Which drugs may be hit with ne­go­ti­a­tions if the rec­on­cil­i­a­tion bill pass­es? Wall St. an­a­lysts ex­plain

Be­yond the back and forth of whether De­moc­rats’ drug price ne­go­ti­a­tion plan is nec­es­sary to bring down costs, or just a thin­ly veiled at­tempt at price con­trols, the nuts and bolts of the deal mean phar­ma com­pa­nies will in­evitably see the tail ends of cer­tain small mol­e­cule and bi­o­log­ic sales pe­ter out be­fore they oth­er­wise would have in to­day’s mar­ket­place.

While the bill’s text is not set in stone, and the Sen­ate par­lia­men­tar­i­an may still take is­sue with the ex­cise tax that CMS will use to en­sure com­pa­nies com­ply with the ne­go­ti­at­ed prices, SVB Se­cu­ri­ties ex­plained to in­vestors how more than a dozen drugs from Eli Lil­ly, As­traZeneca, Ab­b­Vie and J&J, among oth­ers, would lose out on some rev­enue just be­fore their gener­ic com­peti­tors hit the mar­ket.

If Sen­ate De­moc­rats can ral­ly every last mem­ber be­fore next Fri­day, and the House pulls it to­geth­er some­time next month, CMS ne­go­ti­a­tions for drug prices would be­gin in 2026, but on­ly for 10 Part D drugs (i.e. out­pa­tient drugs) to start. In 2028, Medicare would set prices for both Part D and Part B (physi­cian-ad­min­is­tered) drugs. Cu­mu­la­tive­ly, CMS may end up ne­go­ti­at­ing about 60 drugs, de­pend­ing on gener­ic/biosim­i­lar com­pe­ti­tion, SVB Se­cu­ri­ties an­a­lysts wrote.

While ne­go­ti­a­tions won’t be­gin un­til small mol­e­cules are nine years past their ap­provals, or 13 years for bi­o­log­ics, SVB Se­cu­ri­ties warns that “in­no­va­tors’ will­ing­ness to de­vel­op new drugs, in par­tic­u­lar small mol­e­cule ther­a­pies for se­niors, would like­ly di­min­ish.”

Drugs like Ver­tex’s cys­tic fi­bro­sis treat­ment Trikaf­ta could end up see­ing nine years cut off from its ex­clu­siv­i­ty pe­ri­od, al­though the an­a­lysts note that that may not add up to much be­cause most of those who are on the drug are not on Medicare. For J&J’s can­cer drug Darza­lex, eight years might be cut off by the ne­go­ti­a­tions, and “a very high per­cent­age of sales” are from Medicare giv­en its mul­ti­ple myelo­ma in­di­ca­tion.

But oth­er com­pa­nies, like Mer­ck, won’t be too ex­posed to the ne­go­ti­a­tions as its megablock­buster can­cer drug Keytru­da faces biosim­i­lar en­try in 2028, which is the first year for Part B ne­go­ti­a­tions.

As lob­by­ing over the fi­nal bill text hits a fever pitch over the next week, more and more re­ports on what the bill will do are pil­ing up.

Avalere Health, for in­stance, re­cent­ly es­ti­mat­ed, thanks to a Gilead-fund­ed re­port, that the leg­is­la­tion “could re­duce man­u­fac­tur­er rev­enues by $165 bil­lion in Part D and $290 bil­lion in Part B from 2026 to 2032.” And while it’s un­like­ly the ex­cise tax would be used (be­cause of how steep it is), Avalere pro­ject­ed that its es­ti­mat­ed im­pact on man­u­fac­tur­ers’ non-com­pli­ance could be as high as 1,450% of to­tal Part D spend and about 2,500% of Part B spend.

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Uğur Şahin, BioNTech CEO (Kay Nietfeld/picture-alliance/dpa/AP Images)

De­spite falling Covid-19 sales, BioN­Tech main­tains '22 sales guid­ance

While Pfizer raked in almost $28 billion last quarter, its Covid-19 vaccine partner BioNTech reported a rise in total dose orders but a drop in sales.

The German biotech reported over $3.2 billion in revenue in Q2 on Monday, down from more than $6.7 billion in Q1, in part due to falling Covid sales. While management said last quarter that they anticipated a Covid sales drop — CEO Uğur Şahin said at the time that “the pandemic situation is still very much uncertain” — Q2 sales still missed consensus by 14%.

