Re­gen­eron con­tin­ues reign atop the Covid treat­ment field with ex­pand­ed EUA for low­er dose sub­cu­ta­neous ver­sion of mAb cock­tail

The FDA on Fri­day au­tho­rized a new, low­er-dose ver­sion of Re­gen­eron’s Covid-19 mon­o­clon­al an­ti­body cock­tail for those with Covid-19 who are at high-risk of pro­gress­ing to hos­pi­tal­iza­tion.

The new dose is half the orig­i­nal­ly au­tho­rized dose, but the eas­i­er-to-ad­min­is­ter sub­cu­ta­neous ver­sion may not be the game-chang­er that ex­perts once en­vi­sioned. Re­gen­eron said in a state­ment that the com­bo “should be ad­min­is­tered by in­tra­venous (IV) in­fu­sion” and sub­cu­ta­neous in­jec­tions “are an al­ter­na­tive when IV in­fu­sion is not fea­si­ble and would lead to a de­lay in treat­ment.”

Re­gen­eron spokesper­son Alexan­dra Bowie al­so said the sub­cu­ta­neous ver­sion will still need to be giv­en in a health care set­ting (e.g. in­fu­sion cen­ter, hos­pi­tal, doc­tor’s of­fice) at this point, with one hour of ob­ser­va­tion re­quired af­ter­ward.

“The pre­sen­ta­tion (the co­for­mu­lat­ed vials which were al­so just au­tho­rized – this just means the casiriv­imab and imde­vimab an­ti­bod­ies are mixed to­geth­er now vs. in sep­a­rate vials) is the same for in­tra­venous in­fu­sion or sub­cu­ta­neous in­jec­tion,” Bowie added.

The ex­pand­ed EUA comes as Covid-19 vari­ants emerg­ing from In­dia and Brazil have dis­rupt­ed the de­liv­ery of some mAbs across the US, in­clud­ing two Eli Lil­ly prod­ucts, a com­bo of bam­lanivimab and ete­se­vimab, and bam­lanivimab alone, which had its EUA re­voked.

Re­gen­eron’s RE­GEN-COV (casiriv­imab and imde­vimab), fund­ed in part by BAR­DA, is cur­rent­ly the on­ly an­ti­body ther­a­py avail­able na­tion­wide, in­clud­ing eight states (Ari­zona, Cal­i­for­nia, Flori­da, In­di­ana, Ore­gon, Wash­ing­ton, Illi­nois and Mass­a­chu­setts) with high rates of those two vari­ants of con­cern.

Lat­er this sum­mer, Re­gen­eron ex­pects to sub­mit a full BLA for the com­bo treat­ment for the same in­di­ca­tion in non-hos­pi­tal­ized out­pa­tients with Covid-19. The eval­u­a­tion of RE­GEN-COV as a way to pre­vent Covid is al­so on­go­ing and the com­pa­ny said it sub­mit­ted da­ta to the FDA from a pos­i­tive Phase III tri­al on the pre­ven­tion of in­fec­tion among house­hold con­tacts of Covid-in­fect­ed in­di­vid­u­als.

As far as sup­plies, Re­gen­eron ex­pects to de­liv­er 1 mil­lion dos­es by the end of this month, and the US gov­ern­ment has pledged to pur­chase all dos­es of the mAb that are de­liv­ered by the end of this month, with the po­ten­tial for more through the end of Sep­tem­ber, up to a max­i­mum of 1.25 mil­lion dos­es.

That puts Re­gen­eron at an ad­van­tage over an­oth­er re­cent­ly au­tho­rized mAb from Vir and GSK, which are nav­i­gat­ing the open mar­ket with­out gov­ern­ment pur­chas­es. But Vir al­so says its sin­gle an­ti­body can neu­tral­ize each of the vari­ants sci­en­tists sus­pect are pro­lif­er­at­ing.

Ron­ny Gal

And all the mAbs on the mar­ket al­so now ben­e­fit from a widen­ing of who qual­i­fies to re­ceive them, as race or eth­nic­i­ty are now in­clud­ed by the FDA in the el­i­gi­bil­i­ty cri­te­ria.

Bern­stein biotech an­a­lyst Ron­ny Gal said in a note to in­vestors late last month that the pause of the Lil­ly com­bo treat­ment will like­ly push the mar­ket in Re­gen­eron’s fa­vor. He pre­dicts about $375 mil­lion in sales for the re­main­der of the year for Lil­ly, and about $1.6 bil­lion in the same pe­ri­od for Re­gen­eron.

As sup­plies are now plen­ti­ful, “it’s tough to see why any providers would take a chance on the Lil­ly com­bo,” he wrote. “We tip our hats to the Re­gen­eron team who em­pha­sized the im­por­tance tar­get­ing epi­topes less like­ly to mu­tate from the be­gin­ning and was will­ing to state this view pub­licly.”

