Al­ler­gan slammed as fed­er­al judge in­val­i­dates Resta­sis patents, slaps Mo­hawk deal

For weeks now Al­ler­gan has been ham­mered by a grow­ing le­gion of crit­ics in and out of Con­gress for its re­cent de­ci­sion to shift con­trol of its patents for Resta­sis to the Saint Reg­is Mo­hawk Tribe in an at­tempt to shield them from an ad­min­is­tra­tive re­view.

But that may have been all for naught.

A fed­er­al judge in Texas to­day ruled that Al­ler­gan’s Resta­sis patents, the last line of pro­tec­tion from gener­ics which aim to steal away their $1.5 bil­lion fran­chise, are in­valid. But the trib­al rights had noth­ing to do with that de­ci­sion. The judge cen­tered his de­ci­sion on his be­lief that the ideas the patents sought to pro­tect were too ob­vi­ous to pro­tect, ac­cord­ing to Reuters.

Al­ler­gan’s stock tanked on the news, falling 5% on the prospect that it would lose patent pro­tec­tion.

My­lan was gun­ning against Al­ler­gan’s Mo­hawk deal from the start, call­ing it a “sham” as law­mak­ers in the Sen­ate and House vowed to pass new leg­is­la­tion that would make any such trans­fers il­le­gal.

By shift­ing the patents to the tribe, and then es­sen­tial­ly leas­ing back rights to the drug through a mul­ti­mil­lion-dol­lar deal, Al­ler­gan had hoped to guard one flank ex­posed by in­ter partes re­views, or the IPR process. Al­ler­gan CEO Brent Saun­ders al­so vig­or­ous­ly de­fend­ed the deal, which was wide­ly crit­i­cized at a time the drug in­dus­try in gen­er­al finds it­self fight­ing back against at­tacks for cir­cling the le­gal wag­ons around high-priced brand­ed ther­a­pies.

The fed­er­al court, though, had oth­er ar­gu­ments than the Mo­hawk ploy to work with.

While the Mo­hawk deal might be moot, the judge al­so joined the cho­rus of crit­ics who saw it as noth­ing but a scheme to es­cape IPR. In a note out from Ever­cor­eISI’s Umer Raf­fat, the an­a­lyst quotes the judge:

The Court has se­ri­ous con­cerns about the le­git­i­ma­cy of the tac­tic that Al­ler­gan and the Tribe have em­ployed. The essence of the mat­ter is this: Al­ler­gan pur­ports to have sold the patents to the Tribe, but in re­al­i­ty it has paid the Tribe to al­low Al­ler­gan to pur­chase—or per­haps more pre­cise­ly, to rent—the Tribe’s sov­er­eign im­mu­ni­ty.

If that ploy suc­ceeds, any paten­tee fac­ing IPR pro­ceed­ings would pre­sum­ably be able to de­feat. But sov­er­eign im­mu­ni­ty should not be treat­ed as a mon­e­ti­z­able com­mod­i­ty that can be pur­chased by pri­vate en­ti­ties as part of a scheme to evade their le­gal re­spon­si­bil­i­ties.

Novartis CEO Vas Narasimhan [via Bloomberg/Getty]

I’m not per­fect: No­var­tis chief Vas Narasimhan al­most apol­o­gizes in the wake of a new cri­sis

Vas Narasimhan has warily stepped up with what might pass as something close to a borderline apology for the latest scandal to engulf Novartis.

But he couldn’t quite get there.

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Mi­nor­i­ty racial groups con­tin­ue to be dis­mal­ly rep­re­sent­ed in can­cer tri­als — study

Data reveal that different racial and ethnic groups — by nature and/or nurture — can respond differently in terms of pharmacokinetics, efficacy, or safety to therapeutics, but this disparity is not necessarily accounted for in clinical trials. A fresh analysis of the last decade of US cancer drug approvals suggests the trend continues, cementing previous research that suggests oncology trials are woefully under-representative of the racial makeup of the real world.

Van­da shares slide af­ter FDA spurns their big end­point and re­jects a pitch on jet lag re­lief

Back in the spring of last year, Vanda Pharmaceuticals $VNDA served up a hot stew of mixed data for a slate of endpoints related to what they called clear evidence that their melatonin sleep drug Hetlioz (tasimelteon) could help millions of travelers suffering from jet lag.

