SCO­TUS just turned its back on Al­ler­gan’s le­gal ma­neu­ver to take a blow at in­ter partes re­view. What did you ex­pect?

It’s fi­nal­ly over.

Bioreg­num Opin­ion Col­umn by John Car­roll

From the very be­gin­ning, Al­ler­gan’s at­tempt to safe­guard its block­buster Resta­sis fran­chise by hand­ing over the patents to a Mo­hawk tribe in New York looked like a bad par­o­dy of a le­gal loop­hole ma­neu­ver. Now it’s a dead par­o­dy, af­ter the Supreme Court on Mon­day shunned the com­pa­ny’s at­tempt to take its ar­gu­ment to the high­est court in the land with a sin­gle line.

The tribe’s im­mu­ni­ty would safe­guard the patents from the in­ter partes re­view process, they rea­soned, and they could ba­si­cal­ly lease back con­trol of the drug while steer­ing clear of a se­ri­ous threat from gener­ic drug­mak­ers.

Brent Saun­ders speak­ing at an End­points event in 2017 End­points News

But this wasn’t just de­fend­ed by the at­tor­neys, who are paid to make ar­gu­ments of all kinds. Al­ler­gan CEO Brent Saun­ders took up the stan­dard and led the charge him­self. He hurt him­self at every turn, look­ing every bit like a Big Phar­ma ex­ec who would try any gim­mick to pro­tect the cash cow. This was in 2017, as the in­dus­try’s rep was tak­ing a turn for the worse — while the pub­lic and law­mak­ers be­gan to raise a clam­or over drug prices.

Al­ler­gan stuck to its le­gal guns, and the in­dus­try rep slid south right along with their ar­gu­ment.

“We can cer­tain­ly agree to dis­agree,” Saun­ders told me back when this got start­ed, adding adamant­ly that “every­thing we have done here is com­plete­ly con­sis­tent with our so­cial con­tract.”

You don’t hear much about the so­cial con­tract these days, which dates back to the com­pa­ny’s at­tempt to get top play­ers to show some re­straint on drug prices. Al­ler­gan raised many of its drug prices 9.9% at the be­gin­ning of the year, with­in the guide­lines of the so­cial con­tract, and all you hear from the pub­lic now is a de­mand to cut prices.

Aside from a few biotech al­lies who are no big­ger fans of IPR than Al­ler­gan, though, the biotech had few cham­pi­ons to help in the fight. Promi­nent law­mak­ers sin­gled them out to scorn­ful­ly ac­cuse them of try­ing to run a sham. Ac­tivists would add this to their list of trans­gres­sions by Saun­ders as the stock price de­clined.

In­stead of de­feat­ing the IPR process — elim­i­nat­ing a third par­ty chal­lenge to patents that has be­dev­iled bio­phar­ma for years — Al­ler­gan has helped en­shrine it in fed­er­al law. The ap­peals court sided with the patent board, con­clud­ing that IPR was more in line with ex­ec­u­tive branch en­force­ment de­ci­sions than pri­vate par­ty lit­i­ga­tion in fed­er­al court — where im­mu­ni­ty could be ap­plied. 

On Mon­day, the Supreme Court wrote off Al­ler­gan’s case, deny­ing their at­tempt to ar­gue the case in front of the 9 jus­tices. The ap­peals court de­ci­sion stands. The Resta­sis for­tune is slat­ed for dec­i­ma­tion, with My­lan and Te­va push­ing to get out cheap copy­cats. A fed­er­al judge had in­val­i­dat­ed the patents in the fall of 2017, diss­ing the Mo­hawk move as il­le­git­i­mate.

Enough said.


Im­age: Richard Drew AP

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

All about Omi­cron; We need more Covid an­tivi­rals; GSK snags Pfiz­er’s vac­cine ex­ec; Janet Wood­cock’s fu­ture at FDA; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

The slate of products we’re offering here at Endpoints is continuing to grow, and it’s not just limited to editorial. If you haven’t, do visit your reader profile to see if there are any other weekly newsletters you’re interested in — as each comes with its own exclusive content. And don’t miss the publisher’s note from Arsalan Arif on Endpoints Studio, our latest avenue for advertising on Endpoints.

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Usama Malik

Ex-Im­munomedics CFO charged with in­sid­er trad­ing, faces up to 20 years in prison af­ter al­leged­ly tip­ping off girl­friend and rel­a­tives of a PhI­II suc­cess

The former CFO of Immunomedics, who helped steer the company to its $21 billion buyout by Gilead last year, has been charged with insider trading, the Department of Justice announced Thursday.

Usama Malik tipped off his then-girlfriend and four others that a Phase III study for Trodelvy would be stopped early four days before Immunomedics publicly announced the result in April 2020, DoJ alleged in its complaint. The individuals then purchased Immunomedics shares, selling them after the news broke and Immunomedics’ stock price doubled.

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Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

As Omi­cron spread looms, oral an­tivi­rals ap­pear to be one of the best de­fens­es — now we just need more

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

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Ab­b­Vie tacks on a new warn­ing to Rin­voq la­bel as safe­ty frets crimp JAK class

The safety problems that continue to plague the JAK class as new data highlight some severe side effects are casting a large shadow over AbbVie’s Rinvoq.

As a result of a recent readout highlighting major adverse cardiac events (MACE), malignancy, mortality and thrombosis with Xeljanz a couple of months ago, AbbVie put out a notice late Friday afternoon that it is adding the new class risks to its label for their rival drug.

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Biospec­i­men M&A: Dis­cov­ery ac­quires Al­bert Li's he­pa­to­cyte project; PhI­II tri­al on Bay­er's Nube­qa reached pri­ma­ry end­point

Discovery Life Sciences has acquired what claims to be the Maryland-based host of the world’s largest hepatocyte inventory, known as IVAL, to help researchers select more effective and safer drug candidates in the future.

The combined companies will now serve a wider range of drug research and development scientists, according to Albert Li, who founded IVAL in 2004 and is set to join the Discovery leadership team as the CSO of pharmacology and toxicology.

Pfiz­er, Am­gen and Janssen seek fur­ther clar­i­ty on FDA's new ben­e­fit-risk guid­ance

Three top biopharma companies are seeking more details from the FDA on how the agency conducts its benefit-risk assessments for new drugs and biologics.

While Pfizer, Amgen and Janssen praised the agency for further spelling out its thinking on the subject in a new draft guidance, including a discussion of patient experience data as part of the assessment, the companies said the FDA could’ve included more specifics in the 20-page draft document.

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Re­searchers move clos­er to de­ci­pher­ing blood clots from As­traZeneca, J&J's Covid-19 vac­cines

Researchers may be nearing an answer for the mysterious and life-threatening blood clots that appeared on very rare occasions in people who received the J&J or AstraZeneca Covid-19 vaccine.

The new work builds on an early hypothesis researchers in Norway put forward last spring, when the cases first cropped up. They proposed the events were similar to blood clots that can occur in a small subset of patients who receive heparin, one of the most commonly used blood thinners.

Janet Woodcock (AP Images)

Janet Wood­cock plots her fu­ture at FDA, with se­nior ad­vi­sor role to fall back on if Califf wins con­fir­ma­tion

Acting FDA commissioner Janet Woodcock has been the face of just about every drug approval decision at the agency since the turn of the century. Since the pandemic began, she’s moved between the top of the drugs center to the head of therapeutics at Operation Warp Speed, leading the drive for work on Covid-targeted mAbs and antivirals.

Looking forward — and pending a quick Senate confirmation to cement Rob Califf’s return to the top of FDA early next year — Woodcock’s role at the agency will again be in flux.

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