Re­struc­tur­ing the pipeline, Eli Lil­ly says a baric­i­tinib come­back in rheuma­toid arthri­tis could take years

Eli Lil­ly was sup­posed to mark this year with the launch of a new block­buster med­i­cine for rheuma­toid arthri­tis — wag­ing a com­mer­cial war with some high-pro­file ri­vals. In­stead, it is now fac­ing a years-long de­lay in or­der to mount a new study aimed at re­solv­ing the FDA’s safe­ty fears for baric­i­tinib. And its ri­vals are gain­ing a big head start in a ma­jor mar­ket.

In the mean­time, Lil­ly’s Q2 re­port in­cludes the news that the phar­ma gi­ant is re­or­ga­niz­ing its pipeline, pri­or­i­tiz­ing 10 drugs in the on­col­o­gy port­fo­lio while plan­ning to out­li­cense the rest of the slate.

Lil­ly $LLY had been close-mouthed about the rea­sons for the stun­ning re­jec­tion of baric­i­tinib in April. But in a new state­ment out ear­ly Tues­day, the phar­ma gi­ant made it clear that reg­u­la­tors had pulled the plug on baric­i­tinib af­ter fret­ting about a se­ries of throm­boem­bol­ic events — blood clots di­ag­nosed as deep ve­nous throm­bo­sis and pul­monary em­bolism — in two of sev­en Phase II and Phase III stud­ies.

Run­ning a new tri­al to get the FDA the new da­ta reg­u­la­tors are de­mand­ing and re­sub­mit­ting the ap­pli­ca­tion will take at least 18 months, says Lil­ly, which is one of the slow­er drug de­vel­op­ers among the largest phar­mas in the in­dus­try. Drug re­views al­so typ­i­cal­ly take 10 months to com­plete. And some an­a­lysts, like Leerink’s Sea­mus Fer­nan­dez, are shov­ing this one down the line by four long years.

Notes Fer­nan­dez: “While these up­dates are dis­ap­point­ing, it is con­sis­tent with our mod­eled US in­tro­duc­tion in 2021.”

In­vestors didn’t like the news. Lil­ly’s shares dropped close to 3% while its part­ner In­cyte saw its price slide 2.5%.

Lil­ly, mean­while, ap­pears ready to make some big changes in the can­cer drug pipeline it’s been build­ing. From its Q2 re­lease:

Us­ing this frame­work, Lil­ly will now fo­cus on sev­en pipeline as­sets for pri­or­i­ty in­ter­nal de­vel­op­ment and three ad­di­tion­al as­sets which are pend­ing da­ta from on­go­ing tri­als. The com­pa­ny has or will seek ex­ter­nal part­ners on the oth­er mol­e­cules in clin­i­cal de­vel­op­ment as ap­pro­pri­ate.

On the ta­ble for ac­quir­ers are these 6 Phase II pro­grams:

  • Galu­nis­ert­ib, a TGF-b in­hibitor in Phase II for he­pa­to­cel­lu­lar car­ci­no­ma.
  • Ralime­tinib, a p38 mi­to­gen-ac­ti­vat­ed pro­tein ki­nase in­hibitor in Phase II for ovar­i­an can­cer.
  • Emi­betuzum­ab, a MET an­ti­body in Phase II for non-small cell lung can­cer.
  • A notch in­hibitor
  • An FGFR in­hibitor
  • A CX­CR4 pep­tide in­hibitor

Lil­ly ex­ecs are clear­ly not hap­py about the baric­i­tinib set­back.

“We dis­agree with the FDA’s con­clu­sions, and be­lieve the ex­ist­ing com­pre­hen­sive clin­i­cal da­ta demon­strate there is a pos­i­tive ben­e­fit/risk pro­file that sup­ports baric­i­tinib’s ap­proval as a new treat­ment op­tion for peo­ple suf­fer­ing from RA in the Unit­ed States,” said Christi Shaw, pres­i­dent of Lil­ly Bio-Med­i­cines. Yes, the com­pa­ny, ad­mit­ted, there was an im­bal­ance in events if you look at the con­trolled stud­ies that com­pared the drug with a place­bo. But if you step back the rate was the same over the course of the full de­vel­op­ment pro­gram.

Eu­ro­pean and Japan­ese reg­u­la­tors, Lil­ly ar­gues, were will­ing to deal with the da­ta by adding a note of cau­tion warn­ing pa­tients at risk for DVT and PE.

Clear­ly, the FDA isn’t ac­cept­ing that ar­gu­ment.

In the mean­time, Re­gen­eron and Sanofi have strut­ted ahead to win a de­layed OK on sar­ilum­ab while Ab­b­Vie works on its own suc­ces­sor to Hu­mi­ra, ABT-494. And Gilead is mov­ing con­fi­dent­ly ahead with a mas­sive Phase III pro­gram for fil­go­tinib.

All of these drugs have been tapped as new ther­a­pies that could earn any­where from $2 bil­lion to $3 bil­lion each. This is not a race that Lil­ly could af­ford to lose.

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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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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The Avance 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.

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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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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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:”.

David Hoey (Vaxxas)

In for the long vac­cine game, Mer­ck buys in­to patch de­liv­ery tech with pan­dem­ic po­ten­tial

When Merck dived into the R&D fray for a Covid-19 vaccine earlier this week, execs made it clear that they’re not necessarily looking to be first — with CEO Ken Frazier throwing cold water on the hotly-discussed 12- to 18-month timelines. But when it does emerge from behind, the pharma giant clearly expects to play a significant part.

Part of that will depend on next-generation delivery technology that reshapes the world’s imagination of a vaccine.

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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