Am­gen, Sanofi and Mer­ck an­nounce a string of deals at #JPM17; Mc­Do­nough out at So­bi

• Am­gen has tied the knot with Ger­many’s Im­mat­ics, pay­ing $30 mil­lion up­front and of­fer­ing hun­dreds of mil­lions more in pos­si­ble mile­stones for the de­vel­op­ment of bis­pe­cif­ic T cell-en­gag­ing ther­a­peu­tics for a range of can­cers.

• Just weeks af­ter Im­muNext signed Roche up as a part­ner, Sanofi has stepped on board to part­ner on a pre­clin­i­cal CD40L an­ti­body for au­toim­mune dis­ease that has po­ten­tial in treat­ing mul­ti­ple scle­ro­sis and lu­pus. The deal is worth a po­ten­tial $500 mil­lion, though it like­ly starts out on the small side.

• In­cyte and Mer­ck are kick­ing off a slate of new piv­otal stud­ies for their com­bi­na­tion of Keytru­da and the IDO1 in­hibitor epaca­do­stat. They are ex­pand­ing their pact to in­clude non-small cell lung can­cer, re­nal cell car­ci­no­ma, blad­der can­cer and squa­mous cell car­ci­no­ma of the head and neck.

• Swe­den’s So­bi has be­gun look­ing for a re­place­ment for CEO Ge­of­frey Mc­Do­nough, who’s plan­ning to leave the com­pa­ny this sum­mer. Mc­Do­nough has been com­mut­ing from the Boston area to Stock­holm for the job over the last few years, which ap­par­ent­ly has been wear­ing on the board’s nerves. “Giv­en the in­creas­ing de­mand and fo­cus of our busi­ness in Eu­rope, the Board has de­cid­ed that So­bi needs more con­tin­u­ous pres­ence in Stock­holm than Ge­of­frey can sus­tain giv­en his cur­rent lo­ca­tion in Boston,” says Chair­man Håkan Björk­lund.

• Biotech bad boy Mar­tin Shkre­li is back in hot wa­ter. Shkre­li was kicked off Twit­ter over the week­end af­ter stalk­ing a fe­male re­porter on­line, post­ing doc­tored im­ages pair­ing him­self with Lau­ren Duca and writ­ing mock com­men­tary about a re­la­tion­ship that doesn’t ex­ist. Duca has been an out­spo­ken crit­ic of Don­ald Trump, which ev­i­dent­ly trig­gered the Twit­ter taunts Shkre­li’s well known for. Shkre­li is slat­ed to go on tri­al on nu­mer­ous al­le­ga­tions of fraud this sum­mer.

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

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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.

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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.

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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.

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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?’”

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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.”

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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.”

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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.