Adam Steensberg, Zealand Pharma CEO

Fol­low­ing luke­warm launch and lay­offs, Zealand Phar­ma is li­cens­ing out its di­a­betes drug to No­vo Nordisk

In March, Zealand Phar­ma gut­ted its US work­force and said it was look­ing for strate­gic part­ner­ships for its di­a­betes prod­ucts fol­low­ing a dis­ap­point­ing first year on the mar­ket for its di­a­betes treat­ment Ze­ga­logue.

On Wednes­day morn­ing, the Dan­ish biotech fol­lowed up with its plans, an­nounc­ing it is li­cens­ing Ze­ga­logue out to No­vo Nordisk in ex­change for DKK 25 mil­lion up­front (ap­prox­i­mate­ly $3.3 mil­lion USD). In ad­di­tion, Zealand can get DKK 45 mil­lion in near-term mile­stones and DKK 220 mil­lion in sales.

No­vo Nordisk will now take on the mar­ket­ing of Ze­ga­logue world­wide, adding an­oth­er drug to its wide di­a­betes port­fo­lio. But Zealand will still be in charge of cer­tain reg­u­la­to­ry and de­vel­op­ment work to get Ze­ga­logue ap­proved out­side the US.

In March of last year, Zealand won its first ap­proval for Ze­ga­logue, a glucagon ana­logue, to treat se­vere low blood sug­ar in di­a­betes pa­tients old­er than 6 years of age. How­ev­er, Ze­ga­logue fell flat in the mar­ket — and the biotech slashed sales pro­jec­tions for 2022 by more than half as a re­sult.

Hen­ri­ette Wen­nicke

In ad­di­tion to hol­low­ing out its work­force, Zealand re­vamped its lead­er­ship, re­plac­ing CEO Em­manuel Du­lac with R&D head Adam Steens­berg. It al­so hired David Kendall as CMO, and in No­vem­ber, the biotech will be get­ting a new CFO in Hen­ri­ette Wen­nicke, who ac­tu­al­ly be­gan her ca­reer at No­vo Nordisk.

In a state­ment this morn­ing, Steens­berg said, “This agree­ment is an­oth­er im­por­tant step in our strat­e­gy to es­tab­lish com­mer­cial part­ner­ships as we cre­ate and de­vel­op in­no­v­a­tive next gen­er­a­tion pep­tide ther­a­peu­tics.”

Zealand is al­so work­ing on adding to Ze­ga­logue’s in­di­ca­tions — the biotech said it’s plan­ning to sub­mit an NDA ear­ly next year on the back of a Phase III read­out of the glucagon ana­logue for con­gen­i­tal hy­per­in­sulin­ism in in­fants and young chil­dren.

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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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:

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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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.

Uğur Şahin, BioNTech CEO (ddp images/Sipa USA/Sipa via AP Images)

BioN­Tech bets on dif­fi­cult STING field via small mol­e­cule pact with a Pol­ish biotech

BioNTech is beefing up its relatively thin small molecule pipeline by adding weight to a clinically difficult corner of oncology R&D: STING agonists. To do so, BioNTech is teaming up with a 15-year-old Polish biotech and doling out €40 million, about $41.5 million, to start.

The deal is broken into two parts: First, BioNTech obtains an exclusive global license to develop and market Ryvu Therapeutics’ STING agonist portfolio as small molecules, whether alone or in combination with other agents.

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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 Center” in Glasgow, Scotland, to accelerate the development of manufacturing tech and solve longstanding challenges in medicine development and manufacturing.

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.

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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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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