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.

Big Phar­ma's Twit­ter ex­o­dus; Mer­ck wa­gers $1.35B on buy­out; $3.5M gene ther­a­py; and more

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Paul Perreault, CSL Behring CEO

CSL lands FDA ap­proval for he­mo­phil­ia B gene ther­a­py, sets $3.5M list price

The FDA has approved the world’s first gene therapy for hemophilia B, ushering into the market a treatment that’s historic in both what it promises to do and how much it will cost.

CSL will be marketing the drug, Hemgenix, at a list price of $3.5 million — which sets a new record for the most expensive single-use gene therapy in the US.

In a statement provided to Endpoints News, the Australian company noted that the current costs of treating people with moderate to severe hemophilia B can be significant over a lifetime. By some estimates, healthcare systems could spend more than $20 million per person.

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Elon Musk (GDA via AP Images)

Biggest drug com­pa­nies halt­ed Twit­ter ad buys af­ter Lil­ly in­sulin spoof

Almost all of the drug industry’s biggest advertisers cut their spending on Twitter to zero or near-zero over the last two weeks amid worries about impersonation of their brands by pranksters and the future of the social media company.

Among 18 of the biggest pharmaceutical advertisers in the US market, 12 cut their Twitter ad spending to nothing for the week beginning Nov. 14, according to Pathmatics, which tracks data on prescription drug ad spending as well as general corporate advertising. The list of drugmakers cutting spending to zero includes Merck, AstraZeneca, Eli Lilly, Novartis, Pfizer and others.

Rob Davis, Merck CEO

Up­dat­ed: No Seagen here: 'Do more' means a small $1.35B pur­chase of Ima­go for Mer­ck

Merck is making an acquisition, the Big Pharma announced before Monday’s opening bell. No, Seagen is not entering the fold, as had been speculated for quarters.

Folding under Merck’s wings will be Pfizer-backed Imago BioSciences. For nearly a year, Merck CEO Rob Davis has been saying the pharma giant needs to “do more” on the business development front after its 2021 $11.5 billion acquisition of Acceleron.

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MIT re­searchers re­veal DNA "Paste" tech be­hind lat­est gene edit­ing start­up

MIT scientists have developed a tool that they say can insert large gene sequences where they want in the genome.

In a paper published Thursday in Nature Biotechnology, MIT fellows Omar Abudayyeh, Jonathan Gootenberg and colleagues detail a technology they call PASTE, which they say can potentially be used to insert long strands of DNA and treat genetic diseases caused by many different mutations, such as cystic fibrosis and Leber congenital amaurosis, a rare eye disorder that causes blindness.

Dermavant Sciences' first consumer TV ad for its Vtama psoriasis med shows people ready for a new topical treatment.

Roivant’s Der­ma­vant de­buts first-ever TV com­mer­cial for pso­ri­a­sis cream Vta­ma

Dermavant Sciences has been marketing its first product, psoriasis med Vtama, to dermatologists for months, but on Tuesday it rolled out its first consumer campaign. The debut DTC effort including a streaming TV commercial encourages patients to a “Topical Uprising” in a nod to Vtama being a topical cream.

In the new commercial, a swell of people discards scarves and jacket coverings, gathering in the street to converge on a pharmacy to demand a steroid-free prescription. A moment of levity follows when a pharmacist says, “You know you can just talk to your doctor, right?” The gathered crowds collectively says, “Oh.”

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FDA preps for DMD drug gener­ics as Sarep­ta has yet to fin­ish its con­fir­ma­to­ry tri­al

The FDA typically releases guidance to help generic drug manufacturers develop new copycats of small molecule drugs, oftentimes in preparation for a brand name product’s patents or exclusivity to expire.

This week, FDA released such bioequivalence guidance for any generic drugmakers looking to take on Sarepta’s Duchenne muscular dystrophy (DMD) drug Exondys 51 (eteplirsen), even though the drug’s sponsor has yet to convert the accelerated approval to a full approval, showing clinical benefit.

Stanley Erck, Novavax CEO (Andrew Harnik/AP Images)

No­vavax pulls out of Covid-19 vac­cine al­liance with Gavi

Novavax is pulling out of its Covid-19 vaccine deal with Gavi, the Vaccine Alliance, a global partnership tasked with ensuring vaccine access in lower-income countries, following an alleged contract violation.

The Maryland-based company claimed on Friday that Gavi failed to purchase at least 350 million doses of its protein-based vaccine Nuvaxovid by the end of the year, per an advanced purchase agreement. Gavi, the World Health Organization and the Coalition for Epidemic Preparedness Innovations (CEPI) are co-leaders of COVAX, an effort to ensure that all participating countries, regardless of income levels, have access to vaccines.

Fu­ji­film to build $188M man­u­fac­tur­ing plant in North Car­oli­na’s re­search tri­an­gle

As the Japanese conglomerate Fujifilm continues to invest heavily in its CDMO arm, one of its manufacturing divisions is teeing up a major investment.

Fujifilm Irvine Scientific announced on Tuesday that parent Fujifilm is making a $188 million investment to build a cell culture media manufacturing site in the Research Triangle Park in North Carolina. The new site will mark Fujifilm Irvine’s fifth manufacturing site globally and its second in the US.