UP­DAT­ED: US restarts ship­ments of two mAbs that don't work against Omi­cron as Mer­ck pills see wider dis­tri­b­u­tion

For any­one who’s been fol­low­ing how the US gov­ern­ment has been al­lo­cat­ing and ship­ping sup­plies of its Covid-19 treat­ments over the past year, the news has shift­ed so many times that it can be dif­fi­cult to keep track of what’s still be­ing shipped and where.

More change is com­ing this week too, as HHS has now de­cid­ed to re-start ship­ments of both Eli Lil­ly (bam­lanivimab plus ete­se­vimab) and Re­gen­eron (casiriv­imab plus imde­vimab) mon­o­clon­al an­ti­body prod­ucts af­ter a short pause be­cause nei­ther prod­uct works against the new vari­ant Omi­cron. Lil­ly’s com­bo al­so was halt­ed last June due to the pres­ence of oth­er vari­ants.

“If the Delta VOC [vari­ant of con­cern] still rep­re­sents a sig­nif­i­cant pro­por­tion of in­fec­tions in a re­gion and oth­er op­tions are not avail­able or are con­traindi­cat­ed, el­i­gi­ble pa­tients can be of­fered bam­lanivimab plus ete­se­vimab or casiriv­imab plus imde­vimab, with the un­der­stand­ing that these treat­ments would be in­ef­fec­tive if the pa­tients are in­fect­ed with the Omi­cron VOC,” HHS’ AS­PR said in a state­ment.

The an­nounce­ment comes as the US has restart­ed ship­ments of Glax­o­SmithK­line and Vir’s mAb sotro­vimab, which does work against Omi­cron, and as ship­ments be­gan of As­traZeneca’s pro­phy­lac­tic an­ti­body Evusheld, as well as the Mer­ck and Pfiz­er pills to treat Covid, all of which are in short sup­ply as Omi­cron cas­es rise na­tion­wide.

While the restart for the Lil­ly and Re­gen­eron mon­o­clon­al an­ti­bod­ies could po­ten­tial­ly cre­ate is­sues if cer­tain ad­min­is­ter­ing sites can­not iden­ti­fy if some­one who’s test­ed pos­i­tive for Covid-19 has ei­ther the Omi­cron or Delta strain, some doc­tors think the move by HHS still makes sense.

Walid Gel­lad

“I think it’s the right move, since there is still Delta around and some fa­cil­i­ties may have abil­i­ty to de­ter­mine which in­fec­tions are Delta still,” Walid Gel­lad, pro­fes­sor of med­i­cine at the Uni­ver­si­ty of Pitts­burgh, told End­points News. “Yes, the risk is some with Omi­cron will get old­er ver­sions, while risk, on the oth­er hand, is pa­tients with Delta not get­ting a mAb be­cause of se­vere short­ages of sotro­vimab. It’s not an ide­al sit­u­a­tion in any way, but bet­ter in my view to have it avail­able for pre­scribers who are knowl­edge­able to have it as an op­tion.”

On­ly re­gions with greater than 80% Omi­cron preva­lence will not re­ceive the Lil­ly and Re­gen­eron mAbs, HHS said. But sites with more than 80% Omi­cron preva­lence may con­tin­ue to re­ceive prod­uct up­on re­quest.

“It re­al­ly is a provider’s de­ci­sion which treat­ment to use. While of course we want the ef­fec­tive treat­ments to be matched with the ap­pro­pri­ate vari­ants, I think our big­ger con­cern is if pa­tients in­fect­ed with Delta who could ben­e­fit from mAbs are not re­ceiv­ing any treat­ment at all due to a false as­sump­tion that they have Omi­cron,” a Re­gen­eron spokesper­son told End­points.

But oth­ers not­ed the time con­straints and dif­fi­cul­ty in guess­ing, now that the CDC says that more than 90% of cas­es na­tion­wide are due to Omi­cron.

“As far as I am aware, the vast ma­jor­i­ty of sites are not equipped to dis­tin­guish the vari­ants in the short time frame nec­es­sary to give mAbs. Ad­min­is­tra­tion in most cas­es is like­ly to be a mat­ter of play­ing the odds about which vari­ant is the most like­ly cause of the in­fec­tion,” Jeff Hen­der­son, as­so­ciate pro­fes­sor in the in­fec­tious dis­ease de­part­ment of Wash­ing­ton Uni­ver­si­ty School of Med­i­cine in St. Louis, told End­points.

He al­so not­ed that con­va­les­cent plas­ma from donors who have re­cov­ered from in­fec­tion and have been im­mu­nized “may be ef­fec­tive with both Omi­cron and non-Omi­cron vari­ants but is in ex­treme­ly lim­it­ed sup­ply un­less col­lec­tions re­sume.” The FDA re­cent­ly changed its EUA for con­va­les­cent plas­ma to al­low for out­pa­tient use in im­muno­sup­pressed pa­tients.

Mean­while, in a call last week with state health of­fi­cials, AS­PR of­fi­cials said the ju­ris­dic­tions are like­ly to see more of the Mer­ck pill than the Pfiz­er pill un­til at least March. So far, the US has shipped out more than 300,000 cours­es of the Mer­ck pill, and about 65,000 of the Pfiz­er pill, which AS­PR said takes longer to man­u­fac­ture.

In to­tal, the US will have ac­cess to 3 mil­lion cours­es of the Mer­ck pill, and 20 mil­lion of the Pfiz­er pill. But Pfiz­er said in a state­ment on Tues­day that 10 mil­lion of those cours­es will be avail­able by June, and the re­main­ing 10 mil­lion to fol­low by the end of Sep­tem­ber.

