President Biden (AP Images)

'Test to treat': Biden launch­es new Covid pill ini­tia­tive amid out­stand­ing ques­tions on ac­cess

First un­veiled at the State of the Union, the Biden ad­min­is­tra­tion on Tues­day of­fi­cial­ly launched its “Test to Treat” ini­tia­tive that aims to make more free Covid-19 pills from Pfiz­er and Mer­ck read­i­ly avail­able across the coun­try.

Par­tic­i­pat­ing phar­ma­cy chains (al­though Biden stopped short of al­low­ing phar­ma­cists to pre­scribe the pills) can test some­one (or peo­ple can test else­where), and if pos­i­tive for Covid-19, the site can si­mul­ta­ne­ous­ly pro­vide one of the two an­tivi­rals in the same vis­it.

Lo­ca­tions par­tic­i­pat­ing in the Test to Treat ini­tia­tive, which will ini­tial­ly in­clude hun­dreds of fed­er­al­ly-qual­i­fied health cen­ters, phar­ma­cy-based clin­ics at the top chains, and long-term care fa­cil­i­ties across the coun­try will re­ceive the oral an­tivi­ral drugs, Pfiz­er’s Paxlovid and Mer­ck’s mol­nupi­ravir, through a di­rect fed­er­al or­der­ing process.

But this al­lo­ca­tion will be in ad­di­tion to the cur­rent sup­ply of near­ly 100,000 Paxlovid cours­es and al­most 400,000 mol­nupi­ravir cours­es that states and ju­ris­dic­tions are al­ready re­ceiv­ing from the fed­er­al gov­ern­ment every two weeks (click here to see the cur­rent sites na­tion­wide re­ceiv­ing these sup­plies).

It’s un­clear how long this ini­tia­tive might last, or how many may gain ac­cess to the pills who oth­er­wise wouldn’t have.

More than 2 mil­lion of the to­tal 3 mil­lion Mer­ck pills that the gov­ern­ment pur­chased have al­ready been dis­trib­uted to states. For Paxlovid, al­though the US has pur­chased a to­tal of 10 mil­lion cours­es, on­ly about 690,000 cours­es have al­ready been dis­trib­uted be­cause of dif­fi­cul­ties in mak­ing the pill, and on­ly about 100,000 more cours­es have been pro­cured to date, ac­cord­ing to a re­port from Stat News.

As HHS has ef­fec­tive­ly run out of Covid-19 fund­ing, and Dems con­tin­ue fight­ing for what looks like about $15 bil­lion in more funds, ac­cord­ing to the Wash­ing­ton Post, the time­line for the pro­cure­ment of more Paxlovid is un­known. And giv­en the dif­fi­cul­ties in man­u­fac­tur­ing Paxlovid, Pfiz­er said it on­ly ex­pects to have 6 mil­lion cours­es ready for the glob­al mar­ket this month, and 24 mil­lion cours­es glob­al­ly by June.

Ex­perts think the ini­tia­tive will be ham­pered by the rel­a­tive­ly lim­it­ed sup­plies (par­tic­u­lar­ly for the more ef­fec­tive Paxlovid, as there have al­so been ac­counts of US phar­ma­cies run­ning out of stor­age space for mol­nupi­ravir), the lim­its around on­ly al­low­ing sites with med­ical doc­tors, and un­knowns on whether the an­tivi­rals work for the vac­ci­nat­ed or those who have al­ready had Covid-19 may se­vere­ly ham­per this ini­tia­tive.

Michael Ganio, se­nior di­rec­tor at the Amer­i­can So­ci­ety of Health-Sys­tem Phar­ma­cists, ex­plained to End­points News how the Test to Treat ini­tia­tive could be op­ti­mized by hav­ing the FDA get out of the way, and lever­ag­ing the help of phar­ma­cists in en­sur­ing the ap­pro­pri­ate pa­tients are ac­cess­ing the pills. He al­so not­ed that while the de­cline in Omi­cron cas­es means sup­ply con­cerns should be al­le­vi­at­ed, an­oth­er wave of cas­es from a new vari­ant could cre­ate new sup­ply is­sues.

