Covid-19 roundup: Pfiz­er, BioN­Tech start US hu­man tri­al; World lead­ers (not in­clud­ing the US) pledge $8 bil­lion in vac­cine, treat­ment re­search

Last week, part­ners Pfiz­er and BioN­Tech joined the elite group of CanSi­no, Mod­er­na and Ox­ford who have be­gun hu­man tri­als of their ex­per­i­men­tal Covid-19 vac­cine. On Tues­day, the US-Ger­man part­ners kicked off dos­ing in the Unit­ed States.

The team, which kicked off dos­ing in Ger­many in late April, said the first US par­tic­i­pants had been giv­en a vac­cine from the BNT162 pro­gram in a Phase I/II tri­al. The vac­cine pro­gram in­cludes four ex­per­i­men­tal vac­cines — each with com­bi­na­tion of mR­NA for­mat and tar­get anti­gen — the de­sign of the tri­al will al­low for the eval­u­a­tion of the var­i­ous can­di­dates si­mul­ta­ne­ous­ly so that the safest and po­ten­tial­ly most ef­fi­ca­cious can­di­date can be iden­ti­fied.

“The short, less than four-month time­frame in which we’ve been able to move from pre-clin­i­cal stud­ies to hu­man test­ing is ex­tra­or­di­nary…” said Pfiz­er chief Al­bert Bourla in a state­ment.

The Phase I/II study is set to en­roll up to 360 healthy sub­jects in­to two age co­horts (18-55 and 65-85 years of age) — the sub­jects im­mu­nized in the first por­tion of the study will be healthy adults 18-55 years of age. Old­er adults will on­ly be im­mu­nized with a giv­en dose lev­el of a vac­cine can­di­date, once test­ing in younger adults of­fers ini­tial ev­i­dence of safe­ty and im­muno­genic­i­ty.

From the man­u­fac­tur­ing side, the part­ners are scal­ing up pro­duc­tion. Mil­lions of vac­cine dos­es should be avail­able in 2020, and those num­bers should grow to hun­dreds of mil­lions by next year, the com­pa­nies said.

World lead­ers, bar­ring the US, pledge $8 bil­lion in vac­cine, treat­ment re­search — re­port

Last month, Pres­i­dent Don­ald Trump said he would stop fund­ing the WHO, tak­ing is­sue with the way the or­ga­ni­za­tion has been tack­ling the pan­dem­ic. Now, the Unit­ed States is steer­ing clear of a glob­al ef­fort to sup­port vac­cine and treat­ment de­vel­op­ment.

On Mon­day, world lead­ers vowed to raise $8 bil­lion to kick­start the ef­fort, to build on ef­forts by the World Bank, the Bill and Melin­da Gates Foun­da­tion and wealthy in­di­vid­u­als, Reuters re­port­ed. The event was or­ga­nized by the Eu­ro­pean Union and non-EU coun­tries Britain, Nor­way and Sau­di Ara­bia, and in­clud­ed the par­tic­i­pa­tion of Japan, Cana­da, South Africa and Chi­na, among oth­ers.

A se­nior US ad­min­is­tra­tion of­fi­cial de­clined to tell the wire ser­vice specif­i­cal­ly why the Unit­ed States was not par­tic­i­pat­ing.

The suc­cess­ful de­vel­op­ment of a vac­cine is on­ly the first step — easy ac­cess glob­al­ly will be the next big hur­dle. EU of­fi­cials said that the fund­ing will not strip the re­cip­i­ent phar­ma­ceu­ti­cal com­pa­nies of in­tel­lec­tu­al prop­er­ty on any vac­cine or treat­ment, but com­pa­nies will be ex­pect­ed to com­mit to mak­ing them avail­able at af­ford­able prices.

Many lead­ers stressed that any vac­cine must be made avail­able to every­one. Cana­di­an Prime Min­is­ter Justin Trudeau said it should not just be for rich coun­tries.

“Those who in­vent it, of course, will be fair­ly paid, but ac­cess will be giv­en to peo­ple across the globe by the or­ga­ni­za­tion we choose,” French Pres­i­dent Em­manuel Macron said, ac­cord­ing to the Reuters re­port.

The is­sue of how a vac­cine will be dis­trib­uted across the globe, if proved safe and ef­fec­tive, is para­mount. In a Wall Street Jour­nal opin­ion piece late last month en­ti­tled “Amer­i­ca needs to win the coro­n­avirus vac­cine race,” for­mer FDA chief Scott Got­tlieb warned that “while friend­ly na­tions will try to share a suc­cess­ful prod­uct — to a point — the US can’t re­ly on vac­cines from Chi­na or even Eu­rope be­ing avail­able in Amer­i­ca quick­ly.”

