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.

Biogen CEO Michel Vounatsos (via Getty Images)

With ad­u­canum­ab caught on a cliff, Bio­gen’s Michel Vounatsos bets bil­lions on an­oth­er high-risk neu­ro play

With its FDA pitch on the Alzheimer’s drug aducanumab hanging perilously close to disaster, Biogen is rolling the dice on a $3.1 billion deal that brings in commercial rights to one of the other spotlight neuro drugs in late-stage development — after it already failed its first Phase III.

The big biotech has turned to Sage Therapeutics for its latest deal, close to a year after the crushing failure of Sage-217, now dubbed zuranolone, in the MOUNTAIN study.

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Pascal Soriot (AP Images)

As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

Af­ter Ko­dak de­ba­cle, US lends $1.1B to a syn­thet­ic bi­ol­o­gy com­pa­ny and their big Covid-19, mR­NA plans

In mid-August, as Kodak’s $765 million government-backed push into drug manufacturing slowly fell apart in national headlines, Ginkgo Bioworks CEO Jason Kelly got a message from his company’s government liaison: HHS wanted to know if they, too, might want a loan.

The government’s decision to lend Kodak three quarters of a billion dollars raised eyebrows because Kodak had never made drugs before. But Ginkgo, while not a manufacturing company, had spent the last decade refining new ways to produce materials inside cells and building automated facilities across Boston.

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John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

Al­ny­lam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1. The news comes just 4 days after the European Commission took the lead in offering a green light.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

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In fi­nal days at Mer­ck, Roger Perl­mut­ter bets big on a lit­tle-known Covid-19 treat­ment

Roger Perlmutter is spending his last days at Merck, well, spending.

Two weeks after snapping up the antibody-drug conjugate biotech VelosBio for $2.75 billion, Merck announced today that it had purchased OncoImmune and its experimental Covid-19 drug for $425 million. The drug, known as CD24Fc, appeared to reduce the risk of respiratory failure or death in severe Covid-19 patients by 50% in a 203-person Phase III trial, OncoImmune said in September.

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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.

FDA hands Liq­uidia and Re­vance a CRL and de­fer­ral, re­spec­tive­ly, as Covid-19 cre­ates in­spec­tion chal­lenge

Two biotechs said they got turned away by the FDA on Wednesday, in part due to pandemic-related travel restrictions.

North Carolina-based Liquidia Technologies was handed a CRL for its lead pulmonary arterial hypertension drug, citing the need for more CMC data and on-site pre-approval inspections, which the FDA hasn’t been able to conduct due to travel restrictions. The agency also deferred its decision on Revance Therapeutics’ BLA for its frown line treatment, because it needs to inspect the company’s northern California manufacturing facility. The action, Revance emphasized, was not a CRL.

Bax­ter con­tin­ues on-shoring push with $50M In­di­ana ex­pan­sion

It’s been a banner year for the once humdrum business of manufacturing drugs, particularly vaccines. Billions have been spent ramping up facilities for Covid-19 jabs, while individual CDMOs have expanded their facilities, apparently anticipating demand or responding to a government-led push to onshore drug manufacturing.

Now Baxter Biopharma Solutions, the CDMO wing of the many-armed healthcare giant Baxter, is getting in on the game. On Tuesday, they announced plans to spend $50 million to expand their flagship, 600,000 square-foot facility in Bloomington, IN.

Eu­ro­pean Union aims to es­tab­lish patent workaround in case of emer­gen­cies while try­ing to strength­en its own IP

The European Union is looking at ways to bypass patent protections and make it easier to make generic drugs in cases of emergency such as the Covid-19 pandemic, a new document says.

Normally, under WTO regulations, the practice known as “compulsory licensing” is allowed in exceptional circumstances and could be applied as a waiver to bypass patent holders. Wednesday’s document was published as part of the EU’s plan to shore up the intellectual property rights of its member states.