But the Amer­i­can Med­ical As­so­ci­a­tion raised con­cerns about the safe­ty of the ini­tia­tive, par­tic­u­lar­ly giv­en all the neg­a­tive in­ter­ac­tions with Paxlovid, and as mol­nupi­ravir should not be giv­en to preg­nant women or chil­dren un­der 18. AMA pres­i­dent Ger­ald Har­mon said in a state­ment last week:

While the ad­min­is­tra­tion laid out promis­ing plans ear­li­er this week to com­bat COVID-19 and put mea­sures in place to pre­vent fu­ture pan­demics, the phar­ma­cy-based clin­ic com­po­nent of the test-to-treat plan flaunts pa­tient safe­ty and risks sig­nif­i­cant neg­a­tive health out­comes. This ap­proach, though well in­ten­tioned in that it at­tempt­ed to in­crease ac­cess to care for pa­tients with­out a pri­ma­ry care physi­cian, over­sim­pli­fies chal­leng­ing pre­scrib­ing de­ci­sions by omit­ting knowl­edge of a pa­tient’s med­ical his­to­ry, the com­plex­i­ty of drug in­ter­ac­tions, and man­ag­ing pos­si­ble neg­a­tive re­ac­tions.

Michael Lin, as­so­ciate pro­fes­sor of neu­ro­bi­ol­o­gy and bio­engi­neer­ing at Stan­ford Uni­ver­si­ty, al­so ex­plained to End­points that he’s wor­ried about the overuse of these Mer­ck and Pfiz­er pills now, es­pe­cial­ly as this ini­tia­tive from Biden is not be­ing ad­ver­tised as on­ly for un­vac­ci­nat­ed peo­ple, but the on­ly da­ta that’s avail­able on the pills’ ef­fi­ca­cy is in those who are un­vac­ci­nat­ed.

“In the pub­lic mind, it’s or­der­ing the pri­or­i­ties in­cor­rect­ly,” Lin said. “At this stage, an­tivi­rals are im­por­tant for those who need them,” but he not­ed that vac­ci­na­tions and pub­lic mask­ing will be far more ef­fec­tive at stop­ping the next wave of cas­es.

UP­DAT­ED: In a fresh dis­ap­point­ment, Am­gen spot­lights a ma­jor safe­ty is­sue with KRAS com­bo

Amgen had hoped that its latest study matching its landmark KRAS G12C drug Lumakras with checkpoint inhibitors would open up its treatment horizons and expand its commercial potential. Instead, the combo spurred safety issues that blunted efficacy and forced the pharma giant to alter course on its treatment strategy, once again disappointing analysts who have been tracking the drug’s faltering sales and limited therapeutic reach.

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Ad­dress­ing the ‘Ca­pac­i­ty Crunch’ with a Scal­able Plat­form Process Ap­proach

The field of gene therapy has been diligently moving forward over the past several decades to bring potentially life-saving treatments to patients with genetic diseases. In addition to two approved adeno-associated viral (AAV) gene therapies, there are more than 250 AAV gene therapies in various clinical trial stages.1 AAV vectors remain the most frequently used vector for delivering therapeutic transgenes to target tissues due to their demonstrated and lasting clinical efficacy and extensive safety track record. As AAV therapies advance through clinical trials and into commercialization, many biotech companies are turning to contract development and manufacturing organizations (CDMOs) to prepare their programs for late-stage clinical and commercial scale manufacturing. Given the scope and scale of the manufacturing needs that will accompany regulatory approvals for these assets, CDMOs continue to expand their capacity to meet the needs of increasing prevalent patient populations. However, despite rapid growth, projected gene therapy manufacturing demands still outpace the collective capacity of the CDMO industry.

A $5B Pfiz­er buy­out? Am­gen, Gilead head­line M&A Thurs­day; Al­ny­lam's AT­TR sweep; An­drew Lo's rare dis­ease quest; 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.

One of the cool things about adding EndpointsPharma to the daily roster is that my colleagues can now dedicate time to tracking quarterly updates and tuning into calls with Big Pharma companies. Check out their dispatch from the Q2 earnings below.

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George Yancopoulos, Regeneron president and CSO (Brendan McDermid/Reuters/Alamy)

George Yan­copou­los says he's on the trail of the holy grail: ‘This could rep­re­sent the next break­through for im­munother­a­py’

Two of the most outspoken — and successful — drug developers in biotech say they’ve collected early-stage clinical data that are pointing them down the trail to the holy grail in cancer immunotherapy R&D.