Last week, Bloomberg re­port­ed that the Trump ad­min­is­tra­tion is work­ing on ex­e­cut­ing a multi­bil­lion-dol­lar plan “Op­er­a­tion Warp Speed” to as­sure that 300 mil­lion dos­es (of any po­ten­tial vac­cine) — which should cov­er near­ly the en­tire US pop­u­la­tion — are avail­able by Jan­u­ary, the ear­li­est time­line chart­ed by vac­cine de­vel­op­ers. Al­though the de­tails are sparse, the plan brings phar­ma­ceu­ti­cal com­pa­nies, gov­ern­ment agen­cies and the mil­i­tary to co­or­di­nate test­ing of ex­per­i­men­tal vac­cines and in­volves large in­vest­ments in man­u­fac­tur­ing.

The vac­cine part­ner­ship be­tween Ox­ford, As­traZeneca and Vac­citech — which aims to make 100 mil­lion dos­es by the end of 2020 — in­cludes pro­vi­sions to dis­trib­ute the vac­cine to low and medi­um-in­come coun­tries, al­though the de­tails are sparse.

Sep­a­rate­ly, the Serum In­sti­tute of In­dia that has al­so part­nered with Ox­ford sci­en­tists to mass-pro­duce their vac­cine (with plans to pro­duce up to 60 mil­lion dos­es this year) told Reuters that their first pri­or­i­ty is In­dia and its pop­u­la­tion of 1.3 bil­lion. A ma­jor­i­ty of the vac­cine, at least ini­tial­ly, would have to go to our coun­try­men be­fore it goes abroad,” Serum CEO Adar Poon­awal­la said.

Gilead’s promis­ing Covid-19 an­tivi­ral remde­sivir gets Bangladeshi pro­duc­er — re­port

The com­pa­ny, which has pre­vi­ous­ly pledged to do­nate its ex­ist­ing sup­ply of 1.5 mil­lion in­di­vid­ual dos­es of remde­sivir for use in pa­tients in clin­i­cal tri­als and on a com­pas­sion­ate use ba­sis, has re­port­ed­ly found a new sup­pli­er in the form of one of Bangladesh’s largest drug­mak­ers, Bex­im­co Phar­ma­ceu­ti­cals.

The an­tivi­ral, which failed to pass muster as an Ebo­la ther­a­py, quick­ly rose to promi­nence as a po­ten­tial Covid-19 drug af­ter in­duc­ing a sta­tis­ti­cal­ly sig­nif­i­cant im­pact in help­ing hos­pi­tal­ized Covid-19 pa­tients re­cov­er faster in a ran­dom­ized, place­bo-con­trolled study — the gold-stan­dard for ben­e­fit-risk cal­cu­la­tions. Al­though more da­ta are in­com­ing, the drug was grant­ed emer­gency use au­tho­riza­tion by the FDA on Fri­day.

Apart from the $50 mil­lion the com­pa­ny has al­ready in­vest­ed in de­vel­op­ing the drug, an­oth­er $1 bil­lion is ex­pect­ed to be spent, as Gilead ramps up fur­ther de­vel­op­ment and man­u­fac­tur­ing of remde­sivir in an­tic­i­pa­tion of reg­u­la­to­ry ap­provals, ex­ec­u­tives said in a re­cent con­fer­ence call.

Bex­im­co plans to price the drug at be­tween 5000 and 6000 takas per vial ($59-$71/per vial), Bex­im­co’s Chief Op­er­at­ing Of­fi­cer Rab­bur Reza told Reuters, adding a pa­tient might need any­where be­tween 5 and 11 vials.

“We will on­ly know ex­act­ly how much a pa­tient needs once stud­ies are com­plete,” Reza said, not­ing that pro­duc­tion would be­gin this month, ini­tial­ly for do­mes­tic use.

Mod­els pre­dict Amer­i­can dai­ly death rate to hit 3,000 by June 

As part of the Unit­ed States get ready to ease back in­to nor­mal­i­ty, the Uni­ver­si­ty of Wash­ing­ton’s In­sti­tute for Health Mod­el­ing and Eval­u­a­tion says the coro­n­avirus pan­dem­ic will claim near­ly 135,000 Amer­i­can lives by Au­gust, in part due to states eas­ing their so­cial dis­tanc­ing re­stric­tions.

Source: IHME, 2020

Click on the im­age to see the full-sized ver­sion

The pro­jec­tion is grim for the com­ing weeks. IHME pre­dicts that there will be as many as 3,000 deaths per day in by June 1, with a sharp peak hit­ting around mid-May — well ahead of the cur­rent pace of about 1,500 dai­ly deaths.

An­oth­er draft re­port pro­ject­ed Covid-19 cas­es will surge to about 200,000 per day by June 1, with 3,000 deaths ex­pect­ed per day, the Wash­ing­ton Post re­port­ed. The White House and the CDC dis­avowed the re­port, al­though the slides do car­ry the CDC’s lo­go, the Post said, adding that the cre­ator of the mod­el said the num­bers are un­fin­ished pro­jec­tions shown to the CDC as a work in progress.

