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.

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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Covid-19 roundup: Roche pairs Actem­ra with remde­sivir in new PhI­II; GSK makes its own 1B vac­cine man­u­fac­tur­ing plan

A month after a small study in France suggested that Roche’s IL-6 inhibitor Actemra helped Covid-19 patients do better — even as Sanofi and Regeneron found somewhat disappointing results with their rival drug — Roche is doubling down on the strategy.

The Swiss pharma giant is kicking off a second Phase III global placebo-controlled study involving Actemra. But rather than testing it as a monotherapy, they will add Gilead’s remdesivir to the regimen.

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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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FDA ex­plains im­pact of Covid-19 on ap­pli­ca­tions, for­mal meet­ings

The FDA on Tuesday issued immediately effective guidance explaining how the coronavirus disease public health emergency is impacting the conduct of formal meetings and its review of certain user fee-funded applications.

The guidance features 11 questions and answers on how the agency intends to handle disruptions affecting meetings and goals under its user fee programs established by the Prescription Drug User Fee Act (PDUFA), Biosimilar User Fee Act (BSUFA) and the Generic Drug User Fee Amendments (GDUFA).

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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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:”.

Fabrice Chouraqui, Cellarity CEO-partner (LinkedIn)

Drug de­vel­op­er, Big Phar­ma com­mer­cial ex­ec, now an up­start biotech chief — Fab­rice Chouraqui is ready to try some­thing new as a ‘CEO-part­ner’ at Flag­ship

Fabrice Chouraqui’s career has taken some big twists along his life journey. He got his PharmD at Université Paris Descartes and jumped into the drug development game for a bit. Then he took a sharp turn and went back to school to get his MBA at Insead before returning to pharma on the commercial side.

Twenty years later, after steadily rising through the ranks and journeying the globe to nab a top job as president of US pharma for the Basel-based Novartis, Chouraqui exited in another career switch. And now he’s headed into a hybrid position as a CEO-partner at Flagship, where he’ll take a shot at leading Cellarity — one of the VC’s latest paradigm-changing companies of the groundbreaking model that aspires to deliver a new platform to the world of drug R&D.