $529 per course for the Pfiz­er pill, that’s sig­nif­i­cant­ly cheap­er than the $2.2 bil­lion the US paid for just 3 mil­lion cours­es of Mer­ck’s treat­ment, which adds up to about $730 per course.

Both com­pa­nies are still seek­ing EUAs to mar­ket their prod­ucts, al­though based on the size of these deals, those de­ci­sions from FDA may seem like an af­ter­thought.

Da­ta from a sched­uled in­ter­im analy­sis for Pfiz­er’s po­ten­tial drug showed an 89% re­duc­tion in risk of Covid-re­lat­ed hos­pi­tal­iza­tion or death from any cause com­pared to place­bo in pa­tients treat­ed with­in three days of symp­tom on­set. Pfiz­er said it halt­ed en­roll­ment in the tri­al be­cause of the pos­i­tive re­sults, and in con­sul­ta­tion with the FDA.

Mean­while, Pfiz­er said it will con­tin­ue to in­vest up to about $1 bil­lion to sup­port the man­u­fac­tur­ing and dis­tri­b­u­tion of its pill, in­clud­ing ex­plor­ing po­ten­tial con­tract man­u­fac­tur­ing op­tions. And Pfiz­er an­nounced a de­ci­sion ear­li­er this week to sign a vol­un­tary li­cens­ing agree­ment with the Med­i­cines Patent Pool to help ex­pand ac­cess.

US gov­ern­ment to in­vest bil­lions in mR­NA man­u­fac­tur­ing, with Pfiz­er and Mod­er­na’s help

Yes­ter­day’s press brief­ing from the White House COVID-19 Re­sponse Team un­veiled an in­ter­est­ing new nugget of in­fo on how this ad­min­is­tra­tion is plan­ning to ramp up vac­cine man­u­fac­tur­ing, al­though a lot of those plans will de­pend on the kind­ness of Pfiz­er and Mod­er­na.

White House coro­n­avirus re­sponse co­or­di­na­tor Jeff Zients told re­porters that HHS is so­lic­it­ing in­ter­est from com­pa­nies that have ex­pe­ri­ence man­u­fac­tur­ing mR­NA vac­cines to iden­ti­fy op­por­tu­ni­ties to scale up their pro­duc­tion ca­pac­i­ty.

‘Im­por­tant­ly, ini­tial pro­duc­tion could pro­vide more mR­NA COVID vac­cines for the world. The goal of this pro­gram is to ex­pand ex­ist­ing ca­pac­i­ty by an ad­di­tion­al bil­lion dos­es per year, with pro­duc­tion start­ing by the sec­ond half of 2022,’ Zients said.

The pro­gram is geared to pro­duc­ing dos­es with­in six to nine months of iden­ti­fy­ing a fu­ture pathogen and en­sur­ing enough vac­cines for all Amer­i­cans. BioN­Tech’s CEO told End­points in an in­ter­view last week that his com­pa­ny is try­ing to have a plan that would have a vac­cine shipped with­in three months of iden­ti­fy­ing a new vari­ant.

The plan cur­rent­ly is to ‘com­bine the ex­per­tise of the U.S. gov­ern­ment in ba­sic sci­en­tif­ic re­search with the ro­bust abil­i­ty of phar­ma­ceu­ti­cal com­pa­nies to man­u­fac­ture mR­NA vac­cines. We hope com­pa­nies step up and act quick­ly to take us up on this op­por­tu­ni­ty to ex­pand pro­duc­tion of mR­NA vac­cines for the cur­rent pan­dem­ic and set us up to re­act quick­ly to any fu­ture pan­dem­ic threats,’ Zients said.

Com­ing soon: Mod­er­na and Pfiz­er boost­er shots for all adults

Mod­er­na and Pfiz­er have now both asked the FDA to sign off on their boost­er shots for all adults, which the agency could OK as ear­ly as this week, ac­cord­ing to the New York Times.

The CDC’s ad­vi­so­ry com­mit­tee is meet­ing to­mor­row for three hours in the af­ter­noon to dis­cuss the boost­er ef­fi­ca­cy and safe­ty da­ta, which some crit­ics have said is flim­sy, and en­tire­ly based on Is­raeli da­ta. But so far, 31 mil­lion Amer­i­cans have now re­ceived boost­ers too, ac­cord­ing to Zients.

And CDC Di­rec­tor Rochelle Walen­sky of­fered sup­port­ing da­ta on Wednes­day, telling re­porters:

In re­cent weeks, we have al­so seen ad­di­tion­al da­ta that re­in­force the im­por­tance of COVID-19 boost­ers for these pop­u­la­tions at high­er risk of se­vere dis­ease, par­tic­u­lar­ly to en­sure pro­tec­tion against se­vere ill­ness and hos­pi­tal­iza­tions…When we com­pare rates of COVID-19 dis­ease be­tween those who are vac­ci­nat­ed with two dos­es and those who have re­ceived a boost­er dose, the rate of dis­ease is marked­ly low­er for those who re­ceived their boost­er shot, demon­strat­ing our boost­ers are work­ing. FDA is cur­rent­ly eval­u­at­ing da­ta on the au­tho­riza­tion of boost­er dos­es for all peo­ple over age 18.  As we’ve done be­fore, CDC will quick­ly re­view the safe­ty and ef­fec­tive­ness da­ta and make rec­om­men­da­tions as soon as we hear from FDA.

