Geoffrey Porges, SVB Leerink

Se­ries of JAK in­hibitor de­lays may sig­nal an up­com­ing FDA ad­comm

Three-month re­view de­lays from the FDA have be­come the norm in re­cent days for JAK in­hibitors, some of which are seek­ing la­bel ex­pan­sions.

But the push­back of these ac­tion dates for Ab­b­Vie’s Rin­voq, Pfiz­er’s Xel­janz and abroc­i­tinib, and Eli Lil­ly’s Olu­mi­ant may be a sign that the FDA is prepar­ing to hold an ad­vi­so­ry com­mit­tee of out­side ex­perts to re­view the risk/ben­e­fit pro­files of JAK in­hibitors for atopic der­mati­tis, ac­cord­ing to SVB Leerink an­a­lyst Ge­of­frey Porges. This wouldn’t be the first time this year that the FDA wants to re­view a se­ries of drugs be­fore an ad­comm as the agency is hold­ing such a re­view lat­er this month for can­cer drugs that have pre­vi­ous­ly won ac­cel­er­at­ed ap­provals.

“This is not a com­plete sur­prise giv­en the FDA’s cau­tious stance on JAK in­hibitors gen­er­al­ly, their re­luc­tance to ap­prove the high­er dos­es most­ly re­quired for ef­fi­ca­cy in atopic der­mati­tis, and their re­cent ac­tions on ap­pli­ca­tions from all the JAK de­vel­op­ers,” Porges writes. “While the FDA’s more strin­gent ap­proach to JAKs as a drug class in­creas­es the per­ceived lev­el of risk to the cat­e­go­ry’s out­look, we be­lieve that ul­ti­mate­ly Pfiz­er’s abroc­i­tinib should get ap­proved in this in­di­ca­tion giv­en its rel­a­tive­ly clean pro­file (vs. Xel­janz).”

Any fail­ures for these JAK in­hibitors in atopic der­mati­tis will fur­ther firm up Re­gen­eron and Sanofi’s top po­si­tion with Dupix­ent, “giv­en its ex­cel­lent safe­ty track record in this in­di­ca­tion,” Porges writes.

He al­so says Ab­b­Vie in­di­cat­ed that FDA’s re­quest for more in­for­ma­tion on Rin­voq was dri­ven by Pfiz­er’s an­nounce­ment in late Jan­u­ary that Xel­janz failed a six-year safe­ty study man­dat­ed by the FDA.

“While we do not ex­pect any JAKs to be used ahead of Dupix­ent in AD, the strong re­sults from the 30mg dose in the head-to-head study make Rin­voq a con­tender for sec­ond line treat­ment,” he adds. “Giv­en the mixed his­to­ry of JAKs and hes­i­tan­cy from der­ma­tol­o­gists to uti­lize JAKs in AD, an Ad­Comm may be an ef­fec­tive plat­form to dif­fer­en­ti­ate be­tween JAK can­di­dates in AD, which could ben­e­fit Rin­voq.”

Over­all, Porges thinks the JAK in­hibitor de­lays once again show an FDA that’s hard­en­ing its stance against the in­dus­try, par­tic­u­lar­ly with re­spect to safe­ty is­sues.

“There is a per­cep­tion among in­vestors that the FDA has be­come more ac­tive and de­mand­ing un­der new act­ing com­mis­sion­er Janet Wood­cock,” Porges adds in an­oth­er in­vestor note this week. “If this is a sea change (rather than a co­in­ci­dence of tim­ing), then it seems sen­si­ble to as­sume that reg­u­la­to­ry ap­pli­ca­tions with any un­cer­tain­ties or ques­tions have a high­er-than-ex­pect­ed risk of be­ing de­layed and will be sub­ject to fur­ther in­for­ma­tion re­quests and ad­vi­so­ry com­mit­tee re­views. This is con­sis­tent with most of the era of mod­ern reg­u­la­tion of the bio­phar­ma in­dus­try, but not so much with the last 4-5 years.”

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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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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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.

(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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Bristol Myers Squibb (Alamy)

CVS re­sumes cov­er­age of block­buster blood thin­ner af­ter price drop fol­lows Jan­u­ary ex­clu­sion

Following some backlash from the American College of Cardiology and patients, Bristol Myers Squibb and Pfizer lowered the price of their blockbuster blood thinner Eliquis, thus ensuring that CVS Caremark would cover the drug after 6 months of it being off the major PBM’s formulary.

“Because we secured lower net costs for patients from negotiations with the drug manufacturer, Eliquis will be added back to our template formularies for the commercial segment effective July 1, 2022, and patient choices will be expanded,” CVS Health said in an emailed statement. “Anti-coagulant therapies are among the non-specialty products where we are seeing the fastest cost increases from drug manufacturers and we will continue to push back on unwarranted price increases.”

#Can­nes­Lions2022: Con­sumer health ex­ecs call on agen­cies to in­volve pa­tients in cre­ative process

CANNES — When Tamara Rogers joined GSK back in 2018, “science was king and R&D were the gods.” Now the global chief marketing officer of consumer healthcare wants to make room for another supreme being: the consumer.

As health and wellness becomes more relevant to consumers amid the pandemic, four health-focused executives called on marketers to involve patients in their creative process in a panel discussion at the Cannes Lions advertising creativity festival.

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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.