Ron Cooper, Albireo CEO

Liv­er-fo­cused start­up nabs $115M in ex­change for rare dis­ease drug roy­al­ties

A Boston biotech fo­cused on liv­er dis­ease raised some quick cash last week, sell­ing roy­al­ty rights to its sole FDA-ap­proved drug.

Al­bireo Phar­ma sold the roy­al­ties to Cana­da-based in­vest­ment firm Sagard Hold­ings for $115 mil­lion, nab­bing the funds in ex­change for fu­ture sales of Byl­vay, ap­proved last year to treat pru­ri­tus in all sub­types of pro­gres­sive fa­mil­ial in­tra­hep­at­ic cholesta­sis (PF­IC). The mon­ey will help the biotech ex­tend its run­way ahead of a 2024 Phase III read­out in bil­iary atre­sia, CEO Ron Coop­er said in a state­ment.

In­vestors ap­peared mild­ly pleased with the de­ci­sion, as Al­bireo shares $AL­BO closed up about 11% on Thurs­day.

As out­lined in an SEC fil­ing, Al­bireo will get the $115 mil­lion in ex­change for tiered roy­al­ties. For the first $250 mil­lion in rev­enue, Sagard will net 12.5% of sales. For the next $100 mil­lion (the rev­enue be­tween $250 mil­lion and $350 mil­lion), the rate will be 5%. Roy­al­ties for the dol­lars earned above $350 mil­lion will al­so be 5%, un­less Byl­vay is ap­proved for bil­iary atre­sia, when it will fall to 1%.

The full amount of roy­al­ty pay­ments will be capped at $184 mil­lion, but can be in­creased to $230 mil­lion if Sagard doesn’t reach the first thresh­old by the end of 2028. And if the pay­ments to Sagard don’t reach the sec­ond thresh­old by the end of 2036, Al­bireo has agreed to make up the dif­fer­ence.

Al­bireo is at­tempt­ing to build Byl­vay in­to a “bil­lion-dol­lar prod­uct,” Coop­er said, af­ter the biotech fol­lowed the suit of oth­er liv­er play­ers and failed in NASH. Re­searchers had been eval­u­at­ing an­oth­er of its pipeline can­di­dates for the fat­ty liv­er dis­ease, but a Phase II flop in 2020 forced the com­pa­ny to call it quits.

But a year lat­er, Al­bireo se­cured Byl­vay’s first ap­proval with a wide la­bel, lead­ing an­a­lysts to project ex­cit­ing things. Peak sales fig­ures ranged from $162 mil­lion to $762 mil­lion in PF­IC, a rare pe­di­atric dis­ease where Byl­vay’s OK al­so won a pri­or­i­ty re­view vouch­er. Al­bireo is work­ing on ex­pand­ing Byl­vay’s la­bel in­to at least three oth­er liv­er dis­eases.

Sagard, mean­while, is mak­ing an­oth­er move af­ter launch­ing a $725 mil­lion roy­al­ty-buy­ing fund in Feb­ru­ary 2021. The firm is one of a hand­ful of VCs at­tempt­ing to fol­low in Pablo Legor­re­ta and Roy­al­ty Phar­ma’s suc­cess­es, af­ter Black­stone dropped $2 bil­lion for Al­ny­lam stock and its in­clisir­an roy­al­ties, and Health­care Roy­al­ty Part­ners and Or­biMed each raised their own $1 bil­lion-plus funds.

Last Oc­to­ber, Sagard had plunked down $250 mil­lion to buy out Anap­tys­Bio’s roy­al­ties for GSK’s PD-1 drug, Jem­per­li.

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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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 Centre” 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.

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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