So­bi signs $450M deal for rare dis­ease drug ema­palum­ab, boost­ing its in­flam­ma­tion, I/O pipeline

Swedish drug­mak­er So­bi has bought glob­al rights to a late-stage rare dis­ease drug from No­vaim­mune SA, build­ing up its in­flam­ma­tion busi­ness and po­ten­tial­ly lin­ing up a good chunk of new rev­enue should the drug get ap­proved.

So­bi paid $50 mil­lion up­front for the li­cens­ing pact, with an ad­di­tion­al $400 mil­lion over the next 8 years. In re­turn, it’s get­ting a glob­al li­cense for No­vaim­mune’s or­phan drug can­di­date ema­palum­ab, which treats a se­vere rare dis­ease called (stay with me) Haemophago­cyt­ic lym­pho­his­ti­o­cy­to­sis. HLH for short. This is a hema­to­log­ic dis­or­der more of­ten seen in chil­dren than adults. Pa­tients with HLH have over­ac­tive im­mune sys­tems, with a pro­lif­er­a­tion of lym­pho­cytes and macrophages that cause in­flam­ma­tion. In­stead of de­stroy­ing dam­aged cells in the body, the im­mune sys­tem goes af­ter the pa­tient’s own tis­sues and or­gans. HLH is clas­si­fied as one of the cy­tokine storm syn­dromes.

Gui­do Oelk­ers

A Eu­ro­pean fil­il­ng with the EMA is planned lat­er this year.

The drug might have oth­er ther­a­peu­tic val­ue, too. No­vaim­mune has stud­ies in sec­ondary HLH and haematopoi­et­ic stem cell trans­plant (HSCT) on­go­ing or planned. It’s al­so got some im­muno-on­col­o­gy ap­pli­ca­tions still be­ing test­ed out in pre­clin­i­cal tri­als.

The drug could bring in some near-term cash for the com­pa­ny, with sales po­ten­tial from 2019 on­ward, and with an es­ti­mat­ed an­nu­al 2.5 bil­lion-3.0 bil­lion Swedish Kro­na ($281 mil­lion —$337 mil­lion).

So­bi al­so said it’s signed a non-bind­ing let­ter of in­tent for a pos­si­ble ac­qui­si­tion of all ema­palum­ab as­sets, in­clud­ing the trans­fer of rel­e­vant em­ploy­ees. So­bi’s pres­i­dent and CEO Gui­do Oelk­ers had this to say in a state­ment:

We be­lieve this trans­ac­tion is an ex­cel­lent fit for So­bi and con­sis­tent with our strat­e­gy of ex­pand­ing our com­mer­cial Spe­cial­ty Care port­fo­lio, strength­en­ing our ge­o­graph­ic foot­print, par­tic­u­lar­ly in the US, and build­ing our R&D pipeline. The ad­di­tion of ema­palum­ab to So­bi’s port­fo­lio is a nat­ur­al fit that builds up­on our ex­per­tise with Kineret (anakin­ra) and fo­cus­es our busi­ness in in­flam­ma­tion, im­munol­o­gy and im­muno-on­col­o­gy. Our strate­gic goal is to build our Spe­cial­ty Care busi­ness area as a com­ple­ment to Haemophil­ia, al­low­ing So­bi to ad­vance our po­si­tion to be­come glob­al lead­ers in rare dis­eases.

The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; and more

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With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

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Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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Giovanni Caforio, Bristol Myers Squibb CEO (Nicolas Messyasz/Sipa via AP Images)

Bris­tol My­ers turns at­ten­tion to new prod­ucts in wake of Revlim­id patent loss

Bristol Myers Squibb CEO Giovanni Caforio is shifting his focus to newer products as generic sales continue to gnaw at the company’s blockbuster myeloma drug Revlimid.

Both Revlimid and Abraxane sales took a dive last year thanks to generic rivals, BMS reported in its Q4 and full-year results on Thursday. As a result, Q4 sales dipped 5% and full-year sales remained flat. However, Caforio sees a silver lining — or rather, two of them.

