Up­dat­ed: US sees spike in Paxlovid us­age as Mer­ck­'s mol­nupi­ravir and As­traZeneca's Evusheld are slow­er off the shelf

New da­ta from HHS show that more than 162,000 cours­es of Pfiz­er’s Covid-19 an­tivi­ral Paxlovid were ad­min­is­tered across the US over the past week, con­tin­u­ing a streak of in­creased us­age of the pill, and sig­nal­ing not on­ly ris­ing case num­bers but more aware­ness of how to ac­cess it.

In com­par­i­son to this week, about 670,000 cours­es of the Pfiz­er pill have been ad­min­is­tered across the first five months since Paxlovid has been on the US mar­ket, av­er­ag­ing about 33,000 cours­es ad­min­is­tered per week in that time.

A Pfiz­er spokesper­son told End­points News the com­pa­ny does “not have any con­cerns nor fore­see any sup­ply is­sues in our abil­i­ty to sup­port if [us­age] rates in­crease.”

Cu­mu­la­tive­ly, as of May 24, al­most 3.8 mil­lion dos­es of Paxlovid have been made avail­able to states so far by the fed­er­al gov­ern­ment, and about 2.4 mil­lion of those have been or­dered by states, with more than 831,000 cours­es ad­min­is­tered.

Signs for such a spike in us­age were ev­i­dent ear­li­er this month, as in a call with re­porters se­nior HHS of­fi­cials cred­it­ed the surge in the use of Paxlovid to their out­reach, and through the Biden ad­min­is­tra­tion’s Test to Treat ini­tia­tive, which al­lows for use of Paxlovid with a pos­i­tive test at par­tic­i­pat­ing phar­ma­cies.

“We have seen more than a 315% in­crease in Paxlovid use over the past four weeks. In the first week of May, near­ly 115,000 cours­es were dis­pensed,” an of­fi­cial said at the time.

Mean­while, out­side of Paxlovid, few oth­er treat­ment op­tions are re­al­ly in wide use.

Mer­ck’s mol­nupi­ravir, known com­mer­cial­ly as Lagevrio, has strug­gled to make its way out of the in­ven­to­ry clos­et, ac­cord­ing to the lat­est num­bers post­ed by HHS.

On­ly about 20,000 cours­es of the Mer­ck pill were used in the past week, and on­ly about 13% of the to­tal US in­ven­to­ry of mol­nupi­ravir has been used to date. That com­pares with about 35% of over­all us­age of Paxlovid cours­es or­dered by states so far, and the bulk of those or­ders have come with­in the last sev­er­al months.

But for As­traZeneca’s pre­ex­po­sure mAb Evusheld, on­ly about 16,000 cours­es were ad­min­is­tered in the past week. About 38% of all Evusheld or­dered by states has been ad­min­is­tered so far, ac­cord­ing to the lat­est HHS num­bers.

For Eli Lil­ly’s bebtelovimab, which is a mon­o­clon­al an­ti­body that’s sup­posed to be used ahead of mol­nupi­ravir if both are on hand, about 100,000 cours­es in to­tal have been ad­min­is­tered of 379,526 cours­es or­dered (542,330 cours­es avail­able). Bebtelovimab is the fol­low-on mAb af­ter Lil­ly’s for­mer com­bo mAb (850,000+ cours­es dis­trib­uted ear­li­er in the pan­dem­ic) that lost ef­fi­ca­cy against the lat­est vari­ant.

Mean­while, HHS has be­come less and less trans­par­ent with its da­ta and in­for­ma­tion on its dis­tri­b­u­tion of Covid-19 ther­a­peu­tics.

Af­ter the Trump ad­min­is­tra­tion, and the be­gin­ning of the Biden ad­min­is­tra­tion al­lowed for the pub­lic post­ing of week­ly calls be­tween HHS and states on Covid-19 ther­a­peu­tic dis­tri­b­u­tion, those calls have since been made pri­vate and the pri­or record­ings have been delet­ed from the AS­PR web­site.

In ad­di­tion, each week’s ther­a­peu­tic ad­min­is­tra­tion num­bers have to be tal­lied in­de­pen­dent­ly be­cause HHS now deletes the pre­vi­ous week’s num­bers.

