Andrey Tolmachov, Enamine CEO

In pas­sion­ate ap­peal, Enam­ine CEO asks for phar­ma in­dus­try's help to iso­late Rus­sia and slow in­va­sion

As Rus­sia’s in­va­sion of Ukraine con­tin­ues, the CEO of a Ukrain­ian com­pa­ny re­spon­si­ble for sup­ply­ing much of the phar­ma world with chem­i­cal build­ing blocks is ask­ing the in­dus­try for help.

In a di­rect call to ac­tion, Enam­ine CEO An­drey Tol­ma­chov re­leased a let­ter Sat­ur­day de­cry­ing Rus­sia’s war and re­quest­ing help from phar­ma com­pa­nies big and small. Tol­ma­chov not­ed Enam­ine and Ukraine have re­ceived lots of sup­port thus far, but ar­gues it hasn’t been enough yet: He di­rect­ly called on com­pa­nies to pres­sure gov­ern­ments and NA­TO to es­tab­lish a no-fly zone over Ukraine and con­tin­ue iso­lat­ing Rus­sia eco­nom­i­cal­ly.

“All the re­la­tion­ships, projects, col­lab­o­ra­tions with Russ­ian com­pa­nies/in­sti­tu­tions/uni­ver­si­ties must be put on hold un­til the end of the war,” Tol­ma­chov wrote in part. “The soon­er this coun­try is to­tal­ly iso­lat­ed, the soon­er the war will end.”

The let­ter comes as Ukraine’s re­sis­tance to the Russ­ian in­va­sion proved stronger than many ex­pect­ed, re­port­ed­ly slow­ing down sol­diers and tanks through — among oth­er things — the re­moval of road signs.

But over the last few days, Rus­sia has es­ca­lat­ed its at­tacks on Ukraine, launch­ing mis­siles and ar­tillery shells at a Holo­caust memo­r­i­al site and nu­clear pow­er plant. At­tacks on civil­ian ar­eas have al­so in­creased, with Ukraine al­leg­ing Moscow fired up­on a “hu­man­i­tar­i­an cor­ri­dor” meant to al­low non-com­bat­ants to flee the coun­try.

Though much of the world con­tin­ues to levy harsh sanc­tions on Rus­sia and its pres­i­dent, Vladimir Putin, the in­va­sion has not slowed, Tol­ma­chov wrote. He crit­i­cized the re­spons­es thus far as “paci­fi­ca­tion” and ac­cused coun­tries of im­pos­ing rel­a­tive­ly tooth­less pun­ish­ments af­ter Rus­sia il­le­gal­ly seized Crimea in 2014 and be­gan back­ing sep­a­ratists in east­ern Ukraine.

“Now af­ter the in­va­sion, we see how the whole world is unit­ed and en­gaged in the tough sanc­tions, but they are too late to stop the ag­gres­sion,” Tol­ma­chov wrote. “We are glad to re­ceive the fi­nan­cial sup­port, weapons, med­i­cines, but, it is not enough. West­ern coun­tries are afraid of di­rect con­flict with Rus­sia or at least to close the sky for Russ­ian planes and mis­siles.”

Tol­ma­chov, a for­mer uni­ver­si­ty pro­fes­sor, found­ed Enam­ine in 1991 af­ter the col­lapse of the So­vi­et Union, aim­ing to cap­i­tal­ize on sell­ing com­pounds syn­the­sized in the USSR to the US and Eu­ro­pean coun­tries. Since then, Enam­ine and a hand­ful of small­er Ukrain­ian play­ers have de­vel­oped ex­ten­sive re­la­tion­ships with the phar­ma in­dus­try, to the point where the war has put hun­dreds of clin­i­cal tri­als and ear­ly stage R&D projects at risk.

In the big pic­ture, such dis­rup­tions are rel­a­tive­ly small com­pared to the loss of hu­man life and pos­si­ble war crimes. But Tol­ma­chov’s call to ac­tion em­pha­sized the point that every­one needs to play their part, ar­gu­ing Rus­sia will not be sat­is­fied with on­ly Ukraine.

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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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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Vi­a­tris with­draws ac­cel­er­at­ed ap­proval for top­i­cal an­timi­cro­bial 24 years lat­er

After 24 years without confirming clinical benefit, the FDA announced Tuesday morning that Viatris (formed via Mylan and Pfizer’s Upjohn) has decided to withdraw a topical antimicrobial agent, Sulfamylon (mafenide acetate), after the company said conducting a confirmatory study was not feasible.

