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.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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Zhi Hong, Brii Biosciences CEO

Brii Bio­sciences stops man­u­fac­tur­ing Covid-19 an­ti­body com­bo, plans to with­draw EUA re­quest

Brii Biosciences said it will stop manufacturing its Covid-19 antibody combination, sold in China, and is working to withdraw its emergency use authorization request in the US, which it started in October 2021.

The Beijing and North Carolina biotech commercially launched the treatment in China last July but is now axing the work and reverting resources to other “high-priority programs,” per a Friday update. The focus now is namely hepatitis B viral infection, postpartum depression and major depressive disorders.

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FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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Sijmen de Vries, Pharming CEO

FDA ap­proves Pharm­ing drug for ul­tra-rare im­mun­od­e­fi­cien­cy dis­ease

US regulators cleared an ultra-rare drug from Pharming Group, by way of Novartis, on Friday afternoon.

The Dutch biotech said the FDA greenlit leniolisib for an immunodeficiency disease known as activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome, or APDS. People 12 years and older can receive the oral drug, to be marketed as Joenja, beginning early next month, Pharming said, five days ahead of the decision deadline set by the FDA as part of a priority review.

No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

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Ly­me vac­cine test com­ple­tion is pushed back by a year as Pfiz­er, Val­ne­va say they'll ad­just tri­al

Valneva and Pfizer have adjusted the end date for the Phase III study of their investigational Lyme disease vaccine, pushing it back by a year after issues at a contract researcher led to thousands of US patients being dropped from the test.

In a March 20 update to clinicaltrials.gov, Valneva and Pfizer moved the primary completion date on the trial, called VALOR, from the end of 2024 to the end of 2025.

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Stuart Peltz, former PTC Therapeutics CEO

Stu­art Peltz re­signs as PTC Ther­a­peu­tics CEO af­ter 25 years

Stuart Peltz, the longtime CEO of PTC Therapeutics who’s led the rare disease drug developer since its founding 25 years ago, is stepping down.

Succeeding him in the top job is Matthew Klein, who joined PTC in 2019 and was promoted to chief operating officer in 2022. In a call with analysts, he said the CEO transition has been planned for “quite some time” — in fact, as part of it, he gave the company’s presentation at the JP Morgan healthcare conference earlier this year.

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Bet­ter Ther­a­peu­tics cuts 35% of staff while await­ing dig­i­tal ther­a­peu­tic ap­proval

Digital therapeutics company Better Therapeutics announced on Thursday that it’s cutting 35% of its staff as it awaits FDA clearance for its first product.

The company, which launched eight years ago, is one of a growing group of companies seeking a digital alternative to traditional medicine. The space saw a record $7.5 billion in investments in 2021, according to Chris Dokomajilar at DealForma, with uses spanning ADHD, PTSD and other indications. However, private insurers have been slow to hop on board.