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

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

FDA warns Proc­ter & Gam­ble over NyQuil la­bel's in­gre­di­ent list­ings

The FDA on Tuesday released a warning letter sent earlier this month to the Mason, OH-based site of Procter & Gamble Manufactura, raising questions about the list of ingredients on the label and in the electronic filing.

The warning says that for P&G’s over-the-counter Vicks Nyquil Severe Hot Remedy Cold and Flu Plus Congestion, there’s a “mismatched” list of active ingredients between the labeling and the electronic listing file. The listing file for the active ingredients did not match the active ingredients in the electronic file.

No­vo Nordisk re­mains un­der UK scruti­ny as MHRA con­ducts its own re­view in 'in­cred­i­bly rare' case

The UK’s Medicines and Healthcare products Regulatory Agency is now reviewing Novo Nordisk’s marketing violation that resulted in its loss of UK trade group membership last week. Novo Nordisk was suspended on Thursday from the Association of the British Pharmaceutical Industry (ABPI) for two years after an investigation by its regulatory arm found the pharma broke its conduct rules.

MHRA said on Tuesday that its review of the Prescription Medicines Code of Practice Authority (PMCPA) investigation is standard practice. An MHRA spokesperson emphasized in an email to Endpoints News that the situation with Novo Nordisk is “incredibly rare” while also noting ABPI took “swift and proportionate action.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,200+ biopharma pros reading Endpoints daily — and it's free.

FDA in­di­cates will­ing­ness to ap­prove Bio­gen ALS drug de­spite failed PhI­II study

Ahead of Wednesday’s advisory committee hearing to discuss Biogen’s ALS drug tofersen, the FDA appeared open to approving the drug, newly released briefing documents show.

Citing the need for flexibility in a devastating disease like ALS, regulators signaled a willingness to consider greenlighting tofersen based on its effect on a certain protein associated with ALS despite a failed pivotal trial. The documents come after regulatory flexibility was part of the same rationale the agency expressed when approving an ALS drug last September from Amylyx Pharmaceuticals, indicating the FDA’s openness to approving new treatments for the disease.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,200+ biopharma pros reading Endpoints daily — and it's free.

Andy Plump, Takeda R&D chief (Jeff Rumans for Endpoints News)

What kind of PhI­Ib da­ta is worth $4B cash? Take­da’s Andy Plump has some thoughts on that

A few months back, when Takeda caused jaws to drop with its eye-watering $4 billion cash upfront for a mid-stage TYK2 drug from Nimbus, it had already taken a deep dive on the solid Phase IIb data Nimbus had assembled from its dose-ranging study in psoriasis.

Now, it’s rolling that data out, eager to demonstrate what inspired the global biopharma to go long in a neighboring, but new, disease arena for the pipeline. And the most avid students of the numbers will likely be at Bristol Myers Squibb, who will have a multi-year head start on pioneering the TYK2 space with Sotyktu (deucravacitinib) as Takeda makes its lunge for best-in-class status.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

FTC says patent bat­tle over Parkin­son's drug could have 'sig­nif­i­cant im­pli­ca­tion­s' for pa­tients

The Federal Trade Commission has gotten involved in a patent feud over Supernus’ Parkinson’s drug Apokyn, a case the agency said may have ‘‘significant implications” for patients who rely on the drug.

Sage Chemical won the first generic approval for its Apokyn formulation (also known as apomorphine hydrochloride injection) back in 2022. The non-ergoline dopamine agonist is approved to treat Parkinson’s symptoms during “off episodes,” such as difficulty moving, tremors and intense cramping. However, regulators specified that the approval pertained to the generic drug cartridges only, not the injector pen required for administration.

Growth hor­mone from No­vo Nordisk is in short­age over man­u­fac­tur­ing de­lays

Novo Nordisk’s growth hormone Norditropin is in shortage because of manufacturing delays, according to an FDA site that tracks drug shortages as well as the American Society of Health-System Pharmacists’ shortages list.

The FDA has shortages of the drug listed for its 5, 10, 15 and 30 mg doses, while the pharmacists’ group, also known as ASHP, reported shortages of the same doses, except for the 15 mg version.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,200+ biopharma pros reading Endpoints daily — and it's free.

PhRMA calls for more di­verse in­fra­struc­ture up­grades to US emer­gency tri­als frame­work

The White House’s Office of Science and Technology Policy (OSTP) last year sought to find ways to better coordinate large-scale clinical trials in the US — as the UK lead by example during the pandemic — especially for these emergency clinical trials.

The lobbying group PhRMA Tuesday called for more clinical trial diversity in underserved areas, including by making participation less of a burden, and expanding eligibility criteria when appropriate.

President Joe Biden (AP Photo/Susan Walsh)

Biden signs law re­quir­ing more de­clas­si­fi­ca­tions on Covid-19's ori­gins

President Joe Biden yesterday signed into law a bill requiring the Office of the Director of National Intelligence to declassify information on the origins of Covid-19 within 90 days.

The new law directs the federal government to “declassify any and all information relating to potential links between the Wuhan Institute of Virology and the origin of the Coronavirus Disease 2019”, including information regarding researchers at the lab who fell ill in the fall of 2019 like names, symptoms, and job roles.