Carl Hansen, AbCellera CEO

As Omi­cron rages, FDA clears Eli Lil­ly/Ab­Celler­a's new an­ti­body days af­ter $720M sup­ply deal

The FDA has au­tho­rized a new Covid-19 an­ti­body from Eli Lil­ly and Ab­Cellera, adding a much-need­ed weapon to the ar­se­nal fight­ing against Omi­cron.

Just days ago, the two com­pa­nies un­veiled a $720 mil­lion deal to sup­ply 600,000 dos­es of the drug, bebtelovimab, to the US gov­ern­ment. It may now be pre­scribed, un­der emer­gency use au­tho­riza­tion, to adults and teenagers 12 or old­er with pos­i­tive SARS-CoV-2 tests who are ei­ther at high risk for pro­gres­sion to se­vere dis­ease or un­able/in­el­i­gi­ble for al­ter­na­tive treat­ment op­tions.

“At the start of the COVID-19 pan­dem­ic we and our part­ners pri­or­i­tized speed in get­ting ther­a­pies out to pa­tients. This re­sult­ed in the dis­cov­ery of bam­lanivimab, the first COVID-19 an­ti­body to reach the clin­ic and re­ceive FDA Emer­gency Use Au­tho­riza­tion,” said Carl Hansen, CEO of Ab­Cellera, in a state­ment. “We then shift­ed our ef­forts to dis­cov­er­ing a next-gen­er­a­tion an­ti­body ther­a­peu­tic, this time pri­or­i­tiz­ing max­i­mum po­ten­cy and breadth of neu­tral­iza­tion. This re­sult­ed in the dis­cov­ery of bebtelovimab, which neu­tral­izes all known vari­ants of con­cern, and is the most po­tent an­ti­body in de­vel­op­ment against the Omi­cron vari­ant, in­clud­ing BA.2.”

Where­as bam­lanivimab — used in com­bi­na­tion with Eli Lil­ly’s oth­er (Jun­shi-part­nered) an­ti­body ete­se­vimab — played a role in pre­vi­ous waves, it brought lit­tle to the ta­ble when Omi­cron be­came the dom­i­nant vari­ant. The US stopped ship­ping them, as well as Re­gen­eron’s an­ti­body cock­tail, in late Jan­u­ary.

Daniel Skovron­sky

The on­ly mAb cur­rent­ly avail­able in the US to treat Covid-19 is Glax­o­SmithK­line and Vir’s sotro­vimab, but sup­ply is con­strained. States and ju­ris­dic­tions re­ceive about 50,000 dos­es per week; the sev­en-day av­er­age num­ber of re­port­ed cas­es cur­rent­ly stands just north of 172,000.

Dis­cov­ered by Ab­Cellera and de­vel­oped by Lil­ly, bebtelovimab has been in the works since ear­ly 2021, ac­cord­ing to Daniel Skovron­sky, Lil­ly’s chief sci­en­tif­ic and med­ical of­fi­cer. Un­like pre­vi­ous an­ti­bod­ies that were au­tho­rized on Phase III da­ta, tt was test­ed in a Phase II tri­al, dubbed BLAZE-4, that en­rolled both low-risk and high-risk pa­tients.

Pa­trizia Cavaz­zoni

The way the tri­al was de­signed, the place­bo-con­trolled por­tion en­rolled 308 low-risk pa­tients, where the treat­ment cut down the time to sus­tained symp­tom res­o­lu­tion. In an­oth­er part that re­cruit­ed al­so high-risk pa­tients, on­ly bebtelovimab and com­bi­na­tions of bebtelovimab with oth­er an­ti­bod­ies were giv­en, and in­ves­ti­ga­tors re­port­ed that both the monother­a­py and com­bos low­ered the rates of Covid-19 re­lat­ed hos­pi­tal­iza­tion and death com­pared to place­bo rates re­port­ed in pri­or tri­als — a met­ric that reg­u­la­tors ac­knowl­edged could on­ly lead to lim­it­ed con­clu­sions.

The de­tailed da­ta, though, have yet to be pub­lished.

Still, CDER di­rec­tor Pa­trizia Cavaz­zoni sig­nals the ac­tiv­i­ty against Omi­cron on top of all oth­er vari­ants of in­ter­est (as demon­strat­ed with lab da­ta) is key “at a time when we are seek­ing to fur­ther in­crease sup­ply.”

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Dave Marek, Myovant CEO

My­ovant board balks as ma­jor­i­ty own­er Sum­it­o­mo swoops in with a $2.5B deal to buy them out

Three years after Sumitomo scooped up Roivant’s 46% stake in the publicly traded Myovant $MYOV as part of a 5-company, $3 billion deal, they’re coming back for the whole thing.

But these other investors at Myovant want more than what the Japanese pharma company is currently offering to pay at this stage.

Sumitomo is bidding $22.75 a share for the outstanding stock, which now represents 48% of the company after Sumitomo bumped its ownership since the original deal with Roivant. Myovant, however, created a special committee on the board, and they’re shaking their heads over the offer.

