Albert Bourla, Pfizer CEO (Evan Vucci/AP Images)

Covid-19 roundup: Pfiz­er to sup­ply US with 200M more vac­cines as UK study finds high­er an­ti­bod­ies in 8-10 week in­ter­vals

The US gov­ern­ment has pur­chased 200 mil­lion more dos­es of the Pfiz­er/BioN­Tech vac­cine, the com­pa­nies an­nounced Fri­day morn­ing.

Pfiz­er and BioN­Tech ex­pect to de­liv­er 110 mil­lion of the ad­di­tion­al dos­es by Dec. 31, with the re­main­ing 90 mil­lion dos­es to be de­liv­ered no lat­er than April 30, 2022.

“Un­der this con­tract, the U.S. Gov­ern­ment is pay­ing ~$24 a dose for the Pfiz­er-BioN­Tech COVID-19 Vac­cine. The price for this or­der ac­counts for the ad­di­tion­al in­vest­ment nec­es­sary to pro­duce, pack­age and de­liv­er new for­mu­la­tions of the vac­cine, as well as the in­creased cost as­so­ci­at­ed with de­liv­er­ing the vac­cine in small­er pack sizes to fa­cil­i­tate de­liv­ery at in­di­vid­ual provider of­fices, in­clud­ing pe­di­a­tri­cians,” a Pfiz­er spokesman told End­points News.

The US gov­ern­ment has the op­tion to ac­quire an up­dat­ed ver­sion of the vac­cine to ad­dress po­ten­tial vari­ants, as well as new for­mu­la­tions of the vac­cine, if avail­able and au­tho­rized.

The Pfiz­er vac­cine is like­ly to con­vert its EUA in­to a full ap­proval some­time soon, po­ten­tial­ly in Au­gust or Sep­tem­ber, ac­cord­ing to FDA’s top vac­cine of­fi­cial Pe­ter Marks. Pres­i­dent Biden made a sim­i­lar time­line es­ti­mate dur­ing a CNN town hall on Wednes­day evening.

The US has now pur­chased 500 mil­lion dos­es of the Pfiz­er vac­cine for do­mes­tic use, and an­oth­er 500 mil­lion for do­nat­ing to the world’s poor­est coun­tries and oth­er al­lies.

El­i­gi­ble US res­i­dents will con­tin­ue to re­ceive the vac­cine for free, Pfiz­er said. — Zachary Bren­nan

Pfiz­er/BioN­Tech shots pro­duce high­er an­ti­bod­ies af­ter 8-10 week in­ter­vals — study

The UK is tout­ing the re­sults of a new study that it says vin­di­cates the coun­try’s de­ci­sion to space out Covid-19 vac­cine dos­es ear­li­er in the pan­dem­ic.

An in­ter­val of eight to 10 weeks be­tween Pfiz­er/BioN­Tech shots re­sults in high­er neu­tral­iz­ing an­ti­body lev­els than the three-week span test­ed in clin­i­cal tri­als, ac­cord­ing to a Bloomberg re­port. Though the find­ings have yet to be peer-re­viewed, re­searchers found dou­ble the an­ti­bod­ies af­ter 10 weeks com­pared to three weeks.

Fund­ed by the UK’s De­part­ment of Health and So­cial Care, the study looked at the im­mune re­spons­es of 503 British health­care work­ers. About three quar­ters of the par­tic­i­pants were women.

The find­ings come af­ter Britain orig­i­nal­ly ap­proved the Pfiz­er/BioN­Tech shot in ear­ly De­cem­ber 2020 ahead of the FDA and oth­er reg­u­la­to­ry au­thor­i­ties, and sub­se­quent­ly rolled out a plan to space out vac­cine dos­es in or­der to get as many peo­ple as it could their first shots.

Re­gard­ing the best in­ter­val be­tween dos­es, “eight weeks is prob­a­bly the sweet spot,” Uni­ver­si­ty of Ox­ford study lead Su­san­na Dunachie said at a news con­fer­ence, per Bloomberg. In ad­di­tion to boost­ing an­ti­body lev­els, the study al­so re­port­ed­ly found an im­proved re­sponse from helper T cells.

But the find­ings al­so re­lat­ed one sig­nif­i­cant draw­back as the UK and oth­er coun­tries face an­oth­er pan­dem­ic wave amidst the delta vari­ant’s surge: In­di­vid­u­als saw a de­cline in an­ti­body lev­els be­tween their first and sec­ond shots, par­tic­u­lar­ly against Delta. Re­gard­less, both the short and long in­ter­vals in be­tween dos­es lead to strong re­al-world pro­tec­tion against the virus, re­searchers said. — Max Gel­man

Japan’s prime min­is­ter press­es Bourla for more vac­cines

As the Sum­mer Olympics get un­der­way in Japan on Fri­day, the coun­try’s prime min­is­ter is press­ing Pfiz­er to speed up vac­cine de­liv­er­ies.

Japan leader Yoshi­hide Suga re­port­ed­ly met with CEO Al­bert Bourla ear­ly Fri­day in or­der to ask for an ac­cel­er­at­ed vac­cine sched­ule to the coun­try, per a Reuters re­port on Japan­ese me­dia. Suga is at­tempt­ing to se­cure shots that were orig­i­nal­ly sched­uled to ar­rive in Oc­to­ber, with lo­cal gov­ern­ments around the coun­try strug­gling with sup­ply.

Ac­cord­ing to the Reuters vac­cine track­er, on­ly 35% of Japan’s pop­u­la­tion has re­ceived their first vac­cine dose, a slow­er start com­pared to oth­er high-in­come na­tions.

The re­port comes with Japan kick­ing off the Olympics open­ing cer­e­mo­ny Fri­day amidst a swath of con­tro­ver­sies and lo­gis­ti­cal is­sues. Af­ter orig­i­nal­ly post­pon­ing the Games by a year due to the pan­dem­ic, Japan has seen a sig­nif­i­cant rise in cas­es re­cent­ly due to the Delta vari­ant. Though the coun­try had orig­i­nal­ly planned to al­low a lim­it­ed num­ber of spec­ta­tors, the Olympics are now tak­ing place in large­ly emp­ty sta­di­ums and are­nas.

More than 110 ath­letes and Olympics work­ers have al­so test­ed pos­i­tive in the days lead­ing up to the Games, ac­cord­ing to the New York Times, and Japan was forced to dis­miss its open­ing cer­e­mo­ny cre­ative di­rec­tor af­ter footage emerged of him mak­ing fun of the Holo­caust in a 1990s standup rou­tine.

A brouha­ha has al­so emerged over the card­board beds Japan has set up in the Olympic Vil­lage, in what it says is an ef­fort to lim­it in­ti­ma­cy be­tween ath­letes while the pan­dem­ic surges. — Max Gel­man

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.