Sen­a­tors heap abuse on Al­ler­gan's at­tempt at an end run around patent re­views, of­fer bill to stop 'sham'

Brent Saun­ders

Al­ler­gan CEO Brent Saun­ders $AGN ve­he­ment­ly de­fend­ed his move to try and shield the com­pa­ny’s Resta­sis fran­chise by hand­ing its patents over to a Mo­hawk In­di­an tribe as a strike against the in­ter partes re­view process, which the com­pa­ny felt was an in­her­ent­ly un­fair threat to its block­buster drug.

What the com­pa­ny ac­com­plished, though, was to stir up a hor­net’s nest of an­gry law­mak­ers who con­demned the move as a sham. And a bi­par­ti­san group of law­mak­ers heav­i­ly rep­re­sent­ed by Re­pub­li­cans re­tal­i­at­ed this week with a new bill that would pre­vent any­one from try­ing this again.

The patent moves re­ly on the tribe’s claim of sov­er­eign im­mu­ni­ty. If they held the patents, then the IPR process could not be used to wres­tle away their pro­tec­tions. The fact that Al­ler­gan paid them for the patent deal, then leased back the patents, didn’t sit well with crit­ics.

The Pre­serv­ing Ac­cess to Cost Ef­fec­tive Drugs (PACED) Act, a ti­tle that un­der­scores the law­mak­ers’ be­lief that the on­ly thing Al­ler­gan had in mind was pro­tect­ing its sec­ond biggest drug fran­chise, would kill that ma­neu­ver.

Claire Mc­Caskill

“We watched a com­pa­ny brazen­ly try to ex­ploit a po­ten­tial le­gal loop­hole to game the sys­tem in an ef­fort to pro­tect their bot­tom line-and keep Mis­souri­ans from ac­cess to cheap­er gener­ic drug op­tions in the process. That should be il­le­gal, and our bi­par­ti­san bill would make it so by end­ing this as­tound­ing as­ser­tion of sov­er­eign im­mu­ni­ty to avoid patent re­view, be­fore any oth­er com­pa­nies fol­low suit,” said Sen­a­tor Claire Mc­Caskill, a De­mo­c­rat from Mis­souri.

The Re­pub­li­cans were just as harsh in con­demn­ing it.

Pat Toomey

Sen­a­tor Pat Toomey, a Re­pub­li­can from Penn­syl­va­nia: “Sham trans­ac­tions in­volv­ing the trans­fer of patent own­er­ship from a phar­ma­ceu­ti­cal com­pa­ny to a tribe for the sole pur­pose of shield­ing the patent from chal­lenges are a clear abuse of our patent sys­tem and set a dan­ger­ous prece­dent for oth­er con­sumer prod­ucts.”

David Per­due

Sen­a­tor David Per­due, Re­pub­li­can from Geor­gia: ”Gam­ing the patent sys­tem is not good for con­sumers or busi­ness­es. I’m dis­ap­point­ed this leg­is­la­tion even has to be of­fered due to a few bad ac­tors try­ing to do an end run around the U.S. Patent and Trade­mark Of­fice.”

Joni Ernst

Sen­a­tor Joni Ernst, Re­pub­li­can from Iowa: “Con­gress can­not look the oth­er way as some phar­ma­ceu­ti­cal com­pa­nies at­tempt to sti­fle com­pe­ti­tion and pre­vent Amer­i­cans from ac­cess­ing af­ford­able gener­ic drugs.”

Al­ler­gan’s de­ci­sion to try the Mo­hawk so­lu­tion to their trou­bles has al­ready been dissed by the courts as well as the Patent Tri­al and Ap­peal Board. The sen­a­tors’ state­ment al­so list­ed their sup­port­ers, in­clud­ing some promi­nent play­ers in the health in­sur­ance field. This is all lean­ing heav­i­ly in one di­rec­tion.

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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