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

An increase in demand of up to 79% for clinical trials in China has prompted Novotech the Asia-Pacific CRO to rapidly expand the China team, appointing expert local clinical executives to their Shanghai and Hong Kong offices. The company is planning to expand their team by 30% over the next quarter.

Novotech China has seen considerable demand recently which is borne out by research from GlobalData:
A global migration of clinical research is occurring from high-income countries to low and middle-income countries with emerging economies. Over the period 2017 to 2018, for example, the number of clinical trial sites opened by biotech companies in Asia-Pacific increased by 35% compared to 8% in the rest of the world, with growth as high as 79% in China.
Novotech CEO Dr John Moller said China offers the largest population in the world, rapid economic growth, and an increasing willingness by government to invest in research and development.
Novotech’s 23 years of experience working in the region means we are the ideal CRO partner for USA biotechs wanting to tap the research expertise and opportunities that China offers.
There are over 22,000 active investigators in Greater China, with about 5,000 investigators with experience on at least 3 studies (source GlobalData).

From PD-1 targeting to the RAS pathway to the STING complex, Thomas Gajewski has spent the past two decades of his career decoding the various ways the immune system can be unleashed to defend against cancer. So when the University of Chicago professor comes around to putting all his findings into a new platform for finding new targets, VCs and pharma groups alike pay attention.

“He’s been studying T cells for 20 years, plus he’s one of the world’s leaders if not the world leader in the space,” David Steinberg, partner at Longwood Fund, said. “Furthermore, let me add he did a lot of the foundational research and also some of the seminal clinical trials in the existing set of I/O agents. He understands the space really well, he understands the current strengths, and I think he understood really well what was missing, so he knew where to look.”

Earlier this week we got a look at Senator Kamala Harris’ position on drug prices. She’s proposing that HHS take an average price from single-payer systems like the UK, Germany and Canada — which leverage market access for lower prices — and use that to set the US price. Anything drug companies collect above that would be taxed at a rate of 100%.

And the rhetoric is scathing:
While families struggle to make it to the end of the month, pharmaceutical companies are turning record profits. They’re spending nearly as much on advertising as R&D. They’re manipulating their market power to hike prices on lifesaving generic drugs. They’re making twice the profit of the average industry in America and still increased drug prices by 10.5% over the past six months alone. Meanwhile, they are charging dramatically higher prices to American consumers.
That’s an escalation on Joe Biden’s plan, which includes drug importation from those cheaper markets as well as allowing Medicare to negotiate prices — something that virtually all Dems agree on now.