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.

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Rybelsus will be the first GLP-1 pill to enter the type 2 diabetes market — a compelling offering that analysts have pegged as a blockbuster drug with sales estimates ranging from $2 billion to $5 billion.

Ozempic, the once-weekly injectable formulation of semaglutide, brought in around $552 million (DKK 3.75 billion) in the first half of 2019.

As Nas­daq en­rolls the fi­nal batch of 2019 IPOs, how have the num­bers com­pared to past years?

IGM Biosciences’ upsized IPO haul, coming after SpringWorks’ sizable public debut, has revved up some momentum for the last rush of biotech IPOs in 2019.

With 39 new listings on the books and roughly two more months to go before winding down, Nasdaq’s head of healthcare listings Jordan Saxe sees the exchange marking 50 to 60 biopharma IPOs for the year.

“December 15 is usually the last possible day that companies will price,” he said, as companies get ready for business talks at the annual JP Morgan Healthcare Conference in January.

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Scott Got­tlieb is once again join­ing a team that en­joyed good times at the FDA un­der his high-en­er­gy stint at the helm

Right after jumping on Michael Milken’s FasterCures board on Monday, the newly departed FDA commissioner is back today with news about another life sciences board post that gives him a ringside chair to cheer on a lead player in the real-world evidence movement — one with very close ties to the FDA.

Aetion is reporting this morning that Gottlieb is joining their board, a group that includes Mohamad Makhzoumi, a general partner at New Enterprise Associates, where Gottlieb returned after stepping out of his role at the FDA 2 years after he started.

Gottlieb — one of the best connected execs in biopharma — knows this company well. As head of FDA he championed the use of real-world evidence to help guide drug developers and the agency in gaining greater efficiencies, which helped set up Aetion as a high-profile player in the game.

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