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

Aerial view of Genentech's campus in South San Francisco [Credit: Getty]

Genen­tech sub­mits a big plan to ex­pand its South San Fran­cis­co foot­print

The sign is still there, a quaint reminder of whitewashed concrete not 5 miles from Genentech’s sprawling, chrome-and-glass campus: South Francisco The Industrial City. 

The city keeps the old sign, first erected in 1923, as a tourist site and a kind of civic memento to the days it packed meat, milled lumber and burned enough steel to earn the moniker “Smokestack of the Peninsula.” But the real indication of where you are and how much has changed both in San Francisco and in the global economy since a couple researchers and investors rented out an empty warehouse 40 years ago comes in a far smaller blue sign, resembling a Rotary Club post, off the highway: South San Francisco, The Birthplace of Biotech.

Here comes the oral GLP-1 drug for di­a­betes — but No­vo Nordisk is­n't dis­clos­ing Ry­bel­sus price just yet

Novo Nordisk’s priority review voucher on oral semaglutide has paid off. The FDA approval for the GLP-1 drug hit late Friday morning, around six months after the NDA filing.

Rybelsus will be the first GLP-1 pill to enter the type 2 diabetes market — a compelling offering that analysts have pegged as a blockbuster drug with sales estimates ranging from $2 billion to $5 billion.

Ozempic, the once-weekly injectable formulation of semaglutide, brought in around $552 million (DKK 3.75 billion) in the first half of 2019.

As Nas­daq en­rolls the fi­nal batch of 2019 IPOs, how have the num­bers com­pared to past years?

IGM Biosciences’ upsized IPO haul, coming after SpringWorks’ sizable public debut, has revved up some momentum for the last rush of biotech IPOs in 2019.

With 39 new listings on the books and roughly two more months to go before winding down, Nasdaq’s head of healthcare listings Jordan Saxe sees the exchange marking 50 to 60 biopharma IPOs for the year.

“December 15 is usually the last possible day that companies will price,” he said, as companies get ready for business talks at the annual JP Morgan Healthcare Conference in January.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 60,200+ biopharma pros reading Endpoints daily — and it's free.

Oxitec biologist releases genetically modified mosquitoes in Piracicaba, Brazil in 2016 [credit: Getty Images]

In­trex­on unit push­es back against claims its GM mos­qui­toes are mak­ing dis­ease-friend­ly mu­tants

When the hysteria of Zika transmission sprang into the American zeitgeist a few years ago, UK-based Oxitec was already field-testing its male Aedes aegypti mosquito, crafted to possess a gene engineered to obliterate its progeny long before maturation.

But when a group of independent scientists evaluated the impact of the release of these genetically-modified mosquitoes in a trial conducted by Oxitec in Brazil between 2013 and 2015, they found that some of the offspring had managed to survive — prompting them to speculate what impact the survivors could have on disease transmission and/or insecticide resistance.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 60,200+ biopharma pros reading Endpoints daily — and it's free.

[via AP Images]

Pur­due threat­ens to walk away from set­tle­ment, asks to pay em­ploy­ees mil­lions in bonus­es

There are two updates on the lawsuit against Purdue Pharma over its role in fueling the opioid epidemic, as the Sackler family threatens to walk away from their pledge to pay out $3 billion if a bankruptcy judge does not stop outstanding state lawsuits against them. At the same time, the company has asked permission to pay millions in bonuses to select employees.

Purdue filed for chapter 11 bankruptcy this week as part of its signed resolution to over 2,000 lawsuits. The deal would see the Sackler family that owns Purdue give $3 billion from their personal wealth and the company turned into a trust committed to curbing and reversing overdoses.

David Grainger [file photo]

'Dis­con­nect the bas­tard­s' — one biotech's plan to break can­cer cell­s' uni­fied de­fens­es

Chemotherapy and radiotherapy are the current gladiators of cancer treatment, but they come with well-known limitations and side-effects. The emergence of immunotherapy — a ferocious new titan in oncologist’s toolbox — takes the brakes off the immune system to kill cancer cells with remarkable success in some cases, but the approach is not always effective. What makes certain forms of cancer so resilient? Scientists may have finally pieced together a tantalizing piece of the puzzle, and a new biotech is banking on a new approach to fill the gap.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 60,200+ biopharma pros reading Endpoints daily — and it's free.

A fa­vorite in Alex­ion’s C-suite is leav­ing, and some mighty sur­prised an­a­lysts aren’t the least bit hap­py about it

Analysts hate to lose a biotech CFO they’ve come to trust and admire — especially if they’re being blindsided by a surprise exit.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 60,200+ biopharma pros reading Endpoints daily — and it's free.

Scott Gottlieb, AP Images

Scott Got­tlieb is once again join­ing a team that en­joyed good times at the FDA un­der his high-en­er­gy stint at the helm

Right after jumping on Michael Milken’s FasterCures board on Monday, the newly departed FDA commissioner is back today with news about another life sciences board post that gives him a ringside chair to cheer on a lead player in the real-world evidence movement — one with very close ties to the FDA.

Aetion is reporting this morning that Gottlieb is joining their board, a group that includes Mohamad Makhzoumi, a general partner at New Enterprise Associates, where Gottlieb returned after stepping out of his role at the FDA 2 years after he started.

Gottlieb — one of the best connected execs in biopharma — knows this company well. As head of FDA he championed the use of real-world evidence to help guide drug developers and the agency in gaining greater efficiencies, which helped set up Aetion as a high-profile player in the game.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 60,200+ biopharma pros reading Endpoints daily — and it's free.

Tower Bridge in London [Shutterstock]

#UK­BIO19: Join GSK’s Hal Bar­ron and a group of top biotech ex­ecs for our 2nd an­nu­al biotech sum­mit in Lon­don

Over the past 10 years I’ve made a point of getting to know the Golden Triangle and the special role the UK biopharma industry plays there in drug development. The concentration of world class research institutes, some of the most accomplished scientists I’ve ever seen at work and a rising tide of global investment cash leaves an impression that there’s much, much more to come as biotech hubs are birthed and nurtured.