Ed­i­tor’s note: Ar­ti­cle up­dat­ed to add Pfiz­er com­ment and note the stats for Lil­ly’s Covid-19 treat­ments bebtelovimab too.

Lina Gugucheva, NewAmsterdam Pharma CBO

Phar­ma group bets up to $1B-plus on the PhI­II res­ur­rec­tion of a once dead-and-buried LDL drug

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

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How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

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Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Scoop: Roche scraps one of two schiz­o­phre­nia PhII tri­als due to missed pri­ma­ry end­point

Roche has terminated one of two Phase II trials testing its drug ralmitaront in patients with schizophrenia, the Big Pharma confirmed to Endpoints News.

The study was terminated last month, according to a June 22 update to the registry on clinicaltrials.gov. Begun in September 2020, the trial was looking at ralmitaront in patients with acute schizophrenia. The trial enrolled 286 patients out of an originally planned 308.

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Pearl Huang, Dunad Therapeutics CEO (Ken Richardson, PR Newswire)

Long­time biotech leader Pearl Huang takes the reins as CEO of No­var­tis-backed up­start

It has only been a few months since Pearl Huang exited the top seat at Cygnal Therapeutics, but now she’s back at the helm of another biotech.

After taking a few months off — passing an exam in that time to get her captain’s license from the US Coast Guard — she’s been named CEO of Dunad Therapeutics, a biotech focused on developing a small molecule covalent therapies that was founded in 2020. Huang told Endpoints News that two factors attracted her to going back to the c-suite: the company’s technology and its co-founders.

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Matt Gline, Roivant CEO (John Sciulli/Getty Images for GLG)

Roivant chops sick­le cell gene ther­a­py, der­ma­tol­ogy drugs to fo­cus on 'high­er val­ue pro­ject­s'

Roivant is sweeping a suite of drugs, including a gene therapy for sickle cell disease already in the clinic, out of its pipeline.

Six programs from four of its “vants” are being wound down as part of “a company-wide cost optimization and pipeline reprioritization initiative to reduce our expected operating expenses and prioritize our capital resources.”

When reached by Endpoints News, a spokesperson said, “We don’t anticipate a material reduction in headcount but we will likely reassign some folks to higher value projects as part of winding down specific programs.”

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Laurence Reid, Decibel CEO

Still in pre­clin­i­cal test­ing for ear gene ther­a­pies, Deci­bel touts small snap­shot of chemo-in­duced hear­ing loss drug

Though Decibel Therapeutics has largely pivoted toward gene therapies for the inner ear, its lead clinical candidate simply aims to protect cancer patients from chemotherapy-induced hearing loss. On Tuesday, the biotech presented its first efficacy data for the program, and execs like what they see.

Decibel reported interim results from a Phase Ib study showing the experimental drug, dubbed DB-020, largely protected a small group of patients from losing their hearing. Researchers used a particularly unique study design, administering the compound in one of each patients’ ears before they received cisplatin chemotherapy and placebo in the other.

Ben Zimmer, Priovant CEO

Roivant un­veils lat­est spin­out as Pfiz­er en­trusts JAK1/TYK2 to Pri­o­vant

In November, Pfizer disclosed it’s spun out the Phase II dual JAK1/TYK2 inhibitor to a startup formed in collaboration with an unnamed, experienced partner.

We now know who the partner is. And as Pfizer and Roivant officially take the wraps off Priovant Therapeutics, the companies reveal that they have started two registrational trials of the drug, brepocitinib, as part of a broader plan to develop a big, first-in-class franchise spanning multiple orphan and specialty autoimmune diseases.

Albert Bourla, Pfizer CEO (Gian Ehrenzeller/Keystone via AP Images)

Up­dat­ing the Covid-19 vac­cine: FDA of­fers a qual­i­fied thumbs-up ahead of ad­comm

The FDA’s adcomm of outside vaccine experts will meet tomorrow to discuss how to protect the US from a likely coming wave of Omicron cases in the fall and winter, and whether to deploy vaccines that specifically target the Omicron variant.

While the data so far are limited, the FDA sounded an upbeat tone in the briefing documents on Pfizer/BioNTech’s candidates, released this weekend ahead of the VRBPAC meeting.