Ab­b­Vie’s top ex­ecs paint a rosy pic of the mega-block­buster fu­ture loom­ing for Hu­mi­ra and PhI­II drugs

Richard Gon­za­lez

Ab­b­Vie’s top ex­ec­u­tive team has looked to the near fu­ture — and it is a fine and cheery place un­ham­pered by gener­ics or pric­ing pledges.

CEO Rick Gon­za­lez, CFO Bill Chase and CSO Michael Sev­eri­no sat down with Leerink’s Ge­of­frey Porges for a 90-minute dis­cus­sion about the com­pa­ny, giv­ing them a chance to out­line a bull­ish sce­nario for the next few years — which in­cludes some jaw-drop­ping fore­casts for its fran­chise drug Hu­mi­ra as well as its two top drugs in the late-stage pipeline.

In Porges’ telling of the meet­ing, the Ab­b­Vie $AB­BV team be­lieves it has cleared a thick­et of po­ten­tial biosim­i­lar com­pe­ti­tion to Hu­mi­ra, giv­ing them a clear and open mar­ket path­way that stretch­es out to 2022 as the com­pa­ny beefs up its peak rev­enue to $20 bil­lion. And they are mighty fond of two of their top ex­per­i­men­tal drugs — ABT-494/upadac­i­tinib and the an­ti-IL-23 an­ti-in­flam­ma­to­ry drug risankizum­ab — each of which could spawn fran­chise sales of $4 bil­lion to $5 bil­lion.

Michael Sev­eri­no

Ab­b­Vie paid Boehringer $595 mil­lion up­front to li­cense rights to risankizum­ab in ear­ly 2016 and now see it as a core piece of a fu­ture $30 bil­lion im­munol­o­gy fran­chise.

Al­so, af­ter start­ing the year with Pres­i­dent Don­ald Trump trum­pet­ing his op­po­si­tion to out­ra­geous drug pric­ing, they’re fin­ish­ing it con­fi­dent that noth­ing go­ing on in Wash­ing­ton DC — or any­where in the US health­care sys­tem — threat­ens their rosy sce­nario.

Notes Porges:

In the mean­time, the com­pa­ny ap­pears in­creas­ing­ly con­fi­dent about the do­mes­tic con­tract­ing, pric­ing, and reg­u­la­to­ry en­vi­ron­ment, sug­gest­ing that its “one price in­crease per year” com­mit­ment ap­plies on­ly to 2017 and could be re­vis­it­ed in 2018.

Ge­of­frey Porges, Leerink

Gon­za­lez start­ed the year with a pre­sen­ta­tion at JP­Mor­gan that in­clud­ed a promise to lim­it an­nu­al price hikes to sin­gle dig­its, cap­ping it at just un­der 10% with once-off in­creas­es — in­stead of steadi­ly up­ping the ante with stag­gered price hikes — as the phar­ma in­dus­try grap­pled with se­vere crit­i­cism that spurred a num­ber of com­pa­nies to make a pub­lic pledge to rein in the big in­creas­es that in­flat­ed fran­chise rev­enue.

“There’s a strong de­bate go­ing on right now about pric­ing,” Gon­za­lez told in­vestors, ac­cord­ing to a Reuters re­port at the time. “We need to make sure we are op­er­at­ing in an ap­pro­pri­ate way … and demon­strat­ing the val­ue of the prod­ucts that we have.”

We’ll see soon enough if the 2017 pledge goes any fur­ther than 2017.

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.

Try­ing to shake up the Parkin­son's par­a­digm, Ab­b­Vie sub­mits NDA for con­tin­u­ous, 24-hour in­fu­sion ther­a­py

AbbVie is approaching the FDA with a new therapy to potentially treat Parkinson’s disease, using prodrugs of two medications commonly used for the condition.

The Big Pharma submitted its NDA for ABBV-951, a solution of levodopa and carbidopa prodrugs being evaluated in advanced Parkinson’s patients who don’t respond well to oral therapy, AbbVie announced Friday morning. Researchers are hoping a positive Phase III study that reads out in late October will help move things along quickly at the agency.

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.