Af­ter EMA flop, Puma takes Ner­l­ynx to Chi­na in new out-li­cens­ing deal

Fac­ing a like­ly road­block en­ter­ing the Eu­ro­pean mar­ket, Puma Biotech­nol­o­gy $PBYI is ink­ing a string of new deals in dif­fer­ent re­gions for its can­cer drug Ner­l­ynx. Lat­est tar­get: Chi­na.

Puma is bud­dy­ing up on the deal with CAN­bridge Life Sci­ences, which will de­vel­op and com­mer­cial­ize the drug in main­land Chi­na, Tai­wan, Hong Kong, and Macau. Puma gets a $30 mil­lion up­front pay­ment, and biobucks of up to $40 mil­lion if cer­tain reg­u­la­to­ry mile­stones are met. Puma could al­so get dou­ble-dig­it roy­al­ties on sales, and ex­tra mile­stones based on sales.

Alan Auer­bach

“Puma is com­mit­ted to pro­vid­ing ac­cess to Ner­l­ynx to pa­tients around the world, and greater Chi­na rep­re­sents a very large mar­ket op­por­tu­ni­ty,” said Alan Auer­bach, Puma’s pres­i­dent and CEO, in a state­ment. “While we con­tin­ue to fo­cus our com­mer­cial re­sources on the US mar­ket, we be­lieve this new part­ner­ship with CAN­bridge will help pa­tients in greater Chi­na to ac­cess Ner­l­ynx at the ear­li­est op­por­tu­ni­ty.”

Puma’s drug was ap­proved by the FDA in Ju­ly 2017 for pre­vent­ing the re­turn of breast can­cer af­ter ther­a­py. The com­pa­ny planned to take the drug to Eu­rope, but got slapped down by the EMA last month due to con­cerns its reg­u­la­tors had with the drug.

But that set­back hasn’t stopped the com­pa­ny from try­ing to com­mer­cial­ize the drug out­side the US. Late last month, Is­rael’s Medi­son Phar­ma signed an ex­clu­sive li­cens­ing deal to seek reg­u­la­to­ry ap­proval for and com­mer­cial­ize the breast can­cer treat­ment. Medi­son ex­ecs said they ex­pect to re­ceive ap­proval from the Is­raeli Min­istry of Health in 2019.

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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