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

Flagship Pioneering, the incubator of Moderna and dozens of other biotechs, says it has landed upon tens of thousands of previously undiscovered human proteins. The VC shop wants to potentially turn them into therapeutics.

Like other drug developers that have turned proteins into therapeutics (think insulin for diabetes), Flagship’s latest creation, ProFound Therapeutics, wants to tap into this new trove of proteins as part of its mission to treat indications ranging from rare diseases to cancer to immunological diseases.

New data from HHS show that more than 162,000 courses of Pfizer’s Covid-19 antiviral Paxlovid were administered across the US over the past week, continuing a streak of increased usage of the pill, and signaling not only rising case numbers but more awareness of how to access it.

In comparison to this week, about 670,000 courses of the Pfizer pill have been administered across the first five months since Paxlovid has been on the US market, averaging about 33,000 courses administered per week in that time.

The FDA is offering more of an explanation of the guardrails around its program that may soon allow states to import prescription drugs in some select circumstances from Canada, but only if such imports will result in significant cost reductions for consumers.

While the agency has yet to sign off on any of the 5 state plans in the works so far, and PhRMA’s suit to block the Trump-era rule allowing such imports is stalled, the new Q&A guidance spells out the various restrictions that states will have to abide by, potentially signaling that a state approval is coming.

Leading the way to increase access to cheaper drugs worldwide, Pfizer said Wednesday it will provide all current and future patent-protected medicines and vaccines available in the US or EU on a not-for-profit basis to about 1.2 billion people in 45 lower-income countries.

Rwanda, Ghana, Malawi, Senegal and Uganda are the first five countries to sign on to this accord, which will also seek to blaze new paths for quick and efficient regulatory and procurement processes to reduce the usual delays in making new medicines and vaccines available in these countries.

Vanda Pharmaceuticals is making a name for itself, at least in terms of suing the FDA.

The DC-headquartered firm on Monday filed its latest suit against the agency, with the company raising concerns over the FDA’s failure to grant a fast track designation for Vanda’s potential chronic digestive disorder drug tradipitant, which is a neurokinin 1 receptor antagonist.

Specifically, Vanda said FDA’s “essential point” in its one-page denial letter on the designation pointed to “the lack of necessary safety data,” which was “inconsistent with the criteria for … Fast Track designation.”