Af­ter an epic bat­tle of block­busters, Mer­ck leapfrogs Bris­tol-My­ers to take the lead on PD-1/L1 mar­ket

Mer­ck did it.

In one of the most in­tense com­mer­cial and re­search de­vel­op­ment ri­val­ries in bio­phar­ma his­to­ry, Mer­ck’s Keytru­da has edged ahead of Bris­tol-My­ers Squibb’s Op­di­vo for the first time since the show­down got start­ed near­ly 4 years ago.

This morn­ing Mer­ck re­port­ed that Keytru­da earned $1.66 bil­lion in Q2 — an 89% in­crease over the same pe­ri­od just a year ago. Yes­ter­day, Bris­tol-My­ers re­port­ed that their check­point Op­di­vo scored $1.62 bil­lion — up 36% — for the same pe­ri­od.

Roger Perl­mut­ter

To be sure, Mer­ck has pulled out all the stops in its epic head-to-head strug­gle with Bris­tol-My­ers, which took a big, ear­ly lead. But it’s the R&D team un­der Roger Perl­mut­ter who en­joys the li­on’s share of the cred­it here.

Bris­tol-My­ers made a poor de­ci­sion on how to ini­tial­ly tack­le front­line lung can­cer, and it has yet to cor­rect the im­bal­ance, even af­ter bring­ing in Tom Lynch as the new R&D chief in a post-sna­fu change­up. Mer­ck’s de­ci­sion to shift to a Keytru­da/chemo com­bo opened the door ear­ly to some sig­nif­i­cant changes in the stan­dard of care for front­line lung can­cer. And they’re back­ing that up with the mon­ey train. 

Mer­ck doesn’t just have Keytru­da in the pipeline, but you could be for­giv­en for think­ing so. At one point re­cent­ly the phar­ma gi­ant count­ed more than 750 clin­i­cal tri­als un­der­way in­volv­ing their PD-1. To be sure, many of those in­volved col­lab­o­ra­tions with lit­tle biotechs who were pay­ing the freight for the work, but it un­der­scores the over­all im­por­tance Mer­ck as­signs to this mega-block­buster.

It al­so spot­lights the ex­plo­sion of work be­ing done among the oth­er con­tenders for the crown as well as all the next-gen check­point work be­ing done, where a whole new gen­er­a­tion of com­pa­nies looks to make their own mark.

This isn’t base­ball, though. Sec­ond place counts for quite a lot in the game of block­busters, and Bris­tol-My­ers team will just dou­ble down as it con­tin­ues to scrap for every ad­van­tage in a glob­al mar­ket.

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.