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

While the market for antibiotics remains in tatters — unlike many of its bankrupt (or at the brink of bankruptcy) peers — Iterum is suffering not because its antibiotic isn’t selling, but because the compound has now failed back-to-back late-stage studies.

The experimental drug, sulopenem, was designed to tackle drug-resistant infections with an outpatient focus (in addition to hospitals), to avert those reimbursement challenges that incentivize hospitals to prescribe cheaper, generic broad-spectrum antibiotics.

The IPO engine is thriving, never mind the rampage of the coronavirus crisis on R&D timelines.

On Friday, along with synthetic lethality-focused biotech Repare Therapeutics, another Bristol Myers partner Forma Therapeutics also unveiled its plans to vault on to the Nasdaq — penciling in a target of $150 million.

The Watertown, Massachusetts-based company — which poached senior Genentech executive Frank Lee to take over the reins last year after more than a decade under founder Steve Tregay — raised a plump $100 million late last year, while shepherding its sickle cell disease (SCD) drug through an early-stage trial.

For the first time in 12 years, the FDA has approved a new frontline treatment for the most common form of liver cancer.

The agency okayed a combination of Roche’s anti-VEGF antibody Avastin and their immunotherapy Tecentriq for patients with unresectable or metastatic hepatocellular carcinoma (HCC). The approval comes two weeks after Roche and their big biotech sub Genentech published Phase III results showing the combo improved both progression-free survival and, crucially, helped patients live longer than the long-running standard-of-care, Bayer’s Nexavar.