With patent con­cerns loom­ing, Roche gets a new pri­or­i­ty re­view on block­buster IPF drug

Sev­en years af­ter the FDA first ap­proved Es­bri­et, the block­buster Roche IPF drug is get­ting an ex­pe­dit­ed re­view for a sec­ond in­di­ca­tion.

On Thurs­day, the agency gave Es­bri­et pri­or­i­ty re­view for un­clas­si­fied in­ter­sti­tial lung dis­eases, or forms of pul­monary in­flam­ma­tion and scar­ring that don’t fit eas­i­ly in­to the over 200 known types of ILD. The move comes 10 months af­ter Es­bri­et re­ceived break­through des­ig­na­tion and sets Roche up for a de­ci­sion by May.

The Swiss phar­ma is bid­ding for a new in­di­ca­tion at an acute pe­ri­od for their long­time block­buster. One of two ma­jor id­io­path­ic pul­monary fi­bro­sis drugs along­side Boehringer In­gel­heim’s Ofev, Es­bri­et con­tin­ues to bring over $1 bil­lion per year. But sales growth has slowed, par­tic­u­lar­ly in the US, and the com­pa­ny’s or­phan des­ig­na­tion pro­tec­tions in IPF be­gin to ex­pire this year.

With that dead­line loom­ing, Roche has sought to guard against would-be gener­ics, fil­ing around a dozen law­suits to stop Te­va, San­doz and oth­ers from re­leas­ing cheap­er, copy­cat ver­sions of the drug. Es­bri­et’s an­nu­al whole­sale cost is around $100,000.

Roche ac­quired Es­bri­et in their $8.3 bil­lion buy­out of the Cal­i­for­nia biotech In­ter­Mune, two months be­fore the FDA would give the drug a green light. The agency had ini­tial­ly re­ject­ed the drug in 2010, de­mand­ing In­ter­Mune run a sec­ond Phase III tri­al.

The Big Phar­ma, though, would not put the drug in­to a piv­otal tri­al for un­clas­si­fi­able in­ter­sti­tial lung dis­ease un­til 2017. In 2019, in­ves­ti­ga­tors pub­lished Phase II re­sults from 253 un­clas­si­fi­able ILD pa­tients, show­ing pa­tients who took the drug had sig­nif­i­cant­ly more sta­ble lung func­tion, as mea­sured by an end­point called forced vi­tal ca­pac­i­ty.

The new in­di­ca­tion is just one route Roche is us­ing to try to keep its fi­bro­sis fran­chise alive. The com­pa­ny has al­so in­vest­ed in find­ing a new block­buster for IPF, ac­quir­ing Prome­dior and its pipeline of an­ti-fi­brot­ic mol­e­cules for up to $1.4 bil­lon in 2019. The lead drug, which has re­ceived break­through des­ig­na­tion, went in­to Phase III ear­li­er this year.

So far, Roche has stayed ahead of Boehringer in that search; two months af­ter Roche start­ed their Phase III, the Ger­man phar­ma dropped out of its own $1 bil­lion fi­bro­sis pact, cit­ing tox­i­c­i­ty with their part­ner’s drug.

Albert Bourla (Photo by Steven Ferdman/Getty Images)

UP­DAT­ED: Pfiz­er fields a CRL for a $295M rare dis­ease play, giv­ing ri­val a big head start

Pfizer won’t be adding a new rare disease drug to the franchise club — for now, anyway.

The pharma giant put out word that their FDA application for the growth hormone therapy somatrogon got the regulatory heave-ho, though they didn’t even hint at a reason for the CRL. Following standard operating procedure, Pfizer said in a terse missive that they would be working with regulators on a followup.

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A new can­cer im­munother­a­py brings cau­tious hope for a field long await­ing the next big break­through

Bob Seibert sat silent across from his daughter at their favorite Spanish restaurant near his home in Charleston County, SC, their paella growing cold as he read through all the places in his body doctors found tumors.

He had texted his wife, a pediatric intensive care nurse, when he got the alert that his online chart was ready. Although he saw immediately it was bad, many of the terms — peritoneal, right iliac — were inscrutable. But she was five hours downstate, at a loud group dinner the night before another daughter’s cheer competition.

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Graphic: Alexander Lefterov for Endpoints News

Small biotechs with big drug am­bi­tions threat­en to up­end the tra­di­tion­al drug launch play­book

Of the countless decisions Vlad Coric had to make as Biohaven’s CEO over the past seven years, there was one that felt particularly nerve-wracking: Instead of selling to a Big Pharma, the company decided it would commercialize its migraine drug itself.

