Dear Bernie: Cat­a­lyst CEO McE­nany de­fends his $375,000 price tag on an old drug once of­fered for free

Now that Cat­a­lyst has tak­en cen­ter stage as this quar­ter’s most fre­quent­ly pil­lo­ried price gouger, the com­pa­ny $CPRX is try­ing to take a stand in de­fense of the $375,000 an­nu­al price tag it has slapped on its new­ly ap­proved drug Fir­dapse.

Patrick McE­nany

Just ahead of his new­ly an­nounced sec­ond run for the pres­i­den­cy, Ver­mont Sen­a­tor Bernie Sanders called out Cat­a­lyst for “fleec­ing” tax­pay­ers, the “im­moral ex­ploita­tion of pa­tients” and high­light­ed the is­sue as yet an­oth­er ex­am­ple of a drug com­pa­ny’s “cor­po­rate greed.”  And some pa­tients have com­plained bit­ter­ly that they couldn’t af­ford the drug now, once hand­ed out for free to many of the peo­ple who suf­fer from the rare au­toim­mune dis­ease Lam­bert-Eaton myas­thenic syn­drome, or LEMS.

Once the FDA ap­proval came for Cat­a­lyst, that free road was closed.

Cat­a­lyst CEO Patrick McE­nany is now build­ing his stand around the FDA ap­proval. The biotech spent “mil­lions” test­ing the drug, which it claims is not an old drug, but a fresh­ly sanc­tioned new chem­i­cal en­ti­ty that has nev­er been ap­proved be­fore.

Its pric­ing? McE­nany has this to say in his re­sponse to Sanders:

We be­lieve that the pric­ing of our prod­uct is in line with the pric­ing of oth­er prod­ucts that pro­vide sig­nif­i­cant clin­i­cal ben­e­fits  in treat­ing an ul­tra-or­phan dis­ease of sim­i­lar sever­i­ty and in or­der to prop­er­ly com­pen­sate com­pa­nies for the costs as­so­ci­at­ed with de­vel­op­ing, man­u­fac­tur­ing, and mar­ket­ing an or­phan drug in com­pli­ance with reg­u­la­to­ry re­quire­ments.

The CEO al­so says the com­pa­ny will do what­ev­er they can to lim­it pa­tients’ out of pock­et cost, down­play­ing the free sup­ply that had been avail­able, which he says was pro­vid­ed to on­ly a cou­ple of hun­dred pa­tients in the US.

We’ve heard these ar­gu­ments be­fore, from Mar­tin Shkre­li (“it was a busi­ness de­ci­sion”) to Marathon CEO Jeff Aronin, who in­sist­ed that the $89,000 list price for an old steroid was jus­ti­fied by the tri­al work re­quired by the FDA for an ap­proval.

Once in the spot­light, though, there’s no easy way out. A de­fi­ant Shkre­li end­ed up in prison for rea­sons com­plete­ly un­re­lat­ed to drug prices, Aronin laid low and then sold his drug to PTC and moved out of the hot seat as fast as he could. McE­nany will now see if he can weath­er the storm at a time a ma­jor­i­ty of Amer­i­cans — and the pres­i­dent — have voiced their dis­gust over drug prices.

McE­nany has an ace in the hole. He didn’t break any laws set­ting his price as a mo­nop­oly. That’s com­plete­ly le­gal, and com­plete­ly con­tro­ver­sial. His chances of per­suad­ing Sanders and his oth­er crit­ics in Wash­ing­ton DC to leave off, how­ev­er, are mi­nus­cule.


Im­age: Bernie Sanders. SHUT­TER­STOCK

As­traZeneca trum­pets the good da­ta they found for Tagris­so in an ad­ju­vant set­ting for NSCLC — but many of the ex­perts aren’t cheer­ing along

AstraZeneca is rolling out the big guns this evening to provide a salute to their ADAURA data on Tagrisso at ASCO.

Cancer R&D chief José Baselga calls the disease-free survival data for their drug in an adjuvant setting of early stage, epidermal growth factor receptor-mutated NSCLC patients following surgery “momentous.” Roy Herbst, the principal investigator out of Yale, calls it “transformative.”

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Pablo Legorreta, founder and CEO of Royalty Pharma AG, speaks at the annual Milken Institute Global Conference in Beverly Hills, California (Patrick T. Fallon/Bloomberg via Getty Images)

Cap­i­tal­iz­ing Pablo: The world’s biggest drug roy­al­ty buy­er is go­ing pub­lic. And the low-key CEO di­vulges a few se­crets along the way

Pablo Legorreta is one of the most influential players in biopharma you likely never heard of.

Over the last 24 years, Legorreta’s Royalty Pharma group has become, by its own reckoning, the biggest buyer of drug royalties in the world. The CEO and founder has bought up a stake in a lengthy list of the world’s biggest drug franchises, spending $18 billion in the process — $2.2 billion last year alone. And he’s become one of the best-paid execs in the industry, reaping $28 million from the cash flow last year while reserving 20% of the cash flow, less expenses, for himself.

