Hubertus von Baumbach, EFPIA president (Credit: EFPIA via YouTube)

Eu­ro­pean phar­ma group wants to cre­ate PRV-like sys­tem to spur an­tibi­otics R&D

New re­search fund­ed by a Eu­ro­pean phar­ma in­dus­try group is look­ing to rein­vig­o­rate an­timi­cro­bial R&D with a sys­tem that’s sim­i­lar to the pri­or­i­ty re­view vouch­er sys­tems in the US, which spurs new re­search in rare pe­di­atric dis­eases, rare trop­i­cal dis­eases and med­ical coun­ter­mea­sures.

Nathalie Moll

As the need for nov­el an­tibi­otics is ur­gent, EF­PIA is call­ing for a Trans­fer­able Ex­clu­siv­i­ty Ex­ten­sion (TEE) vouch­er sys­tem where de­vel­op­ers of nov­el an­tibi­otics can win a vouch­er that can then be used to ex­tend the ex­clu­siv­i­ty of an­oth­er drug for a pe­ri­od of time, or sold to an­oth­er com­pa­ny, there­by pay­ing for the an­tibi­ot­ic re­search.

“The sys­tem could bring two new an­tibi­otics a year to pa­tients over the next decade, pre­vent­ing some of the 400,000 deaths as­so­ci­at­ed with AMR every year in the EU,” EF­PIA claims.

But the re­search notes that the in­creased ex­clu­siv­i­ty will come at a cost as gener­ics won’t come to mar­ket as quick­ly. France, Ger­many and Italy could end up los­ing more than $100 mil­lion per year for each new an­tibi­ot­ic due to the ex­clu­siv­i­ty ex­ten­sion, but the re­port says, “It is clear from our case stud­ies that the ben­e­fits out­weigh the costs for all the coun­tries and case study ex­am­ples.”

EF­PIA Di­rec­tor Gen­er­al Nathalie Moll added:

Nu­mer­ous ideas to stim­u­late new re­search have been pro­posed across the pub­lic and pri­vate sec­tors, and this re­search leaves lit­tle doubt that TEE is the best so­lu­tion for Eu­rope. Not on­ly can TEE de­liv­er new an­tibi­otics it will bring sig­nif­i­cant eco­nom­ic ben­e­fits to each Mem­ber State.

The re­port al­so stress­es the need to in­vest in main­tain­ing Eu­rope’s ar­se­nal of ef­fec­tive an­timi­cro­bials.

“TEE has the ad­van­tage of pro­vid­ing a suf­fi­cient­ly pow­er­ful in­cen­tive to stim­u­late de­vel­op­ment of new an­timi­cro­bials that is fea­si­ble and rel­a­tive­ly straight­for­ward to im­ple­ment at the joint EU lev­el, with min­i­mal up-front ad­min­is­tra­tive costs to the Eu­ro­pean Med­i­cines Agency (EMA) and a cost that is spread across all Eu­ro­pean” mem­ber states, the re­port adds.

Paul Hudson, Sanofi CEO (Romuald Meigneux/Sipa via AP Images)

Sanofi and DN­Di aim to elim­i­nate sleep­ing sick­ness in Africa with promis­ing Ph II/III re­sults for new drug

The Drugs for Neglected Diseases initiative (DNDi) and Sanofi today said that their potential sleeping sickness treatment saw success rates of up to 95% from a Phase II/III study investigating the safety and efficacy of single-dose acoziborole.

The potentially transformative treatment for sleeping sickness would mainly be targeted at African countries, according to data published today in The Lancet Infectious Diseases medical journal. The clinical trial was led by DNDi and its partners in the Democratic Republic of the Congo (DRC) and Guinea, with the authors noting:

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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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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Pro­tect­ing its megablock­buster, Janssen chal­lenges Am­gen's Ste­lara biosim­i­lar ahead of planned 2023 launch

Johnson & Johnson unit Janssen on Wednesday sued Amgen over the company’s proposed biosimilar to its megablockbuster Stelara (ustekinumab), after Amgen said it was ready to launch next May or as soon as the FDA signs off on it.

If Amgen carries through with that plan, Janssen told the Delaware district court that the Thousand Oaks, CA-based company will infringe on at least two Janssen patents.

Digital render of CPI's Medicines Manufacturing Innovation Centre in Glasgow, Scotland (Image:

CPI opens the doors to a new $100M+ man­u­fac­tur­ing fa­cil­i­ty in Scot­land

A manufacturing site that has received interest and investments from large pharma companies and the UK government is opening its doors in Scotland.

The manufacturer CPI (Centre for Process Innovation) has opened a new £88 million ($105 million) “Medicines Manufacturing Innovation Centre” in Glasgow, Scotland, to accelerate the development of manufacturing tech and solve longstanding challenges in medicine development and manufacturing.

Lex­i­con slams FDA over hear­ing de­nial fol­low­ing a CRL for its SGLT2 in­hibitor can­di­date

Lexicon Pharmaceutical is not giving up on its Type I diabetes candidate, despite FDA’s repeated rejections. This week the company laid out is argument again for a hearing on sotagliflozin in response to the FDA’s most recent denial.

The issue goes back to March 2019 when the FDA made very clear to Lexicon and its now departed partner Sanofi that it would not approve their application for a potential Type I diabetes drug because it does not appear to be safe.

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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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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