“I remember some investors yelling and pounding on the table like, you can’t do this. What are you thinking? You’re going to get crushed by AbbVie,” he recalled.

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Mar­ket­ingRx roundup: Pfiz­er de­buts Pre­vnar 20 TV ads; Lil­ly gets first FDA 2022 pro­mo slap down let­ter

Pfizer debuted its first TV ad for its Prevnar 20 next-generation pneumococcal pneumonia vaccine. In the 60-second spot, several people (actor portrayals) with their ages listed as 65 or older are shown walking into a clinic as they turn to say they’re getting vaccinated with Prevnar 20 because they’re at risk.

The update to Pfizer’s blockbuster Prevnar 13 vaccine was approved in June, and as its name suggests is a vaccine for 20 serotypes — the original 13 plus seven more that cause pneumococcal disease. Pfizer used to spend heavily on TV ads to promote Prevnar 13 in 2018 and 2019 but cut back its TV budgets in the past two fall and winter seasonal spending cycles. Prevnar had been Pfizer’s top-selling drug, notching sales of just under $6 billion in 2020, and was the world’s top-selling vaccine before the Covid-19 vaccines came to market last year.

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Roy Baynes, Merck

FDA bats back Mer­ck’s ‘pipeline in a prod­uct,’ de­mands more ef­fi­ca­cy da­ta

Despite some heavy blowback from analysts, Merck execs maintained an upbeat attitude about the market potential of its chronic cough drug gefapixant. But the confidence may be fading somewhat today as Merck puts out news that the FDA is handing back its application with a CRL.

Dubbed by Merck’s development chief Roy Baynes as a “pipeline in a product” with a variety of potential uses, Merck had fielded positive late-stage data demonstrating the drug’s ability to combat chronic cough. The drug dramatically reduced chronic cough in Phase III, but so did placebo, leaving Merck’s research team with a marginal success on the p-value side of the equation.

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Florida Gov. Ron DeSantis (AP Photo/Wilfredo Lee, File)

Opin­ion: Flori­da is so mAb crazy, Ron De­San­tis wants to use mAbs that don't work

Florida Gov. Ron DeSantis is trying so hard to politicize the FDA and demonize the federal government that he entered into an alternate universe on Monday evening in describing a recent FDA action to restrict the use of two monoclonal antibody, or mAb, treatments for Covid-19 that don’t work against Omicron.

Without further ado, let’s break down his statement from last night, line by line, adjective by adjective.

Steve Worland, eFFECTOR CEO

Sur­prise piv­ot rocks eF­FEC­TOR's I/O plans — al­though ex­ecs promise big­ger slice of the NSCLC mar­ket in the long run

When eFFECTOR Therapeutics went public last summer on the coattails of a reverse merger with Locust Walk’s SPAC, the potential of its lead drug, tomivosertib, as a combo agent with Merck’s flagship PD-1 Keytruda was hailed as the main draw.

But the biotech is now axing those plans and essentially starting over.

In a surprise move, San Diego-based eFFECTOR said it’s halting the development of tomivosertib in non-small cell lung cancer patients who have already progressed on Keytruda monotherapy after running into enrollment challenges in a Phase IIb trial.

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Not cheap­er by the dozen: Bris­tol My­ers be­comes the 12th phar­ma com­pa­ny to re­strict 340B sales

Bristol Myers Squibb recently joined 11 of its peer pharma companies in limiting how many contract pharmacies can access certain drugs discounted by a federal program known as 340B.

Bristol Myers is just the latest in a series of high-profile pharma companies moving in their own direction as the Biden administration’s Health Resources and Services Administration struggles to rein in the drug discount program for the neediest Americans.

Joaquin Duato, J&J CEO (Photo by Charles Sykes/Invision/AP)

New J&J CEO Joaquin Du­a­to promis­es an ag­gres­sive M&A hunt in quest to grow phar­ma sales

Joaquin Duato stepped away from the sideline and directly into the spotlight on Tuesday, delivering his first quarterly review for J&J as its newly-tapped CEO after an 11-year run in senior posts. And he had some mixed financial news to deliver today while laying claim to a string of blockbuster drugs in the making and outlining an appetite for small and medium-sized M&A deals.

Duato also didn’t exactly shun large buyouts when asked about the future of the company’s medtech business — where they look to be in either the top or number 2 position in every segment they’re in — even though the bar for getting those deals done is so much higher.

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