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.

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Pfiz­er's big block­buster Xel­janz flunks its post-mar­ket­ing safe­ty study, re­new­ing harsh ques­tions for JAK class

When the FDA approved Pfizer’s JAK inhibitor Xeljanz for rheumatoid arthritis in 2012, they slapped on a black box warning for a laundry list of adverse events and required the New York drugmaker to run a long-term safety study.

That study has since become a consistent headache for Pfizer and their blockbuster molecule. Last year, Pfizer dropped the entire high dose cohort after an independent monitoring board found more patients died in that group than in the low dose arm or a control arm of patients who received one of two TNF inhibitors, Enbrel or Humira.

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Covid-19 roundup: EU and As­traZeneca trade blows over slow­downs; Un­usu­al unions pop up to test an­ti­bod­ies, vac­cines

After coming under fire for manufacturing delays last week, AstraZeneca’s feud with the European Union has spilled into the open.

The bloc accused the pharma giant on Wednesday of pulling out of a meeting to discuss cuts to its vaccine supplies, the AP reported. AstraZeneca denied the reports, saying it still planned on attending the discussion.

Early Wednesday, an EU Commission spokeswoman said that “the representative of AstraZeneca had announced this morning, had informed us this morning that their participation is not confirmed, is not happening.” But an AstraZeneca spokesperson later called the reports “not accurate.”

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Adeno-associated virus-1 illustration; the use of AAVs resurrected the gene therapy field, but companies are now testing the limits of a 20-year-old technology (File photo, Shutterstock)

Af­ter 3 deaths rock the field, gene ther­a­py re­searchers con­tem­plate AAV's fu­ture

Nicole Paulk was scrolling through her phone in bed early one morning in June when an email from a colleague jolted her awake. It was an article: Two patients in an Audentes gene therapy trial had died, grinding the study to a halt.

Paulk, who runs a gene therapy lab at the University of California, San Francisco, had planned to spend the day listening to talks at the American Association for Cancer Research annual meeting, which was taking place that week. Instead, she skipped the conference, canceled every work call on her calendar and began phoning colleagues across academia and industry, trying to figure out what happened and why. All the while, a single name hung in the back of her head.

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Pascal Soriot, AP

As­traZeneca CEO Pas­cal So­ri­ot sev­ers an un­usu­al board con­nec­tion, steer­ing clear of con­flicts while re­tain­ing im­por­tant al­liances

CSL Behring chief Paul Perreault scored an unusual coup last summer when he added AstraZeneca CEO Pascal Soriot to the board, via Zoom. It’s rare, to say the least, to see a Big Pharma CEO take any board post in an industry where interests can simultaneously connect and collide on multiple levels of operations.

The tie set the stage for an important manufacturing connection. The Australian pharma giant agreed to supply the country with 10s of millions of AstraZeneca’s Covid-19 vaccine, once it passes regulatory muster.

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Mer­ck scraps Covid-19 vac­cine pro­grams af­ter they fail to mea­sure up on ef­fi­ca­cy in an­oth­er ma­jor set­back in the glob­al fight

After turning up late to the vaccine development game in the global fight against Covid-19, Merck is now making a quick exit.

The pharma giant is reporting this morning that it’s decided to drop development of 2 vaccines — V590 and V591 — after taking a look at Phase I data that simply don’t measure up to either the natural immune response seen in people exposed to the virus or the vaccines already on or near the market.

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Anthony Fauci, NIAID director (AP Images)

As new Covid-19 task force gets un­der­way, threat looms of vac­cine, mon­o­clon­al an­ti­body-re­sis­tant vari­ants

Hours before President Biden’s Covid-19 team gave their first virtual press conference, the famed AIDS researcher David Ho delivered concerning news in a new pre-print: SARS-CoV-2 B.1.351, the variant that emerged in South Africa, is “markedly more resistant” to antibodies from convalescent plasma and vaccinated individuals.

The news for several monoclonal antibodies, including Eli Lilly’s bamlanivimab, was even worse: Their ability to neutralize was “completely or markedly abolished,” Ho wrote. Lilly’s antibody cocktail, which was just shown to dramatically reduce the risk of hospitalizations or death, also became far less potent.

Florian Brand (L) and Srinivas Rao (ATAI)

Psy­che­del­ic biotech ATAI hopes to ex­pand port­fo­lio through re­search part­ner­ship with Mass Gen­er­al

Psychedelics have made a comeback for mental health research, with companies like startup biotech ATAI Life Sciences raising millions and earning the backing of prominent investors like Peter Thiel, but there’s a hole at the heart of the resurgence: Researchers still don’t fully understand how they work.

A new partnership between ATAI and world-renowned Mass General Hospital hopes to change that.

Bomb squad called to As­traZeneca vac­cine plant; Lu­men nabs CARB-X award for low-cost an­tidiar­rheal

A plant located in Wrexham, Wales that is packing the Oxford/AstraZeneca Covid-19 vaccine into vials was surrounded by a bomb squad after officials called police to report a suspicious package.

The alert caused a partial evacuation of the plant, the BBC was among those to report Wednesday. The owner of the plant, British drugmaker Wockhardt UK, said it was cooperating with local authorities and that there were no reports of any injuries.