Mer­ck­'s wom­en's health spin­out snags mid-stage can­di­date for preterm birth; Keytru­da nails down TNBC ap­proval af­ter March CRL

Near­ly two months af­ter spin­ning out from Mer­ck, women’s health busi­ness Organon has struck its first half-bil­lion-dol­lar deal.

Organon $OGN has promised $25 mil­lion up­front and an­oth­er $475 mil­lion in biobucks for world­wide rights to ebopiprant, Ob­sE­va’s in­ves­ti­ga­tion­al treat­ment for preterm la­bor. Ebopiprant, a se­lec­tive prostaglandin F2α (PGF2α) re­cep­tor an­tag­o­nist, was orig­i­nal­ly li­censed from Mer­ck KGaA in 2015. The can­di­date works by re­duc­ing in­flam­ma­tion and uter­ine con­trac­tions.

“This de­vel­op­ment-stage as­set is be­ing stud­ied in one of the most cru­cial un­met needs for women glob­al­ly,” Organon CEO Kevin Ali said in a state­ment. There are cur­rent­ly no ap­proved drugs for the acute treat­ment of preterm la­bor in the US.

Back in No­vem­ber, Ob­sE­va said ebopiprant re­duced the de­liv­ery of preg­nan­cies (not in­clud­ing twin preg­nan­cies) by 55% at 48 hours when ad­min­is­tered with atosi­ban (the ex-US stan­dard of care), com­pared to atosi­ban alone. Over­all, 12.5% of women in the treat­ment arm de­liv­ered ba­bies with­in 48 hours of start­ing treat­ment, com­pared to 21.8% in the place­bo arm, Ob­sE­va said of the Phase IIa tri­al.

“The in­ci­dence of ma­ter­nal, fe­tal and neona­tal ad­verse events were com­pa­ra­ble be­tween sub­jects in the ebopiprant group and the place­bo group,” the com­pa­ny said.

Organon of­fi­cial­ly spun out from Mer­ck on June 3 with a port­fo­lio of more than 60 med­i­cines, in­clud­ing Nex­planon, its long-ac­tive re­versible con­tra­cep­tive. Nex­planon is one of the top hor­mon­al con­tra­cep­tives in the coun­try, ac­cord­ing to IQVIA da­ta, and grew at an an­nu­al com­pound growth rate of 9% be­tween 2014 and 2019. — Nicole De­Feud­is 

Keytru­da nails down TNBC ap­proval af­ter March CRL

Mer­ck’s block­buster check­point in­hibitor Keytru­da has won an­oth­er FDA ap­proval, this time in a line of triple-neg­a­tive breast can­cer.

Reg­u­la­tors hand­ed down the green­light for the treat­ment of pa­tients with high-risk ear­ly-stage TNBC in com­bi­na­tion with chemo, as neoad­ju­vant and then con­tin­ued as a sin­gle agent as ad­ju­vant treat­ment af­ter surgery. The thumbs up marks the 30th in­di­ca­tion for which the Keytru­da is ap­proved in the US, Mer­ck said.

Ad­di­tion­al­ly, the FDA con­vert­ed the Keytru­da-chemo com­bo ac­cel­er­at­ed ap­proval in lo­cal­ly re­cur­rent un­re­sectable or metasta­t­ic TNBC for tu­mors ex­press­ing PD-L1 to full ap­proval.

The TNBC ap­proval comes af­ter the FDA hand­ed Mer­ck a rare CRL for Keytru­da back in March, af­ter an ad­comm unan­i­mous­ly vot­ed to rec­om­mend wait­ing for more da­ta for the study in ques­tion. Ad­vis­ers and reg­u­la­tors point­ed to­ward con­cerns over the tri­al’s event-free sur­vival pri­ma­ry end­point over place­bo, say­ing re­searchers hadn’t watched pa­tients long enough af­ter treat­ment to de­ter­mine EFS and OS.

But a few weeks lat­er, Mer­ck claimed a win in the study af­ter claim­ing it reached the in­ter­im analy­sis check­point. The tri­al, known as KEYNOTE-522, met its dual pri­ma­ry end­points of event-free sur­vival and patho­log­i­cal com­plete re­sponse. — Max Gel­man

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.

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.

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.