SEC in­ves­ti­ga­tion trig­gers sus­pen­sion of Mol­e­culin Biotech’s stock

Every few years, a pub­lic health cri­sis (think Ebo­la, Zi­ka) spurred by a rogue pathogen trig­gers a small-biotech ral­ly, as drug­mak­ers emerge from the wood­work with am­bi­tious plans to treat the mount­ing out­break. In most cas­es, that en­thu­si­asm nev­er quite de­liv­ers.

With Covid-19 hav­ing rav­aged much of the globe, the ever op­por­tune biotech is al­ways around the cor­ner.

On Mon­day, Texas can­cer-fo­cused biotech Mol­e­culin said its shares had been placed in a tem­po­rary trad­ing halt fol­low­ing no­ti­fi­ca­tion from the SEC.

The small com­pa­ny, which has a mar­ket cap of about $65 mil­lion, has been mak­ing state­ments in a smat­ter­ing of reg­u­la­to­ry fil­ings and press re­leas­es since March 19 sug­gest­ing its ex­per­i­men­tal drug, WP1122, was a po­ten­tial can­di­date for use in Covid-19 and that it could ex­pe­dite the reg­u­la­to­ry ap­proval of the treat­ment. Be­tween March 18 and May 1st (when the trad­ing sus­pen­sion came in­to ef­fect), the val­ue of the com­pa­ny’s stock has more than dou­bled to $1.o7.

The sus­pen­sion will ter­mi­nate at 11:59 p.m. ET on May 15th, 2020. Mol­e­culin said it be­lieves it will be able to demon­strate the ac­cu­ra­cy and ad­e­qua­cy of its pub­lic dis­clo­sures.

Milken In­sti­tute track­er iden­ti­fies loads more Covid-19 treat­ment and vac­cine can­di­dates in de­vel­op­ment

In ear­ly March, the think tank had tracked 55 treat­ments and 38 vac­cine can­di­dates. Fast for­ward to May 4, those num­bers have jumped to more than 111 vac­cines and 197 treat­ments in the pipeline to treat and pre­vent Covid-19.

Of this bur­geon­ing group, nine vac­cines and more than 50 treat­ments cur­rent­ly are in clin­i­cal tri­als.

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

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

15 LGBTQ lead­ers in bio­phar­ma; Paul Stof­fels’ Gala­pa­gos re­vamp; As­traZeneca catch­es up in AT­TR; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

A return to in-person conferences also marks a return to on-the-ground reporting. My colleagues Beth Synder Bulik and Nicole DeFeudis were on-site at Cannes Lions, bringing live coverage of pharma’s presence at the ad festival — accompanied by photos from Clara Bui, our virtual producer, that bring you right to the scene. You can find a recap (and links to all the stories) below.

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David Loew (Ipsen)

Ipsen snags an ap­proved can­cer drug in $247M M&A deal as an­oth­er bat­tered biotech sells cheap

You can add Paris-based Ipsen to the list of discount buyers patrolling the penny stock pack for a cheap M&A deal.

The French biotech, which has had plenty of its own problems to grapple with, has swooped in to buy Epizyme $EPZM for $247 million in cash and a CVR with milestones attached to it. Epizyme shareholders, who had to suffer through a painfully soft launch of their EZH2a inhibitor cancer drug Tazverik, will get $1.45 per share along with a $1 CVR tied to achieving $250 million in sales from the drug over four consecutive quarters as well as an OK for second-line follicular lymphoma by 1 Jan. 2028.

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AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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Sanofi, GSK tout 72% Omi­cron ef­fi­ca­cy in PhI­II tri­al of next-gen, bi­va­lent shot — with an eye to year-end roll­out

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.

Rwanda president Paul Kagame and BioNTech CEO Uğur Şahin (via BioNTech)

BioN­Tech breaks ground on first mR­NA vac­cine man­u­fac­tur­ing fa­cil­i­ty in Africa

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.

GSK says its drug for chron­ic hep B could ‘lead to a func­tion­al cure’ — but will it be alone or in com­bi­na­tion?

GSK, newly branded and soon-to-be demerged, shared interim results from its Phase II trial on its chronic hepatitis B treatment, one that it says has the “potential to lead to a functional cure.”

At a presentation at the EASL International Liver Congress, GSK shared that in around 450 patients who received its hep B drug bepirovirsen for 24 weeks, just under 30% had hepatitis B surface antigen and viral DNA levels that were too low to detect.

Stéphane Bancel (AP Photo/Charles Krupa)

Mod­er­na to se­cure a UK pres­ence with $1B+ in new man­u­fac­tur­ing and R&D fa­cil­i­ties

As Moderna keeps up the fight against Covid-19, recently winning authorization in the US for children under the age of five, the company is also looking to make a serious investment in the UK.

According to the UK government, Moderna will be looking to establish a vaccine research center and a manufacturing site for a series of vaccines.

Moderna will establish this new mRNA Innovation and Technology Centre to develop mRNA vaccines for a wide range of respiratory diseases, including Covid-19.

De­spite a slow start to the year for deals, PwC pre­dicts a flur­ry of ac­tiv­i­ty com­ing up

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.