Is Tesaro play­ing a pric­ing game with Ze­ju­la? Not at all, says the CEO. And here's why

A few weeks af­ter the FDA ap­proved Ze­ju­la (ni­ra­parib), Tesaro’s new PARP in­hibitor for re­cur­rent ovar­i­an can­cer, the biotech got around to nam­ing the whole­sale list price. And that is:

$9,833 for a one-month sup­ply of Ze­ju­la at a dose of 200 mil­ligrams once per day.

Why did they pick 200 mg? Be­cause, they said, that’s what the most com­mon­ly used dose was in Phase III.

But hold on. The ap­proved start­ing dose of the drug is 300 mg a day. And if you use sim­ple math the price for that would be $14,749.50 a month. A year’s sup­ply would be $176,994.

There is an­oth­er PARP on the mar­ket, Rubra­ca from Clo­vis, which sells for $13,750 a month. And Tesaro’s new drug price now rings in sig­nif­i­cant­ly high­er, at that ap­proved dose. The key ini­tial ri­val­ry will be be­tween As­traZeneca’s Lyn­parza and Ze­ju­la.

Wed­bush’s David Nieren­garten and Brad Lon­car both guessti­mat­ed that Ze­ju­la would come in at least around that Rubra­ca price, so the re­jigged num­ber caused a quick dou­ble-take on Twit­ter. Fol­lowed by a num­ber of barbed jokes, which I added to.

Lon­nie Moul­der

But hold on, again. It’s not a pric­ing game at all, says Tesaro CEO Lon­nie Moul­der, who wasn’t in a jok­ing mood when he saw this sto­ry Wednes­day night. Most pa­tients will not wind up at the rec­om­mend­ed start­ing dose, says the CEO, who says that the ma­jor­i­ty of pa­tients will be treat­ed for far less than the top price.

His com­ment:

Not sure why you char­ac­ter­ized the pric­ing for Ze­ju­la the way you did (as a pric­ing game to hide the high­er cost) but the facts re­gard­ing Ze­ju­la pric­ing are as fol­lows.  If you read the FDA ap­proved la­bel­ing you will see that 69% of pa­tients are down-dosed, which means 31% con­tin­ue on the 300 mg dai­ly start­ing dose and ap­prox­i­mate­ly 70% of the pa­tients will re­ceive ei­ther 200 mg with a WAC of $9,833 or 100 mg with a WAC of $4,917. Ap­prox­i­mate­ly 30% will con­tin­ue to re­ceive 300 mg with a WAC of 14,750.

The down dos­ing oc­curs over the first 1-3 months which is not un­com­mon for oral an­ti­cancer agents as the physi­cian “di­als in” the dose.  The me­di­an dose and the most com­mon dose were 200 mg.

Ze­ju­la is sup­plied as a 100mg cap­sule which means a pa­tient takes ei­ther 1 or 2 or 3 cap­sules once dai­ly based up­on what they are pre­scribed.

Piper Jaf­fray an­a­lysts backed him up, not­ing:

“(O)ve­r­all, from what we can tell, 30% of pa­tients stayed on the 300 mg dose, with ~60% on 200 mg and ~10% on 100 mg, im­ply­ing an ef­fec­tive price of ~$10,800/mo. Based on some of our re­cent doc checks, whether or not physi­cians all be­gin at 300 mg or ini­ti­ate treat­ment at 200 mg is al­so an open ques­tion that re­al world ex­pe­ri­ence will an­swer over time.”

So let’s call it a range.

Drug com­pa­nies have been com­ing un­der some heavy pres­sure for the way they price drugs, though com­pa­nies still have sig­nif­i­cant free­dom in the way they set a list price. It will be up to pay­ers now to wres­tle a low­er dis­count price as they dan­gle for­mu­la­ry po­si­tions in front of ea­ger sales op­er­a­tions.

Moul­der seems con­fi­dent that they can play well in that dis­cus­sion.

Added Piper Jaf­fray:

As the PARPi field con­tin­ues to evolve with every dataset and ap­proval, there are still mul­ti­ple mov­ing parts, one of which may be price. As po­ten­tial­ly the low­er cost PARPi based on ef­fec­tive re­al world dose, whether or not Ze­ju­la can dif­fer­en­ti­ate with pay­ers and gain pre­ferred for­mu­la­ry sta­tus is un­known, and we note that PARP in­hibitors are re­im­bursed un­der Part D and dis­count­ing / re­bates may make all the dif­fer­ence. That said, while there will con­tin­ue to be some un­cer­tain­ty around price and mar­ket share, the class con­tin­ues to be well po­si­tioned to ex­pand in­to ad­di­tion­al sol­id tu­mors and we firm­ly be­lieve that PARP in­hibitors will be a big class in on­col­o­gy.

Robert Bradway (Photographer: Scott Eisen/Bloomberg via Getty Images)

UP­DAT­ED: Am­gen snaps up can­cer drug play­er Five Prime, adding PhI­II-ready FGFR2b drug in $2B M&A play

Amgen is making a long-awaited move on the M&A side, buying South San Francisco-based Five Prime $FPRX for close to $2 billion and adding a slate of new cancer drugs to the pipeline.

