As it takes Lartru­vo off the shelves, Lil­ly is set­ting up pro­gram to pro­vide drug ac­cess to cur­rent pa­tients

When Lil­ly’s ap­proved soft tis­sue sar­co­ma drug Lartru­vo un­ex­pect­ed­ly failed to help pa­tients live longer in a late-stage study in Jan­u­ary, US and EU reg­u­la­tors dis­cour­aged new pa­tients from start­ing treat­ment with the med­i­cine, and the drug­mak­er sus­pend­ed its pro­mo­tion of the ther­a­py.

Lartru­vo was cleared for use by the FDA un­der the ac­cel­er­at­ed ap­proval path­way — an in­creas­ing­ly pop­u­lar mech­a­nism used by the agency to has­ten the pace of ap­provals —  in 2016, and the con­fir­ma­to­ry Phase III tri­al was in­tend­ed to con­firm the drug’s ben­e­fit. Since the tri­al was un­suc­cess­ful, Lil­ly was ex­pect­ed to re­scind the drug from the mar­ket.  On Thurs­day, the com­pa­ny $LLY said it was work­ing on set­ting up a pro­gram so cur­rent pa­tients can still ac­cess Lartru­vo with “lim­it­ed in­ter­rup­tion” af­ter it is of­fi­cial­ly with­drawn.

Lil­ly said it was un­able to spec­u­late when the drug will be of­fi­cial­ly with­drawn, a spokesper­son told End­points News.

Lartru­vo, which gen­er­at­ed near­ly $305 mil­lion in sales last year, was ap­proved in com­bi­na­tion with the chemother­a­py dox­oru­bicin as a front­line treat­ment for a sub­set of pa­tients with soft tis­sue sar­co­ma (STS), a dis­ease that had seen no new ap­provals in decades.

In 2019, an es­ti­mat­ed 12,750 new STS cas­es will be di­ag­nosed, and more than 5,000 Amer­i­cans will suc­cumb to the dis­ease, ac­cord­ing to the Amer­i­can Can­cer So­ci­ety.

“(P)atients who are cur­rent­ly re­ceiv­ing Lartru­vo may, in con­sul­ta­tion with their physi­cian, con­tin­ue their course of ther­a­py if they have been in­formed of the risks of Lartru­vo and the re­sults of the (failed) AN­NOUNCE study and wish to con­tin­ue, sub­ject to lo­cal laws and reg­u­la­tions,” Lil­ly said in a state­ment.

Physi­cians will need to work with the com­pa­ny to set up con­tracts to en­roll their fa­cil­i­ties, and pa­tients will need to pro­vide writ­ten con­sent to en­roll in the pro­gram — if these steps are tak­en then cur­rent pa­tients should be able to ac­cess Lartru­vo free of charge, the spokesper­son said.

The US list price for the drug was $2,456 per 500 mg vial and $933.28 per 190 mg vial, and the av­er­age price at six month du­ra­tion of ex­po­sure would be $106,099.20, the spokesper­son not­ed, adding that a pa­tient’s out-of-pock­et cost would de­pend on var­i­ous fac­tors in­clud­ing in­sur­ance cov­er­age and med­ical as­sis­tance pro­grams.

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.

Altogether, Gilead is gaining rights to 6 clinical-stage assets, 20 preclinical programs and everything else being hatched in translation.

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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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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).