Janet Woodcock, director of the Center for Drug Evaluation and Research (AP Images)

Gov­ern­ment gears for un­prece­dent­ed chal­lenge of Eli Lil­ly an­ti­body roll­out as ef­fi­ca­cy ques­tions linger

Af­ter months of an­tic­i­pa­tion, the FDA has au­tho­rized the first an­ti­body treat­ment for Covid-19. Now what?

The US gov­ern­ment faces a chal­lenge un­like vir­tu­al­ly any it has faced dur­ing or be­fore the pan­dem­ic. They will have to dis­trib­ute scarce quan­ti­ties of a much-sought drug through­out the coun­try at a time when cas­es are reach­ing record lev­els, over­bur­den­ing hos­pi­tals to the point where, in North Dako­ta, Covid-19 pos­i­tive nurs­es have been au­tho­rized to con­tin­ue work­ing.

The gov­ern­ment did not ini­tial­ly fare well last time it had to roll out a Covid-19 drug; in the spring, baf­fled doc­tors re­port­ed that hos­pi­tals with few Covid-19 pa­tients re­ceived pre­cious vials of remde­sivir, while those with many were over­looked. Dis­trib­ut­ing an an­ti­body pos­es an even greater chal­lenge, as it’s in­di­cat­ed for pa­tients with mild or mod­er­ate dis­ease — a much larg­er group of peo­ple, none of whom are al­ready in a hos­pi­tal, where an IV in­fu­sion can be eas­i­ly ad­min­is­tered.

On Tues­day, CDER chief Janet Wood­cock, who stepped away from the FDA to run the treat­ment arm of Op­er­a­tion Warp Speed, out­lined the gov­ern­ment’s plan to dis­trib­ute the 300,000 dos­es they’ve agreed to pur­chase from Eli Lil­ly. They will re­ly large­ly on a sys­tem that of­fi­cials even­tu­al­ly de­vel­oped for dis­trib­ut­ing remde­sivir: Rather than give the drug di­rect­ly to med­ical cen­ters, they will al­lo­cate it to states and ter­ri­to­ries ac­cord­ing to how many Covid-19 cas­es and hos­pi­tal­iza­tions they have. Lo­cal gov­ern­ments would then al­lo­cate it with­in their ju­ris­dic­tions.

For ex­am­ple, in the first al­lo­ca­tion this week, the large and hard-hit state of Texas will re­ceive 5,780 dos­es. Ver­mont, which is small and has kept the virus un­der rel­a­tive con­trol, will re­ceive 20.

Still, out­side ex­perts said that left key ques­tions unan­swered. Much of the coun­try still does not have enough test­ing ca­pac­i­ty to catch cas­es with­in the nar­row win­dow where ear­ly stud­ies in­di­cate the an­ti­body may be ben­e­fi­cial. And al­though au­thor­i­ties want to re­serve the drug for pa­tients who are at high risk, such as those with di­a­betes or obe­si­ty, that still leaves far more de­mand than sup­ply.

“In some pop­u­la­tions, you have half the peo­ple who will meet that high-risk cri­te­ria, so who you give it to and how you make that de­ci­sion isn’t clear,” said He­len Bouch­er, chief of in­fec­tious dis­eases at Tufts Med­ical Cen­ter in Boston, told The Wash­ing­ton Post. “The wor­ry is whether black and brown peo­ple get ac­cess who we know are be­ing dis­pro­por­tion­ate­ly af­fect­ed by this dis­ease.”

The dis­tri­b­u­tion will hap­pen while ques­tions linger about how ef­fec­tive the drug re­al­ly is. Al­though on­ly the medi­um, 2800 mg dose of the an­ti­body met the pri­ma­ry end­point of re­duc­ing vi­ral load in Lil­ly’s piv­otal tri­al, the FDA au­tho­rized a 700 mg dose and HHS is send­ing vials con­tain­ing that dose to the states.

The 700 mg dose will al­low them to give the drug to far more peo­ple, and Lil­ly says that all dos­es showed “sim­i­lar clin­i­cal ef­fects,” such as de­creas­ing the risk of hos­pi­tal­iza­tion and re­duc­ing symp­toms. Wood­cock de­fend­ed the gov­ern­ment’s de­ci­sion on a call with re­porters, point­ing to the da­ta Eli Lil­ly col­lect­ed on hos­pi­tal­iza­tion and symp­tom al­le­vi­a­tion.

She ar­gued that most peo­ple clear the virus on their own and that, among those who didn’t, all three dos­es of the drug re­duced vi­ral load. The p-val­ue for the 700 mg dose was 0.38.

“I think you are sort of ac­cept­ing a di­choto­mous view of p-val­ues,” she said, ac­cord­ing to Bio­Cen­tu­ry. “If you look at the vi­rol­o­gy da­ta, there was al­most no dif­fer­ence in virus clear­ance amongst the dif­fer­ent dos­es.”

For Wood­cock, the big­ger ques­tion is the roll­out. The gov­ern­ment is plan­ning to dis­trib­ute the an­ti­body in two phas­es, and even­tu­al­ly hopes to dis­trib­ute it, via states, to park­ing lot tents or trail­ers, which may be more ac­ces­si­ble. First, though, they’ll have to see if old-fash­ioned hos­pi­tals, ur­gent care cen­ters and ERs can do the trick.

“For the next two weeks, what we’re go­ing to be look­ing at very close­ly is the abil­i­ty of the health­care sys­tem to ac­tu­al­ly get this in­to peo­ple’s veins,” Wood­cock said.

Tar­get­ing a Po­ten­tial Vul­ner­a­bil­i­ty of Cer­tain Can­cers with DNA Dam­age Re­sponse

Every individual’s DNA is unique, and because of this, every patient responds differently to disease and treatment. It is astonishing how four tiny building blocks of our DNA – A, T, C, G – dictate our health, disease, and how we age.

