It may be the end of the road for colchicine, an in­ex­pen­sive oral an­ti-in­flam­ma­to­ry drug com­mon­ly used to treat gout, as a po­ten­tial Covid-19 treat­ment — at least in hos­pi­tal­ized pa­tients.

The UK’s RE­COV­ERY tri­al put out the word on Fri­day that it’s halt­ing en­roll­ment in its colchicine study af­ter a da­ta mon­i­tor­ing com­mit­tee saw “no con­vinc­ing ev­i­dence that fur­ther re­cruit­ment would pro­vide con­clu­sive proof of worth­while mor­tal­i­ty ben­e­fit ei­ther over­all or in any pre-spec­i­fied sub­group.”

In a pre­lim­i­nary analy­sis of 11,162 pa­tients ran­dom­ized to re­ceive ei­ther colchicine or stan­dard care alone, there was no sig­nif­i­cant dif­fer­ence in the pri­ma­ry end­point of 28-day mor­tal­i­ty, ac­cord­ing to re­searchers. The mor­tal­i­ty rate was 20% in the colchicine group ver­sus 19% in the usu­al care group. The fi­nal re­sults will be pub­lished “as soon as pos­si­ble,” ac­cord­ing to a state­ment.

The RE­COV­ERY tri­al was es­tab­lished to test a range of po­ten­tial treat­ments for Covid-19. Re­cruit­ment to all the oth­er treat­ment arms — in­clud­ing as­pirin, baric­i­tinib, Re­gen­eron’s an­ti­body cock­tail, and (in se­lect­ed hos­pi­tals) di­methyl fu­marate — will go forth as planned.

“We do large ran­domised tri­als to es­tab­lish whether a drug that seems promis­ing in the­o­ry has re­al ben­e­fits for pa­tients in prac­tice,” Ox­ford Uni­ver­si­ty and joint chief in­ves­ti­ga­tor Mar­tin Lan­dray said in a state­ment. “Un­for­tu­nate­ly, colchicine is not one of those.”

RE­COV­ERY tri­al up­date:

Colchicine arm stopped for lack of ef­fi­ca­cy in pa­tients hos­pi­talised with COVID-19.https://t.co/hcn9PytegJ pic.twit­ter.com/q09ed­dYXYL

— Mar­tin Lan­dray (@Mar­tin­Lan­dray) March 5, 2021

The news comes just over a month af­ter Mon­tre­al re­searchers read out some con­tro­ver­sial da­ta on colchicine’s ef­fect as a Covid-19 treat­ment. While that study al­so failed its pri­ma­ry end­point, re­searchers said the drug “re­duces the com­pos­ite rate of death or hos­pi­tal­iza­tion” in non-hos­pi­tal­ized pa­tients.

Out of 2,235 pa­tients in the colchicine group, 104 had been hos­pi­tal­ized or died; among 2,253 in the place­bo co­hort, 131 re­port­ed those events. That trans­lates to a 4.7% event rate ver­sus 5.8% on the pri­ma­ry end­point — or an odds ra­tio of 0.79 — with a p-val­ue of 0.08. Five pa­tients died in the colchicine arm, ver­sus nine in the place­bo group. On the sec­ondary end­point, 11 pa­tients tak­ing colchicine re­quired me­chan­i­cal ven­ti­la­tion while 21 who were giv­en place­bo did.

But if you look on­ly at the 4,159 pa­tients with PCR-con­firmed Covid-19, in­ves­ti­ga­tors wrote, the dif­fer­ence widens slight­ly to 4.6% ver­sus 6.0% and the 0.75 odds ra­tio be­comes sta­tis­ti­cal­ly sig­nif­i­cant (p=0.04).

Lan­dray com­ment­ed that it was a “trav­es­ty” that in­ves­ti­ga­tors in the tri­al had stopped en­roll­ment with on­ly 75% of pa­tients, adding that it re­sult­ed in in­con­clu­sive re­sults and un­cer­tain­ty. — Nicole De­Feud­is 

Italy blocks As­traZeneca vac­cine ship­ment meant for Aus­tralia

The As­traZeneca/Ox­ford vac­cine roll­out has run in­to yet an­oth­er speed bump.

As the British drug­mak­er prepped a vac­cine ship­ment for Aus­tralia of about 250,000 dos­es, Italy de­cid­ed to pre­vent the de­liv­ery from leav­ing its bor­ders, per a Fi­nan­cial Times re­port. It’s the first such in­ter­ven­tion in vac­cine ex­ports since the Eu­ro­pean Union in­tro­duced new rules gov­ern­ing such ship­ments out­side the bloc in late Jan­u­ary.

Per the FT re­port, the EU had the pow­er to ob­ject to Italy’s move and block their ef­fort, but did not do so. And ear­ly Fri­day morn­ing, France backed Italy’s plan to stop the ship­ment head­ed to Aus­tralia.

The con­tro­ver­sial ex­port plan was put in­to place by the EU in the wake of As­traZeneca say­ing it wouldn’t be able to pro­vide the amount of dos­es pledged in its con­tracts a lit­tle over a month ago. Their hope is to force com­pa­nies to dis­close ex­port plans, the FT cit­ed Eu­ro­pean of­fi­cials as say­ing, as the bloc seeks to re­assert con­trol of dos­es man­u­fac­tured in­side its bor­ders.

