Top biotech an­a­lyst projects a gloomy out­look for Pfiz­er's JAK port­fo­lio

Many in the phar­ma world are hop­ing — bet­ter yet, ex­pect­ing — JAK in­hibitors to pro­vide one of the next big boons for the in­dus­try. Few have in­vest­ed as heav­i­ly in this area as Pfiz­er, which boasts a port­fo­lio in­clud­ing Xel­janz and at least five mid-to-late stage can­di­dates in the pipeline.

But a top Wall Street an­a­lyst is pump­ing the brakes on just how much good for­tune is in store for the Big Phar­ma.

Ge­of­frey Porges

Ge­of­frey Porges of SVB Leerink, one of the mar­quee names in biotech, wrote in a let­ter to in­vestors this week that Pfiz­er is far be­hind the com­pe­ti­tion in the JAK race. Per Porges, “near­ly all in­di­ca­tions” sug­gest that Pfiz­er’s can­di­dates could be beat­en to mar­ket, or by bet­ter clin­i­cal da­ta, by oth­er oral­ly ad­min­is­tered JAK chal­lengers.

“At this stage Pfiz­er’s JAK op­por­tu­ni­ties ap­pear too lit­tle or too late,” Porges wrote. “Based on the low ma­te­ri­al­i­ty and risks to our fore­cast, we do not see the im­munol­o­gy port­fo­lio as a sig­nif­i­cant dri­ver of Pfiz­er’s stock per­for­mance in the near-term.”

Porges went on to say that Pfiz­er’s de­pen­dence on JAK in­hibitors and the bumpy road Xel­janz has faced in re­cent years, with black box warn­ings slapped on the en­tire JAK class by the FDA, will com­pli­cate the phar­ma’s fi­nan­cials. Xel­janz is cur­rent­ly ap­proved to treat rheuma­toid arthri­tis, pso­ri­at­ic arthri­tis and ul­cer­a­tive col­i­tis, but Pfiz­er had to sus­pend tri­als on its use for atopic der­mati­tis and Crohn’s dis­ease and end­ed up pulling high­er dos­es from shelves af­ter safe­ty risks arose. Porges al­so writes that giv­en the drug’s slow up­take in IBD, it might quick­ly be re­placed by oth­er JAK in­hibitors in this area.

Those black box la­bels that stunt­ed Xel­janz sales will al­so es­sen­tial­ly rel­e­gate Pfiz­er’s up­com­ing abroc­i­tinib to sec­ond-line AD treat­ment be­hind Re­gen­eron’s Dupix­ent. Porges specif­i­cal­ly men­tions two ri­vals that could out­do Pfiz­er and fur­ther hin­der the phar­ma gi­ant’s suc­cess: Ab­b­Vie’s Rin­voq and Bris­tol My­ers Squibb’s loom­ing TYK2 in­hibitor.

Porges said he ex­pects Rin­voq to be pre­ferred by sec­ond-line AD pa­tients due to its “sub­stan­tial­ly” high­er ef­fi­ca­cy than abroc­i­tinib in a cross-tri­al com­par­i­son. This damp­ens find­ings from oth­er tri­als that have shown promis­ing da­ta when com­par­ing abroc­i­tinib to Dupix­ent, the lead­ing first-line treat­ment for AD, Porges writes.

Pfiz­er is hop­ing abroc­i­tinib can even­tu­al­ly re­place Dupix­ent as the Re­gen­eron drug is an in­jectable, which caus­es some pa­tients to dis­con­tin­ue use, and Porges notes physi­cians may ul­ti­mate­ly choose to pre­scribe the can­di­date as they be­come more com­fort­able.

Mean­while, Bris­tol has gone all in on its up­com­ing TYK2 in­hibitor, BMS-986165, af­ter sell­ing off its high­ly suc­cess­ful pso­ri­a­sis drug Ote­zla when the com­pa­ny merged with Cel­gene. The can­di­date has shown “more than dou­ble the ef­fi­ca­cy” of Ote­zla with com­pa­ra­ble safe­ty in tests pub­lished by the phar­ma, Porges writes, and Phase III re­sults are ex­pect­ed in late 2020. This would ef­fec­tive­ly place Pfiz­er’s TYK2 pso­ri­a­sis can­di­date, cur­rent­ly in Phase II clin­i­cal tri­als, “rough­ly two years” be­hind Bris­tol’s.

Per Porges’ most op­ti­mistic fore­cast, over­all sales of JAK in­hibitors are es­ti­mat­ed to grow from $2.7 bil­lion in 2019 to $19.3 bil­lion by the end of 2024. But giv­en the cur­rent po­si­tion of Xel­janz, the black box FDA warn­ing and heavy com­pe­ti­tion, Pfiz­er “might on­ly get a small share” if such growth ma­te­ri­al­izes.

“Com­pared to oth­er large cap com­pa­nies in our cov­er­age uni­verse, we see more op­por­tu­ni­ty else­where,” Porges wrote. “At best we ex­pect the op­er­at­ing mar­gin to be flat from 2020, and this means our EPS es­ti­mates are al­so be­low con­sen­sus by 15 to 20 per­cent be­yond 2020.”

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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