Leonard Schleifer, Regeneron CEO (Andrew Harnik/AP)

Trail­ing Eli Lil­ly by 12 days, Re­gen­eron gets the FDA OK for their Covid-19 an­ti­body cock­tail

A month and a half af­ter be­com­ing the ex­per­i­men­tal treat­ment of choice for a new­ly di­ag­nosed pres­i­dent, Re­gen­eron’s an­ti­body cock­tail has re­ceived emer­gency use au­tho­riza­tion from the FDA. It will be used to treat non-hos­pi­tal­ized Covid-19 pa­tients who are at high-risk of pro­gress­ing.

Al­though the Rgen­eron drug is not the first an­ti­body treat­ment au­tho­rized by the FDA, the news comes as a sig­nif­i­cant mile­stone for a com­pa­ny and a treat­ment sci­en­tists have watched close­ly since the out­break be­gan.

Da­ta the com­pa­ny re­leased at the end of last month showed the drug, known as REGN-CoV2, re­duced virus lev­els and hos­pi­tal­iza­tion rates in new­ly di­ag­nosed pa­tients. Ide­al­ly, it could be used to pre­vent se­vere dis­ease in the el­der­ly and peo­ple with mul­ti­ple co­mor­bidi­ties at a time when cas­es and hos­pi­tal­iza­tions are surg­ing to record lev­els across the coun­try.

Along with the Eli Lil­ly treat­ment the FDA au­tho­rized ear­li­er this month, REGN-CoV-2 will rough­ly dou­ble the amount of an­ti­body drug avail­able this year. No oth­er drug is avail­able for out­pa­tients.

Still, the im­pact may not be as pro­found as many had hoped it would be in the spring or sum­mer. A tri­al for pa­tients on oxy­gen was abort­ed af­ter fail­ing a risk-ben­e­fit cal­cu­la­tion, end­ing hopes that the drug could help in se­vere dis­ease. And al­though the fed­er­al gov­ern­ment in­vest­ed over the sum­mer in ex­pand­ing Re­gen­eron’s ca­pac­i­ty, sup­ply will still be se­vere­ly lim­it­ed.

The biotech ex­pects 80,000 dos­es to be avail­able this month, which is less than the num­ber of di­ag­noses just in the state of Illi­nois in the last week. Al­though most cas­es are not high-risk and not-el­i­gi­ble, ex­perts point­ed out af­ter the Eli Lil­ly EUA that in some com­mu­ni­ties, the ma­jor­i­ty of peo­ple are.

Re­gen­eron CEO Leonard Schleifer ac­knowl­edged the like­ly con­straints and pushed for the gov­ern­ment to play a heavy hand in dis­tri­b­u­tion.

“This FDA Emer­gency Use Au­tho­riza­tion is an im­por­tant step in the fight against COVID-19, as high-risk pa­tients in the Unit­ed States will have ac­cess to a promis­ing ther­a­py ear­ly in the course of their in­fec­tion,” he said in a state­ment. “Even with these in­cred­i­ble ef­forts, de­mand may ex­ceed sup­ply ini­tial­ly, mak­ing it even more crit­i­cal that fed­er­al and state gov­ern­ments en­sure the casiriv­imab and imde­vimab an­ti­body cock­tail is dis­trib­uted fair­ly and eq­ui­tably to the pa­tients most in need.”

The gov­ern­ment has al­ready sent states two de­liv­er­ies of the Eli Lil­ly an­ti­body, but it re­mains un­clear how and to whom many of those dos­es will be giv­en out.

There are lin­ger­ing ques­tions around how med­ical cen­ters will ad­min­is­ter the an­ti­body treat­ments, which have to be in­fused over the course of an hour but are in­di­cat­ed on­ly for pa­tients who are not hos­pi­tal­ized. With hos­pi­tals around the coun­try reach­ing ca­pac­i­ty, some have con­sid­ered sim­ply turn­ing down the Eli Lil­ly an­ti­body, rather than try to ad­min­is­ter it while si­mul­ta­ne­ous­ly han­dling huge in­flux­es of se­vere Covid-19 pa­tients.

Adding to their ret­i­cence were the sparse da­ta around the Eli Lil­ly’s an­ti­body: The low dose the FDA au­tho­rized had failed the pri­ma­ry end­point in the phar­ma’s study, and the In­fec­tious Dis­ease So­ci­ety of Amer­i­ca rec­om­mend­ed against pre­scrib­ing it.

Re­gen­eron has ar­guably shown stronger da­ta, but they have not dis­closed re­sults for the low dose they plan to de­liv­er to pa­tients. They have al­so not re­leased da­ta on whether the drug helped al­le­vi­ate symp­toms, dis­ap­point­ing some an­a­lysts.

The com­pa­ny ex­pects to be able to make 300,000 dos­es by the first week of Jan­u­ary. A part­ner­ship with Roche, ex­pect­ed to get ful­ly on­line at the start of 2021, should al­low them to churn out 250,000 dos­es per month, ex­ec­u­tives said in late Sep­tem­ber.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

Janet Woodcock (AP Images)

End­points poll: Janet Wood­cock takes the (in­ter­im) helm at the FDA. And a large ma­jor­i­ty of our read­ers want her to stay there

It’s official: Janet Woodcock is now the acting chief of the FDA.

And — according to an Endpoints poll — most industry readers would like her to stay there, although a significant minority is strongly opposed.

