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.

Op­ti­miz­ing Cell and Gene Ther­a­py De­vel­op­ment and Pro­duc­tion: How Tech­nol­o­gy Providers Like Corn­ing Life Sci­ences are Spurring In­no­va­tion

Remarkable advances in cell and gene therapy over the last decade offer unprecedented therapeutic promise and bring new hope for many patients facing diseases once thought incurable. However, for cell and gene therapies to reach their full potential, researchers, manufacturers, life science companies, and academics will need to work together to solve the significant challenges facing the industry.

Amid mon­key­pox fears, biotechs spring to ac­tion; Mod­er­na’s CFO trou­ble; Cuts, cuts every­where; Craft­ing the right pro­teins; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

It’s always a bittersweet moment saying goodbye, but as Josh Sullivan goes off to new adventures we are grateful for the way he’s built up the Endpoints Manufacturing section — which the rest of the team will now carry forward. If you’re not already, this may be a good time to sign up for your weekly dose of drug manufacturing news. Thank you for reading and wish you a restful weekend.

Bay­er sounds re­treat from a $670 mil­lion CAR-T pact in the wake of a pa­tient death

Two months after Atara Biotherapeutics hit the hold button on its lead CAR-T 2.0 therapy following a patient death, putting the company under the watchful eye of the FDA, its Big Pharma partners at Bayer are bowing out of a $670 million global alliance. And the move is forcing a revamp of Atara’s pipeline plans, even as research execs vow to continue work on the two drugs allied with Bayer 18 months ago, which delivered a $60 million cash upfront.

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Sanofi and Re­gen­eron clear the fin­ish line in an in­flam­ma­to­ry esoph­a­gus dis­ease, leav­ing Take­da in the dust

With atopic dermatitis rivals breathing down Dupixent’s neck, Sanofi and Regeneron on Friday secured a first win in new territory in what Sanofi’s head of immunology and inflammation Naimish Patel called the fastest approval he’s ever seen.

The FDA approved Dupixent on Friday to treat patients 12 years and older with eosinophilic esophagitis (EoE), an inflammatory condition that causes swelling and scarring of the esophagus. The approval came just a couple months after regulators granted Dupixent priority review, and months ahead of its PDUFA date on Aug. 3.

Fu­ji­film con­tin­ues its biotech build­ing spree with new fa­cil­i­ty in Chi­na

A Japanese conglomerate is making a big play in China with the opening of a new facility, as it continues to expand.

Fujifilm Irvine Scientific has opened its new Innovation and Collaboration Center in Suzhou New District, China, an area in Jiangsu province specifically designated for technological and industrial development.

According to Fujifilm, the 12,000-square-foot site will be responsible for the company’s cell culture media optimization, analysis and design services. Cell culture media itself often requires customization of formulas and protocols to achieve the desired quantity and quality of therapeutic desired. Fujifilm Irvine Scientific is offering these services from its headquarters in California and Japan to its customers globally, as well as in China now.

Rob Etherington, Clene CEO

Mary­land of­fers loan to Clene de­spite ALS tri­al bumps

Even after Utah-based Clene failed to hit its primary endpoints for its ALS drug last year, the state of Maryland is putting its money at least behind Clene’s manufacturing facility.

The Maryland Board of Public Works has finalized a $3 million, 60-month loan facility with Clene Nanomedicine. The loan was provided by the state’s Neighborhood BusinessWorks program within the Maryland Department of Housing and Community Development.

Armon Sharei, SQZ founder and CEO

SQZ's out­side-the-box man­u­fac­tur­ing method slash­es pro­duc­tion time in ear­ly in study

At ASCO 2021 in June of last year, SQZ Biotech showcased a glimpse of its unorthodox cell therapy manufacturing tech. And on Wednesday, the Watertown, MA, company announced that its first-generation system showed comparable or better performance than a conventional clean-room-based manufacturing process.

The study was non-clinical. Clinical trials are expected by the first half of 2023.

SQZ’s device opens up a temporary window by cell-squeezing to deliver cargoes into cells. Its average processing time was less than six hours per batch, which is more than half the time than conventional methods. The company is planning to use the technology in its first red blood cell derived program for celiac disease. That IND is set to be submitted in the first half of 2023, the company said.

Bobby Sheng, Bora Pharmaceuticals CEO

With new ac­qui­si­tion, Bo­ra to ven­ture in­to bi­o­log­ics

Last week, Taiwan-based CDMO Bora Pharmaceuticals announced that it acquired Eden Biologics. Now, it says that purchase has helped established Bora Biologics, expanding into the biopharmaceutical market.

The acquisition of the company’s assets, which are located in the Hsinchu Biomedical Science Park in Taiwan, is helping Bora build its presence in the biopharma world by expanding production capacity of cell lines for the production of protein drugs. It will also improve the quality control and inspection specifications, as well as cell bank generation. The facility has four 500-liter bioreactors that have been approved by European and Taiwanese regulators.

Paul Chaplin, Bavarian Nordic president and CEO

With mon­key­pox cas­es ris­ing, one Eu­ro­pean coun­try is lock­ing down a small­pox vac­cine con­tract

As the global number of confirmed and suspected monkeypox cases continues to slowly climb, one country is trying to get a head start on potential vaccine stocking.

Bavarian Nordic signed a contract with an undisclosed European nation to supply its smallpox vaccine in response to new cases this month, the company announced Thursday morning. The continent saw its first monkeypox case confirmed about two weeks ago, with both the UK and Portugal seeing cases, according to the Washington Post.

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