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

The End­points 11: They've got mad mon­ey and huge am­bi­tions. It's time to go big or go home

These days, selecting a group of private biotechs for the Endpoints 11 spotlight begins with a sprint to get ahead of IPOs and the M&A teams at Big Pharma. I’ve had a couple of faceplants earlier this year, watching some of the biotechs on my short list choose a quick leap onto Nasdaq or into the arms of a buyer.

Vividion, you would have been a great pick for the Endpoints 11. I’m sorry I missed you.

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FDA au­tho­rizes Pfiz­er's vac­cine boost­er for se­niors, those at high risk for se­vere Covid-19

The Biden administration’s goal of kicking off its booster shot drive for the entire US population this week is not quite going as planned.

First, Pfizer applied for approval of a supplemental application for the booster shots, but since last Friday’s adcomm reviewing them, the plan has devolved into an EUA, which the FDA issued late Thursday evening.

The population that is now eligible for the booster, six months after receiving the first pair of Pfizer-BioNTech vaccines, also narrowed from what Pfizer applied for (everyone who’s eligible for the initial Pfizer shots) to just those who are 65 or older, or at high-risk of a Covid infection, including health care workers and others with occupational hazards.

Dave Lennon, former president of Novartis Gene Therapies

So what hap­pened with No­var­tis Gene Ther­a­pies? Here's your an­swer

Over the last couple of days it’s become clear that the gene therapy division at Novartis has quietly undergone a major reorganization. We learned on Monday that Dave Lennon, who had pursued a high-profile role as president of the unit with 1,500 people, had left the pharma giant to take over as CEO of a startup.

Like a lot of the majors, Novartis is an open highway for head hunters, or anyone looking to staff a startup. So that was news but not completely unexpected.

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Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

Stéphane Bancel, AP Images

Fi­nal analy­sis of US-fund­ed Mod­er­na Covid vac­cine tri­al shows 98% ef­fi­ca­cy against se­vere dis­ease

A final look at the results of the placebo-controlled Moderna trial in the New England Journal of Medicine, published Thursday afternoon, shows how the vaccine continues to prevent Covid-19 and severe cases after more than five months following the second shot.

Of the more than 30,000 enrolled in the trial that ultimately led to the vaccine’s EUA, only two people in the vaccine group got a severe form of the disease, compared to 106 in the placebo group — leading to an efficacy of 98%.

FDA+ roundup: Bs­U­FA III ready for show­time, court tells FDA to re-work com­pound­ing plan, new guid­ance up­dates and more

The FDA has now spelled out what exactly will be included in the third iteration of Biosimilar User Fee Act (BsUFA) from 2023 through 2027, which similarly to the prescription drug deal, sets fees that industry has to pay for submitting applications, in exchange for firm timelines that the agency must meet.

This latest deal includes several sweeteners for the biosimilar industry, which has yet to make great strides in the US market, with shorter review timelines for safety labeling updates and updates to add or remove an indication that does not contain efficacy data.

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When ef­fi­ca­cy is bor­der­line: FDA needs to get more con­sis­tent on close-call drug ap­provals, agency-fund­ed re­search finds

In the exceedingly rare instances in which clinical efficacy is the only barrier to a new drug’s approval, new FDA-funded research from FDA and Stanford found that the agency does not have a consistent standard for defining “substantial evidence” when flexible criteria are used for an approval.

The research comes as the FDA is at a crossroads with its expedited-review pathways. The accelerated approval pathway is under fire as the agency recently signed off on a controversial new Alzheimer’s drug, with little precedent to explain its decision. Meanwhile, top officials like Rick Pazdur have called for a major push to simplify and clarify all of the various expedited pathways, which have grown to be must-haves for sponsors of nearly every newly approved drug.

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Emma Walmsley, GlaxoSmithKline CEO (Credit: Fang Zhe/Xinhua/Alamy Live News)

The fire un­der Glax­o­SmithK­line's Em­ma Walm­s­ley grows as an­oth­er well-known ac­tivist in­vestor grabs its pitch­fork — re­port

Bluebell Capital Partners, a proxy brawler fresh off a campaign to oust global food giant Danone’s CEO and most of its board of directors, has bought a stake in UK drugmaker GlaxoSmithKline with its eyes trained directly on Emma Walmsley, the Financial Times reported Wednesday.

The London-based hedge fund joins another notorious activist firm in Paul Singer’s Elliott Management, which earlier this year called for a shakeup in leadership at GSK to handle what the company described as a wealth of riches across the drug giant’s portfolio hindered by limited vision from top staff.