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Rob Davis, Merck CEO

Mer­ck’s Keytru­da nears $21B in sales, dou­bles down on com­bo tri­als

Merck’s cancer immunotherapy Keytruda notched sales of $20.9 billion in 2022, cementing its status as one of the world’s top-selling drugs. However, it’s far from resting on that accomplishment.

Merck executives touted nine ongoing trials in its annual earnings call on Thursday, including five studies in Phase III, for Keytruda (pembrolizumab) in combination with other immuno-oncology drugs. The trials include combinations with Merck’s own developments as well as other pharma companies’ candidates, including its melanoma collaboration with Moderna and its mRNA technology plus Keytruda, aimed at creating a personalized vaccine treatment to reduce the risk of cancer recurrence or death.

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Uğur Şahin, BioNTech CEO (Andreas Arnold/picture-alliance/dpa/AP Images)

BioN­Tech opens new plas­mid DNA man­u­fac­tur­ing fa­cil­i­ty in Ger­many

German mRNA player BioNTech opened the doors to a new manufacturing facility on Thursday, this one just about 75 miles north of its headquarters in Mainz, Germany.

BioNTech announced on Thursday that it has completed the construction of its first plasmid DNA manufacturing facility in Marburg, Germany. The facility will produce materials for mRNA-based vaccines and therapies along with cell therapies.

FDA ap­proves GSK's ane­mia drug with safe­ty warn­ing — af­ter bat­ting back sim­i­lar drugs

GSK has secured the first of four US approvals it’s hoping for this year, as the FDA greenlit daprodustat as a treatment for anemia due to chronic kidney disease.

But the FDA limited the use of the drug, to be marketed as Jesduvroq, to patients who have been receiving dialysis for at least four months and stopped short of approving it for patients not dependent on dialysis — in line with the recommendations of the advisory committee it consulted.

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Lars Fruergaard Jørgensen, Novo Nordisk CEO (Christopher Goodney/Bloomberg via Getty Images)

No­vo Nordisk notch­es big GLP-1 sales amid re­bound­ing sup­plies, but cau­tions on fu­ture 'pe­ri­od­ic con­straints'

With Novo Nordisk’s obesity treatment Wegovy fully back in stock in December, sales are beginning to soar, the Danish pharma reported during its annual earnings call on Wednesday. Total scripts of the glucagon-like peptide 1 (GLP-1) Wegovy topped 37,000 weekly in mid-January, a hockey stick uptick from end-of-year levels below 15,000 per week.

The new prescriptions come on top of the overall momentum of Novo obesity drug sales in 2022, although the then supply-constrained Wegovy was only part of that. Sibling obesity med Saxenda accounted for DKK 10.7 billion ($1.58 billion) of the total DKK 16.9 billion ($2.49 billion), or about 63%, in Novo Nordisk’s reported obesity segment sales.

Vas Narasimhan, Novartis CEO (Gian Ehrenzeller/Keystone via AP)

Go­ing block­buster hunt­ing, Vas Narasimhan out­lines vi­sion for ‘pure-play’ No­var­tis

By the time 2023 is over, Novartis expects to be moving much lighter: It will have spun out its generics subsidiary Sandoz, completed layoffs of thousands of staffers worldwide and put in new internal structures for running the company.

And it will be ready to hunt for blockbusters.

CEO Vas Narasimhan underscored Novartis’ upcoming transformation into a “pure-play” company, reiterating across a series of calls — one with reporters, two with investors and analysts — that the new structure would boost its R&D productivity and sharpen its focus on big, new medicines.

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Te­va drops out of in­dus­try trade group PhRMA

Following in AbbVie’s footsteps, Teva confirmed on Friday that it’s dropping out of the industry trade group Pharmaceutical Research and Manufacturers of America (PhRMA).

Teva didn’t give a reason for its decision to leave, saying only in a statement to Endpoints News that it annually reviews “effectiveness and value of engagements, consultants and memberships to ensure our investments are properly seated.”

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