BioReg­num: An­oth­er great rea­son emerges for As­traZeneca to tar­get new biotech deals

Bioreg­num
The view from End­points

The pres­sure on As­traZeneca CEO Pas­cal So­ri­ot to get its glob­al R&D op­er­a­tion to per­form while ex­e­cut­ing new deals just soared. The phar­ma gi­ant has lost a bid to keep cheap gener­ic ver­sions of Crestor off the mar­ket. That drug earned some $5 bil­lion of the $23 bil­lion it made last year.

To put this in­to a per­spec­tive that must be in­creas­ing­ly un­com­fort­able at the phar­ma gi­ant, As­traZeneca will soon have a new, block­buster-sized hole to fill as in­vestors con­tin­ue to in­sist that the com­pa­ny keep its promise to hit $45 bil­lion in sales in just sev­en more years.

It’s no won­der that As­traZeneca has been ru­mored to be lurk­ing near the bar­gain­ing ta­ble for the Medi­va­tion buy­out. An es­tab­lished drug plus a promis­ing late-stage PARP in­hibitor could be just what the doc­tor or­dered. And if an­oth­er com­pa­ny like Sanofi wins the bid­ding war, As­traZeneca is go­ing to be forced to find oth­er drugs to help with its am­bi­tious mis­sion.

The com­pa­ny’s lawyers had kept peo­ple guess­ing about the out­come un­til late yes­ter­day, when a fed­er­al judge ruled against As­traZeneca’s bid to use a re­cent ap­proval to use a high dose of the drug for rare cas­es of ho­mozy­gous fa­mil­ial hy­per­c­ho­les­terolemia in chil­dren. The lawyers tried to ar­gue that FDA la­bel­ing rules on pe­di­atric drugs should keep the gener­ic off the ta­ble.

The judge, though, wasn’t in­ter­est­ed in pro­tect­ing the mega-fran­chise at the pub­lic’s ex­pense and re­ject­ed the re­quest for a tem­po­rary re­strain­ing or­der. Sen­a­tors Su­san Collins and Claire Mc­Caskill weren’t amused, ei­ther. They not­ed in a let­ter to So­ri­ot that the ap­proval they based their chal­lenge on rest­ed on 300 pa­tients, rais­ing con­cerns about the mil­lions who would ben­e­fit from a cheap copy­cat.

Cut off from the le­gal gam­bit, So­ri­ot will be forced to fo­cus on deals, as it’s un­like­ly the pipeline will get him to where he needs to be.

As­traZeneca—the world’s 7th largest drug de­vel­op­er by R&D bud­get—won big with its re­cent ap­proval for Tagris­so. But with its check­point in­hibitor rel­e­gat­ed to a late fourth-place fin­ish, it will need a lot of help to come even close to the fin­ish line it set for it­self as Pfiz­er looked to buy the com­pa­ny.

Any biotech com­pa­ny that sees them com­ing won’t over­look that sim­ple fact. As­traZeneca will need to pay a pre­mi­um for sheer need­i­ness.

In the mean­time, As­traZeneca may al­so feel pres­sure to shed more R&D jobs. The com­pa­ny con­firmed last week that it was cut­ting back at Med­Im­mune, even as it fo­cused more on im­muno-on­col­o­gy. Now comes con­fir­ma­tion of some small but note­wor­thy cut­backs in Boston as well.

Any­one not work­ing on a pri­or­i­ty project—par­tic­u­lar­ly in can­cer—may be feel­ing par­tic­u­lar­ly vul­ner­a­ble right now. – John Car­roll, fol­low me @John­Cendpts

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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