UP­DAT­ED: US ships out all re­main­ing sup­plies of the on­ly Covid mAb treat­ment that works against Omi­cron

Right as the new Omi­cron vari­ant is poised to in­crease rapid­ly across the US, the fed­er­al gov­ern­ment has ef­fec­tive­ly run out of the on­ly mon­o­clon­al an­ti­body treat­ment that works against it, and at least one ma­jor hos­pi­tal sys­tem is now halt­ing all mAb in­fu­sions.

Late last month, the fed­er­al gov­ern­ment paused ship­ments of Glax­o­SmithK­line and Vir’s mAb treat­ment sotro­vimab in or­der to con­serve sup­plies of the on­ly treat­ment that might work against the Omi­cron vari­ant. Last week, how­ev­er, HHS told End­points News that the move to hold back sotro­vimab was un­re­lat­ed to Omi­cron, and due to a sur­plus of Eli Lil­ly mAbs, which aren’t ef­fec­tive against Omi­cron.

But late Fri­day, HHS con­firmed to End­points that the gov­ern­ment was with­hold­ing the sup­plies due to the Omi­cron vari­ant (and apol­o­gized for pro­vid­ing in­ac­cu­rate in­for­ma­tion a day ear­li­er).

HHS al­so si­mul­ta­ne­ous­ly an­nounced that it’s ship­ping its re­main­ing 55,000 dos­es of sotro­vimab, which will be­gin ar­riv­ing in the states on Tues­day un­til more sup­plies hope­ful­ly be­come avail­able the week of Jan. 3. The de­part­ment said in a state­ment:

Ear­ly in vit­ro da­ta sug­gests sotro­vimab works against the Omi­cron vari­ant. As such, we are ac­tive­ly prepar­ing ap­prox­i­mate­ly 55,000 dos­es of sotro­vimab for im­me­di­ate al­lo­ca­tion to state and ter­ri­to­r­i­al health de­part­ments. Ju­ris­dic­tions will be­gin re­ceiv­ing the prod­uct as ear­ly as Tues­day, De­cem­ber 21, 2021. Cur­rent sup­ply of sotro­vimab is lim­it­ed; how­ev­er, we ex­pect it to grow to ap­prox­i­mate­ly 300,000 ad­di­tion­al dos­es in Jan­u­ary.

Scott Got­tlieb

“The feds had no choice but to for­ward de­ploy the lim­it­ed stock­piles they have of the on­ly an­ti­body we know is like­ly to be high­ly po­tent against omi­cron,” for­mer FDA com­mis­sion­er Scott Got­tlieb said.

But the about-face from HHS on why it was with­hold­ing sotro­vimab re­veals an agency scrap­ing to turn a mAb short­age in­to a pos­i­tive sto­ry about how it planned ahead.

In re­al­i­ty, very few hos­pi­tals na­tion­wide will have ad­e­quate sup­plies of sotro­vimab lat­er this week and next week, when cas­es will like­ly surge due to hol­i­day trav­el.

New York, Ohio, Penn­syl­va­nia, Michi­gan and Illi­nois were the on­ly states to re­ceive more than 3,000 dos­es of sotro­vimab each in the lat­est ship­ment.

And HHS is ad­vis­ing states to be cau­tious with its lim­it­ed sup­plies, adding, “Un­til lo­cal preva­lence of Omi­cron is greater than 20%, ju­ris­dic­tions are en­cour­aged to di­rect sotro­vimab to sites that can pro­vide IV treat­ment (with­in 48 hours of col­lec­tion of a pa­tient sam­ple) to high­est risk, el­i­gi­ble in­di­vid­u­als di­ag­nosed with a test that may iden­ti­fy a po­ten­tial case of the Omi­cron vari­ant.”

A spokesper­son for Glax­o­SmithK­line said that GSK and Vir have es­tab­lished a strate­gic man­u­fac­tur­ing net­work that will en­able the man­u­fac­ture of ap­prox­i­mate­ly 2 mil­lion dos­es of sotro­vimab to sup­port emer­gency sup­ply in the first year fol­low­ing EUA.

HHS al­so said Fri­day that the two oth­er avail­able mAbs, from Eli Lil­ly and Re­gen­eron, con­tin­ue to work against the Delta vari­ant, which re­mains the dom­i­nant strain in the US. But with Omi­cron now over 70% of Covid-19 cas­es in the US, use of those two mAbs will like­ly be paused.

The Mt. Sinai hos­pi­tal sys­tem in New York said late Sun­day that it’s sus­pend­ing in­fu­sions of the Lil­ly and Re­gen­eron mAbs due to Omi­cron.

“Due to the in­creas­ing preva­lence of the Omi­cron vari­ant of SARS-CoV-2 and the lack of ef­fi­ca­cy of both bam­lanivimab/ete­se­vimab and casiriv­imab/imde­vimab, we have sus­pend­ed of­fer­ing these two treat­ments for treat­ment or for post-ex­po­sure pro­phy­lax­is,” Mt. Sinai said in a state­ment.

Look­ing for­ward, states will have to pro­tect against Omi­cron with­out the mAb treat­ments, which will like­ly com­pound prob­lems for those who re­main un­vac­ci­nat­ed.

Ed­i­tor’s note: This ar­ti­cle was up­dat­ed with com­ment from GSK.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,300+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,300+ biopharma pros reading Endpoints daily — and it's free.

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.

Abortion-rights protesters regroup and protest following Supreme Court's decision to overturn Roe v. Wade. (AP Photo/Gemunu Amarasinghe)

Fol­low­ing SCO­TUS de­ci­sion to over­turn abor­tion pro­tec­tions, AG Gar­land says states can't ban the abor­tion pill

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.”

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.

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.

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.