Sulfamylon first won FDA’s accelerated nod in 1998 as a topical burn treatment, with the FDA noting that last December, Mylan told the agency that it wasn’t running the trial.

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Tim Walbert, Horizon Therapeutics CEO (via YouTube)

Hori­zon Ther­a­peu­tics in takeover talks with Am­gen, J&J, Sanofi as po­ten­tial buy­ers

Amgen, J&J’s Janssen and Sanofi are all in talks to acquire Horizon Therapeutics, the rare disease biotech disclosed late Tuesday.

Horizon confirmed “highly preliminary discussions” with those companies regarding a potential buyout offer after the Wall Street Journal reported takeover interest.

Although the company — which commands a market cap of close to $18 billion — emphasized that “there can be no certainty that any offer will be made for the Company,” shares $HZNP still surged 31% in after-hours trading to near $103, bringing it to the point where it started the year.

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Sana, Codex­is lay off staff, reshuf­fle pipeline in bid to fo­cus cell ther­a­py, en­zyme en­gi­neer­ing work

As its market cap shrinks to a fraction of its heyday, flashy cell therapy startup Sana Biotechnology is laying off 15% of its staffers in a move to rejig the pipeline and restructure the company.

Sana is among a growing group of biotechs that, feeling the weight of a broader market downturn and seeing their shares tumble steadily, are tightening the purse strings and adjusting their focus. Also on Tuesday, Codexis, an enzyme engineering company based in California and now helmed by former Sierra Oncology CEO Stephen Dilly, announced it will reduce the workforce by 18%.

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Susan Galbraith, AstraZeneca EVP, oncology R&D, at EUBIO22 (Rachel Kiki for Endpoints News)

Up­dat­ed: As­traZeneca jumps deep­er in­to cell ther­a­py 2.0 space with $320M biotech M&A

Right from the start, the execs at Neogene had some lofty goals in mind when they decided to try their hand at a cell therapy that could tackle solid tumors.

Its founders have helped hone a new approach that would pack in multiple neoantigen targets to create a personalized TCR treatment that would not just make the leap from blood to solid tumors, but do it with durability. And they managed to make their way rapidly to the clinic, unveiling their first Phase I program for advanced tumors just last May.

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Mar­ket­ingRx roundup: Pfiz­er, BioN­Tech re-up iHeartRa­dio hol­i­day spon­sor­ship; WHO re­names mon­key­pox to 'm­pox'

It’s that time of year again for pop music fans with the return of the iHeartRadio Jingle Ball tour — and Pfizer and BioNTech’s sponsorship. For the second year, the Covid-19 vaccine collaborators are the pharma national sponsors among consumer brand partners, including ESPN, Dunkin, M&Ms, Mercedes and Pepsi.

Pfizer and BioNTech are also sponsoring the official Jingle Ball Radio streaming station on iHeart’s network, programmed with music from past and present concert performers. This year they include Lizzo, Dua Lipa, Dove Cameron and Charlie Puth. Pfizer-sponsored radio ads and online video and digital banner ads encourage listeners to get updated Covid-19 booster shots.

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Mark Schneider, Nestlé CEO (AP Images)

Nestlé re­con­sid­ers peanut al­ler­gy pro­gram two years af­ter $2.6B buy­out

It seems Nestlé is experiencing some buyer’s remorse two years after throwing down $2.6 billion for Aimmune Therapeutics and its peanut allergy pill Palforzia.

CEO Mark Schneider announced on Tuesday that Nestlé is “exploring strategic options” for Palforzia following lower-than-expected demand. A company spokesperson declined to confirm whether a potential sale is in consideration.

“The review is expected to be completed in the first half of 2023. Going forward, Nestlé Health Science will sharpen its focus on Consumer Care and Medical Nutrition,” the company said in a news release.

Jeb Keiper, Nimbus Therapeutics CEO

PhI­Ib win puts Nim­bus one step clos­er to chal­leng­ing Bris­tol My­ers in TYK2

Bristol Myers Squibb might be the first to clinch an FDA approval for a TYK2 inhibitor, but Nimbus Therapeutics is out to prove that it has the best drug in the class. The biotech says it now has positive mid-stage data to back up those claims — although it’s saving the hard numbers for now.

Topline results from a Phase IIb study involving 259 patients with moderate-to-severe plaque psoriasis showed that Nimbus’ drug, NDI-034858, hit the primary endpoint of helping more patients achieve PASI-75 than placebo at 12 weeks.