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Casey McPherson shows his daughters Rose (left) and Weston around Everlum Bio, a lab that he co-founded to spark a treatment for Rose and others with ultra-rare conditions. (Ilana Panich-Linsman)

Fa­ther starts lab af­ter in­tel­lec­tu­al prop­er­ty is­sues stymie rare dis­ease drug de­vel­op­ment

Under bright lab lights, Casey McPherson holds his 6-year-old daughter, Rose. His free hand directs Rose’s gaze toward a computer screen with potential clues in treating her one-of-a kind genetic condition.

Gray specks on the screen show her cells that scientists reprogrammed with the goal of zeroing in on a custom medicine. McPherson co-founded the lab, Everlum Bio, to spark a treatment for Rose — and others like her. A regarded singer-songwriter, McPherson never imagined going into drug development.

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Vlad Coric, Biohaven CEO

Vlad Coric charts course for new Bio­haven with neu­ro­science push and Big Phar­ma vets on board

What’s Biohaven without its CGRP portfolio? That’s what CEO Vlad Coric is tasked with deciding as he maps out the new Biohaven post-Pfizer takeover.

Pfizer officially scooped up Biohaven’s CGRP assets on Monday, including blockbuster migraine drug Nurtec and the investigational zavegepant, for $11.6 billion. As a result, Coric spun the broader pipeline into an independent company on Tuesday — with the same R&D team behind Nurtec but about 1,000 fewer staffers and a renewed focus on neuroscience and rare disease.

In AstraZeneca's latest campaign, wild eosinophils called Phils personify the acting up often seen in uncontrolled asthma

As­traZeneca de­buts an­noy­ing pur­ple ‘Phil’ crea­tures, per­son­i­fied asth­ma eosinophils ‘be­hav­ing bad­ly’

There are some odd-looking purple creatures lurking around the halls of AstraZenca lately. The “Phil” character cutouts are purple, personified eosinophils with big buggy eyes and wide mouths, and they’re a part of AZ’s newest awareness effort to help people understand eosinophilic asthma.

The “Asthma Behaving Badly” characters aren’t only on the walls at AZ to show the new campaign to employees, however. The “Phils” are also showing up online on the campaign website, and in digital and social ads and posts on Facebook and Instagram.

Big Phar­ma heavy­weights seek tweaks to FDA's clin­i­cal out­come as­sess­ment guid­ance

Pfizer, GSK, Janssen, Regeneron, Boehringer Ingelheim and at least a half dozen other companies are calling on the FDA to provide significantly more clarity in its draft guidance from this summer on clinical outcome assessments, which are a type of patient experience.

The draft is the third in a series of four patient-focused drug development guidance documents that the FDA had to create as part of the 21st Century Cures Act, and they describe how stakeholders (patients, caregivers, researchers, medical product developers and others) can collect and submit patient experience data and other relevant information for medical product development and regulatory decision-making.

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Robert Califf, FDA commissioner (via AP Images)

User fees in ac­tion: FDA un­veils new short­ened sup­ple­ment re­view, rare dis­ease pi­lots

Thanks to PDUFA VII, signed into law last Friday by President Joe Biden, the FDA this week unveiled two new industry-friendly pilot programs to advance new rare disease endpoints via additional meetings, and to shorten FDA review times for supplemental apps aimed at unmet medical needs.

The agency this week released eagerly-awaited details behind the shortened pilot, known as the Split Real Time Application Review or STAR pilot program, which will speed up certain FDA reviews of efficacy supplements across all therapeutic areas (thanks to earlier submissions of data), but only for those that propose addressing an unmet medical need.

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Mar­ket­ingRx roundup: No­var­tis re­cruits NFL coach for Leqvio cam­paign; Pfiz­er pro­motes ‘Sci­ence’ merch on so­cial me­dia

Novartis is turning to a winning coach to talk about Leqvio and the struggles of high cholesterol — including his own. Bruce Arians, the retired NFL head coach of the Arizona Cardinals and Super Bowl-winning Tampa Bay Buccaneers, is partnering with the pharma for its “Coaching Cholesterol” digital, social and public relations effort.

In the campaign, Arians talks about the potential for “great comebacks” in football and heart health. Once nicknamed a “quarterback whisperer,” he is now retired from fulltime coaching (although still a front-office consultant for Tampa Bay), and did a round of media interviews for Novartis, including one with People and Forbes.

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Amy West, Novo Nordisk head of US digital innovation and transformation (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Q&A: No­vo Nordisk dig­i­tal in­no­va­tion chief Amy West dis­cuss­es phar­ma pain points and a health­care 'easy but­ton’

Amy West joined Novo Nordisk more than a decade ago to oversee marketing strategies and campaigns for its US diabetes portfolio. However, her career path shifted into digital, and she hasn’t looked back. West went from leading Novo’s first digital health strategy in the US to now heading up digital innovation and transformation.

She’s currently leading the charge at Novo Nordisk to not only go beyond the pill with digital marketing and health tech, but also test, pilot and develop groundbreaking new strategies needed in today’s consumerized healthcare world.

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