While analysts largely busied themselves today with chronicling the ongoing success of Regeneron’s two big cash cows — Dupixent and Eylea — chief scientist George Yancopoulos and CEO Len Schleifer used the Q2 call to spotlight their early success with a combination of the “homegrown” PSMAxCD28 costimulatory bispecific antibody REGN5678 in combination with their PD-1 checkpoint Libtayo. The presentation comes just weeks after Regeneron completed a deal to gather all rights to the PD-1 that had been in Sanofi’s hands. And the two top execs are unstinting in their praise of the potential of a whole set of costimulatory pipeline projects which they say may finally deliver the long-awaited next-level approach to broadening the immunotherapy field of drugs.

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Albert Bourla, Pfizer CEO (Laurent Gillieron/Keystone via AP)

Break­ing: Pfiz­er in hot pur­suit of a $5B buy­out of Glob­al Blood Ther­a­peu­tics — re­port

Pfizer CEO Albert Bourla has vowed to leave no stone unturned in the search for new biotech deals, and the BD team is not letting him down.

The Wall Street Journal reported today that Pfizer is in the final stages of acquiring Global Blood Therapeutics for $5 billion. According to the Journal report, though, Pfizer is not the only buyer at the deal table and while the pharma giant may be close to clinching it, there are no guarantees it will continue.

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Bob Bradway, Amgen CEO (Justin Kase Conder/AP Images for Amgen)

UP­DAT­ED: Am­gen chief Brad­way nabs a rare dis­ease play­er in $4B buy­out as the M&A tem­po ac­cel­er­ates

Amgen CEO Bob Bradway is bellying up to the M&A table today, scooping up the newly anointed commercial biotech ChemoCentryx $CCXI and its recently approved rare disease drug for $3.7 billion out of the cash stockpile. The deal comes in at $52 a share — a hefty increase over the $24.11 close yesterday.

Bradway and the Amgen team get a drug called Tavneos (avacopan) in the deal, a complement factor C5a inhibitor OK’d to treat anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis, an autoimmune disease which can be lethal.

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(AP Photo/Richard Vogel, File)

US de­clares mon­key­pox a na­tion­al health emer­gency, as new drug­mak­ers con­sid­er en­ter­ing vac­cine race

Rising monkeypox cases have put the US on high alert as it announces a national health emergency, which grants the government more power in its response.

The news comes as Bavarian Nordic continues to fill orders for its Jynneos vaccine and other companies – including Moderna – consider jumping into the vaccine race. Meanwhile, the New York Times reports that the US has allowed around 20 million doses of smallpox vaccine in its stockpile to expire.

Vlad Coric, Biohaven CEO

Bio­haven touts surge in Nurtec sales ahead of Pfiz­er takeover

Forget buyer’s remorse, Pfizer is likely feeling pretty good about its $11.6 billion Biohaven takeover deal following reports of a 57% sales boost for migraine med Nurtec.

Biohaven reported in Q2 results on Friday that it’s cleared the necessary antitrust hurdles to move forward with the sale of its calcitonin gene-related peptide (CGRP) assets to Pfizer. However, because the company is “focused on workstreams related to the closing” of the deal, it did not host a call with analysts and investors.

Pharma ads are showing up on cooler screens at retail pharmacies, including Walgreens and CVS, under a new OptimizeRx deal (OptimizeRx)

Phar­ma brands chill in the phar­ma­cy re­tail aisle with new style ads on re­frig­er­a­tion screens

Want a prescription drug with that soda? While not directly possible, ads for pharma brands now running on beverage and snack cooler screens at pharmacy retailers may at least inspire customers to think about it.

OptimizeRx is hooking up with Cooler Screens media company to bring prescription drug advertising to refrigerator front doors at pharmacies including Walgreens, CVS and Kroger.

The “point of dispense” ads show a full-door image on the cooler doors when a shopper is 12 feet away, but shrinks down to a smaller banner-sized ad so that the refrigerator contents can be seen when a person gets closer. The doors — which have to be specially installed by Cooler Screens — can detect when a person is nearby, how long a person “dwells” in front of the ad and if they do or don’t open the door.

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