Christine Roth, Bayer global oncology head

'Pluck­ing our way up that list': Bay­er high­lights on­col­o­gy am­bi­tions in new Kendall Square labs

It’s been just a few months since Bay­er opened its new $140 mil­lion on­col­o­gy re­search and in­no­va­tion cen­ter in Cam­bridge, MA, just down the road from its old Kendall Square digs. Now it’s all hands on deck to beef up the pipeline — and that means deals are com­ing, ac­cord­ing to glob­al on­col­o­gy head Chris­tine Roth.

Though the phar­ma gi­ant is still hold­ing its cards close to the vest, Roth told End­points News on Wednes­day that she’s most in­ter­est­ed right now “in that Phase I-plus space.”

“Mid-stage de­vel­op­ment, things where Bay­er can ei­ther pro­vide ex­per­tise and de­vel­op­ment, so our ex­per­tise in chem­istry, small mol­e­cule man­u­fac­tur­ing, or places where we al­ready have es­tab­lished in­fra­struc­ture, boots on the ground in a giv­en coun­try,” she said in an in­ter­view at Bay­er’s US Sci­ence & In­no­va­tion Fo­rum at the new lo­ca­tion.

It’s all part of Bay­er’s strat­e­gy to be­come a top 10 on­col­o­gy play­er by 2030, start­ing in prostate can­cer and the com­pa­ny’s re­cent­ly ap­proved Nube­qa and ear­li­er treat­ment Xofi­go. Nube­qa was first ap­proved in 2019 for men with non-metasta­t­ic cas­tra­tion-re­sis­tant prostate can­cer, but swung an ad­di­tion­al in­di­ca­tion in com­bi­na­tion with do­c­etax­el last month.

Bay­er faces a suite of ri­vals in the prostate can­cer space, in­clud­ing Pfiz­er and Astel­las’ Xtan­di and John­son & John­son’s Er­lea­da. De­spite on­ly rak­ing in $239 mil­lion in 2021, Bay­er raised its peak sales fore­casts for Nube­qa in Feb­ru­ary from €1 bil­lion to €3.4 bil­lion. The com­pa­ny has since plucked two on­col­o­gy heads from ri­val GSK — Roth and Tara Fren­kl, the new head of on­col­o­gy de­vel­op­ment.

The path ahead lies in com­bi­na­tions, Roth said, while al­so tout­ing the com­pa­ny’s new state-of-the-art pre­ci­sion med­ical on­col­o­gy labs in Kendall Square.

The sun­ny lab spaces with stun­ning views of the Charles Riv­er — in­clud­ing space for cell and tis­sue ex­per­i­ments and chem­istry pro­teomics labs — oc­cu­py the top floor of Bay­er’s new of­fices, which al­so house Bay­er’s busi­ness de­vel­op­ment and li­cens­ing units. She called Vi­t­rakvi, ap­proved in 2018 for TRK fu­sion can­cers, “our very first suc­cess sto­ry” in pre­ci­sion on­col­o­gy.

“I grew up in IO. I think if we can be­come the Keytru­da back­bone ther­a­py, the one that any prostate can­cer in­ves­ti­ga­tor will want to have as their com­bi­na­tion part­ner, that will al­so fur­ther dif­fer­en­ti­ate Nube­qa in the fu­ture,” Roth said. “In five years, I’d like to see us have the mar­ket lead­ing po­si­tion in prostate can­cer through mul­ti­ple as­sets there and the com­bi­na­tions.”

The on­col­o­gy head wouldn’t di­vulge much about the com­pa­ny’s BD strat­e­gy. How­ev­er, she did say that “it’s very easy for us to look at small­er deals that are ei­ther ad­ja­cen­cies to where we are to­day, or add-ons to the com­mer­cial foot­print that we have around the world.”

That doesn’t mean big deals are out of the pic­ture. “We have a very clear idea of what a very ex­pen­sive mid-stage ac­qui­si­tion would have to look like for us to do it,” she added.

The com­pa­ny’s new lab space puts it close to Blue­Rock, AskBio and Vi­vid­ion, all com­pa­nies Bay­er ac­quired and has said it will work with at the Kendall Square fa­cil­i­ty. It’s al­so home to ven­ture cap­i­tal arm Leaps by Bay­er, which just yes­ter­day an­nounced the launch of Cap­stan Ther­a­peu­tics, put to­geth­er by a who’s who group of cell ther­a­py sci­en­tists, in­clud­ing for­mer Sil­ver­back CEO Lau­ra Shawver, cell en­gi­neer­ing ex­perts Carl June and Bruce Levine, among oth­ers.

Leaps head Juerg Eck­hardt told End­points that the ven­ture arm will make a to­tal of 10 in­vest­ments this year, and will make progress in Asia in the com­ing years, where “we be­lieve there are op­por­tu­ni­ties there that we don’t want to miss.”

