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.

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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UP­DAT­ED: Leg­end fetch­es $424 mil­lion, emerges as biggest win­ner yet in pan­dem­ic IPO boom as shares soar

Amid a flurry of splashy pandemic IPOs, a J&J-partnered Chinese biotech has emerged with one of the largest public raises in biotech history.

Legend Biotech, the Nanjing-based CAR-T developer, has raised $424 million on NASDAQ. The biotech had originally filed for a still-hefty $350 million, based on a range of $18-$20, but managed to fetch $23 per share, allowing them to well-eclipse the massive raises from companies like Allogene, Juno, Galapagos, though they’ll still fall a few dollars short of Moderna’s record-setting $600 million raise from 2018.

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As it hap­pened: A bid­ding war for an an­tibi­ot­ic mak­er in a mar­ket that has rav­aged its peers

In a bewildering twist to the long-suffering market for antibiotics — there has actually been a bidding war for an antibiotic company: Tetraphase.

It all started back in March, when the maker of Xerava (an FDA approved therapy for complicated intra-abdominal infections) said it had received an offer from AcelRx for an all-stock deal valued at $14.4 million.

The offer was well-timed. Xerava was approved in 2018, four years after Tetraphase posted its first batch of pivotal trial data, and sales were nowhere near where they needed to be in order for the company to keep its head above water.

Drug man­u­fac­tur­ing gi­ant Lon­za taps Roche/phar­ma ‘rein­ven­tion’ vet as its new CEO

Lonza chairman Albert Baehny took his time headhunting a new CEO for the company, making it absolutely clear he wanted a Big Pharma or biotech CEO with a good long track record in the business for the top spot. In the end, he went with the gold standard, turning to Roche’s ranks to recruit Pierre-Alain Ruffieux for the job.

Ruffieux, a member of the pharma leadership team at Roche, spent close to 5 years at the company. But like a small army of manufacturing execs, he gained much of his experience at the other Big Pharma in Basel, remaining at Novartis for 12 years before expanding his horizons.

Covid-19 roundup: Ab­b­Vie jumps in­to Covid-19 an­ti­body hunt; As­traZeneca shoots for 2B dos­es of Ox­ford vac­cine — with $750M from CEPI, Gavi

Another Big Pharma is entering the Covid-19 antibody hunt.

AbbVie has announced a collaboration with the Netherlands’ Utrecht University and Erasmus Medical Center and the Chinese-Dutch biotech Harbour Biomed to develop a neutralizing antibody that can treat Covid-19. The antibody, called 47D11, was discovered by AbbVie’s three partners, and AbbVie will support early preclinical work, while preparing for later preclinical and clinical development. Researchers described the antibody in Nature Communications last month.

Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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Bris­tol My­ers is clean­ing up the post-Cel­gene merg­er pipeline, and they’re sweep­ing out an ex­per­i­men­tal check­point in the process

Back during the lead up to the $74 billion buyout of Celgene, the big biotech’s leadership did a little housecleaning with a major pact it had forged with Jounce. Out went the $2.6 billion deal and a collaboration on ICOS and PD-1.

Celgene, though, also added a $530 million deal — $50 million up front — to get the worldwide rights to JTX-8064, a drug that targets the LILRB2 receptor on macrophages.

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GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.

UP­DAT­ED: Es­ti­mat­ing a US price tag of $5K per course, remde­sivir is set to make bil­lions for Gilead, says key an­a­lyst

Data on remdesivir — the first drug shown to benefit Covid-19 patients in a randomized, controlled trial setting — may be murky, but its maker Gilead could reap billions from the sales of the failed Ebola therapy, according to an estimate by a prominent Wall Street analyst. However, the forecast, which is based on a $5,000-per-course US price tag, triggered the ire of one top drug price expert.