The FDA has placed on hold an emer­gency au­tho­riza­tion for the use of plas­ma as a Covid-19 treat­ment fol­low­ing the in­ter­ven­tion of top fed­er­al health of­fi­cials who claimed the avail­able da­ta were too weak, ac­cord­ing to a re­port in the New York Times.

NI­AID clin­i­cal di­rec­tor H. Clif­ford Lane con­firmed the hold to the Times, adding plas­ma may still be au­tho­rized some­time in the fu­ture.

Much has been made about the prospect of uti­liz­ing do­nat­ed plas­ma from re­cov­ered Covid-19 pa­tients to treat those cur­rent­ly in­fect­ed with the dis­ease. The the­o­ry goes that an­ti­bod­ies in the plas­ma can help re­duce the time pa­tients spend in hos­pi­tals as well as mor­tal­i­ty rates if the treat­ment is ad­min­is­tered quick­ly.

The use of plas­ma to treat dis­ease has been around since the ear­ly 20th cen­tu­ry and doc­tors used sim­i­lar ther­a­pies dur­ing the in­fluen­za pan­dem­ic of 1918. One of the biggest stud­ies in­to adapt­ing the tech­nique for Covid-19 came from the Mayo Clin­ic last week, which showed sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ments in mor­tal­i­ty rates among the most se­vere cas­es. In­di­vid­u­als re­ceiv­ing plas­ma treat­ment with­in three days of di­ag­no­sis had a sev­en-day death rate of 8.7% while those who got plas­ma four days or lat­er had an 11.9% rate.

How­ev­er, that study was lim­it­ed by the lack of a place­bo group, a draw­back the Mayo Clin­ic it­self ad­dressed at the time. Sev­er­al top health of­fi­cials, such as Lane, An­tho­ny Fau­ci and Fran­cis Collins, urged the FDA to hold off on plas­ma au­tho­riza­tion based on the da­ta from that study, the Times wrote.

Wednes­day’s hold fol­lows a cadre of for­mer FDA com­mis­sion­ers ac­knowl­edg­ing the po­ten­tial ben­e­fits of plas­ma treat­ments in an op-ed to the Wash­ing­ton Post two weeks ago. They cau­tioned, though, that more re­search in­to the ther­a­py’s safe­ty and ef­fi­ca­cy is need­ed. — Max Gel­man

UP­DAT­ED: Roche part­ners with Re­gen­eron on a Covid-19 an­ti­body cock­tail, adding glob­al man­u­fac­tur­ing/mar­ket­ing mus­cle

It’s one of those un­like­ly al­liances you’d on­ly see in a pan­dem­ic: Roche is sign­ing on to be a man­u­fac­tur­ing and dis­tri­b­u­tion part­ner for Re­gen­eron’s tai­lor-made Covid-19 an­ti­body cock­tail.

There’s no up­front or mile­stones, but the com­pa­nies say they’ve al­ready be­gun the tech trans­fer process for Roche, with an agree­ment in place since late Ju­ly. The Swiss phar­ma gi­ant will be tasked with dis­tri­b­u­tion — plus all the clin­i­cal and reg­u­la­to­ry work need­ed — out­side of the US, while the Tar­ry­town, NY-based biotech fo­cused on the home turf.

By team­ing up with Roche, Re­gen­eron ex­pects to in­crease sup­ply of REGN-COV2 by at least three and a half times. Roche will hold the rights for at least sev­en years af­ter the first com­mer­cial sales in the Eu­ro­pean Union, as­sum­ing all goes smooth­ly.

In Ge­of­frey Porges’ view, the col­lab­o­ra­tion adds cred­i­bil­i­ty to a pro­gram that still doesn’t have clin­i­cal val­i­da­tion and could have been re­strict­ed by man­u­fac­tur­ing ca­pac­i­ty, crowd­ed out by US or­ders.

“While the Roche col­lab­o­ra­tion will re­duce REGN’s prof­its from REGN-COV2, it should sub­stan­tial­ly re­duce the de­vel­op­ment cost, which would have bur­dened Re­gen­eron for the next few years (est. half-bil­lion dol­lar cost for REGN-COV2 in 2020E based on Re­gen­eron’s Q2 guid­ance re­vi­sion),” he wrote.

