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.

Hal Barron, GSK

Break­ing the death spi­ral: Hal Bar­ron talks about trans­form­ing the mori­bund R&D cul­ture at GSK in a crit­i­cal year for the late-stage pipeline

Just ahead of GlaxoSmithKline’s Q2 update on Wednesday, science chief Hal Barron is making the rounds to talk up the pharma giant’s late-stage strategy as the top execs continue to woo back a deeply skeptical investor group while pushing through a whole new R&D culture.

And that’s not easy, Barron is quick to note. He told the Financial Times:

I think that culture, to some extent, is as hard, in fact even harder, than doing the science.

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Aca­dia is mak­ing the best of it, but their lat­est PhI­II Nu­plazid study is a bust

Acadia’s late-stage program to widen the commercial prospects for Nuplazid has hit a wall. The biotech reported that their Phase III ENHANCE trial flat failed. And while they $ACAD did their best to cherry pick positive data wherever they can be found, this is a clear setback for the biotech.

With close to 400 patients enrolled, researchers said the drug flunked the primary endpoint as an adjunctive therapy for patients with an inadequate response to antipsychotic therapy. The p-value was an ugly 0.0940 on the Positive and Negative Syndrome Scale, which the company called out as a positive trend.

Their shares slid 12% on the news, good for a $426 million hit on a $3.7 billion market cap at close.

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Some Big Phar­mas stepped up their game on da­ta trans­paren­cy — but which flunked the test?

The nonprofit Bioethics International has come out with their latest scorecard on data transparency among the big biopharmas in the industry — flagging a few standouts while spotlighting some laggards who are continuing to underperform.

Now in its third year, the nonprofit created a new set of standards with Yale School of Medicine and Stanford Law School to evaluate the track record on trial registration, results reporting, publication and data-sharing practice.

Busy Gilead crew throws strug­gling biotech a life­line, with some cash up­front and hun­dreds of mil­lions in biobucks for HIV deal

Durect $DRRX got a badly needed shot in the arm Monday morning as Gilead’s busy BD team lined up access to its extended-release platform tech for HIV and hepatitis B.

Gilead, a leader in the HIV sector, is paying a modest $25 million in cash for the right to jump on the platform at Durect, which has been using its technology to come up with an extended-release version of bupivacaine. The FDA rejected that in 2014, but Durect has been working on a comeback.

In­tec blitzed by PhI­II flop as lead pro­gram fails to beat Mer­ck­'s stan­dard com­bo for Parkin­son’s

Intec Pharma’s $NTEC lead drug slammed into a brick wall Monday morning. The small-cap Israeli biotech reported that its lead program — coming off a platform designed to produce a safer, more effective oral drug for Parkinson’s — failed the Phase III at the primary endpoint.

Researchers at Intec, which has already seen its share price collapse over the past few months, says that its Accordion Pill-Carbidopa/Levodopa failed to prove superior to Sinemet in reducing daily ‘off’ time. 

Cel­gene racks up third Ote­zla ap­proval, heat­ing up talks about who Bris­tol-My­ers will sell to

Whoever is taking Otezla off Bristol-Myers Squibb’s hands will have one more revenue stream to boast.

The drug — a rising star in Celgene’s pipeline that generated global sales of $1.6 billion last year — is now OK’d to treat oral ulcers associated with Behçet’s disease, a common symptom for a rare inflammatory disorder. This marks the third FDA approval for the PDE4 inhibitor since 2014, when it was greenlighted for plaque psoriasis and psoriatic arthritis.

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Francesco De Rubertis

Medicxi is rolling out its biggest fund ever to back Eu­rope's top 'sci­en­tists with strange ideas'

Francesco De Rubertis built Medicxi to be the kind of biotech venture player he would have liked to have known back when he was a full time scientist.

“When I was a scientist 20 years ago I would have loved Medicxi,’ the co-founder tells me. It’s the kind of place run by and for investigators, what the Medicxi partner calls “scientists with strange ideas — a platform for the drug hunter and scientific entrepreneur. That’s what I wanted when I was a scientist.”

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Af­ter a decade, Vi­iV CSO John Pot­tage says it's time to step down — and he's hand­ing the job to long­time col­league Kim Smith

ViiV Healthcare has always been something unique in the global drug industry.

Owned by GlaxoSmithKline and Pfizer — with GSK in the lead as majority owner — it was created 10 years ago in a time of deep turmoil for the field as something independent of the pharma giants, but with access to lots of infrastructural support on demand. While R&D at the mother ship inside GSK was souring, a razor-focused ViiV provided a rare bright spot, challenging Gilead on a lucrative front in delivering new combinations that require fewer therapies with a more easily tolerated regimen.

They kept a massive number of people alive who would otherwise have been facing a death sentence. And they made money.

And throughout, John Pottage has been the chief scientific and chief medical officer.

Until now.

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Vlad Coric (Biohaven)

In an­oth­er dis­ap­point­ment for in­vestors, FDA slaps down Bio­haven’s re­vised ver­sion of an old ALS drug

Biohaven is at risk of making a habit of disappointing its investors.

Late Friday the biotech $BHVN reported that the FDA had rejected its application for riluzole, an old drug that they had made over into a sublingual formulation that dissolves under the tongue. According to Biohaven, the FDA had a problem with the active ingredient used in a bioequivalence study back in 2017, which they got from the Canadian drugmaker Apotex.

Apotex, though, has been a disaster ground. The manufacturer voluntarily yanked the ANDAs on 31 drugs — in late 2017 — after the FDA came across serious manufacturing deficiencies at their plants in India. A few days ago, the FDA made it official.

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