The tricky thing about DNA is that it is constantly exposed to damage by sources such as ultraviolet light, certain chemicals, toxins, and even natural biochemical processes inside our cells.¹ If ignored, DNA damage will accumulate in replicating cells, giving rise to mutations that can lead to premature aging, cancer, and other diseases.

Ken Frazier, Merck CEO (Bess Adler/Bloomberg via Getty Images)

UP­DAT­ED: Mer­ck takes a swing at the IL-2 puz­zle­box with a $1.85B play for buzzy Pan­dion and its au­toim­mune hope­fuls

When Roger Perlmutter bid farewell to Merck late last year, the drugmaker perhaps best known now for sales giant Keytruda signaled its intent to take a swing at early-stage novelty with the appointment of discovery head Dean Li. Now, Merck is signing a decent-sized check to bring an IL-2 moonshot into the fold.

Merck will shell out roughly $1.85 billion for Pandion Pharmaceuticals, a biotech hoping to gin up regulatory T cells (Tregs) to treat a range of autoimmune disorders, the drugmaker said Thursday.

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Roivant par­lays a $450M chunk of eq­ui­ty in biotech buy­out, grab­bing a com­pu­ta­tion­al group to dri­ve dis­cov­ery work

New Roivant CEO Matt Gline has crafted an all-equity upfront deal to buy out a Boston-based biotech that has been toiling for several years now at building a supercomputing-based computational platform to design new drugs. And he’s adding it to the Erector set of science operations that are being built up to support their network of biotech subsidiaries with an eye to growing the pipeline in a play to create a new kind of pharma company.

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Fol­low biotechs go­ing pub­lic with the End­points News IPO Track­er

The Endpoints News team is continuing to track IPO filings for 2021, and we’ve designed a new tracker page for the effort.

Check it out here: Biopharma IPOs 2021 from Endpoints News

You’ll be able to find all the biotechs that have filed and priced so far this year, sortable by quarter and listed by newest first. As of the time of publishing on Feb. 25, there have already been 16 biotechs debuting on Nasdaq so far this year, with an additional four having filed their S-1 paperwork.

Doug Ingram (file photo)

Why not? Sarep­ta’s third Duchenne MD drug sails to ac­cel­er­at­ed ap­proval

Sarepta may be running into some trouble with its next-gen gene therapy approach to Duchenne muscular dystrophy. But when it comes to antisense oligonucleotides, the well-trodden regulatory path is still leading straight to an accelerated approval for casimersen, now christened Amondys 45.

We just have to wait until 2024 to find out if it works.

Amondys 45’s approval was unceremonious, compared to its two older siblings. There was no controversy within the FDA over approving a drug based on a biomarker rather than clinical benefit, setting up a powerful precedent that still haunts acting FDA commissioner Janet Woodcock as biotech insiders weighed her potential permanent appointment; no drama like the FDA issuing a stunning rejection only to reverse its decision and hand out an OK four months later, which got more complicated after the scathing complete response letter was published; no anxious tea leaf reading or heated arguments from drug developers and patient advocates who were tired of having corticosteroids as their loved ones’ only (sometimes expensive) option.

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J&J ad­comm live blog: Com­mit­tee votes 22-0 to rec­om­mend an FDA OK for the J&J vac­cine, set­ting up 3rd US Covid-19 jab

The US could have a third authorized Covid-19 vaccine within hours.

The FDA’s advisory committee voted unanimously — 22-0 — to recommend the agency issue an emergency use authorization for J&J’s vaccine. If they follow the precedent of the Pfizer and Moderna vaccine,  the FDA will likely authorize the vaccine by Saturday, immediately adding a few million doses to the US supply and adding a 100 million by June. An authorization would give the world its first single-dose vaccine, a major weapon in the effort to vaccinate the world and bring the virus to heel, particularly in rural and developing areas.

S&P ex­pects steady ero­sion in Big Phar­ma's cred­it pro­file in 2021 as new M&A deals roll in — but don't un­der­es­ti­mate their un­der­ly­ing strength

S&P Global has taken a look at the dominant forces shaping the pharma market and come to the conclusion that there will be more downgrades than upgrades in 2021 — the 8th straight year of steady decline.

But it’s not all bad news. Some things are looking up, and there’s still plenty of money to be made in an industry that enjoys a 30% to 40% profit margin, once you factor in steep R&D expenses.

Glax­o­SmithK­line re­thinks strat­e­gy for Covid-19 an­ti­body — not the Vir ones — af­ter tri­al flop. Is there hope in high-risk pa­tients?

In the search for a better Covid-19 therapeutic, GlaxoSmithKline and Vir have partnered up on two antibodies they hope have a chance. GSK is also testing its own in-house antibody, and early results may have shut the door on its widespread use.

A combination of GSK’s monoclonal antibody otilimab plus standard of care couldn’t best standard of care alone in preventing death and respiratory failure in hospitalized Covid-19 patients after 28 days, according to data from the Phase IIa OSCAR study unveiled Thursday.

Covid-19 roundup: US se­cures 100,000 dos­es of Eli Lil­ly's an­ti­body cock­tail; Mer­ck­'s $356M sup­ply deal on hold as FDA asks for more da­ta

A couple weeks after racking up its third EUA for a Covid-19 treatment — this one for its antibody cocktail — Eli Lilly has struck a deal with the US government for at least 100,000 doses.

The US will pay $210 million for doses of bamlanivimab and etesevimab, which will be delivered through March 31, Lilly said in a statement. The deal builds on 1.45 million doses of bamlanivimab alone that the US has already purchased, more than 1 million of which have been delivered. Another 450,000 doses of the single antibody are also expected to arrive by March 31.

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