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Paul Hudson, Sanofi CEO (Getty Images)

Sanofi CEO Paul Hud­son has $23B burn­ing a hole in his pock­et. And here are some hints on how he plans to spend that

Sanofi has reaped $11.1 billion after selling off a big chunk of its Regeneron stock at $515 a share. And now everyone on the M&A side of the business is focused on how CEO Paul Hudson plans to spend it.

After getting stung in France for some awkward politicking — suggesting the US was in the front of the line for Sanofi’s vaccines given American financial support for their work, versus little help from European powers — Hudson now has the much more popular task of managing a major cash cache to pull off something in the order of a big bolt-on. Or two.

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The Advance Clinical leadership team: CEO Yvonne Lungershausen, Sandrien Louwaars - Director Business Development Operations, Gabriel Kremmidiotis - Chief Scientific Officer, Ben Edwards - Chief Strategy Officer

How Aus­tralia De­liv­ers Rapid Start-up and 43.5% Re­bate for Ear­ly Phase On­col­o­gy Tri­als

About Avance Clinical

Avance Clinical is an Australian owned Contract Research Organisation that has been providing high-quality clinical research services to the local and international drug development industry for 20 years. They specialise in working with biotech companies to execute Phase 1 and Phase 2 clinical trials to deliver high-quality outcomes fit for global regulatory standards.

As oncology sponsors look internationally to speed-up trials after unprecedented COVID-19 suspensions and delays, Australia, which has led the world in minimizing the pandemic’s impact, stands out as an attractive destination for early phase trials. This in combination with the streamlined regulatory system and the financial benefits including a very favourable exchange rate and the R & D cash rebate makes Australia the perfect location for accelerating biotech clinical programs.

Dan O'Day, Gilead CEO (Andrew Harnik, AP Images)

UP­DAT­ED: Gilead leas­es part­ner rights to TIG­IT, PD-1 in a $2B deal with Ar­cus. Now comes the hard part

Gilead CEO Dan O’Day has brokered his way to a PD-1 and lined up a front row seat in the TIGIT arena, inking a deal worth close to $2 billion to align the big biotech closely with Terry Rosen’s Arcus. And $375 million of that comes upfront, with cash for the buy-in plus equity, along with $400 million for R&D and $1.22 billion in reserve to cover opt-in payments and milestones..

Hotly rumored for weeks, the 2 players have formalized a 10-year alliance that starts with rights to the PD-1, zimberelimab. O’Day also has first dibs on TIGIT and 2 other leading programs, agreeing to an opt-in fee ranging from $200 million to $275 million on each. There’s $500 million in potential TIGIT milestones on US regulatory events — likely capped by an approval — if Gilead partners on it and the stars align on the data. And there’s another $150 million opt-in payments for the rest of the Arcus pipeline.

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No­var­tis jumps in­to Covid-19 vac­cine hunt, as Big Phar­ma and big biotech com­mit to bil­lions of dos­es

After spending most of the pandemic on the sidelines, Novartis is offering its aid in the race to develop a Covid-19 vaccine.

AveXis, the Swiss pharma’s gene therapy subsidiary, has agreed to manufacture the vaccine being developed by Massachusetts Eye and Ear and Massachusetts General Hospital. The biotech will begin manufacturing this month, while the vaccine undergoes further preclinical testing. They’ve agreed to provide the vaccine for free for clinical trials beginning in the second half of 2020, but have not disclosed financials for after.

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Bris­tol My­ers Squibb fi­nal­ly gets in the front­line NSCLC game dom­i­nat­ed by Mer­ck, adding a sec­ond Op­di­vo/Yer­voy-based op­tion

Bristol Myers Squibb may be trailing Merck and Roche in the checkpoint race to treat frontline cases of non-small cell lung cancer, but as it does, it makes sure to bring its best feet forward.

Just days after scoring a landmark NSCLC approval for Opdivo and Yervoy alone for PD-L1 positive patients, the company said the FDA has also OK’d using the two agents with a limited course of chemo regardless of the biomarker status.

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Bryan Roberts, Venrock

Ven­rock sur­vey shows grow­ing recog­ni­tion of coro­n­avirus toll, wan­ing con­fi­dence in ar­rival of vac­cines and treat­ments

When Venrock partner Bryan Roberts went to check the results from their annual survey of healthcare leaders, what he found was an imprint of the pandemic’s slow arrival in America.

The venture firm had sent their form out to hundreds of insurance and health tech executives, investors, officials and academics on February 24 and gave them two weeks to fill it out. No Americans had died at that point but the coronavirus had become enough of a global crisis that they included two questions about the virus, including “Total U.S. deaths in 2020 from the novel coronavirus will be:”.

Roger Perlmutter, Merck R&D chief (YouTube)

UP­DAT­ED: Backed by BAR­DA, Mer­ck jumps in­to Covid-19: buy­ing out a vac­cine, part­ner­ing on an­oth­er and adding an­tivi­ral to the mix

Merck execs are making a triple play in a sudden leap into the R&D campaign against Covid-19. And they have more BARDA cash backing them up on the move.

Tuesday morning the pharma giant simultaneously announced plans to buy an Austrian biotech that has been working on a preclinical vaccine candidate, added a collaboration on another vaccine with the nonprofit IAVI and inked a deal with Ridgeback Biotherapeutics on an early-stage antiviral.

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