Boehringer In­gel­heim boosts R&D com­mit­ment, promis­es up to 15 new prod­uct launch­es by 2025

Com­ing off a strong year of growth for its Eli Lil­ly-part­nered SGLT2 in­hibitor Jar­diance, Boehringer In­gel­heim is putting those gains right back in­to R&D — and set­ting some lofty goals for the next few years.

The Ger­man com­pa­ny spent near­ly $4.5 bil­lion (20% of net sales) on R&D last year, putting it just be­hind some of the phar­ma in­dus­try’s top spenders. And over the next five years, it plans on sink­ing more than $27 bil­lion in­to drug de­vel­op­ment.

By 2025, Boehringer hopes to have as many as 15 new prod­ucts on the mar­ket.

Michael Schmelmer

“All our busi­ness­es con­tributed to the sol­id fi­nan­cial re­sults in 2021, a strong achieve­ment, es­pe­cial­ly when con­sid­er­ing the over­all pan­dem­ic and eco­nom­ic sit­u­a­tion,” Michael Schmelmer, a mem­ber of the board of man­ag­ing di­rec­tors re­spon­si­ble for fi­nance, said in a news re­lease. “As a re­sult, we can con­tin­ue mak­ing sig­nif­i­cant in­vest­ments and have strength­ened our over­all fi­nan­cial ba­sis — and thus our in­de­pen­dence.”

The news comes just a month af­ter Boehringer and Lil­ly snagged a new ap­proval for Jar­diance to re­duce the risk of car­dio­vas­cu­lar death and hos­pi­tal­iza­tion for adults with heart fail­ure, re­gard­less of ejec­tion frac­tion. Since ap­proved as a type 2 di­a­betes drug in 2014, Jar­diance has since moved in­to the heart fail­ure space, where it com­petes di­rect­ly with As­traZeneca’s Farx­i­ga. Back in Au­gust, it won an in­di­ca­tion in heart fail­ure pa­tients with re­duced ejec­tion frac­tion (HFrEF), a con­di­tion where the mus­cle of the left ven­tri­cle doesn’t pump nor­mal­ly.

Last year, Jar­diance raked in more than $4.2 bil­lion, up 28.6% from the pre­vi­ous year.

Boehringer al­so broke $1 bil­lion in sales for its bio­phar­ma­ceu­ti­cals man­u­fac­tur­ing busi­ness, months af­ter open­ing a new plant fo­cused on large-scale cell cul­ture tech­nol­o­gy in Vi­en­na. The unit, known as Boehringer In­gel­heim BioX­cel­lence, saw a 9.5% sales in­crease from last year.

Boehringer says the near­ly $4.5 bil­lion it spent on R&D last year was the high­est in its 137-year his­to­ry. In that re­gard, it’s not far be­hind some of the top spenders in the in­dus­try, in­clud­ing Eli Lil­ly on the low­er end with $7 bil­lion last year. Roche, mean­while, spent more than $16 bil­lion.

“We present these re­sults at a time when war has been brought back to Eu­rope,” con­tin­ued board chair Hu­ber­tus von Baum­bach said in a state­ment, adding that the com­pa­ny will con­tin­ue its sup­ply of do­na­tions and med­i­cines. “Our thoughts are with all Ukraini­ans.”

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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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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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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Catal­ent to cut about 200 jobs in Mary­land and Texas

Contract manufacturing company Catalent is cutting about 200 jobs in Maryland and Texas, according to WARN notices, trimming back some of its pandemic-era expansion.

The company will cut 77 jobs by Jan. 15 of next year at a cell therapy facility in Webster, TX, just outside of Houston. In Maryland, the company is reducing staff at two locations, with 82 jobs being eliminated at Catalent’s facility in Gaithersburg, and 53 in Rockville. The layoffs go into effect at those locations on Jan. 14.

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iECURE CEO Joe Truitt and founder Jim Wilson

Jim Wil­son biotech iECURE gets fresh $65M to push pe­di­atric liv­er dis­ease gene ther­a­py in­to the clin­ic

Jim Wilson-founded biotech iECURE has wrapped a $65M Series A extension round to get its lead candidate — a gene replacement therapy for a rare inherited liver disease known as ornithine transcarbamylase deficiency, or OTC — into the clinic.

This round was co-led by Novo Holdings and LYFE Capital, followed by initial investors Versant and OrbiMed as well. In September 2021, iECURE raised a $50 million Series A led by the latter two. The new cash infusion will get iECURE through an initial in-human trial, which CEO Joe Truitt told Endpoints News iECURE hopes to read out in 2024.

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John Carroll with David Chang, Allogene CEO (Credit: Jeff Rumans Photography)

Al­lo­gene takes the stage in New York to go deep on its off-the-shelf cell ther­a­pies — de­clar­ing a first for sol­id tu­mors

NEW YORK — In most cases, a biotech like Allogene would wait until the next big science conference to offer its latest series of snapshots of its data. But most biotechs aren’t like Allogene, where the veteran leaders from Kite garnered a substantial number of kudos over the years for their in-depth reviews of the company’s progress.

So on Tuesday, the leaders at Allogene converged on Manhattan once again to give a detailed breakdown of their latest steps forward, looking to stay out front in the busy off-the-shelf cell therapy arena, keep a clean bill of health on the safety front and prove that they can not only match the autologous pioneers they helped create but make the all-important leap into solid tumors. It’s another step forward in a journey that has a long way to go before even the first big regulatory finish lines appear on the track. But for CEO David Chang, who spent some time with me running through the data ahead of the Tuesday session, it all amounts to forward momentum toward the desired goal.

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UK reg­u­la­tor warns of se­vere eye re­ac­tions fol­low­ing use of Sanofi and Re­gen­eron's Dupix­ent

The UK’s Medicines and Healthcare Regulatory Agency (MHRA) on Tuesday warned of some new and serious eye-related side effects following the use of Sanofi and Regeneron’s atopic dermatitis and asthma treatment Dupixent (dupilumab).

While Dupixent is already associated with cases of conjunctivitis and allergic conjunctivitis, dry eye and with infrequent cases of keratitis and ulcerative keratitis, the MHRA is calling on health professionals to be on the lookout for any of these eye-related side effects as “it is not currently possible to predict who may experience the rarer and most severe ocular adverse reactions, such as ulcerative keratitis.”

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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