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.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Albert Bourla, Pfizer CEO (Efren Landaos/Sipa USA/Sipa via AP Images)

Pfiz­er makes an­oth­er bil­lion-dol­lar in­vest­ment in Eu­rope and ex­pands again in Michi­gan

Pfizer is continuing its run of manufacturing site expansions with two new large investments in the US and Europe.

The New York-based pharma giant’s site in Kalamazoo, MI, has seen a lot of attention over the past year. As a major piece of the manufacturing network for Covid-19 vaccines and antivirals, Pfizer is gearing up to place more money into the site. Pfizer announced it will place $750 million into the facility, mainly to establish “modular aseptic processing” (MAP) production and create around 300 jobs at the site.

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Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Yuling Li, Innoforce CEO

In­no­force opens new man­u­fac­tur­ing site in Chi­na

Innoforce is off to the races at its new site in the city of Hangzhou, China.

The Chinese CDMO announced last week that it has started manufacturing at the new facility, which was built to offer process development and manufacturing operations for RNA, plasmid DNA, viral vectors and other cell therapeutics. It will also serve as Innoforce’s corporate HQ.

The company said it’s investing more than $200 million in the 550,000-square-foot manufacturing base for advanced therapies. The GMP manufacturing facility features space for producing plasmids with three 30-liter bioreactors. For viral vector manufacturing, Innoforce also has 200- and 500-liter bioreactors at its disposal, along with eight suites to make cell therapies. The site also includes several labs and warehouse spaces.

FDA grants or­phan drug des­ig­na­tion to Al­ger­non's ifen­prodil, while ex­clu­siv­i­ty re­mains un­clear

As the FDA remains silent on orphan drug exclusivity in the wake of a controversial court case, the agency continues to hand out new designations. The latest: Algernon Pharmaceuticals’ experimental lung disease drug ifenprodil.

The Vancouver-based company announced on Monday that ifenprodil received orphan designation in idiopathic pulmonary fibrosis (IPF), a chronic lung condition that results in scarring of the lungs.  Most IPF patients suffer with a dry cough, and breathing can become difficult.

Vas Narasimhan, Novartis CEO (Thibault Camus/AP Images, Pool)

No­var­tis bol­sters Plu­vic­to's case in prostate can­cer with PhI­II re­sults

The prognosis is poor for metastatic castration-resistant prostate cancer (mCRPC) patients. Novartis wants to change that by making its recently approved Pluvicto available to patients earlier in their course of treatment.

The Swiss pharma giant unveiled Phase III results Monday suggesting that Pluvicto was able to halt disease progression in certain prostate cancer patients when administered after androgen-receptor pathway inhibitor (ARPI) therapy, but without prior taxane-based chemotherapy. The drug is currently approved for patients after they’ve received both ARPI and chemo.

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Rick Modi, Affinia Therapeutics CEO

Ver­tex-part­nered gene ther­a­py biotech Affinia scraps IPO plans

Affinia Therapeutics has ditched its plans to go public in a relatively closed-door market that has not favored Nasdaq debuts for the drug development industry most of this year. A pandemic surge in 2020 and 2021 opened the doors for many preclinical startups, which caught Affinia’s attention and gave the gene therapy biotech confidence in the beginning days of 2022 to send in its S-1.

But on Friday, Affinia threw in the S-1 towel and concluded now is not the time to step onto Wall Street. The biotech has put out few public announcements since the spring of this year. Endpoints News picked the startup as one of its 11 biotechs to watch last year.

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Af­ter M&A fell through, Ther­a­peu­tic­sMD sells hor­mone ther­a­py, con­tra­cep­tive ring for $140M cash plus roy­al­ties

TherapeuticsMD, a women’s health company whose one-time billion-dollar valuation seems a distant memory as its blockbuster aspirations petered out, is finally cashing out.

Australia’s Mayne Pharma is paying $140 million upfront to license essentially TherapeuticsMD’s whole portfolio, including two prescription drugs that treat conditions relating to menopause, a contraceptive vaginal ring as well as its prescription prenatal vitamin brands.

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Big week for Alzheimer’s da­ta; As­traZeneca buys cell ther­a­py start­up; Dig­i­tal ther­a­peu­tics hits a pay­er wall; and more

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