In stun­ning about-face, FDA in­vites Eli Lil­ly to quick­ly re­file block­buster hope­ful baric­i­tinib

Just a few weeks ago Eli Lil­ly $LLY made it clear that the FDA was de­mand­ing a new clin­i­cal study to clar­i­fy the safe­ty pro­file of its would-be rheuma­toid arthri­tis block­buster baric­i­tinib, de­lay­ing any re­sub­mis­sion by at least 18 months and per­haps years.

But this morn­ing the phar­ma gi­ant and its biotech part­ners at In­cyte $IN­CY say they’re fil­ing a new mar­ket­ing pitch in just 5 months in an at­tempt to bull their way to an ap­proval by mid-year.

In a state­ment to En­doints News, Lil­ly says the FDA in­vit­ed a new ap­pli­ca­tion with­out the re­quire­ment to com­plete a new study, mark­ing a po­ten­tial­ly dra­mat­ic change in its stance.

The FDA has grant­ed us the op­por­tu­ni­ty to file our re­sub­mis­sion pack­age with­out a new clin­i­cal study.

That’s no guar­an­tee of a quick ap­proval, but it re­flects a ma­jor shift in the FDA’s stance on an im­por­tant new drug, one that comes af­ter Pres­i­dent Don­ald Trump ap­point­ed Scott Got­tlieb to run the FDA.

Lil­ly shares surged 2.4% on the news, with In­cyte spik­ing 4%.

The FDA de­clined to com­ment, a stan­dard prac­tice at the agency, which lets the com­pa­nies do all the talk­ing.

Lil­ly took months to ex­plain the FDA’s rea­son for the stun­ning re­jec­tion, re­cent­ly not­ing that reg­u­la­tors con­cerns about throm­boem­bol­ic events –clot­ting — in two of 7 stud­ies raised an alarm, even though Lil­ly com­plete­ly dis­agreed with the agency’s po­si­tion on safe­ty while in­sist­ing that there was noth­ing aber­rant about the rate of clots. Lil­ly not­ed in a state­ment this morn­ing:

Lil­ly will re­sub­mit the New Drug Ap­pli­ca­tion (NDA) for baric­i­tinib be­fore the end of Jan­u­ary 2018. The re­sub­mis­sion pack­age will in­clude new safe­ty and ef­fi­ca­cy da­ta. The com­pa­nies an­tic­i­pate the FDA will clas­si­fy the ap­pli­ca­tion as a Class II re­sub­mis­sion, which will start a new six-month re­view cy­cle.

Said Christi Shaw, pres­i­dent of Lil­ly Bio-Med­i­cines:

“We are pleased with the op­por­tu­ni­ty to pro­vide our re­sub­mis­sion pack­age for baric­i­tinib soon­er than an­tic­i­pat­ed and look for­ward to con­tin­u­ing to work with the FDA as we seek to bring baric­i­tinib to peo­ple with RA in the U.S.”

Got­tlieb won law­mak­ers’ sup­port for his ap­point­ment a few weeks af­ter Lil­ly was hand­ed a re­jec­tion in April. While he vowed to main­tain the gold stan­dard on safe­ty and ef­fi­ca­cy, Got­tlieb al­so pledged to do every­thing pos­si­ble to ac­cel­er­ate new drug OKs, urg­ing that all of the agency groups fol­low the path pur­sued by its ag­gres­sive on­col­o­gy di­vi­sion.

If the agency fol­lows through with an ap­proval soon, the im­pli­ca­tions would be pro­found for every­one in drug de­vel­op­ment, par­tic­u­lar­ly the larg­er play­ers like Lil­ly.

George Yancopoulos (Regeneron)

Re­gen­eron co-founder George Yan­copou­los of­fers a com­bat­ive de­fense of the po­lice at a high school com­mence­ment. It didn’t go well

Typically, the commencement speech at Yorktown Central School District in Westchester — like most high schools — is an opportunity to encourage students to face the future with confidence and hope. Regeneron president and co-founder George Yancopoulos, though, went a different route.

In a fiery speech, the outspoken billionaire defended the police against the “prejudice and bias against law enforcement” that has erupted around the country in street protests from coast to coast. And for many who attended the commencement, Yancopoulos struck the wrong note at the wrong time, especially when he combatively challenged someone for interrupting his speech with a honk for “another act of cowardness.”

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Elias Zerhouni (Photo by Vincent Isore/IP3/Getty Images)

Elias Zer­houni dis­cuss­es ‘am­a­teur hour’ in DC, the de­struc­tion of in­fec­tious dis­ease R&D and how we need to prep for the next time

Elias Zerhouni favors blunt talk, and in a recent discussion with NPR, the ex-Sanofi R&D and ex-NIH chief had some tough points to make regarding the pandemic response.

