Covid-19 roundup: Pfiz­er li­cens­es its pill to the Med­i­cines Patent Pool; NYC joins states in au­tho­riz­ing boost­ers for all adults ahead of FDA

Fol­low­ing a sim­i­lar deal forged by Mer­ck for its Covid-19 drug mol­nupi­ravir, Pfiz­er on Tues­day agreed to al­low the UN-backed Med­i­cines Patent Pool to li­cense the com­pa­ny’s po­ten­tial treat­ment Paxlovid to make it more read­i­ly avail­able in 95 low- and mid­dle-in­come coun­tries.

The agree­ment al­lows MPP to grant sub-li­cens­es to qual­i­fied gener­ic drug man­u­fac­tur­ers to fa­cil­i­tate ad­di­tion­al pro­duc­tion and dis­tri­b­u­tion of the in­ves­ti­ga­tion­al an­tivi­ral, which has yet to be au­tho­rized.

Pfiz­er has not dis­closed a price for its treat­ment but ex­ec­u­tives have said they will price it sim­i­lar­ly to Mer­ck’s mol­nupi­ravir, which costs about $700 per treat­ment course in high-in­come coun­tries.

While the move to li­cense its drug, even be­fore its au­tho­riza­tion, may be viewed as a no­ble ef­fort, Doc­tors With­out Bor­ders said in a state­ment, “Li­cens­ing deals by phar­ma­ceu­ti­cal cor­po­ra­tions that cre­ate un­cer­tain­ties and seg­men­ta­tion for gener­ic pro­duc­tion and sup­ply con­tin­ue to be part of the prob­lem rather than part of a re­al so­lu­tion. There is no patent yet on the ex­per­i­men­tal can­di­date PF-07321332, and ri­ton­avir has been off patent since last year. In the ab­sence of patents on both com­pounds, able man­u­fac­tur­ers, par­tic­u­lar­ly those based in coun­tries ex­clud­ed from this li­cense, have an op­por­tu­ni­ty to ex­plore gener­ic pro­duc­tion di­rect­ly.”

NYC joins states in au­tho­riz­ing Covid-19 boost­ers for all adults ahead of FDA au­tho­riza­tion

New York City is join­ing Cal­i­for­nia, Col­orado, Arkansas, and New Mex­i­co in al­low­ing any adult to ac­cess a Covid-19 boost­er shot. Some, like car­di­ol­o­gist Er­ic Topol, called the de­ci­sion “ful­ly backed by the da­ta,” as Pfiz­er and BioN­Tech main­tain that the wan­ing im­mu­ni­ty from the ini­tial 2-dose se­ries needs the boost to get back in­to the 90%+ range for pro­tec­tion.

Oth­ers seem con­cerned that such a de­ci­sion isn’t nec­es­sar­i­ly backed by ro­bust da­ta, or that such dos­es should be shipped abroad as ini­tial dos­es. Oth­ers still ques­tion the need for states to over­ride the FDA’s de­ci­sion to on­ly au­tho­rize the boost­ers so far for cer­tain groups of peo­ple, in­clud­ing those old­er than 65.

The FDA, how­ev­er, wasn’t keen to dis­cuss the is­sue. An agency spokesper­son told End­points News to con­tact the CDC for as­sis­tance with any ques­tions, adding, “It is im­por­tant to note that FDA does not make im­mu­niza­tion or clin­i­cal rec­om­men­da­tions.”

On whether states should be au­tho­riz­ing boost­ers ahead of an FDA de­ci­sion for the same age group, or if this was more an is­sue of off-la­bel use (be­cause Pfiz­er’s vac­cine is FDA ap­proved), the agency spokesper­son said, “We do not have any­thing ad­di­tion­al to add to our pre­vi­ous re­sponse.”

Twist Bio­science re­veals an an­ti­body off­shoot with a start in Covid-19

Twist Bio­science un­veiled an off­shoot biotech this morn­ing — Rev­e­lar Bio­ther­a­peu­tics, which is work­ing on a po­ten­tial Covid-19 an­ti­body.