Never mind that they couldn’t get a planned 90 people in the study, settling for 25 instead; Vanda CEO Mihael H. Polymeropoulos said they were building on a body of data to prove it would help jet-lagged patients looking for added sleep benefits. And that, they added, would be worth a major upgrade from the agency as they sought to tackle a big market.

Jim Mellon [via YouTube]

Health­i­er, longer lifes­pans will be a re­al­i­ty soon­er than you think, Ju­ve­nes­cence promis­es as it clos­es $100M round

Earlier this year, an executive from Juvenescence-backed AgeX predicted the field of longevity will eventually “dwarf the dotcom boom.” Greg Bailey, the UK-based anti-aging biotech’s CEO, certainly hopes so.

On Monday, Juvenescence completed its $100 million Series B round of financing. The company is backed by British billionaire Jim Mellon — who wrote his 400-page guide to investing in the field of longevity shortly after launching the company in 2017. Bailey, who served as a board director for seven years at Medivation before Pfizer swallowed the biotech for $14 billion, is joined by Declan Doogan, an industry veteran with stints at Pfizer $PFE and Amarin $AMRN.

UP­DAT­ED: AveX­is sci­en­tif­ic founder was axed — and No­var­tis names a new CSO in wake of an ethics scan­dal

Now at the center of a storm of controversy over its decision to keep its knowledge of manipulated data hidden from regulators during an FDA review, Novartis CEO Vas Narasimhan has found a longtime veteran in the ranks to head the scientific work underway at AveXis, where the incident occurred. And the scientific founder has hit the exit.

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Ab­b­Vie gets its FDA OK for JAK in­hibitor upadac­i­tinib, but don’t look for this one to hit ex­ecs’ lofty ex­pec­ta­tions

Another big drug approval came through on Friday afternoon as the FDA OK’d AbbVie’s upadacitinib — an oral JAK1 inhibitor that is hitting the rheumatoid arthritis market with a black box warning of serious malignancies, infections and thrombosis reflecting fears associated with the class.

It will be sold as Rinvoq — at a wholesale price of $59,000 a year — and will likely soon face competition from a drug that AbbVie once controlled, and spurned. Reuters reports that a 4-week supply of Humira, by comparison, is $5,174, adding up to about $67,000 a year.

John Hood [file photo]

UP­DAT­ED: Cel­gene and the sci­en­tist who cham­pi­oned fe­dra­tinib's rise from Sanofi's R&D grave­yard win FDA OK

Six years after Sanofi gave it up for dead, the FDA has approved the myelofibrosis drug fedratinib, now owned by Celgene.

The drug will be sold as Inrebic, and will soon land in the portfolio at Bristol-Myers Squibb, which is finalizing a deal to acquire Celgene.

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The top 10 fran­chise drugs in bio­phar­ma his­to­ry will earn a to­tal of $1.4T (tril­lion) by 2024 — what does that tell us?

Just in case you were looking for more evidence of just how important Amgen’s patent win on Enbrel is for the company and its investors, EvaluatePharma has come up with a forward-looking consensus estimate on what the list of top 10 drugs will look like in 2024.

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UP­DAT­ED: Sci­en­tist-CEO ac­cused of im­prop­er­ly us­ing con­fi­den­tial in­fo from uni­corn Alec­tor

The executive team at Alector $ALEC has a bone to pick with scientific co-founder Asa Abeliovich. Their latest quarterly rundown has this brief note buried inside:

On June 18, 2019, we initiated a confidential arbitration proceeding against Dr. Asa Abeliovich, our former consulting co-founder, related to alleged breaches of his consulting agreement and the improper use of our confidential information that he learned during the course of rendering services to us as our consulting Chief Scientific Officer/Chief Innovation Officer. We are in the early stage of this arbitration proceeding and are unable to assess or provide any assurances regarding its possible outcome.

There’s no explicit word in the filing on what kind of confidential info was involved, but the proceeding got started 2 days ahead of Abeliovich’s IPO.

Abeliovich, formerly a tenured associate professor at Columbia, is a top scientist in the field of neurodegeneration, which is where Alector is targeted. More recently, he’s also helped start up Prevail Therapeutics as the CEO, which raised $125 million in an IPO. And there he’s planning on working on new gene therapies that target genetically defined subpopulations of Parkinson’s disease. Followup programs target Gaucher disease, frontotemporal dementia and synucleinopathies.

But this time Abeliovich is the CEO rather than a founding scientist. And some of their pipeline overlaps with Alector’s.

Abeliovich and Prevail, though, aren’t taking this one lying down.

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