Care about R&D strate­gies? Have we got a sum­mit for you

If there’s one un­der­ly­ing les­son I’ve learned watch­ing bio­phar­ma in ac­tion over the past 20 years or so, it’s that no R&D or­ga­ni­za­tion can rest on its lau­rels. Es­pe­cial­ly the larg­er ones. You’ve had a big suc­cess? Great. Now how do you plan to fol­low up on that? And how soon? Hit by fail­ure? What’s Plan B, C, D and E?

Lars Fruer­gaard Jør­gensen

And that’s the cen­tral mes­sage of my up­com­ing Eu­ro­pean Bio­phar­ma Sum­mit com­ing up next week. I’ll be talk­ing to 5 top bio­phar­ma ex­ec­u­tives about their next-gen game plans.

— No­vo Nordisk CEO Lars Fruer­gaard Jør­gensen and I have had a lot to talk about. Semaglu­tide has been the kind of suc­cess sto­ry any com­pa­ny likes to tell, es­pe­cial­ly now that it looks to make block­buster re­turns in fight­ing obe­si­ty — one of the tough­est nuts to crack in drug R&D his­to­ry. But we know that al­ready. What hap­pens now in R&D? The com­pa­ny has some am­bi­tious plans for build­ing the pipeline, and a clear strat­e­gy for where it wants to head. And there are even more plans for semaglu­tide in R&D.

Su­san Gal­braith

Su­san Gal­braith had a big role to fill when she took José Basel­ga’s job at As­traZeneca, fol­low­ing the top sci­en­tist’s trag­ic death. But com­ing from the trans­la­tion­al side of can­cer drug re­search, she’s top­ping a lengthy ca­reer in Big Phar­ma by fol­low­ing in­sights in­to the 2.0 gen­er­a­tion of can­cer drugs and com­bos. She has a lot to say, and I’m pay­ing close at­ten­tion. You should too.

John Tsai

— One of the key is­sues in any big de­vel­op­ment group is defin­ing risk. How do you em­brace the idea of a high-risk, high-re­ward pro­gram? For No­var­tis de­vel­op­ment chief John Tsai, that in­volves a “wild card” strat­e­gy we’ll be dis­cussing, where the phar­ma picks up a tough chal­lenge and goes in­to the clin­ic — know­ing that a win could de­liv­er a com­pa­ny-build­ing drug, but that suc­cess is far from se­cure. That’s one of sev­er­al things we’ll be talk­ing about No­var­tis’ de­vel­op­ment strat­e­gy.

Jean-François Tou­s­saint

— Then there’s mR­NA. You don’t even need to ex­plain it any­more. What start­ed out with a hand­ful of star­tups a decade ago has be­come the New, New Thing in bio­phar­ma now that the tech has de­liv­ered the top 2 vac­cines be­ing used to fight a pan­dem­ic. Of course, there’s a lot — and I mean a lot — that still has to be done to prove the full po­ten­tial. And there are def­i­nite­ly no guar­an­tees. I’ll be talk­ing with Jean-François Tou­s­saint, the head of glob­al R&D at Sanofi Pas­teur, which is in­vest­ing heav­i­ly in the field, and Sean Marett, a top ex­ec at BioN­Tech.

Sean Marett

One of the most in­ter­est­ing star­tups in the in­dus­try has been Centes­sa, as­sem­bled by the start­up crew at Medicxi. David Grainger played a big role in that com­pa­ny, and now he’s tak­en on the task of chief deal­mak­er as they con­tin­ue to build up the pipeline. Grainger and End­points News pub­lish­er Ar­salan Arif will be ex­plor­ing that in a one-on-one ses­sion.

David Grainger

And fi­nal­ly, my co-host for this year’s event, Sil­i­con Val­ley Bank’s Nooman Haque, will be wrap­ping up with an­oth­er look at the Eu­ro­pean biotech fi­nance land­scape with 3 top play­ers: Alex Pas­teur at F-Prime, Juli­ette Au­det from For­bion and Thomas Burt at Sofinno­va. These have been boom times in the glob­al biotech busi­ness — how is that play­ing out in Eu­rope?

It’s a packed pro­gram. If you’re in­to R&D strat­e­gy, or you’re grow­ing your own com­pa­ny, I hope you’ll join us on Oct. 12. You can look over the sched­ule and sign up here — at no cost — by hit­ting the link.

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.

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.

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.

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.

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.

Christophe Weber, Takeda CEO (Photographer: Shoko Takayasu/Bloomberg via Getty Images)

Take­da fo­cus­es on ‘di­verse’ pipeline prospects on heels of two ac­qui­si­tions

After a whopping $4 billion asset buy from Nimbus Therapeutics, along with a $400 million deal with Hutchmed for a colorectal cancer drug, Takeda executives touted pipeline optimism on its latest earnings call this week.

That’s because the TYK2 inhibitor for psoriasis Takeda is getting from Nimbus, along with the Hutchmed fruquintinib commercialization outside of China, are just two of what it reports are 10 late-stage development programs of promising candidates.

Regeneron CSO George Yancopoulos (L) and CEO Len Schleifer at a groundbreaking for its new Tarrytown, NY facility, June 2022 (Lev Radin/Pacific Press/LightRocket via Getty Images)

In show­down with Roche, Re­gen­eron gears up for po­ten­tial Eylea ex­pan­sion amid Covid de­cline

Regeneron faced a substantial slump in overall revenue last year, but the focus still remains on some of its biggest blockbusters.

The pharma with several high-profile partnerships — Sanofi and Bayer among them — said Friday that Q4 revenue was down 31% for the quarter, and down 24% for the entire year. However, that won’t stop blockbuster expansion plans.

One of those is Eylea, the Bayer-partnered eye disease drug that has been in major competition with Roche’s Vabysmo. While Eylea is currently only approved in a 2 mg dose, the company recently filed for approval to give a 8 mg dose, in hopes of making a longer-lasting treatment.