Werner Lanthaler, Evotec CEO

Boehringer In­gel­heim, Evotec band with di­ag­nos­tics play­er to tack­le 'su­per­bugs' through joint ven­ture

Hav­ing of­fered fi­nan­cial sup­port to com­pa­nies de­vel­op­ing an­tibi­otics and fight­ing an­timi­cro­bial re­sis­tance, Boehringer In­gel­heim is launch­ing its own.

The Ger­man phar­ma is team­ing up with Evotec — the drug dis­cov­ery and de­vel­op­ment play­er with whom it al­ready has a long-run­ning R&D al­liance in oth­er ar­eas — and French di­ag­nos­tic com­pa­ny bio­Mérieux to start a joint ven­ture that will cre­ate both next-gen an­timi­cro­bials and di­ag­nos­tics to tack­le in­fec­tious dis­eases.

Au­robac, as the joint ven­ture will be known, wants to shift from what it calls broad spec­trum and un­fo­cused med­i­cines to a pre­ci­sion ap­proach pow­ered by tar­get­ed modal­i­ties. Un­der this par­a­digm, clin­i­cians could al­so make use of di­ag­nos­tics to “quick­ly iden­ti­fy pathogens and their re­sis­tance pat­terns,” al­low­ing them to make de­ci­sions ac­cord­ing­ly.

Armed with €40 mil­lion (close to $41 mil­lion) in ini­tial fund­ing, Au­robac will be head­quar­tered in Ly­on, France.

Glob­al pub­lic health ad­vo­cates have long warned about the loom­ing threat of “su­per­bugs” that are re­sis­tant to all avail­able an­tibi­otics, which can cre­ate a dire world where even rou­tine sur­gi­cal pro­ce­dures could be life-threat­en­ing. Per an es­ti­mate, an­timi­cro­bial re­sis­tance could ac­count for as many as 10 mil­lion deaths per year by 2050, “mak­ing it po­ten­tial­ly dead­lier than can­cer,” said Michel Pairet, head of Boehringer In­gel­heim’s in­no­va­tion unit.

At the urg­ing of the WHO, a hand­ful of heavy­weight phar­ma play­ers in­clud­ing Pfiz­er, Eli Lil­ly, Mer­ck, John­son & John­son, Boehringer and GSK pooled to­geth­er the AMR Ac­tion Fund. Boehringer in­vest­ed €50 mil­lion in the fund and its cor­po­rate ven­ture arm has com­mit­ted to pour up to €12 mil­lion in­to AMR in­fec­tion com­pa­nies.

“The grim prospect of a post-an­tibi­ot­ic era has many caus­es but on­ly one so­lu­tion: The de­vel­op­ment of new, tar­get­ed, and ef­fec­tive an­timi­cro­bial ther­a­pies,” Evotec CEO Wern­er Lan­thaler said in a state­ment.

As the lead in­vestor, Boehringer is con­tribut­ing €30 mil­lion while Evotec and bio­Mérieux adds €5 mil­lion each.

Evotec brings re­search ex­per­tise with more than 200 sci­en­tists on the an­tibac­te­r­i­al R&D team, while bio­Mérieux will spear­head the de­vel­op­ment and com­mer­cial­iza­tion of di­ag­nos­tics. Boehringer chimes in on drug dis­cov­ery and clin­i­cal de­vel­op­ment.

In ad­di­tion to de­vel­op­ing new treat­ments, bio­Mérieux echoed ex­perts in not­ing that an ap­pro­pri­ate use of an­tibi­otics would be cru­cial to sus­tain an­tibi­ot­ic ef­fi­ca­cy for fu­ture gen­er­a­tions.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

No­vo Nordisk re­mains un­der UK scruti­ny as MHRA con­ducts its own re­view in 'in­cred­i­bly rare' case

The UK’s Medicines and Healthcare products Regulatory Agency is now reviewing Novo Nordisk’s marketing violation that resulted in its loss of UK trade group membership last week. Novo Nordisk was suspended on Thursday from the Association of the British Pharmaceutical Industry (ABPI) for two years after an investigation by its regulatory arm found the pharma broke its conduct rules.

MHRA said on Tuesday that its review of the Prescription Medicines Code of Practice Authority (PMCPA) investigation is standard practice. An MHRA spokesperson emphasized in an email to Endpoints News that the situation with Novo Nordisk is “incredibly rare” while also noting ABPI took “swift and proportionate action.”

