Tedros Adhanom Ghebreyesus, Director General of the WHO (Denis Balibouse/Pool Photo via AP Images)

Bavar­i­an Nordic nabs EU ap­proval for mon­key­pox vac­cine as WHO de­clares glob­al health emer­gency

As the WHO de­clared the mon­key­pox out­break to be a glob­al health emer­gency, Bavar­i­an Nordic ob­tained an ex­pand­ed Eu­ro­pean la­bel for its small­pox vac­cine to in­clude the surg­ing virus.

The move comes rough­ly a month af­ter the biotech filed for a la­bel ex­pan­sion, and af­ter sev­er­al coun­tries on the con­ti­nent, and else­where, se­cured their own sup­ply deals for the shot. Bavar­i­an Nordic has said it’s seen “over­whelm­ing” in­ter­est in the vac­cine, and its stock price $BVRNY has fol­lowed in short or­der — shares are up 124% since the first mon­key­pox case was de­tect­ed on May 6.

Mon­day’s ap­proval will like­ly help boost sup­ply of the vac­cine across Eu­rope just a few days af­ter the WHO raised the mon­key­pox alert lev­el to its high­est clas­si­fi­ca­tion Sat­ur­day, of­fi­cial­ly de­clar­ing the out­break a glob­al health emer­gency. There had been more than 17,000 cas­es around the world as of Sat­ur­day, rough­ly a 50% in­crease over the last week, with cas­es in over 75 coun­tries.

“WHO’s as­sess­ment is that the risk of mon­key­pox is mod­er­ate glob­al­ly and in all re­gions, ex­cept in the Eu­ro­pean re­gion where we as­sess the risk as high,” WHO di­rec­tor-gen­er­al Tedros Ad­hanom Ghe­breye­sus said in a state­ment Sat­ur­day. “There is al­so a clear risk of fur­ther in­ter­na­tion­al spread, al­though the risk of in­ter­fer­ence with in­ter­na­tion­al traf­fic re­mains low for the mo­ment.”

The de­c­la­ra­tion was a re­ver­sal from WHO’s pre­vi­ous stance a month ago, when the WHO de­clined to el­e­vate the out­break’s sta­tus.

Last week, Eu­rope se­cured an­oth­er sup­ply deal for Bavar­i­an Nordic’s shot, or­der­ing 54,000 dos­es to bring its to­tal stash to 160,000. An ini­tial or­der of 110,000 shots came in late June, pro­vid­ing more ac­cess to the vac­cine on the con­ti­nent where in­di­vid­u­als had strug­gled to get it.

Oth­er coun­tries, too, have been or­der­ing the jab. Cana­da signed a $56 mil­lion con­tract last month and Bavar­i­an Nordic has pre­vi­ous­ly said it’s been in dis­cus­sions with coun­tries in Asia, Eu­rope, South Amer­i­ca and the Mid­dle East as well.

BAR­DA, mean­while, bought 2.5 mil­lion dos­es for the US na­tion­al stock­pile ear­li­er this month, and has said it ex­pects to de­liv­er 1.6 mil­lion dos­es by the end of the year.

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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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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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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(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.

Pfiz­er ter­mi­nates PhI­II study of rare car­dio­vas­cu­lar drug picked up in $11.4B Ar­ray ac­qui­si­tion

While Pfizer’s $11.4 billion acquisition of Array BioPharma in the summer of 2019 was mainly focused on oncology, namely Braftovi and Mektovi, there were a few non-cancer assets, including a Phase III drug being tested in a rare cardiovascular disease.

The late-stage trial is now being axed, alongside any further development of the oral small molecule, the pharma giant disclosed after the closing bell on Wednesday. Based on an interim futility analysis of the global Phase III REALM-DCM trial, Pfizer determined a path forward was not in its best interest. Pfizer no longer expected the study would meet its primary goal.

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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.