Jazz Phar­ma’s $1B bet pays off with ac­cel­er­at­ed lung can­cer ap­proval

Jazz Phar­ma­ceu­ti­cals’ $1 bil­lion bet last year looks to be pay­ing off so far: for them and their part­ner.

Sev­en months af­ter the Irish bio­phar­ma li­censed Phar­ma­Mar’s small cell lung can­cer drug lur­binecte­din, the FDA has grant­ed it ac­cel­er­at­ed ap­proval. The drug, which was sub­mit­ted two days be­fore Jazz signed on in De­cem­ber and lat­er grant­ed pri­or­i­ty re­view, will be mar­ket­ed as Zepzel­ca.

Zepzel­ca won’t en­ter the mar­ket un­til Ju­ly, at which point Jazz will face the dif­fi­cult hur­dles of com­mer­cial­iz­ing a drug in a pan­dem­ic, but the ap­proval should trig­ger an im­me­di­ate pay­off for Phar­ma­Mar. Al­though the ex­act terms aren’t spelled out, the orig­i­nal li­cens­ing agree­ment in­clud­ed “up to $250 mil­lion up­on the achieve­ment of ac­cel­er­at­ed and/or full reg­u­la­to­ry ap­proval of lur­binecte­din by FDA with­in cer­tain time­lines.” That deal al­so in­clud­ed $200 mil­lion up­front and $550 mil­lion in com­mer­cial mile­stones.

It’s a bit of re­demp­tion for the Span­ish bio­phar­ma. Orig­i­nal­ly found­ed in 1986 and lat­er re­spon­si­ble for the sar­co­ma drug Yon­delis, Phar­ma­Mar’s stock crashed in 2018 af­ter Zepzel­ca failed in a late-stage ovar­i­an can­cer study.

Still, that left a pair of tri­als on small cell lung can­cer. And at AS­CO in 2019, Phar­ma­Mar an­nounced the Phase II study had shown a 35.2% over­all re­sponse rate as a sec­ond-line ther­a­py — and 45% for the co­hort they de­ter­mined most sen­si­tive to treat­ment. Those pa­tients saw a pro­gres­sion-free sur­vival of 4.6 months and an over­all sur­vival of 11.9 months.

That may not trans­late in­to ac­cel­er­at­ed ap­proval for every in­di­ca­tion, but small cell lung can­cer has for years been a dif­fi­cult field for drug de­vel­op­ment. Be­fore 2018, when Bris­tol My­ers Squibb’s im­munother­a­py Op­di­vo was ap­proved for third-line pa­tients, no drug had been ap­proved for the tu­mor type in over a decade, ac­cord­ing to the Lung Can­cer Re­search Foun­da­tion. Since then, Keytru­da won ap­proval as a third-line treat­ment, and Tecen­triq and Imfinzi were cleared as a first-line ther­a­pies.

This is Jazz’s sec­ond ap­proval in a lit­tle over a year, af­ter their fol­low-on nar­colep­sy drug Sunosi was OK’ed last March. It is their third can­cer ap­proval. Ac­cel­er­at­ed ap­provals can be con­tin­gent on a con­fir­ma­to­ry tri­al, and a Phase III study is al­ready un­der­way.

Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Vas Narasimhan (Photographer: Jason Alden/Bloomberg via Getty Images)

No­var­tis de­tails plans to axe 8,000 staffers as Narasimhan be­gins sec­ond phase of a glob­al re­org

We now know the number of jobs coming under the axe at Novartis, and it isn’t small.

The pharma giant is confirming a report from Swiss newspaper Tages-Anzeiger that it is chopping 8,000 jobs out of its 108,000 global staffers. A large segment will hit right at company headquarters in Basel, as CEO Vas Narasimhan axes some 1,400 of a little more than 11,000  jobs in Switzerland.

The first phase of the work is almost done, the company says in a statement to Endpoints News. Now it’s on to phase two. In the statement, Novartis says:

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Lina Gugucheva, NewAmsterdam Pharma CBO

Phar­ma group bets up to $1B-plus on the PhI­II res­ur­rec­tion of a once dead-and-buried LDL drug

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

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How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

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Aurobindo Pharma co-founders P. V. Ram Prasad Reddy (L) and K. Nityananda Reddy

Au­robindo Phar­ma re­ceives warn­ing let­ter from In­di­a's SEC fol­low­ing more FDA ques­tion marks

Indian-based generics manufacturer Aurobindo Pharma has been in the crosshairs of the FDA for several years now, but the company is also attracting attention from regulators within the subcontinent.

According to the Indian business news site Business Standard, a warning letter was sent to the company from the Securities Exchange Board of India, or SEBI.

The letter is related to disclosures made by the company on an ongoing FDA audit of the company’s Unit-1 API facility in Hyderabad, India as well as observations made by the US regulator between 2019 and 2022.

Ankit Mahadevia, Spero CEO

Spero’s UTI can­di­date gets the CRL ham­mer as the com­pa­ny falls in­to pen­ny stock sta­tus

Spero Therapeutics has been struggling in the past few years, dealing with FDA holds and staff reductions amidst a rough biotech market, and the latest news from the Massachusetts-based company confirms what it anticipated in May: a CRL.

The company was slapped with the no-go for its NDA, the biotech disclosed Monday. The company was seeking approval for tebipenem HBr oral tablets, intended for the treatment of adult patients with complicated urinary tract infection, or cUTI, including pyelonephritis. The FDA had set a PDUFA date of June 27.

Scoop: Roche scraps one of two schiz­o­phre­nia PhII tri­als af­ter fail­ing the pri­ma­ry end­point

Roche has terminated one of two Phase II trials testing its drug ralmitaront in patients with schizophrenia, the Big Pharma confirmed to Endpoints News.

The study was terminated last month, according to a June 22 update to the registry on clinicaltrials.gov. Begun in September 2020, the trial was looking at ralmitaront in patients with acute schizophrenia. The trial enrolled 286 patients out of an originally planned 308.

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(AP Photo/Gemunu Amarasinghe)

Some phar­ma com­pa­nies promise to cov­er abor­tion-re­lat­ed trav­el costs — while oth­ers won't go that far yet

As the US Department of Health and Human Services promises to support the millions of women who would now need to cross state lines to receive a legal abortion, a handful of pharma companies have said they will pick up employees’ travel expenses.

GSK, Sanofi, Johnson & Johnson, BeiGene, Alnylam and Gilead have all committed to covering abortion-related travel expenses just four days after the Supreme Court overturned Roe v. Wade and revoked women’s constitutional right to an abortion.

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Herriot Tabuteau, Axsome CEO (Owen Hoffmann/Patrick McMullan via Getty Images)

Ax­some's long de­layed de­pres­sion drug is back up for la­bel dis­cus­sions at the FDA, trig­ger­ing a big spike in the share price

Axsome’s on-and-off quest to obtain an FDA approval for their depression drug AXS-05 is back on again.

After the markets closed on Monday, the biotech issued a short, simple alert in an SEC filing saying the team had “received from the U.S. Food and Drug Administration (the “FDA”) proposed labeling for the Company’s AXS-05 product candidate with respect to its New Drug Application (the “NDA”) for AXS-05 for the treatment of major depressive disorder. The Company is reviewing the proposed labeling and will reply to the FDA to secure final labeling agreement.”