Amgen is paying $38 a share, putting the deal value at $1.9 billion. The stock closed at $21.26 last night, giving investors a 78% premium.

The jewel in the crown of this deal is bemarituzumab, which Amgen describes as a first-in-class, Phase III-ready anti-FGFR2b antibody. Amgen was drawn to the bargaining table by Five Prime’s mid-stage data on gastric cancer, satisfied by PFS and OS data helping to validate FGFR2b as a target. Amgen researchers will now expand on the R&D program in other epithelial cancers, including lung, breast, ovarian and other cancers.

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David Liu (Casey Atkins Photography courtesy Broad Institute)

David Liu has a new big idea: pro­teome edit­ing. It could one day shred tau, RAS and some of the worst dis­ease-caus­ing pro­teins

Before David Liu became famous for inventing new forms of gene editing, he was known around academia in part for a more obscure innovation: a Rube Goldberg-esque system that uses bacteria-infecting viruses to take one protein and turn it into another.

Since 2011, Liu’s lab has used the system, called PACE, to dream up fantastical new proteins: DNA base editors far more powerful than the original; more versatile forms of the gene editor Cas9; insecticides that kill insecticide-resistant bugs; enzymes that slide synthetic amino acids into living organisms. But they struggled throughout to master one of the most common and powerful proteins in the biological world: proteases, a set of Swiss army knife enzymes that cut, cleave or shred other proteins in everything from viruses to humans.

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The 2021 top 100 bio­phar­ma in­vestors: As the pan­dem­ic hit and IPOs boomed, VCs swung in­to ac­tion like nev­er be­fore

The global pandemic may have roiled economies, killed hundreds of thousands and throttled entire industries, but the only effect it had on biopharma venture investing was to help turbocharge the field to giddy new heights.

Below you’ll find the new top 100 venture investors in the industry, ranked by the number of deals they were publicly involved in, as tracked by DealForma chief Chris Dokomajilar. The numbers master then calculated the estimated amount of money they put into each deal — divvying up the cash by the number of players — to indicate how they managed their syndicates.

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UP­DAT­ED: Mer­ck pulls Keytru­da in SCLC af­ter ac­cel­er­at­ed nod. Is the FDA get­ting tough on drug­mak­ers that don't hit their marks?

In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders?

Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday.

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In the lat­est big in­vest­ment in gene ther­a­py man­u­fac­tur­ing, Bio­gen com­mits $200M to a ma­jor new fa­cil­i­ty in NC

You’d be forgiven for thinking that the only R&D effort of any consequence at Biogen belongs to aducanumab, its controversial Alzheimer’s drug. But behind the uproar around that drug, the big biotech has a full scale pipeline in play that includes a growing focus on developing gene therapies.

Now Biogen plans to build up the kind of manufacturing muscle that will give it an advantage in gaining FDA approvals — where CMC is always key — and then marketing them around the world.

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Lat­est Mass­Bio re­port shows just how much bio­phar­ma's biggest sec­tor boomed in 2020

It’s clear by now that biopharma experienced a massive boom in 2020, but a new report out Thursday says the Massachusetts hub was particularly successful.

The trade group MassBio released its latest industry snapshot, summarizing the last calendar year as the most successful for the Massachusetts biopharma sector. Overall, Massachusetts-based biotechs raised $5.8 billion in 2020, marking a hefty 93% increase from the previous year.

Eli Lil­ly claims a TKO in its long-run­ning ti­tle fight with No­vo Nordisk for the block­buster di­a­betes mar­ket — but there’s a hitch

Eli Lilly isn’t just gunning for a better diabetes drug in tirzepatide. They want to cut ahead of Novo Nordisk’s blockbuster rival Ozempic (semaglutide) on the obesity front as well. But a newly-claimed win in a head-to-head Phase III showdown over reducing A1C while shedding pounds — complete with clear evidence of superiority over the approved rival — could prove a tough sell right now.

Let’s start with the latest data from Lilly.

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Amid back of­fice con­sol­i­da­tion, Gilead ax­es 179 jobs in Cal­i­for­nia

Gilead is chopping 179 jobs in its home state of California as it scales down its headquarters in favor of a hub in North Carolina.

Up to half of the roles would shift to Research Triangle Park, where the company is setting up a new business services and information technology center, the San Francisco Chronicle reported. The precise number will depend on how many employees choose to relocate.

Per a WARN notice filed with the state, the layoffs are expected to be effective May 30.

In­tro­duc­ing End­points FDA+, our new pre­mi­um week­ly reg­u­la­to­ry news re­port led by Zachary Bren­nan

CRLs. 483s. CBER, CDER and RWE. For biopharma professionals, these acronyms command attention because of the fundamental role FDA plays in drug development. Now Endpoints is doubling down on regulatory coverage, and launching a weekly report focusing on developments out of White Oak, with analysis and insight into what it all means.

Coverage will be led by our new senior editor, Zachary Brennan. He joins Endpoints from POLITICO, where he covered pharma. Prior to that he was the managing editor for Regulatory Focus, a news publication from the Regulatory Affairs Professionals Society.