To recap: Joe Biden is reportedly choosing between Woodcock and former deputy FDA commissioner Joshua Sharfstein as his nominee for the permanent position. Given their respective track records, the decision is set to determine the agency’s lodestar for years to come.

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5AM Ven­tures: Fu­el­ing the Next Gen­er­a­tion of In­no­va­tors

By RBC Capital Markets
With Andy Schwab, Co-Founder and Managing Partner at 5AM Ventures

Key Points

Prescription Digital Therapeutics, cell therapy technologies, and in silico medicines will be a vital part of future treatment modalities.
Unlocking the potential of the microbiome could be the missing link to better disease diagnosis.
Growing links between academia, industry, and venture capital are spinning out more innovative biotech companies.
Biotech is now seen by investors as a growth space as well as a safe haven, fuelling the recent IPO boom.

An Endpoints Zoom meeting; and the email header employees will see if your company is a Premium subscriber

What’s next for End­points — and how to sup­port our in­de­pen­dent bio­phar­ma news mis­sion

The firehose of biopharma news is gushing these days.

That’s why broader and deeper is the theme for 2021 at Endpoints. You can expect new coverage outside our core R&D focus, with deeper reporting in some key areas. When John Carroll and I launched Endpoints nearly five years ago, we were wading in waist-high waters. Now we’re a team of 25 full-time staffers (and growing) with plans to cover the flood of biopharma news, Endpoints-style.

Eli Lil­ly's an­ti­body cuts risk of Covid-19 by up to 80% among the most vul­ner­a­ble — but will it have a place next to vac­cines?

Eli Lilly says bamlanivimab lowered the risk of contracting symptomatic Covid-19 in a first-of-its-kind trial involving nursing home residents and staff, paving the way for a new option to protect against the virus.

But how big of an impact it might have, and what role it will play, at a time vaccines are being rolled out to the exact population it is targeting still remains unclear.

Among 965 participants in the study — all of whom tested negative for the coronavirus at baseline — the number of symptomatic cases reported in the bamlanivimab arm was 57% lower than that in the placebo arm (odds ratio 0.43, p=0.00021). In addition to that primary endpoint, all secondary endpoints reached statistical significance.

Janet Woodcock and Joshua Sharfstein (AP, Images)

Poll: Should Joshua Sharf­stein or Janet Wood­cock lead the FDA from here?

It’s time for a new FDA commissioner to come on board, a rite of passage for Joe Biden’s administration that should help seal the new president’s rep on seeking out the experts to lead the government over the next 4 years.

As of now, the competition for the top job appears to have narrowed down to 2 people: The longtime CDER chief Janet Woodcock and Joshua Sharfstein, the former principal deputy at the FDA under Peggy Hamburg. Both were appointed by Barack Obama.

Covid-19 roundup: Italy won­ders aloud if it can sue Pfiz­er for vac­cine short­falls; US recom­mits to WHO un­der Biden ad­min­is­tra­tion

As reports crop up that deliveries of Pfizer and BioNTech’s Covid-19 vaccine are being unexpectedly cut, Italy wonders if it can take the vaccine developers to court, according to the Wall Street Journal. 

After its shipment for this week was cut by 29%, the Italian government consulted its attorney general about taking legal action, the WSJ reported. Pfizer and BioNTech had warned the EU and Canada last week that their allocations would be reduced as Pfizer upgrades its Belgium factory. What Italy says it doesn’t appreciate, though, is the short notice.

Michelle McMurry-Heath, BIO CEO (BIO via YouTube)

BIO looks to re­struc­ture, lay­ing off staff amid chal­lenge to the trade org's nor­mal face-to-face style

The biopharma industry, on the whole, had a red-letter year in 2020 amid Covid-19, with fundraising at an all-time high and major players speeding vaccines ahead to approval. But for BIO, the industry’s leading trade organization, the pandemic has prompted a reconsideration of the game plan.

BIO will pivot to digital as the Covid-19 pandemic continues to rage, making “some staff reductions” as it looks to bring its roughly 37,000 in-person meetings each year to the web, the organization said Thursday.

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Hal Barron, GSK R&D chief (GSK via YouTube)

Glax­o­SmithK­line's $4B bis­pe­cif­ic can­cer drug al­liance with Mer­ck KGaA hit by big set­back with a PhI­II fail­ure on NSCLC

Close to 2 years ago, GSK’s R&D team eagerly agreed to pay up to $4 billion-plus to ally itself with Merck KGaA on a mid-stage bispecific called bintrafusp alfa, which intrigued them with the combination of a TGF-β trap with the anti-PD-L1 mechanism in one fusion protein.

But today the German pharma company says that their lead study on lung cancer was a bust, as independent monitors said there was no reason to believe that the experimental drug — targeting PD-L1/TGF-Beta — could beat Keytruda.

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Mike Grey, Plexium chairman (Horizon Therapeutics)

Plex­i­um adds in­dus­try vet Mike Grey to the brain trust with new in­vestor cash fund­ing its pro­tein degra­da­tion play

About 15 months since closing a $28 million Series A, a San Diego protein-degradation upstart returned to the venture well Thursday with an extension of that round and some new hires, including one of the city’s best-connected biotech execs.

Plexium has bagged an additional $35 million in financing, the biotech said, money that will push undisclosed oncology and immuno-oncology programs into the clinic. In addition, longtime industry vet Mike Grey is jumping on as chairman of the board, and two others from Thursday’s leads — Adam Goulburn from Lux Capital and Rob Hopfner from Pivotal BioVentures — joined the board too.