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FDA commissioner Rob Califf (Tom Williams/CQ Roll Call via AP Images)

With drug pric­ing al­most done, Con­gress looks to wrap up FDA user fee leg­is­la­tion

The Senate won’t return from its summer recess until Sept. 6, but when it does, it officially has 18 business days to finalize the reauthorization of the FDA user fee programs for the next 5 years, or else thousands of drug and biologics reviewers will be laid off and PDUFA dates will vanish in the interim.

FDA commissioner Rob Califf recently sent agency staff a memo explaining how, “Our latest estimates are that we have carryover for PDUFA [Prescription Drug User Fee Act], the user fee funding program that will run out of funding first, to cover only about 5 weeks into the next fiscal year.”

Pascal Soriot, AstraZeneca CEO (David Zorrakino/Europa Press via AP Images)

As­traZeneca and Dai­ichi Sankyo sprint to mar­ket af­ter FDA clears En­her­tu in just two weeks

Regulators didn’t keep AstraZeneca and Daiichi Sankyo waiting long at all for their latest Enhertu approval.

The partners pulled a win on Friday in HER2-low breast cancer patients who’ve already failed on chemotherapy, just two weeks after submitting a supplemental BLA. While this isn’t the FDA’s fastest approval — Bristol Myers Squibb won an OK for its blockbuster checkpoint inhibitor Opdivo in just five days back in March — it comes well ahead of Enhertu’s original Q4 PDUFA date.

Ted Love, Global Blood Therapeutics CEO

Up­dat­ed: Pfiz­er scoops up Glob­al Blood Ther­a­peu­tics and its sick­le cell ther­a­pies for $5.4B

Pfizer is dropping $5.4 billion to acquire Global Blood Therapeutics.

Just ahead of the weekend, word got out that Pfizer was close to clinching a $5 billion buyout — albeit with other potential buyers still at the table. The pharma giant, flush with cash from Covid-19 vaccine sales, apparently got out on top.

The deal immediately swells Pfizer’s previously tiny sickle cell disease portfolio from just a Phase I program to one with an approved drug, Oxbryta, plus a whole pipeline that, if all approved, the company believes could make for a $3 billion franchise at peak.

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David Reese, Amgen R&D chief

UP­DAT­ED: In a fresh dis­ap­point­ment, Am­gen spot­lights a ma­jor safe­ty is­sue with KRAS com­bo

Amgen had hoped that its latest study matching its landmark KRAS G12C drug Lumakras with checkpoint inhibitors would open up its treatment horizons and expand its commercial potential. Instead, the combo spurred safety issues that blunted efficacy and forced the pharma giant to alter course on its treatment strategy, once again disappointing analysts who have been tracking the drug’s faltering sales and limited therapeutic reach.

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GSK and IQVIA launch plat­form of US vac­ci­na­tion da­ta, show­ing drop in adult rates

Throughout the Covid-19 pandemic, the issue of vaccine uptake has been a point of contention, but a new platform from GSK and IQVIA is hoping to shed more light on vaccine data, via new transparency and general awareness.

The two companies have launched Vaccine Track, a platform intended to be used by public health officials, medical professionals and others to strengthen data transparency and display vaccination trends. According to the companies, the platform is intended to aid in increasing vaccine rates and will provide data on trends to assist public health efforts.

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Ab­b­Vie sur­veys emo­tion­al im­pact of chron­ic leukemia con­di­tion, finds 'roller coast­er' of emo­tions

Rare diseases often have more than just physical effects on patients — especially when it comes to chronic conditions. In the case of the rare slow-growing blood cancer chronic lymphocytic leukemia (CLL), AbbVie wanted to try to assess the mental and emotional toll on patients.

So it surveyed more than 300 CLL patients, caregivers and physicians. While each group differed in how they felt — caregivers overwhelmingly (81%) felt positive about their role, for instance — patients described a “roller coaster” of emotions traversing diagnosis to treatment to remission and even relapse for some.

Sen­ate Dems cling to a sim­ple ma­jor­i­ty to pass some of the biggest drug pric­ing re­forms ever

The Pharmaceutical Research and Manufacturers of America — and their fleet of drug industry lobbyists on Capitol Hill — are known for never losing.

Whenever a big drug pricing bill comes up, an army of the industry group’s lobbyists descend onto the Hill and either smash it outright or dismantle it piece by piece.

But for perhaps the largest drug pricing reforms ever enacted, after more than a decade of Congress trying and failing to allow Medicare to negotiate prescription drug prices, those same lobbyists and their biopharma clients were dealt a stunning blow on Sunday afternoon.