While Re­gen­eron CEO Len Schleifer has pre­vi­ous­ly pre­dict­ed it could have emer­gency dos­es ready by the end of sum­mer, clin­i­cal tri­als ap­pear to be tak­ing longer than ex­pect­ed as in­ves­ti­ga­tors strug­gle to en­roll pa­tients in over­whelmed hos­pi­tals. In the most re­cent an­a­lyst call, Schleifer said they’re now hop­ing to gen­er­ate ini­tial da­ta by ear­ly Sep­tem­ber.

Porges es­ti­mates the bench­mark for ef­fi­ca­cy in the treat­ment set­ting to be 50% to 60% re­duc­tion in dis­ease mor­tal­i­ty, and that for pro­phy­lax­is to be 60% or greater re­duc­tion in clin­i­cal­ly sig­ni­cant, symp­to­matic Covid-19 dis­ease — both like­ly achiev­able judg­ing from pri­mate da­ta.

A spokesper­son told End­points News that the ini­tial da­ta in Sep­tem­ber will in­clude vi­rol­o­gy and bio­mark­ers.

In ad­di­tion to hav­ing Roche joint­ly fund the on­go­ing Phase III pre­ven­tion study, a Phase I mul­ti-dose safe­ty tri­al and any new glob­al stud­ies, Re­gen­eron is al­so keep­ing its hand on a sig­nif­i­cant por­tion of the prof­its.

From the 8-K:

Any world­wide gross prof­its from the An­ti­body Prod­uct will be ag­gre­gat­ed and shared based on a pre-spec­i­fied for­mu­la, which is es­ti­mat­ed to re­sult in Re­gen­eron re­ceiv­ing ap­prox­i­mate­ly 50% – 60% of the world­wide gross prof­its, de­pend­ing on the amount of man­u­fac­tured An­ti­body Prod­uct de­liv­ered by each par­ty.

Bill An­der­son

Bill An­der­son, the CEO of Roche Phar­ma, high­light­ed the po­ten­tial for REGN-COV2 both as a treat­ment and pro­tec­tion for peo­ple ex­posed to the coro­n­avirus, mak­ing it a “crit­i­cal line of de­fense.” De­signed specif­i­cal­ly to com­bat SARS-CoV-2, the ther­a­py com­pris­es two dif­fer­ent virus-neu­tral­iz­ing an­ti­bod­ies that bind to the re­cep­tor bind­ing do­main of the virus’ spike pro­tein.

“We’re com­mit­ting our man­u­fac­tur­ing ex­per­tise and ca­pac­i­ty, and our glob­al dis­tri­b­u­tion net­work to bring Re­gen­eron’s po­ten­tial an­ti­body com­bi­na­tion to as many peo­ple around the world as we pos­si­bly can,” he said.

That trans­lates to at least 100,000 liters of “an­nu­al­ized biore­ac­tor ca­pac­i­ty on a full-time cam­paign ba­sis” to man­u­fac­ture the prod­uct, ac­cord­ing to an SEC fil­ing from Re­gen­eron. On its part, Re­gen­eron will ded­i­cate 40,000 liters of its in-house ca­pac­i­ty to the Covid-19 pro­gram.

His­toric ri­vals in eye dis­eases and in­flam­ma­to­ry con­di­tions, Roche and Re­gen­eron (part­nered with Sanofi) took their re­spec­tive IL-6 an­ti­bod­ies to tri­als in hopes of damp­en­ing the dam­ag­ing im­mune re­sponse that plague pa­tients with se­vere Covid-19 — on­ly to be slapped by fail­ures. That left Roche with lit­tle to of­fer in the ther­a­peu­tic fight against the coro­n­avirus, even as its di­ag­nos­tics unit con­tin­ues to sell much-need­ed anti­gen and an­ti­body tests.

Schleifer sees the deal as val­i­da­tion for his team’s record speed and tire­less work as the phar­ma part­ner pro­vides “im­por­tant scale” to the en­deav­or.

He has struck a $450 mil­lion deal with Op­er­a­tion Warp Speed to sup­ply up to 1.6 mil­lion dos­es in the US, both for ther­a­peu­tic and pro­phy­lac­tic use. Back in March he not­ed the com­pa­ny could be­gin mak­ing 200,000 clin­i­cal dos­es a month be­gin­ning in Au­gust, and it’s been look­ing to max­i­mize ca­pac­i­ty on com­mer­cial scale ma­te­r­i­al. — Am­ber Tong

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

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