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

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 and Amarin.

John Hood [file photo]

UP­DATE: 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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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.

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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Chi­na has be­come a CEO-lev­el pri­or­i­ty for multi­na­tion­al phar­ma­ceu­ti­cal com­pa­nies: the trend and the im­pli­ca­tions

After a “hot” period of rapid growth between 2009 and 2012, and a relatively “cooler” period of slower growth from 2013 to 2015, China has once again become a top-of-mind priority for the CEOs of most large, multinational pharmaceutical companies.

At the International Pharma Forum, hosted in March in Beijing by the R&D Based Pharmaceutical Association Committee (RDPAC) and the Pharmaceutical Research and Manufacturers of America (PhRMA), no fewer than seven CEOs of major multinational pharmaceutical firms participated, including GSK, Eli Lilly, LEO Pharma, Merck KGaA, Pfizer, Sanofi and UCB. A few days earlier, the CEOs of several other large multinationals attended the China Development Forum, an annual business forum hosted by the research arm of China’s State Council. It’s hard to imagine any other country, except the US, having such drawing power at CEO level.

As dis­as­ter struck, Ab­b­Vie’s Rick Gon­za­lez swooped in on Al­ler­gan with an of­fer Brent Saun­ders couldn’t say no to

Early March was a no good, awful, terrible time for Allergan CEO Brent Saunders. His big lead drug had imploded in a Phase III disaster and activists were after his hide — or at least his chairman’s title — as the stock price continued a steady droop that had eviscerated share value for investors.

But it was a perfect time for AbbVie CEO Rick Gonzalez to pick up the phone and ask Saunders if he’d like to consider a “strategic” deal.

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CEO Pascal Soriot via Getty Images

As­traZeneca's jug­ger­naut PARP play­er Lyn­parza scoops up an­oth­er dom­i­nant win in PhI­II as the FDA adds a 'break­through' for Calquence

AstraZeneca’s oncology R&D group under José Baselga keeps churning out hits.

Wednesday morning the pharma giant and their partners at Merck parted the curtains on a successful readout for their Phase III PAOLA-1 study, demonstrating statistically significant improvement in progression-free survival for women with ovarian cancer in a first-line maintenance setting who added their PARP Lynparza to Avastin. This is their second late-stage success in ovarian cancer, which will help stave off rivals like GSK.

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