Mer­ck spin­out grabs some as­sets and launch­es a quest for the Holy Grail in an­tibi­otics R&D

Ter­ry Roe­mer

Ter­ry Roe­mer did a lot more than clean out his desk when he de­cid­ed to leave Mer­ck af­ter a 13-year ca­reer de­vel­op­ing an­ti­bod­ies at the phar­ma gi­ant. With R&D chief Roger Perl­mut­ter’s bless­ings, he al­so gath­ered some pre­clin­i­cal pro­grams to take with him that now form the pipeline at his new, up­start biotech based in Union, New Jer­sey. And he’s work­ing with a small team of ex-Mer­ck sci­en­tists ready to get things mov­ing to­ward the clin­ic.

Like the rest of the big phar­mas, Mer­ck has more R&D pro­grams than it can con­sume. And it had al­ready demon­strat­ed a lim­it­ed ap­petite for an­tibi­otics re­search af­ter bag­ging Cu­bist three years ago for $9.5 bil­lion, shut­ter­ing the ear­ly-stage work right af­ter the deal went through. So a spin­out — with a promised pay­back from mile­stones and roy­al­ties — makes good sense here for ac­cel­er­at­ing the de­vel­op­ment side of things.

Roe­mer’s new com­pa­ny is Prokary­otics, which has tak­en up res­i­dence at a New Jer­sey in­cu­ba­tor where he and his sci­en­tif­ic col­leagues have be­gun the busi­ness of de­vel­op­ing some lead as­sets that they be­lieve are the es­sen­tial in­gre­di­ents to an en­tire­ly nov­el an­tibi­ot­ic class that can con­quer the drug re­sis­tance that fre­quent­ly thwarts ex­ist­ing prod­ucts.

“To be hon­est,” Roe­mer tells me, “we have a ways to go. The pro­grams we in-li­censed are up to lead op­ti­miza­tion. De­pend­ing on the pro­gram, we have mul­ti­ple years ahead of us to get in­to the clin­ic. But I’m not too con­cerned about that.”

What he is con­cerned about: Com­ing up “with the next new an­tibi­otics class; a first-in-class agent. It’s a tremen­dous chal­lenge, there’s a lot in­volved.”

Roe­mer and his col­leagues at Mer­ck caused a stir in re­search cir­cles in the spring of 2016 with their pre­clin­i­cal work on a new ap­proach to de­feat­ing dead­ly, drug-hes­i­tant MR­SA. They iden­ti­fied small mol­e­cules — tarocins — that threw a mon­key wrench in­to the con­struc­tion of MR­SA cell walls, mak­ing them vul­ner­a­ble to the usu­al run of be­ta-lac­tam an­tibi­otics now in use. But Roe­mer stressed the team has broad am­bi­tions to go far be­yond the con­fines of tarocins and de­vel­op com­plete­ly new gram neg­a­tive pro­grams for the next gen­er­a­tion of be­ta-lac­tams.

Kei­th Bos­t­ian

Kei­th Bos­t­ian, an ex­pe­ri­enced biotech vet who set up the in­cu­ba­tor where Prokary­otics is based, is tak­ing the CEO spot in the com­pa­ny. He says that the plan now is to get start­ed with some non-di­lu­tive fund­ing, look­ing to a va­ri­ety of sources like BAR­DA and the Well­come Trust ea­ger to ex­tend sup­port to vet­er­an teams out to de­vel­op some break­through an­tibi­otics. Lat­er, he says, they can get in­volved in some more tra­di­tion­al fundrais­ing and al­liances.

Pub­lic health of­fi­cials have been rais­ing the alarm for years that drug-re­sis­tant su­per­bugs threat­en more and more peo­ple each year around the globe, but de­spite a num­ber of reg­u­la­to­ry in­cen­tives, much of the ear­ly-stage work re­mains in the hands of biotechs. R&D is chal­leng­ing in this field, it’s ex­pen­sive, and the mar­ket can still re­ly on some stan­dard reme­dies — in­clud­ing some in­cred­i­bly cheap ones — for most cas­es.

But as Prokary­otics con­tin­ues its work, Roe­mer and his team be­lieve that the de­mand for new an­tibi­otics can on­ly grow, putting him on the right course for right now.

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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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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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.

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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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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.

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.