Ac­cord­ing to Twist, the in­de­pen­dent new biotech will be de­vel­op­ing and com­mer­cial­iz­ing an an­ti­body that has neu­tral­ized all known vari­ants of SARS-Cov-2 in pre­clin­i­cal tri­als.

That said, Rev­e­lar can lever­age Twist’s an­ti­body plat­form and li­cense ad­di­tion­al an­ti­bod­ies — up to five more tar­gets over the next four years, each of which will be sub­ject to ad­di­tion­al up­front, mile­stone and roy­al­ty pay­ments to Twist.

Twist CEO Emi­ly Lep­roust said in a state­ment that she hopes the an­ti­body will en­ter clin­i­cal stud­ies in 2022.

Twist is start­ing out with a $10 mil­lion seed in­vest­ment, based on Rev­e­lar’s de­vel­op­ment of the first an­ti­body and the po­ten­tial for suc­cess-based mile­stone pay­ments to­tal­ing over $100 mil­lion. In ex­change for the in­vest­ment and an­ti­body li­cens­ing, Twist got mi­nor­i­ty own­er­ship in Rev­e­lar — but at an un­spec­i­fied per­cent­age.

Rev­e­lar’s ex­ec­u­tive lead­er­ship team in­cludes Boehringer vet Glenn Ma­ri­na as CEO. Lep­roust and Twist CCO Patrick Finn are al­so part of the board of di­rec­tors.

“We look for­ward to com­plet­ing pre­clin­i­cal and CMC de­vel­op­ment in sup­port of fil­ing an IND,” said Ma­ri­na in a state­ment. — Paul Schloess­er

EU and EEA coun­tries agreed to do­nate 70+ mil­lion dos­es of Mod­er­na vax to low- and mid­dle-in­come coun­tries by year’s end

Mod­er­na to­day an­nounced an agree­ment that en­ables the EU and EEA coun­tries to do­nate dos­es of their Covid-19 vac­cine pur­chased un­der the EU Vac­cines Strat­e­gy to CO­V­AX for low and mid­dle-in­come coun­tries for the rest of the year.

The vac­cine dos­es will be head­ed to 92 coun­tries con­sid­ered as low- and mid­dle-in­come.

Ac­cord­ing to a Mod­er­na state­ment, the com­pa­ny ex­pects to see more than 70 mil­lion dos­es giv­en away by year’s end as part of the ini­tia­tive spear­head­ed by France, Swe­den and Nor­way. Ini­tial do­na­tions have in­clud­ed 15 mil­lion from France and 40 mil­lion from Ger­many.

“We be­lieve that dose shar­ing, among oth­er strate­gies, will help en­sure an eq­ui­table glob­al dis­tri­b­u­tion of COVID-19 vac­cines,” said Mod­er­na’s CEO Stéphane Ban­cel, who has come un­der fire re­cent­ly from the Biden ad­min­is­tra­tion for not help­ing enough on the in­ter­na­tion­al stage. — Paul Schloess­er

Op­ti­miz­ing Cell and Gene Ther­a­py De­vel­op­ment and Pro­duc­tion: How Tech­nol­o­gy Providers Like Corn­ing Life Sci­ences are Spurring In­no­va­tion

Remarkable advances in cell and gene therapy over the last decade offer unprecedented therapeutic promise and bring new hope for many patients facing diseases once thought incurable. However, for cell and gene therapies to reach their full potential, researchers, manufacturers, life science companies, and academics will need to work together to solve the significant challenges facing the industry.

David Baker working with a student on their protein design (Jason Mast)

Sci­en­tists are fi­nal­ly learn­ing how to de­sign pro­teins from scratch. Drug de­vel­op­ment may nev­er be the same

SEATTLE — It’s a cloudy Thursday afternoon in mid-July and David Baker is reclining into the futon in his corner office at the University of Washington, arms splayed out like a daytime talk show host as he coaches another one of his postdocs through the slings and arrows of scientific celebrity.

“Be jealous of your time,” he says, before plotting ways of sneaking her out of Zooms. “It’s this horrible cost to science that you’re tied up in some stupid meeting.”

