Phar­ma's new 'Ber­lin De­c­la­ra­tion' seeks to re­serve vac­cines, ther­a­peu­tics in pro­duc­tion for low-in­come coun­tries

As Pfiz­er/BioN­Tech and Mod­er­na re­main re­luc­tant to share IP or pro­vide tech trans­fer to ex­pand the man­u­fac­ture of their life-sav­ing mR­NA vac­cines for Covid-19, the In­ter­na­tion­al Fed­er­a­tion of Phar­ma­ceu­ti­cal Man­u­fac­tur­ers & As­so­ci­a­tions on Tues­day un­veiled a new plan, build­ing off those Covid suc­cess­es, to en­sure more eq­ui­table pan­dem­ic pre­pared­ness.

The plan, known as the “Berlin De­c­la­ra­tion,” will be brought be­fore G7 and G20 coun­tries soon and pro­pos­es to re­serve an al­lo­ca­tion of the re­al-time pro­duc­tion of drugs, vac­cines and di­ag­nos­tics for dis­tri­b­u­tion to pri­or­i­ty pop­u­la­tions in low­er in­come coun­tries, as de­ter­mined by health au­thor­i­ties dur­ing pan­demics.

José Manuel Bar­roso, Gavi chair and CO­V­AX co-chair, said re­gard­ing the pro­pos­al:

We saw ef­fec­tive in­no­va­tion and man­u­fac­tur­ing scal­ing up with this pan­dem­ic; but we al­so saw the chal­lenges we had to over­come to get the vac­cines to all those who need­ed them.  The in­dus­try’s com­mit­ment to re­serve part of pro­duc­tion of vac­cines and treat­ments at re­al time for vul­ner­a­ble pop­u­la­tions in low-in­come coun­tries pro­vides an op­por­tu­ni­ty to work to­geth­er strate­gi­cal­ly to forge a new so­cial con­tract. I hope that po­lit­i­cal lead­ers will do their part and en­gage with in­dus­try on how to make this work.

The de­c­la­ra­tion will be based on com­mit­ments and con­tri­bu­tions from a glob­al con­sor­tia of pub­lic, pri­vate and char­i­ta­ble com­pa­nies, the com­pa­nies said in a state­ment, as many in the West­ern world re­ceived boost­ers be­fore those in low­er-in­come coun­tries re­ceived their first Covid-19 vac­cine dos­es.

That lack of eq­ui­ty re­gard­ing ear­ly Covid-19 boost­er dos­es even led two high-pro­file FDA vac­cine lead­ers to leave the agency last Au­gust.

But more re­cent­ly, low-in­come coun­tries have de­clined large do­na­tions of vac­cines, and mil­lions of dos­es have end­ed up in the trash as ex­pi­ra­tion dates neared with­out any­one to use them.

“For this po­ten­tial­ly life-sav­ing con­cept to be­come re­al­i­ty, we will need to work with G7, and lat­er this year in Bali with G20 to flesh out how to make it work,” Jean-Christophe Tel­li­er, IF­P­MA pres­i­dent and CEO of UCB, said in a state­ment. “The re­ward if suc­cess­ful will help shape a fu­ture where every­one has a chance to be bet­ter pro­tect­ed from the threat of pan­demics from the out­set, no mat­ter where they live.”

Gov­ern­ments should com­mit to un­re­strict­ed trade and no ex­port bans across the sup­ply chain for vac­cines, ther­a­peu­tics and di­ag­nos­tics, the Berlin De­c­la­ra­tion says. And it calls for “ex­pe­dit­ed process­es for im­port and ex­port dur­ing a pan­dem­ic to help sup­port fast and ef­fi­cient glob­al dis­tri­b­u­tion.”

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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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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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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(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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