Boehringer ax­es biosim­i­lar de­vel­op­ment out­side US; Macro­Gen­ics, Chi­na's Zai Labs join forces to de­vel­op I/O treat­ments

→ Ger­many’s Boehringer has elect­ed to wash its hands off biosim­i­lar de­vel­op­ment out­side the Unit­ed States. The de­ci­sion like­ly comes in re­ac­tion to the painful patent bat­tle with Ab­b­Vie $AB­BV — the mak­er of the world’s best sell­ing drug Hu­mi­ra, which last year raked in about $18.4 bil­lion. Last year, Boehringer’s Hu­mi­ra copy­cat Cyl­te­zo was the first to win EU ap­proval and nabbed the run­ner-up ap­proval in the Unit­ed States. Ab­b­Vie’s tac­tics to pro­long the life of its block­buster in the Unit­ed States suc­ceed­ed to a de­gree, with a slate of biosim­i­lar mak­ers agree­ing to de­lay their launch­es to 2023, but Boehringer con­tin­ues to wres­tle with Ab­b­Vie to launch Cyl­te­zo soon­er. Mean­while, Hu­mi­ra biosim­i­lars in Eu­rope by firms such as No­var­tis $NVS, My­lan $MYL and Am­gen $AMGN have been launched. Boehringer wants to fo­cus its ef­forts en­tire­ly in the Unit­ed States, the com­pa­ny said in a state­ment to Bio­process In­sid­er on Wednes­day. “While Boehringer In­gel­heim had planned to bring Cyl­te­zo to pa­tients in the EU, due to the patent lit­i­ga­tion with Ab­b­Vie in the US, we will not com­mer­cial­ize our biosim­i­lar in the EU,” a spokesper­son said, adding that the com­pa­ny is al­so stop­ping biosim­i­lar de­vel­op­ment ac­tiv­i­ties for the rest of the world.

→ An­oth­er US biotech is join­ing hands with a Chi­nese out­fit. Rockville, Mary­land-based Macro­Gen­ics on Thurs­day se­cured $25 mil­lion up­front to col­lab­o­rate and li­cense three of its im­muno-on­col­o­gy pro­grams with Shang­hai-based Zai Lab $ZLAB. Un­der the deal, Zai Lab will gain the de­vel­op­ment and com­mer­cial­iza­tion rights for the pro­grams in main­land Chi­na, Hong Kong, Macau and Tai­wan, and to­geth­er, the two com­pa­nies will al­so ini­ti­ate a glob­al study. Macro­Gen­ics is al­so el­i­gi­ble to re­ceive up to $140 mil­lion in mile­stone pay­ments.

→ Britain’s As­traZeneca $AZN is join­ing forces with Brus­sels-based mol­e­c­u­lar di­ag­nos­tics com­pa­ny Bio­car­tis to has­ten bio­mark­er re­sults for lung can­cer pa­tients, us­ing the lat­ter’s Idyl­la plat­form.

The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; 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.

With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 158,500+ biopharma pros reading Endpoints daily — and it's free.

Trodelvy notch­es a win in most com­mon form of breast can­cer

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.

Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 158,500+ biopharma pros reading Endpoints daily — and it's free.

Ei­sai cut­ting 91 jobs af­ter out-li­cense deal; Mer­ck touts first-line Keytru­da re­sults in en­dome­tri­al can­cer

Eisai will eliminate 91 after it out-licensed a seizure drug.

An Eisai spokesperson told Endpoints News that the change-up is tied to Fycompa, a seizure treatment that Florida rare disease biotech Catalyst Pharmaceuticals agreed to pay $160 million to Eisai in exchange for commercial rights back in December. The job cuts were originally flagged in a New Jersey state WARN notice.

The spokesperson said that Catalyst indicated interest in retaining up to 40 employees who work on Fycompa. Those who qualify will have an opportunity to interview with Catalyst.

Raymond Stevens, Structure Therapeutics CEO

Be­hind Fri­day's $161M IPO: A star sci­en­tist, GPCR drug dis­cov­ery and a plan to chal­lenge phar­ma in di­a­betes

What does it take to pull off a $161 million biotech IPO these days?

In Structure Therapeutics’ case, it means having a star scientist co-founder paired with the computational drug discovery company Schrödinger, $198 million in private funding from blue-chip investors, almost six years of research work on G protein-coupled receptors and a slate of oral, small-molecule drugs, with an eye on the huge and growing diabetes and weight-loss market.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 158,500+ biopharma pros reading Endpoints daily — and it's free.

Af­ter 13 years, Ramy Mah­moud steps in­to CEO seat at Opti­nose; Ru­pert Vessey set to ex­it Bris­tol My­ers in Ju­ly

After 13 years as president and COO at Optinose, Ramy Mahmoud has stepped into a new role as its CEO. He is taking the place of Peter Miller, who stepped down earlier this week, though Miller is still staying with the company as a consultant.

In 2010, the two business partners joined Optinose to take it in a new direction, transforming it from a delivery platform to product company. They previously worked together at Johnson & Johnson, when Miller was president at Janssen and Mahmoud headed medical affairs. Miller said after he learned about Optinose, “I did what I always do, which is find people smarter than me to talk with about the idea. And the first person I called was Ramy … and I said, ‘Hey, Ramy, what do you think of this technology?’”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 158,500+ biopharma pros reading Endpoints daily — and it's free.

Ma­gen­ta halts stem cell work and may sell it­self fol­low­ing pa­tient death, clin­i­cal hold

Magenta Therapeutics said it is halting work on its stem cell transplant drug pipeline and may sell itself, a week after the company reported the death of a patient in an early stage trial of its antibody-drug conjugate.

The Cambridge, MA-based company said it will conduct a “review of strategic alternatives,” and that could include an “acquisition, merger, business combination, or other transaction.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 158,500+ biopharma pros reading Endpoints daily — and it's free.

Te­va drops out of in­dus­try trade group PhRMA

Following in AbbVie’s footsteps, Teva confirmed on Friday that it’s dropping out of the industry trade group Pharmaceutical Research and Manufacturers of America (PhRMA).

Teva didn’t give a reason for its decision to leave, saying only in a statement to Endpoints News that it annually reviews “effectiveness and value of engagements, consultants and memberships to ensure our investments are properly seated.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 158,500+ biopharma pros reading Endpoints daily — and it's free.

Sanofi CFO Jean-Baptiste de Chatillon (L) and CEO Paul Hudson (Romuald Meigneux/Sipa via AP Images)

Sanofi sees downtick in flu sales as it preps for launch of RSV an­ti­body

Sanofi expects its RSV antibody jointly developed with AstraZeneca will be available next season, executive VP of vaccines Thomas Triomphe announced on the company’s quarterly call.

Beyfortus, also known as nirsevimab, was approved in the EU back in November and is currently under FDA review with an expected decision coming in the third quarter of this year. The news comes as the FDA plans to hold advisory committee meetings over the next couple months to review RSV vaccines from Pfizer and GSK.