For years, paper-based processes and individual point solutions dominated the clinical research landscape, and patient participation in clinical trials was largely an in-person engagement. But when the COVID-19 pandemic took a stronghold, traditional clinical trial methods emerged as inadequate, putting clinical trials and the life sciences industry at a crossroads. Practically overnight, the industry had to rapidly shift to decentralized clinical trial methods, while maintaining data quality and regulatory compliance.

Douglas Fambrough, Dicerna CEO (Dicerna via YouTube)

Early this year researchers at Novo Nordisk were beaming as they announced the first drug identified in their RNAi alliance with Dicerna was headed into the clinic. And now they’re coming back for the whole thing.

This morning the Copenhagen-based pharma giant put out word that it is buying Dicerna $DRNA — an RNAi pioneer that has had its up and downs over the years — for $3.3 billion. Novo is paying $38.25 a share — an 80% premium.

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Gilead is going all in — hook, line and sinker — on its oncology alliance with Arcus. And they are going for broke.

The big biotech unveiled a deal that now delivers $725 million in opt-in payments covering the clinical development programs for Arcus, ranging from their closely watched anti-TIGIT programs for domvanalimab and AB308 to etrumadenant (the A2a/A2b adenosine receptor antagonist) and quemliclustat, the small molecule CD73 inhibitor. Gilead will also cover half of the development costs, handing Terry Rosen’s biotech a deal that gives them a clear cash runway to achieving all its goals in oncology.

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Thermo Fisher CEO Mark Casper

Another week, another win for the North Carolina biotech community.

This time, it’s Thermo Fisher Scientific, the Massachusetts-based contract giant, that recently announced it had plans to build a manufacturing plant. The winner is? Mebane, NC, a 15,000-person town 25 miles northwest of Durham.

The 375,000-square-foot plant at the Buckhorn Industrial Park will manufacture pipette tips for laboratory research and bioscience use. It’s a result from a $192.5 million contract with the Department of Defense that was announced back in September, in which the company pledged to increase its ability to support Covid-19 testing.

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A new cell and gene therapy testing facility in Philadelphia’s Navy Yard is officially opened, WuXi ATU announced Monday.

The new facility includes 140,000 square feet worth of laboratories, and will enhance the company’s contract testing, development and manufacturing organization business model by tripling the company’s previous capacity.

The move helps strengthen the existing testing capacity and capability, and combines the company’s powerful testing capabilities with its advanced therapies’ process development and manufacturing platforms, such as TESSA technology for AAV manufacturing and XLenti stable solutions for lentiviral manufacturing, it says in a press release.

The holding company of a South Korean vaccine maker is in the final talks to make an investment into a US gene therapy firm.

SK Biosciences is in the process of signing a deal with the Center for Breakthrough Medicines (CBM), a Philadelphia-based CDMO. If finalized, the deal will come eight months after SK’s takeover of the French gene and cell therapy company Yposkesi.

With this move, SK takes itself a step closer to establishing a value chain of synthetic and bio pharmaceuticals in the US, Europe and Asia by 2025, the company’s head of the investment center Lee Dong-hoon said in a presentation. The CBM is known for its production of plasmid DNA. With SK’s investment, it will expand manufacturing facility in the Cellicon Valley cell and gene therapy cluster by 699,654 square feet.

Catherine Stehman-Breen and Vic Myer, Chroma CEO and CSO

A handful of the world’s most prominent gene editing-focused academics have been working for over a year on a new company built around a new approach for modifying DNA to treat disease. Known as Chroma Medicine, it launched on Wednesday with $125 million in early funding from Atlas, Newpath, Cormorant and several other VCs.

Chroma will focus on a markedly different way of modifying the genome than most of the gene editing biotechs that have arisen since CRISPR was pioneered nearly a decade ago. Instead of trying to erase or rewrite portions of a patient’s actual DNA — those As, Ts, Cs and Gs — Chroma will try to change the way that DNA is expressed in the cell.

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Sree Kant, BAKX Therapeutics CEO

BAKX Therapeutics emerged from stealth in a big way back in July, striking an $852 million deal with Ipsen for its lead cancer candidate, a small molecule designed to activate the body’s natural process for programmed cell death. And Ipsen’s putting a bit more cash in the company’s coffers to see that program into the clinic.

CEO Sree Kant unveiled a $25 million Series A round on Thursday, led by AB Magnitude Ventures Group with a hand from Ipsen and Sherpa Healthcare Partners. The funds will be used to advance the company’s BAKX activator program, which traces back to pioneering work around apoptosis by the Dana-Farber Cancer Institute’s Loren Walensky and Albert Einstein College of Medicine’s Evripidis Gavathiotis.

J&J and AbbVie are competing for the same Crohn’s disease market with their respective IL-23 drugs, Tremfya and Skyrizi. On Wednesday, J&J’s Janssen unit revealed data it thinks could prove a key differentiator but appears to lack key context.

In long-term, Phase II follow-up data stretching to 48 weeks, 65% of patients taking Tremfya saw their Crohn’s disease enter clinical remission, J&J announced. The company did not say what proportion of patients hit remission in the placebo group, however, saying researchers didn’t measure for comparison to placebo after week 12.
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