Al­ler­gan shows how you can de­stroy your rep and get mobbed by law­mak­ers in 4 easy steps

The view from End­points
John Car­roll, Ed­i­tor

First came the on­slaught of me­dia re­ports. Then came the out­raged let­ter from the US Sen­a­tors fol­lowed by the launch of a House probe and a bi­par­ti­san de­mand for doc­u­ments. Now, a few weeks in, comes the first piece of leg­is­la­tion aimed at killing the source of the out­rage.

Al­ler­gan’s Mo­hawk gam­bit on the patent front is fast be­com­ing a text­book study in how to shoot your­self in the foot while at­tract­ing a large and un­sym­pa­thet­ic crowd.

Claire Mc­Caskill, the De­mo­c­ra­t­ic Sen­a­tor from Mis­souri, has fol­lowed up a scold­ing let­ter to PhRMA chief Stephen Ubl about how Al­ler­gan was gam­ing the sys­tem, and her plans for leg­is­la­tion that would ban com­pa­nies from us­ing trib­al im­mu­ni­ty laws to pro­tect them­selves from in­ter partes re­view patent chal­lenges.

Al­ler­gan man­aged to cap­ture every­one’s at­ten­tion with a nifty lawyer’s trick. They paid the Saint Reg­is Mo­hawk Tribe $13.75 mil­lion for a deal that trans­ferred its patents for the $1.5 bil­lion drug Resta­sis to the tribe, then es­sen­tial­ly leased them back for roy­al­ties. And the tribe vir­tu­al­ly hung a big ban­ner say­ing it was open for busi­ness for the rest of the phar­ma in­dus­try and any­one else that would like them to claim im­mu­ni­ty against the IPR process and guard against gener­ics.

I’m doubt­ing that any oth­er phar­mas will fol­low, no mat­ter how bad­ly tempt­ed they may feel. This is how you can dam­age your com­pa­ny’s rep­u­ta­tion at con­sid­er­able ex­pense and an­tag­o­nize law­mak­ers with­out ben­e­fit­ing at all — not an ap­pe­tiz­ing prospect.

Mc­Caskill’s state­ment, re­port­ed by Reuters, neat­ly sum­ma­rizes Al­ler­gan’s dilem­ma.

Any think­ing per­son would look at what this com­pa­ny did and say, ‘That should be il­le­gal.’ Well, I agree. Con­gress nev­er imag­ined tribes would al­low them­selves to be used by phar­ma­ceu­ti­cal com­pa­nies to avoid chal­lenges to patents, and this bill will shut the prac­tice down be­fore oth­ers fol­low suit.

Al­ler­gan CEO Brent Saun­ders has been try­ing might­i­ly hard to make this in­to a con­tro­ver­sy over the IPR process, which they say is in­her­ent­ly un­fair, forc­ing them to fight si­mul­ta­ne­ous­ly on two le­gal fronts.

He may be right. But no one is pay­ing much at­ten­tion. He’s giv­en Con­gress too much to dis­tract them.

The Saint Reg­is Mo­hawk Tribe says it’s “out­raged” that law­mak­ers would sin­gle out strug­gling In­di­an tribes while al­low­ing state uni­ver­si­ties to re­tain their own im­mu­ni­ty.

The Tribe re­mains com­mit­ted to work­ing with all Mem­bers of Con­gress to dis­cuss how its re­cent eco­nom­ic di­ver­si­fi­ca­tion ef­forts ben­e­fits the Tribe, its mem­bers, and the sur­round­ing com­mu­ni­ties with­out harm­ing com­pe­ti­tion among phar­ma­ceu­ti­cal com­pa­nies (both pri­vate and gener­ic) or ar­ti­fi­cial­ly in­flat­ing drug prices.

The Mo­hawks al­ready made it clear that their casi­no isn’t enough. But it’s un­like­ly that the eco­nom­ic di­ver­si­fi­ca­tion ar­gu­ment will be a big win­ner in Con­gress, where high drug prices and ac­cess to cheap gener­ics re­main a source of con­sid­er­able pub­lic rage.

This doesn’t end well for Al­ler­gan. The ques­tion is, can they stop dig­ging and climb out of the hole they’re in.

Im­age: Brent Saun­ders AP Im­ages

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

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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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