Bavar­i­an Nordic's Dan­ish fa­cil­i­ty gets FDA thumbs up to ex­pand mon­key­pox vac­cine pro­duc­tion

With the WHO de­clar­ing the mon­key­pox out­break a glob­al health emer­gency, the FDA has now signed off on a Bavar­i­an Nordic man­u­fac­tur­ing fa­cil­i­ty that will in­crease the pro­duc­tion of the on­ly vac­cine.

On Wednes­day, Bavar­i­an Nordic an­nounced the ap­provals from the FDA and EMA to man­u­fac­ture the Jyn­neos small­pox vac­cine at its fill-fin­ish fa­cil­i­ty in Den­mark. With the ap­provals in hand, the com­pa­ny is now al­lowed to de­liv­er the vac­cine man­u­fac­tured at its site to the US and the EU. The in­spec­tions were com­plet­ed with no ob­ser­va­tions made by the reg­u­la­tors.

A pre-ap­proval in­spec­tion in Den­mark was al­ready con­duct­ed by the FDA at the fa­cil­i­ty at the be­gin­ning of Ju­ly, and an or­der for 2.5 mil­lion more dos­es of the vac­cine was placed and is be­ing ful­filled at a CMO in the US.

Ac­cord­ing to an FDA state­ment, the ap­proval will pave the way for ad­di­tion­al man­u­fac­tur­ing ca­pa­bil­i­ties at the Dan­ish plant, as the agency com­plet­ed its in­spec­tion ear­li­er this month.

The FDA al­so fa­cil­i­tat­ed the ship­ment of pre­vi­ous­ly man­u­fac­tured dos­es to the US so that they could be dis­trib­uted once the man­u­fac­tur­ing changes were ap­proved. Man­u­fac­tured dos­es can al­so now be fur­ther dis­trib­uted. Ac­cord­ing to HHS, an ad­di­tion­al 786,000 dos­es of vac­cine can now be dis­trib­uted for use in the US.

“This ac­tion by the FDA is a crit­i­cal step for­ward in our plans to strength­en and ac­cel­er­ate our mon­key­pox re­sponse, which in­cludes dis­trib­ut­ing a safe and ef­fec­tive vac­cine to those at high­est risk of ex­po­sure to mon­key­pox,” HHS Sec­re­tary Xavier Be­cer­ra said in a state­ment.

Paul Chap­lin

The thumbs-up from the EMA came af­ter Bavar­i­an ap­plied for au­tho­riza­tion in June 2022 and re­ceived it late last week. An ear­li­er ap­proval was al­so grant­ed by the Dan­ish Med­i­cines Agency.

“We are thank­ful to both FDA and EMA for ac­cel­er­at­ing their re­view, dur­ing this mon­key­pox out­break, which now has been named a pub­lic health emer­gency of in­ter­na­tion­al con­cern by the WHO, and we look for­ward to con­tin­u­ing our work with health au­thor­i­ties around the globe to en­sure sup­ply of vac­cines against mon­key­pox,” said Bavar­i­an Nordic CEO Paul Chap­lin.

The FDA and EMA ap­provals come at a piv­otal time as the cas­es of mon­key­pox are over 19,000 and still ris­ing, ac­cord­ing to the CDC. The US now has over 3,500 cas­es, and the virus is in 76 coun­tries to­tal.

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.

Sen. Kyrsten Sinema (D-AZ) (Tom Williams/CQ Roll Call via AP Images)

De­moc­rats se­cure sup­port from key sen­a­tor ahead of po­ten­tial drug pric­ing vote

Senate Democrats may have all the votes they need to pass major drug pricing reform, after Sen. Kyrsten Sinema (D-AZ) reportedly pledged her support on Thursday — but will they fit it in before recess?

Sinema said she has agreed to “move forward” with the reconciliation bill with some stipulations, including the removal of a carried tax provision, according to recent reports. The bill is still expected to reduce the deficit by $300 billion, and Sen. Chuck Schumer (D-NY) said that he now anticipates “support from the entire Senate Democratic conference,” the Washington Post reported. 

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.