“Whether we ac­quire the sci­ence or not, it just starts your mind think­ing in new di­rec­tions,” Roth said of Leaps in­vest­ments.

As for Bay­er, Roth added that the com­pa­ny is go­ing to keep “pluck­ing our way up that list.” The com­pa­ny is cur­rent­ly among the top 20 on­col­o­gy play­ers. “In five years, I think we could prob­a­bly make it to 13,” she added.

Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls



Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

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Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Ei­sai’s ex­pand­ed Alzheimer’s da­ta leave open ques­tions about safe­ty and clin­i­cal ben­e­fit

Researchers still have key questions about Eisai’s investigational Alzheimer’s drug lecanemab following the publication of more Phase III data in the New England Journal of Medicine Tuesday night.

In the paper, which was released in conjunction with presentations at an Alzheimer’s conference, trial investigators write that a definition of clinical meaningfulness “has not been established.” And the relative lack of new information, following topline data unveiled in September, left experts asking for more — setting up a potential showdown to precisely define how big a difference the drug makes in patients’ lives.

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Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

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Roche HQ in Basel, Switzerland. (Image credit: Kyle LaHucik/Endpoints News)

As com­peti­tors near FDA goal­post, Roche spells out its re­peat Alzheimer's set­back

Before Roche can turn all eyes on a new version of its more-than-once-failed Alzheimer’s drug gantenerumab, the Big Pharma had to flesh out data on the November topline failure at an annual conference buzzier than in years past thanks to hotly watched rivals in the field: Eisai and Biogen’s lecanemab, and Eli Lilly’s donanemab.

There was less than a 10% difference between Roche’s drug and placebo at slowing cognitive decline across two Phase III trials, which combined enrolled nearly 2,000 Alzheimer’s patients. In its presentation at the conference Wednesday, Roche said it saw less sweeping away of toxic proteins than it had anticipated. For years, researchers and investors have put their resources behind the idea that more amyloid removal would equate to reduced cognitive decline.

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Lynn Baxter, Viiv Healthcare's head of North America

Vi­iV dri­ves new cor­po­rate coali­tion in­clud­ing Uber, Tin­der and Wal­mart, aimed at end­ing HIV

ViiV Healthcare is pulling together an eclectic coalition of consumer businesses in a new White House-endorsed effort to end HIV by the end of the decade.

The new US Business Action to End HIV includes pharma and health companies — Gilead Sciences, CVS Health and Walgreens — but extends to a wide range of consumer companies that includes Tinder, Uber and Walmart.

ViiV is the catalyst for the group, plunking down more than half a million dollars in seed money and taking on ringmaster duties for launch today on World AIDS Day, but co-creator Health Action Alliance will organize joint activities going forward. ViiV and the alliance want and expect more companies to not only join the effort, but also pitch in funding.

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Matt Gline, Roivant Sciences CEO (Photo by John Sciulli/Getty Images for GLG)

Pfiz­er and Roivant team up again for an­oth­er 'Van­t', set­ting up an­ti-in­flam­ma­to­ry show­down with Prometheus

Pfizer and Roivant are teaming up to launch a new ‘Vant’ aimed at bringing a mid-stage anti-inflammatory drug to market, the pair announced Thursday.

There’s no name for the startup yet, nor are there any employees. Thus far, the new company and Roivant can be considered “one and the same,” Roivant CEO Matt Gline tells Endpoints News. But Pfizer is so enthusiastic about the target that it elected to keep 25% of equity in the drug rather than take upfront cash from Roivant, Gline said.

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SQZ Biotech slash­es head­count by 60% as founder/CEO hits ex­it — while Syn­log­ic lays off 25%

It’s a tough time for early-stage companies developing highly promising, but largely unproven, new technologies.

Just ask SQZ Biotechnologies and Synlogic. The former is bidding farewell to its founder and CEO and slashing the headcount by 60% as it pivots from its original cell therapy platform to a next-gen approach; the latter — a synthetic biology play founded by MIT’s Jim Collins and Tim Lu — is similarly “optimizing” the company to focus on lead programs. The resulting realignment means 25% of the staffers will be laid off.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

Twit­ter dis­ar­ray con­tin­ues as phar­ma ad­ver­tis­ers ex­tend paus­es and look around for op­tions, but keep tweet­ing

Pharma advertisers on Twitter are done — at least for now. Ad spending among the previous top spenders flattened even further last week, according to the latest data from ad tracker Pathmatics, amid ongoing turmoil after billionaire boss Elon Musk’s takeover now one month ago.

Among 18 top advertisers tracked for Endpoints News, only two are spending: GSK and Bayer. GSK spending for the full week through Sunday was minimal at just under $1,900. Meanwhile, German drugmaker Bayer remains the industry outlier upping its spending to $499,000 last week from $480,000 the previous week. Bayer’s spending also marks a big increase from a month ago and before the Musk takeover, when it spent $16,000 per week.

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