Emer Cooke, EMA executive director (Geert Vanden Wijngaert/AP Images)

EMA re­views re­pur­posed ex­per­i­men­tal can­cer drug for Covid-19, even with­out a sub­mis­sion

In a rare move for any reg­u­la­tor, the Eu­ro­pean Med­i­cines Agency said Wednes­day it’s be­gun re­view­ing da­ta on the use of an ex­per­i­men­tal can­cer drug for treat­ing Covid-19, even though the Mi­a­mi-based spon­sor, Veru, has not sub­mit­ted an ap­pli­ca­tion.

The EMA re­view by its emer­gency task force fol­lows the re­lease of study re­sults ear­li­er this month show­ing the drug, known as sabiz­ab­u­lin, re­duced the risk of death by 55% in a study of 134 vol­un­teers hos­pi­tal­ized with Covid-19 who re­ceived sabiz­ab­u­lin and 70 who re­ceived place­bo. But ex­perts have been cau­tious about over­in­ter­pret­ing the re­sults, which were pub­lished in the NE­JM, par­tic­u­lar­ly as there have been very few ef­fec­tive treat­ments for those hos­pi­tal­ized with Covid.

Still, the tri­al showed that af­ter 60 days, 45.1% of those in the place­bo group died com­pared with just 20.2% of those who re­ceived the new drug, which amount­ed to a 55.2% rel­a­tive re­duc­tion in the risk of death. The In­de­pen­dent Da­ta Mon­i­tor­ing Com­mit­tee unan­i­mous­ly halt­ed the study for over­whelm­ing ef­fi­ca­cy and safe­ty.

Mitchell Stein­er

Sabiz­ab­u­lin works by dis­rupt­ing mi­cro­tubules, which form part of the in­ter­nal skele­ton in cells, ac­cord­ing to the EMA, and which play a role in help­ing SARS-CoV-2 en­ter and leave cells. By bind­ing to parts of the mi­cro­tubules, sabiz­ab­u­lin is ex­pect­ed to in­ter­fere with the life cy­cle of the virus and lim­it its repli­ca­tion and spread.

The Veru drug, which is al­so un­der re­view in the US — for an EUA — and the UK, is the first to be trig­gered un­der Ar­ti­cle 18 of the new EU reg­u­la­tion that ex­pand­ed the role of the agency dur­ing pub­lic health emer­gen­cies.

Shares of Veru stock are up more than 170% over the last six months.

Mitchell Stein­er, chair­man, pres­i­dent, and CEO of Veru, said in a state­ment on Wednes­day:

COVID-19 in­fec­tions are sharply ris­ing in Eu­rope. Un­for­tu­nate­ly, the death rate in hos­pi­tal­ized pa­tients with mod­er­ate to se­vere COVID-19 who are at risk for ARDS re­mains un­ac­cept­ably high with cur­rent stan­dard of care. By re­duc­ing deaths in hos­pi­tal­ized COVID-19 pa­tients, sabiz­ab­u­lin has great po­ten­tial to play a crit­i­cal role in the bat­tle against COVID-19 in the EU. We are ex­cit­ed with this de­vel­op­ment at the EMA by the Emer­gency Task Force. We were just no­ti­fied yes­ter­day that sabiz­ab­u­lin trig­gered Ar­ti­cle 18.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,200+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,200+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,200+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,200+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

(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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,200+ biopharma pros reading Endpoints daily — and it's free.