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Andy Plump, Takeda R&D chief (Jeff Rumans for Endpoints News)

What kind of PhI­Ib da­ta is worth $4B cash? Take­da’s Andy Plump has some thoughts on that

A few months back, when Takeda caused jaws to drop with its eye-watering $4 billion cash upfront for a mid-stage TYK2 drug from Nimbus, it had already taken a deep dive on the solid Phase IIb data Nimbus had assembled from its dose-ranging study in psoriasis.

Now, it’s rolling that data out, eager to demonstrate what inspired the global biopharma to go long in a neighboring, but new, disease arena for the pipeline. And the most avid students of the numbers will likely be at Bristol Myers Squibb, who will have a multi-year head start on pioneering the TYK2 space with Sotyktu (deucravacitinib) as Takeda makes its lunge for best-in-class status.

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FTC says patent bat­tle over Parkin­son's drug could have 'sig­nif­i­cant im­pli­ca­tion­s' for pa­tients

The Federal Trade Commission has gotten involved in a patent feud over Supernus’ Parkinson’s drug Apokyn, a case the agency said may have ‘‘significant implications” for patients who rely on the drug.

Sage Chemical won the first generic approval for its Apokyn formulation (also known as apomorphine hydrochloride injection) back in 2022. The non-ergoline dopamine agonist is approved to treat Parkinson’s symptoms during “off episodes,” such as difficulty moving, tremors and intense cramping. However, regulators specified that the approval pertained to the generic drug cartridges only, not the injector pen required for administration.

Growth hor­mone from No­vo Nordisk is in short­age over man­u­fac­tur­ing de­lays

Novo Nordisk’s growth hormone Norditropin is in shortage because of manufacturing delays, according to an FDA site that tracks drug shortages as well as the American Society of Health-System Pharmacists’ shortages list.

The FDA has shortages of the drug listed for its 5, 10, 15 and 30 mg doses, while the pharmacists’ group, also known as ASHP, reported shortages of the same doses, except for the 15 mg version.

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PhRMA calls for more di­verse in­fra­struc­ture up­grades to US emer­gency tri­als frame­work

The White House’s Office of Science and Technology Policy (OSTP) last year sought to find ways to better coordinate large-scale clinical trials in the US — as the UK lead by example during the pandemic — especially for these emergency clinical trials.

The lobbying group PhRMA Tuesday called for more clinical trial diversity in underserved areas, including by making participation less of a burden, and expanding eligibility criteria when appropriate.

Francesco Marincola, newly-appointed Sonata Therapeutics CSO

Kite's head of re­search leaves for Flag­ship start­up Sonata

Another leader is departing Kite Pharma, and will to spend the “last part” of his career exploring how cancer evades the immune system.

Kite’s senior VP and global head of cell therapy research Francesco Marincola left the Gilead CAR-T unit last week for Sonata Therapeutics. Flagship last May unveiled the startup, which was pieced together from two fledgling biotechs Inzen and Cygnal Therapeutics. As CSO, Marincola will lead Sonata’s push to reprogram cancer cells to make them more immunogenic.

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FDA in­di­cates will­ing­ness to ap­prove Bio­gen ALS drug de­spite failed PhI­II study

Ahead of Wednesday’s advisory committee hearing to discuss Biogen’s ALS drug tofersen, the FDA appeared open to approving the drug, newly released briefing documents show.

Citing the need for flexibility in a devastating disease like ALS, regulators signaled a willingness to consider greenlighting tofersen based on its effect on a certain protein associated with ALS despite a failed pivotal trial. The documents come after regulatory flexibility was part of the same rationale the agency expressed when approving an ALS drug last September from Amylyx Pharmaceuticals, indicating the FDA’s openness to approving new treatments for the disease.

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President Joe Biden (AP Photo/Susan Walsh)

Biden signs law re­quir­ing more de­clas­si­fi­ca­tions on Covid-19's ori­gins

President Joe Biden yesterday signed into law a bill requiring the Office of the Director of National Intelligence to declassify information on the origins of Covid-19 within 90 days.

The new law directs the federal government to “declassify any and all information relating to potential links between the Wuhan Institute of Virology and the origin of the Coronavirus Disease 2019”, including information regarding researchers at the lab who fell ill in the fall of 2019 like names, symptoms, and job roles.