Sev­er­al coun­tries had been ex­empt­ed from the plan, al­low­ing for As­traZeneca shots to be able to flow to poor­er na­tions and those with­out their own pro­duc­tion ca­pa­bil­i­ties. EU of­fi­cials drew harsh crit­i­cism, how­ev­er, af­ter in­clud­ing the UK on the ex­emp­tion list de­spite leav­ing off oth­er in­dus­tri­al­ized na­tions like the US and Japan.

Fri­day’s de­vel­op­ments fol­low a rocky road for the As­traZeneca/Ox­ford vac­cine. Though Britain and the EU have au­tho­rized the shot for use, there has been slow up­take around the world as the drug­mak­er and the bloc fought pub­licly over the dos­es the com­pa­ny would pro­vide. And some peo­ple in Eu­ro­pean coun­tries are re­port­ed­ly shun­ning the vac­cine in fa­vor of mR­NA-based shots with high­er topline ef­fi­ca­cy lev­els. — Max Gel­man

Ger­many al­lows use of As­traZeneca’s vac­cine in se­niors — re­port

Days af­ter Cana­di­an of­fi­cials said As­traZeneca’s Covid-19 vac­cine should not be used on se­niors, Ger­many has re­versed its de­ci­sion to re­strict the jab from those 65 and old­er.

The Ger­man Health Min­istry’s Per­ma­nent Vac­cine Com­mis­sion OK’d the vac­cine for use on se­niors on Thurs­day, and an­nounced it would up­date guid­ance to in­cor­po­rate a new rec­om­men­da­tion that dos­es be spaced 12 weeks apart, BBC re­port­ed. 

Health Min­is­ter Jens Spahn called the de­ci­sion “good news for old­er peo­ple who are wait­ing for an in­jec­tion,” per BBC.

The move was based on new ev­i­dence that As­traZeneca and Ox­ford Uni­ver­si­ty pre­sent­ed last month, which they said proves their vac­cine is more ef­fec­tive when ad­min­is­tered over the course of 12 weeks. The new reg­i­men has al­ready been ap­proved by the UK.

In­ves­ti­ga­tors wrote in a Lancet study:

In our study, vac­cine ef­fi­ca­cy was high­er, af­ter the sec­ond dose, in those with a longer prime-boost in­ter­val, reach­ing 82.4% in those with a dos­ing in­ter­val of 12 weeks or more. Point es­ti­mates of ef­fi­ca­cy were low­er with short­er dos­ing in­ter­vals, though it should be not­ed that there is some un­cer­tain­ty as con­fi­dence in­ter­vals over­lap. High­er bind­ing and neu­tral­is­ing an­ti­body titres were ob­served in sera at the longer prime-boost in­ter­val, sug­gest­ing that, as­sum­ing there is a re­la­tion­ship be­tween the hu­moral im­mune re­sponse and ef­fi­ca­cy, these may be true find­ings and not arte­facts of the da­ta.

Back in Jan­u­ary, an ex­pert pan­el in Ger­many rec­om­mend­ed against giv­ing As­traZeneca’s vac­cine to those over the age of 65, cit­ing “in­suf­fi­cient da­ta avail­able to as­sess the vac­cine ef­fi­ca­cy.”

While a Cana­di­an pan­el of vac­cine ex­perts said ear­li­er this week that vac­cines from Pfiz­er/BioN­Tech and Mod­er­na are pre­ferred for those over 65, France al­so de­cid­ed Mon­day to al­low the vac­cine’s use in se­niors. — Nicole De­Feud­is 

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

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

Sometimes, being late can give you an advantage.

That’s what Sanofi and GSK are trying to say as the Big Pharma partners report positive results from a late-stage trial of their next-gen bivalent Covid-19 vaccine, which was designed to protect against both the original strain of the SARS-CoV-2 virus and the Beta variant. Specifically, against Omicron, they note, the vaccine delivered 72% efficacy in all adults and 93.2% in those previously infected.

Covid vaccine access to lower- and middle-income nations has been a concern during the length of the pandemic, but BioNTech is now pushing forward with plans to increase vaccine access for Africa.

Construction work has kicked off for an mRNA manufacturing facility in Kigali, Rwanda. According to BioNTech, the facility, dubbed the African modular mRNA manufacturing facility, has a target for the first set of manufacturing tools to be delivered to the site by the end of this year.

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.

The story of Amryt Pharma’s candidate for the genetic skin condition epidermolysis bullosa, or EB, will soon enter another chapter.

After the Irish drugmaker’s candidate, dubbed Oleogel-S10 and marketed as Filsuvez, was handed a CRL earlier this year, the company announced in a press release that it plans to submit a formal dispute resolution request for the company’s NDA for Oleogel-S10.

North Carolina Republican Sen. Thom Tillis made a name for himself in the 2020 election cycle as the darling of the pharma industry, accepting hundreds of thousands in campaign contributions, even from the likes of Pfizer CEO Albert Bourla.

Those contributions have led Tillis to attempt to re-write patent laws in pharma’s favor, a move which failed to gain steam in 2019, and request for a third time since January that the FDA should help stop “the false narrative that patent protections are to blame for high drug prices.”