Rather than interpret them, I thought it would be best to provide snippets straight from the interview.

On the Trump administration response:

It was basically amateur hour. There is no central concept of operations for preparedness, for pandemics, period. This administration doesn’t want to or has no concept of what it takes to protect the American people and the world because it is codependent. You can’t close your borders and say, “OK, we’re going to be safe.” You’re not going to be able to do that in this world. So it’s a lack of vision, basically just a lack of understanding, of what it takes to protect the American people.

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An ex­pe­ri­enced biotech is stitched to­geth­er from transpa­cif­ic parts, with 265 staffers and a fo­cus on ‘new bi­ol­o­gy’

Over the past few years, different teams at a pair of US-based biotechs and in labs in Japan have labored to piece together a group of cancer drug programs, sharing a single corporate umbrella with research colleagues in Japan. But now their far-flung operations have been knit together into a single unit, creating a pipeline with 10 cancer drug development programs — going from early-stage right into Phase III — and a host of discovery projects managed by a collective staff of some 265 people.

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New stan­dard of care? FDA hands Pfiz­er, Mer­ck KGaA an OK for Baven­cio in blad­der can­cer

The breakthrough therapy designation Pfizer and Merck KGaA notched for Bavencio in bladder cancer has quickly paved way for a full approval.

The PD-L1 drug is now sanctioned as a first-line maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma, applicable in cases where cancer hasn’t progressed after platinum-containing chemotherapy.

Petros Grivas, the principal investigator of the supporting Phase III JAVELIN Bladder 100, called the approval “one of the most significant advances in the treatment paradigm in this setting in 30 years.”

On a roll, Mer­ck blazes through a new seg­ment of the bio­mark­er trail

Merck has notched an approval for using Keytruda to treat a biomarker-based subset of first-line colorectal cancer patients with unresectable or metastatic tumors, as the pharma giant continues to find new niches for its blockbuster PD-1 star.

The OK is significant in a number of ways. Not only does it build on an accelerated approval for all tumors characterized as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR); it also marks the first single treatment for colorectal cancer that doesn’t contain chemotherapy.

Pfiz­er shares surge on pos­i­tive im­pact of their mR­NA Covid-19 vac­cine — part­nered with BioN­Tech — in an ear­ly-stage study

Pfizer and their partners at the mRNA specialist BioNTech have published the first glimpse of biomarker data from an early-stage study spotlighting the “robust immunogenicity” triggered by their Covid-19 vaccine, which is one of the leaders in the race to vanquish the global pandemic.

Researchers selected 45 healthy volunteers 18-55 years of age for the study. They were randomized to receive 2 doses, separated by 21 days, of 10 µg, 30 µg, or 100 µg of BNT162b1, “a lipid nanoparticle-formulated, nucleoside-modified, mRNA vaccine that encodes trimerized SARS-CoV-2 spike glycoprotein RBD.” Their responses were compared against the effect of a natural, presumably protective defense offered by a regular infection.

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Sec­ond death trig­gers hold on Astel­las' $3B gene ther­a­py biotech's lead pro­gram, rais­ing fresh con­cerns about AAV

Seven months after Astellas shelled out $3 billion to acquire the gene therapy player Audentes, the biotech company’s lead program has been put on hold following the death of 2 patients taking a high dose of their treatment. And there was another serious adverse event recorded in the study as well, with a total of 3 “older” patients in the study affected.

The incidents are derailing plans to file for a near-term approval, which had been expected right about now.

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Paul Hudson, Sanofi CEO (Getty Images)

Sanofi preps an­oth­er round of lay­offs as new ex­ecs look to slim down the glob­al phar­ma in an on­go­ing re­or­ga­ni­za­tion — re­port

Sanofi is reportedly once again sharpening up the budget axe as the pharma giant prepares to chop more jobs.

Reuters reports this morning that Sanofi has its sights set on cutting 1,680 jobs in Europe, where the unions have been combating rounds of cutbacks at the Paris-based player. Sanofi itself hasn’t said anything about these cuts, as the company looks to discuss a 3-year plan with staff representatives.

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Covid-19 roundup: Vac­cines will need to beat place­bo by 50% to qual­i­fy for FDA OK; UK tri­al drops Kale­tra

The FDA will set the bar for approving a Covid-19 vaccine at 50% efficacy, the Wall Street Journal reported, meaning any successful candidate will have to reduce the risk of coronavirus disease by at least half compared to placebo.

That requirement is part of guidance that the agency is set to release later today, laying out detailed criteria for vaccine developers — some of whom are eyeing an OK by the end of the year, in line with expectations at Operation Warp Speed.

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