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

Daniel O'Day [via AP Images]

UP­DAT­ED: Look­ing to re­solve lin­ger­ing doubts, Gilead un­leash­es a $5B late-stage cash al­liance with Gala­pa­gos

Daniel O’Day is executing his first major development deal since taking over as CEO of Gilead $GILD. And he’s going in deep to ally himself with a longstanding partner.

O’Day announced today that he is spending $5 billion in cash to add new late-stage drugs to Gilead’s pipeline, picking up rights to Galapagos’ $GLPG Phase III IPF drug GLPG1690 alongside adoption of the biotech’s Phase IIb drug GLPG1972 for osteoarthritis. And Gilead is also putting billions more on the table for milestones, gaining options for everything else in Galapagos’ pipeline, with a shot at all rights outside of Europe.

UP­DAT­ED: Am­gen, No­var­tis scrap Alzheimer's stud­ies — is BACE fi­nal­ly dead or will Bio­gen and Ei­sai car­ry on?

The BACE theory of controlling Alzheimer’s died with failed pivotal projects at Merck, Eli Lilly and their partners at AstraZeneca. Now Amgen and Novartis have come along to bulldoze it under a mound of safety threats — leaving only Biogen and Eisai to carry on with a less than zero chance of success — with the notable addition that they may actually be doing harm to patients.

After the market closed Thursday, Amgen and Novartis announced that they were dumping two pivotal programs underway with the Banner Alzheimer’s Institute on their BACE drug CNP520 (umibecestat) after an independent review of the data indicated that patients’ cognitive abilities were actually worsening at a faster pace than the placebo arm.

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Christi Shaw at JP Morgan 2019. Jeff Rumans for Endpoints News

Fresh out of Eli Lil­ly, Christi Shaw sur­faces as Daniel O'­Day's new CEO at CAR-T pi­o­neer Kite

Well, that didn’t take long. 

We found out Thursday evening that Christi Shaw has given up her top post as the head of the Bio-Medicines group at Eli Lilly for the helm at CAR-T pioneer Kite. New Gilead CEO Daniel O’Day, a Roche veteran, had made finding a Kite CEO a top priority on his arrival at Gilead. And he went right for a headliner.

O’Day was clearly excited about the coup.

“We conducted an extensive search for a new leader at Kite and we believe that Christi’s unique set of skills will allow us to continue to build on our leadership position in cell therapy,” he said in a prepared statement. “Christi’s vast experience across complex therapeutic areas, and particularly in oncology, will serve Kite very well. She is clearly a leader who will bring teams and individuals together and I am confident she will build upon the entrepreneurial spirit at Kite as we seek to help more people with cancer around the world.”

Christi Shaw at JP Morgan 2019. Jeff Rumans for Endpoints News

Eli Lil­ly's Christi Shaw bows out of top post at the Bio-Med­i­cines unit

Less than 3 years after Eli Lilly CEO David Ricks recruited Novartis vet Christi Shaw to run their big Bio-Medicines business, she’s out.

In a statement put out Thursday morning, Lilly said that Shaw’s last day will come at the end of August. Patrik Jonsson, currently president and general manager of Lilly Japan, will succeed Shaw once he gets the paperwork sorted out.

Lilly’s shares dropped 4% on the news.

Jeff Poulton

Al­ny­lam’s Maraganore switch­es ‘per­haps the best CFO in mid-cap biotech’ with Shire vet Jeff Poul­ton

There’s a new CFO taking charge of the numbers at RNAi pioneer Alnylam.

Alnylam chief John Maraganore says that CFO Manmeet S. Soni is leaving in the proverbial pursuit of new opportunities. And he’s being replaced by ex-Shire CFO Jeff Poulton, not long after the Takeda takeover obliterated that position.

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Analy­sis: In most of the Big Phar­ma world, R&D spend­ing tow­ers over rev­enue from new drugs. Guess who beat the odds

It’s always been the case that there’s no medicine less useful than one that doesn’t make it to patients (unless you regard the task of R&D to be perpetually learning about swimming, while under water…). Yet, launching new medicines that physicians want, that payers will cover, and that patients will take, is a discipline that is unevenly distributed among the big players.

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President Donald Trump at State of the Union. AP Images

White House changes course to kill re­bate re­form

So what exactly is the White House’s plan to tackle rising drug prices? It doesn’t look like we will get definitive answers anytime soon. On the heels of President Donald Trump’s surprise revelation that an executive order is in the works to implement a “favored nations clause,” his administration is now putting out word that it has abandoned an earlier proposal to overhaul rebates.

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Janet Woodcock, AP Images

The FDA's Janet Wood­cock talks about some big changes she's push­ing for in drug de­vel­op­ment, and agency re­views

Janet Woodcock is perhaps the most influential regulator at the FDA. And when the head of CDER talks about the changes being made at the agency when it comes to clinical trial designs, or the need to reorganize for a specific disease arena, an assessment of the expansion of gene therapy or I/O, common development mistakes, and so on, you can be sure the industry pays attention to every word.

So it was with some eagerness that I opened up Geoffrey Porges’ summary of their recent conversation about the FDA. And I wasn’t disappointed. In a wide-ranging exchange with the SVB Leerink analyst, Woodcock discussed the growing importance of patient-reported outcomes in clinical trials, a campaign underway now to see if CROs would help spur more basket studies to compare drugs head-to-head, and much, much more.

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Ex-DARPA di­rec­tor pur­sues all-in-one can­cer pill as NED CEO; Karyopharm los­es com­mer­cial chief ahead of drug roll­out

“Why not try?”

That’s what Geoffrey Ling told me over the phone when asked about what led him to his journey to the position of CEO at NED Biosciences — a company with a lofty goal of creating an all-in-one oral drug to treat all types of cancer and making this drug available to not only developed nations, but also the developing world. 

Ling comes from an extensive background in medicine and the government. He is the co-leader of The Brain Health Project, a professor of neurology and an attending neurocritical care physician at John Hopkins University and Hospital, as well as the assistant director for Medical Innovation of the Science Division in president Obama’s White House Office of Science and Technology Policy (OSTP).