Bioreg­num — The view from End­points News

Al­ler­gan CEO Brent Saun­ders scored some heavy­weight ku­dos last fall with a so­cial con­tract that con­demned preda­to­ry drug pric­ing by the likes of Mar­tin Shkre­li and out­lined the com­pa­ny’s com­mit­ment to R&D and ac­cess. But on Fri­day he squan­dered what­ev­er moral clout he may have earned along the way with a le­gal gam­bit that looked too clever by half.

Here’s what hap­pened:

Fac­ing a patent chal­lenge to its fran­chise drug Resta­sis, Al­ler­gan hand­ed over the patents to the St. Reg­is Mo­hawk Tribe, which has sov­er­eign im­mu­ni­ty against in­ter partes re­view chal­lenges. The tribe — best known for its casi­no ops — hand­ed back an ex­clu­sive li­cense to the drug, col­lect­ed $13.75 mil­lion and can look for­ward to mil­lions more in roy­al­ties each year, un­less the courts toss it all out as a cyn­i­cal ploy cooked up by at­tor­neys.

This had all the in­gre­di­ents any re­porter looks for in an at­ten­tion-grab­bing sto­ry.

1. Toss in a phar­ma com­pa­ny at a time the in­dus­try is tagged with a rep for greed and a weak grasp of ethics.
2. Add a le­gal ma­neu­ver that looked like it came from the of­fice of Break­ing Bad’s Saul Good­man.
3. Stir in some protests from the tribe that casi­no gam­bling doesn’t of­fer a se­cure enough rev­enue stream to guar­an­tee their fu­ture in­come.

What you get are some fresh­ly baked goods from a long line of pub­li­ca­tions, in­clud­ing the New York Times, the Wall Street Jour­nal, CN­BC, etc., etc., etc.

“I be­lieve it’s nov­el,” Al­ler­gan CEO Brent Saun­ders told CN­BC. “The ac­tions to­day re­al­ly al­low us to fo­cus the de­fense of the Resta­sis patents in the fed­er­al court sys­tem and avoid the dou­ble jeop­ardy cre­at­ed by the IPR sys­tem.”

A car sales­man I knew in Texas once told me if it doesn’t look good in a head­line, don’t do it.

Al­ler­gan just vault­ed that line.

The tribe, mean­while, is of­fer­ing its patent pro­tec­tion ser­vices to any­one else in the phar­ma in­dus­try that would like to shift their patents to their pro­tect­ed trib­al lands — in ex­change for a hefty fee of course.

Im­age: Brent Saun­ders Get­ty

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.

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.

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.

While Novartis painstakingly works to mop up the stench of the data manipulation scandal associated with its expensive gene therapy for spinal muscular atrophy (SMA) Zolgensma— rival Biogen is attempting to expand the use of its SMA therapy, Spinraza. 

The US drugmaker $BIIB secured US approval for Spinraza for use in the often fatal genetic disease in 2016. The approval covered a broad range of patients with infantile-onset (most likely to develop Type 1) SMA.