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Patty Murray, D-WA (Graeme Sloan/Sipa USA)(Sipa via AP Images)

Sen­ate user fee reau­tho­riza­tion bill omits ac­cel­er­at­ed ap­proval re­forms, shows wide gaps with House ver­sion

The Senate health committee on Tuesday released its first version of the bill to reauthorize all the different FDA user fees. But unlike the House version, there are only a few controversial items in the Senate’s version, which does not address either accelerated approval reforms or clinical trial diversity (as the House did).

While it’s still relatively early in the process of finalizing this legislation (the ultimate statutory deadline is the end of September), the House and Senate, at least initially, appear to be starting off in different corners on what should be included.

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Pre­sent­ing a live End­points News event: Man­ag­ing a biotech in tur­bu­lent times

Biotech is one of the smartest, best educated industries on the planet. PhDs abound. We’ve had a long enough track record to see a new generation of savvy, experienced execs coming together to run startups.

And in these times, they are being tested as never before.

Biotech is going through quite a rough patch right now. For 2 years, practically anyone with a decent resume and some half-baked ideas on biotech could start a company and get it funded. The pandemic made it easy in many ways to pull off an IPO, with traditional road shows shut down in exchange for a series of quick Zoom meetings. Generalist investors flocked as the numbers raised soared into the stratosphere.

FDA lob­bies Con­gress over rare dis­ease court rul­ing with wide im­pli­ca­tions

Usually reserved for making decisions on drug applications or enforcing what Congress stipulates, the FDA is now dipping its toe into the wild world of congressional politics as it attempts to fix a major court decision that could have a chilling effect on rare disease R&D.

The case in question from last October saw a US appeals court overturn a prior FDA court win, saying that the agency never should’ve approved a rare disease drug because a previously approved but more expensive drug with the same active ingredient has orphan drug exclusivity barring such an approval.

Peter Marks (Greg Nash/Pool via AP)

Even FDA's Pe­ter Marks is wor­ried about the com­mer­cial vi­a­bil­i­ty of gene and cell ther­a­pies

When bluebird bio’s gene therapy to treat beta thalassemia won European approval in 2019, the nearly $2 million per patient price tag for the potential cure seemed like a surmountable hurdle.

Fast forward two years later, and bluebird has withdrawn Zynteglo, the beta thal drug, along with the rest of its gene therapy portfolio from Europe, which the company said is generally unwilling to pay a fair price for the treatment.

Pri­cy in­halers re­main ex­pen­sive due to de­vice tweaks that keep com­peti­tors at bay, re­searchers find

New research published in Health Affairs today highlights the way in which the FDA’s inhaler regulations have rewarded incremental adjustments to older products, thereby enabling companies to skirt around cheaper competition.

A DC appeals court clerk and researchers from Harvard and the University of Calgary dug through all the patents and regulatory exclusivities granted to inhalers approved by the FDA between 1986 and 2020, finding that of the 62 inhalers approved, 53 (or 85%) were brand-name products, with a median of 16 years of protection from generic competition.

Warren Buffett, Berkshire Hathaway CEO

Berk­shire Hath­away pulls out of Ab­b­Vie, Bris­tol My­ers Squibb in­vest­ments

It looks like Warren Buffett is sticking to ice cream and railroads for the moment.

The billionaire CEO of Berkshire Hathaway backed out of two major holdings in the pharma industry, Forexlive first reported, including a $410 million investment in AbbVie and a $324.4 million stake in Bristol Myers Squibb.

The move comes after Berkshire abandoned its Teva shares just last quarter, Bloomberg reported.

Long-ex­pect­ed UK lay­offs im­mi­nent for No­var­tis fol­low­ing sale

Nearly a year ago, more than 200 workers at Novartis’ Grimsby, UK, facility were able to hang on to their jobs after the pharma closed a Switzerland site as a part of its workforce restructuring plan. Now, it looks like those employees’ time is up, as the site has been sold, Grimsby Telegraph reported today.

The manufacturing site has been sold to Humber Industrials, a subsidiary of International Process Plants. None of the current staff members will be working with the new owners, however.