Cur­rent­ly, the pills are be­ing dis­trib­uted based on pop­u­la­tion da­ta, but AS­PR said the two oral an­tivi­rals will be dis­trib­uted based on dis­ease bur­den in the com­ing weeks. Al­so new: A web­site that says which phar­ma­cies have the Mer­ck and Pfiz­er pills.

“As you can imag­ine we re­ly heav­i­ly on good re­port­ing of use, to see where there’s up­take of prod­uct and match that against sur­veil­lance da­ta on dis­ease bur­den,”  BAR­DA’s Derek Eis­nor said on the call.

Ar­ti­cle up­dat­ed with new in­for­ma­tion on Omi­cron from CDC, and com­ment from Dr. Hen­der­son.

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

Tony Coles, Cerevel CEO

Cerev­el takes the pub­lic of­fer­ing route, with a twist — rais­ing big mon­ey thanks to ri­val da­ta

As public biotechs seek to climb out of the bear market, a popular strategy to raise cash has been through public offerings on the heels of positive data. But one proposed raise Wednesday appeared to take advantage not of a company’s own data, but those from a competitor.

Cerevel Therapeutics plans to raise $250 million in a public offering and another $250 million in debt, the biotech announced Wednesday afternoon, even though it did not report any news on its pipeline. However, the move comes days after rival Karuna Therapeutics touted positive Phase III data in schizophrenia, a field where Cerevel is pursuing a similar program.

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Who are the women blaz­ing trails in bio­phar­ma R&D? Nom­i­nate them for End­points' 2022 spe­cial re­port

Over the past three years, Endpoints News has spotlighted 60 women who have blazed trails and supercharged R&D across the biopharma world. And judging from the response we’ve received, to both our special reports and live events, telling their stories — including any obstacles they may have had to overcome — has inspired our readers in many different ways.

But change takes time, and the fact remains that women are still underrepresented at the upper ranks of the drug-making world.

Bernat Olle, Vedanta Biosciences CEO

Cit­ing 'chal­leng­ing eco­nom­ic en­vi­ron­ment,' PhI­II-ready mi­cro­bio­me biotech lays off 20% of staffers

The market downturn isn’t just sweeping up public biotechs.

Vedanta Biosciences, a developer of oral drugs derived from the human microbiome, is laying off about 20% of its staff — an unfortunately common occurrence these days. But CEO Bernat Olle took the unusual step of sharing the decision on LinkedIn and offering to connect the employees being let go with any company that’s hiring in their areas.

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Up­dat­ed: Amid mas­sive re­struc­tur­ing, Bio­gen looks to re­duce phys­i­cal pres­ence in Boston

Biogen is putting a sizable chunk of office and research space in Kendall Square and Weston, MA up for sublease, marking another big change as the biotech grapples with the aftershock of a disastrous and controversial rollout for its Alzheimer’s drug.

The subbleases are “part of Biogen’s overall implementation of the ‘Future of Work,’ which is allowing us to optimize our footprint and reduce the amount of space we occupy, taking into consideration new elements such as the hybrid work model,” Biogen spokesperson Ashleigh Koss wrote in a statement to Endpoints News, adding that the company has had subleases across several buildings for years.

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Hervé Affagard, MaaT Pharma CEO

One year in­to clin­i­cal hold, FDA has more ques­tions about 'pooled' mi­cro­bio­me ther­a­py

The FDA is still wary about a trial testing a microbiome therapy in patients with steroid-resistant acute graft-versus-host disease (aGVHD).

A year after MaaT Pharma’s IND application in the US was first met with a clinical hold, the French biotech said the agency is maintaining the hold. The crux of the matter, MaaT suggested, has to do with the way it puts together its drug candidate, which is administered as an enema (i.e. an injection of fluid into the bowel).

Pfiz­er launch­es re­bate pro­gram for rare dis­ease pa­tients who have to stop tak­ing Panzy­ga

Pfizer is launching its second-ever rebate program, this time for Panzyga, its treatment for a rare neurological disease of the peripheral nerves.

The program began last month, according to STAT which first reported the news, and offers a refund of out-of-pocket costs for patients who must discontinue their course before the fifth treatment for “clinical reasons.”

Panzyga was approved back in 2018 to treat primary immunodeficiency (PI) in patients two years and older and chronic immune thrombocytopenia (cITP) in adults. It has since picked up an indication in chronic inflammatory demyelinating polyneuropathy (CIDP), a condition that’s characterized by weakness of the arms or legs, tingling or numbness, and a loss of deep tendon reflexes, according to the NIH.

Horizon's back-to-school campaign for children with cystinosis includes an all about me poster as part of a care package box.

Hori­zon read­ies kids and fam­i­lies for back to school with week­long ac­tiv­i­ties around rare dis­ease cysti­nosis

Going back to school is usually a bumpy readjustment from summer freedom for all kids, but especially for kids with chronic health conditions. Horizon Therapeutics is hoping to help smooth the way for some who have the rare disease cystinosis. Cystinosis is a genetic disease that causes the amino acid cystine to build up in different tissues and organs.

The “Gear Up” for school campaign is running all week with different online and at-home events and activities for families and children with cystinosis. Each family who signed up receives a care package mailed to their home including an activity coloring book “Michael’s Show-and-Tell.” The book tells Michael’s story about living with cystinosis while offering kids matching, coloring and finding object games along with information.

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Alessandro Maselli, Catalent CEO

Catal­ent ac­quires North Car­oli­na CD­MO for $475M, boost­ing oral solids work

As Catalent has been expanding its reach in the US this year, as well as recently completing a C-suite shuffle, the company announced last night that it has acquired the CDMO Metrics Contract Services for $475 million from Mayne Pharma Group.

The acquisition will increase Catalent’s capabilities in oral solid formulation development, manufacturing and packaging as well as expand its capacity to handle more highly potent compounds.

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