No­var­tis pe­ti­tions FDA to block 18 gener­ic com­peti­tors for its megablock­buster heart drug un­til 2024

No­var­tis is look­ing to milk one of its most prized pos­ses­sions a lit­tle while longer with­out any gener­ic com­pe­ti­tion, most­ly be­cause of a new­ly ap­proved use that the Big Phar­ma won ear­li­er this year for its megablock­buster heart drug En­tresto.

In ad­di­tion to bat­tling (and win­ning) lit­i­ga­tion last month to block a hand­ful of In­di­an gener­ics from en­ter­ing the mar­ket ear­ly along­side En­tresto, the com­pa­ny last week pe­ti­tioned the FDA to try to stop a to­tal of 18 En­tresto gener­ics from launch­ing be­fore 2024 at the ear­li­est.

Un­der No­var­tis’ read­ing of FDA’s “same la­bel­ing” reg­u­la­tions, the com­pa­ny con­tends that “the agency can­not ap­prove an AN­DA [gener­ic drug] seek­ing to omit the patent- and ex­clu­siv­i­ty-pro­tect­ed use un­til ex­pi­ra­tion of the ex­clu­siv­i­ty in Feb­ru­ary 2024 – and even then, on­ly if the AN­DA ap­pli­cants sub­mit a para­graph IV cer­ti­fi­ca­tion to each of the HF­pEF Patents.”

While such pe­ti­tions to FDA are of­ten de­nied, and No­var­tis un­der­stands that gener­ics will eat away at its mas­sive sales for En­tresto soon-ish, many com­pa­nies of­ten file the FDA pe­ti­tions any­way in an at­tempt to fur­ther de­lay gener­ics.

No­var­tis has al­ready sued gener­ic drug­mak­ers look­ing to bring copy­cats of En­tresto to mar­ket in Ju­ly 2023, which is when a reg­u­la­to­ry stay on FDA’s au­thor­i­ty to grant fi­nal ap­proval to these AN­DAs will lift. Oth­er law­suits are al­so cur­rent­ly pend­ing, and a tri­al in the Delaware dis­trict court has been sched­uled to start on Sept. 8, 2022. No­var­tis al­so filed oth­er law­suits against cer­tain gener­ic com­pa­nies in Sep­tem­ber and Oc­to­ber that were tar­get­ing three oth­er patents, one of which doesn’t ex­pire un­til 2036.

En­tresto won its first FDA ap­proval in the HFrEF pop­u­la­tion in Ju­ly 2015 and hauled in al­most $2.5 bil­lion in sales in 2020, and an­oth­er $2.6 bil­lion in the first nine months of 2021.

Back in Feb­ru­ary, the FDA al­so ap­proved En­tresto as the first and on­ly ther­a­py in the US to treat pa­tients di­ag­nosed with heart fail­ure, in­clud­ing both those with heart fail­ure with re­duced ejec­tion frac­tion (HFrEF) and with heart fail­ure with pre­served ejec­tion frac­tion (HF­pEF). That means that of the more than 6 mil­lion Amer­i­cans suf­fer­ing from chron­ic heart fail­ure, about 5 mil­lion may be ap­pro­pri­ate for treat­ment with En­tresto, the com­pa­ny con­tend­ed.

That new use for En­tresto is al­so pro­tect­ed by three more years of ex­clu­siv­i­ty, which could amount to bil­lions more for the com­pa­ny.

No­var­tis told FDA that a gener­ic com­peti­tor seek­ing ap­proval be­fore the ex­pi­ra­tion of En­tresto’s ex­clu­siv­i­ty must pro­pose la­bel­ing that omits the ex­clu­siv­i­ty-pro­tect­ed con­di­tions of ap­proval and does not dis­close the patent­ed use, adding:

An AN­DA ap­pli­cant may on­ly seek ap­proval for the con­di­tions of use that ex­ist­ed in the En­tresto la­bel­ing pri­or to Feb­ru­ary 2021, i.e., to re­duce the risk of car­dio­vas­cu­lar death and hos­pi­tal­iza­tion for heart fail­ure in pa­tients with chron­ic heart fail­ure and re­duced ejec­tion frac­tion. How­ev­er, there is no per­mis­si­ble way for AN­DA ap­pli­cants to draft an in­di­ca­tion state­ment for use in pa­tients with re­duced ejec­tion frac­tion by delet­ing words or mak­ing de min­imis changes to the ex­ist­ing in­di­ca­tion state­ment.

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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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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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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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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Amgen's Twitter campaign #DearAsthma inspired thousands of people to express struggles and frustrations with the disease

Am­gen’s #Dear­Asth­ma spon­sored tweet lands big on game day, spark­ing thou­sands to re­spond

Amgen wanted to know how people with asthma really felt about daily life with the disease. So it bought a promoted tweet on Twitter noting the not-so-simple realities of life with asthma and ended the post with a #DearAsthma hashtag, a megaphone emoji and a re-tweet button.

That was just over one week ago and the responses haven’t stopped. More than 7,000 posts so far on Twitter replied to #DearAsthma to detail struggles of daily life, expressing humor, frustration and sometimes anger. More than a few f-bombs have been typed or gif-ed in reply to communicate just how much many people “hate” the disease.

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.

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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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Pfiz­er, Bris­tol My­ers dom­i­nate top 10 pre­dic­tions for the best-sell­ing drugs of 2022

The annual exercise where analysts try and predict which drugs will become blockbusters and make the most money tends to highlight the biggest trends in biopharma R&D. 2022 is no exception.

The team at Evaluate Vantage published its predictions for the top 10 selling drugs for the year — expecting tens of billions of dollars in sales and highlighting an industry-wide focus on certain diseases and indications.

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