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.

The Fac­tors Dri­ving a Rapid Evo­lu­tion of Gene & Cell Ther­a­py and CAR-T Clin­i­cal Re­search in APAC

APAC is the fastest growing region globally for cell & gene therapy trials representing more than a third of all cell & gene studies globally, with China leading in the region. 

APAC is the leading location globally for CAR-T trials with China attracting ~60% of all CAR-T trials globally between 2015-2022. The number of CAR-T trials initiated by Western companies has rapidly increased in recent years (current CAGR of about 60%), with multiple targets being explored including CD19, CD20, CD22, BCMA, CD30, CD123, CD33, CD38, and CD138.

The End­points 11; blue­bird's $3M gene ther­a­py; Bio­gen tout new neu­ro da­ta; Harsh re­views for can­cer drugs; 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.

Reading about John Carroll’s pick of biotech’s most promising startups has become a treasured tradition. If you ever get curious about previous classes of the Endpoints 11, you can find all of them (plus a number of our other regular specials) here.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,800+ biopharma pros reading Endpoints daily — and it's free.

EMA warns of short­ages of two Boehringer heart drugs due to a spike in de­mand

The EMA is putting EU member states on alert over the shortage of two drugs that counter heart attacks due to an uptick in demand.

On Friday, the EMA sent out a warning that two Boehringer Ingelheim drugs are experiencing a shortage: Actilyse and Metalyse. The drugs are used as emergency treatments for adults experiencing acute myocardial infarction, or a heart attack, by dissolving blood clots that have formed in the blood vessels.

The End­points 11: The top pri­vate biotechs in pur­suit of new drugs. Push­ing the en­ve­lope with pow­er­ful new tech­nolo­gies

Right around the beginning of the year, we got a close-up look at what happens after a boom ripples through biotech. The crash of life sciences stocks in Q1 was heard around the world.

In the months since, we’ve seen the natural Darwinian down cycle take effect. Reverse mergers made a comeback, with more burned out shells to go public at a time IPOs and road shows are out of favor. And no doubt some of the more recent arrivals on the investing side of the business are finding greener pastures.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

As­traZeneca, Mer­ck cull one Lyn­parza in­di­ca­tion in heav­i­ly pre­treat­ed ovar­i­an can­cer pa­tients

Just one day after blockbuster Lynparza got access to another indication in China, its Big Pharma owners have decided to withdraw it in certain patients after reviewing Phase III data.

The two companies that work together on Lynparza decided to recall one of the indications several weeks ago in a specific type of ovarian cancer, Lynparza’s first indication when it was first FDA-approved in 2014. Initial data showed that rates of overall survival in patients with at least three rounds of chemo before getting on the PARP inhibitor were lower than in patients with less previous chemo treatment.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,800+ biopharma pros reading Endpoints daily — and it's free.

Fu­ji­film con­tin­ues CD­MO ex­pan­sion, break­ing ground on $435M UK site

Fujifilm’s CDMO arm, Fujifilm Diosynth, has been on a roll this month as the company has recently broken ground on a major project in Europe and it appears to be keeping up the momentum.

Fujifilm Diosynth announced that it has kicked off an expansion project for its microbial manufacturing facility at its campus in the town of Billingham, UK, in the northeast of England.

The 20,000 square-foot, £400 million ($435 million) expansion will add clean rooms, purification suites and a packing area along with more space for the manufacturing itself.

An­oth­er Cipla site lands a Form 483 over clean­ing is­sues and QC con­trols

A Cipla drug manufacturing site in India has once again landed in the crosshairs of FDA inspectors.

The facility in question is Cipla’s drug manufacturing facility in the village of Verna, in the state of Goa in India’s southwest. In a sign that foreign inspections might ramp up again, the FDA’s visit from Aug. 16 to Aug. 22 uncovered six observations.

The 11-page report noted that environmental monitoring at the site did not properly ensure that microbial contaminants were not making any impact in the aseptic filling areas. It also found that procedures meant to stop microbial contamination were not adequately conducted in aseptic areas of the facility.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,800+ biopharma pros reading Endpoints daily — and it's free.

FDA ad­comm takes down Se­cu­ra Bio's leukemia drug af­ter fi­nal tri­al re­sults show po­ten­tial OS detri­ment

The FDA’s Oncologic Drugs Advisory Committee on Friday voted 8-4 against the benefit-risk profile of Secura Bio’s PI3K inhibitor Copiktra (duvelisib), which won approval in September 2018 as a third-line treatment for relapsed or refractory CLL or SLL, but updated pivotal trial results raised safety questions.

In addition to the serious and fatal toxicities of duvelisib, FDA speakers at the ODAC meeting pointed to an evolved treatment landscape for CLL and SLL, with targeted BTK or BCL2 inhibitors (front-line or second-line), and data pointing to a “potential detriment” in overall survival for duvelisib. But some ODAC members noted that the detriment was likely small and that there is some efficacy even as the data are difficult to interpret.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,800+ biopharma pros reading Endpoints daily — and it's free.

Solicitor General Elizabeth Prelogar

Should SCO­TUS hear Am­gen's Repatha case? So­lic­i­tor gen­er­al says no

Back in April, Amgen said it was encouraged by the solicitor general’s anticipated review of its Supreme Court petition to rehear a Repatha patent case. They’re likely much less optimistic about the outcome now.

Solicitor General Elizabeth Prelogar wrote in a recent 27-page brief that Amgen’s arguments “lack merit and further review is not warranted.”

The case traces back to a suit filed in 2014 against Sanofi and Regeneron’s Praluent, which ended up beating Amgen’s PCSK9 blockbuster Repatha to market by a month just a year later.