A fed­er­al court has signed off on a set­tle­ment that will see Vi­a­tris pay $264 mil­lion to re­solve claims that it con­spired with Pfiz­er to “mo­nop­o­lize the mar­ket” for life-sav­ing EpiPens.

Kansas Judge Daniel Crab­tree pre­lim­i­nar­i­ly agreed to the set­tle­ment on Fri­day, paving the way for a fi­nal ap­proval that won’t come un­til at least the sec­ond half of the year. A fair­ness hear­ing will take place on Ju­ly 6, ac­cord­ing to court doc­u­ments.

The case dates back to 2017, when plain­tiffs filed a com­plaint al­leg­ing Vi­a­tris — cre­at­ed out of the merg­er of Up­john and My­lan — “de­vised an il­le­gal scheme” to pre­vent EpiPen com­peti­tors from com­ing to mar­ket. The com­pa­ny has been un­der heavy fire since 2016, when the price of two EpiPens surged to $608, up from $100 in 2007.

“As a re­sult, mil­lions of Amer­i­cans re­ly­ing on this life-sav­ing de­vice have paid ex­or­bi­tant prices for EpiPens that are in no way teth­ered to or con­strained by a com­pet­i­tive mar­ket,” an amend­ed com­plaint states.

The com­plaint ac­cus­es both My­lan and Pfiz­er, which man­u­fac­tured the EpiPen, of en­gag­ing in an­ti-com­pet­i­tive con­duct that cre­at­ed a mo­nop­oly.

The “scheme” con­sist­ed of mul­ti­ple parts, plain­tiffs said, al­leg­ing that the de­fen­dants: mis­clas­si­fied EpiPen un­der Med­ic­aid’s Med­ical Drug Re­bate Pro­gram; of­fered ag­gres­sive re­bates and in­cen­tives to phar­ma­cy ben­e­fit man­agers con­di­tioned on ex­clud­ing com­peti­tors from the mar­ket; of­fered free EpiPens to schools through its Ac­cess to Schools pro­gram, on the ex­clu­sion of com­peti­tor prod­ucts; cre­at­ed a patent thick­et; and as­sert­ed that EpiPens should be sold sole­ly in two-packs, dri­ving up cost.

These ac­tions “en­dan­gered the lives of mil­lions of Amer­i­cans,” the amend­ed com­plaint al­leges.

“It is al­so time to send a mes­sage that the law will not tol­er­ate the fraud­u­lent and an­ti­com­pet­i­tive ac­tions of Amer­i­ca’s phar­ma­ceu­ti­cal gi­ants,” the doc­u­ment states.

Heather Bresch

Then-My­lan CEO Heather Bresch, daugh­ter of De­mo­c­ra­t­ic Sen­a­tor Joe Manchin, left the com­pa­ny af­ter the merg­er in 2020. But she vig­or­ous­ly de­fend­ed the price in­crease be­fore the House Over­sight and Gov­ern­ment Re­form Com­mit­tee, say­ing, “Price and ac­cess ex­ist in a bal­ance, and we be­lieve we have struck that bal­ance.”

Vi­a­tris has de­nied any wrong­do­ing, but agreed to pay $264 mil­lion to re­solve the cas­es pend­ing in the US Dis­trict Court for the Dis­trict of Kansas.

“The Board of Di­rec­tors be­lieves that this set­tle­ment is in the best in­ter­ests of the Com­pa­ny and its stake­hold­ers. The res­o­lu­tion of these in­di­rect pur­chas­er cas­es will al­low the Com­pa­ny to move for­ward and con­tin­ue fo­cus­ing on its strate­gic pri­or­i­ties,” it said last month.

Crab­tree dis­missed much of the case against My­lan last June, leav­ing on­ly a claim con­cern­ing a 2012 patent lit­i­ga­tion set­tle­ment with gener­ic drug­mak­er Te­va. Pfiz­er al­so struck a $345 mil­lion set­tle­ment last year.

It was great getting back to a live ESMO conference/webinar in Paris followed by a live pop-up event for the Endpoints 11 in Boston. We’re staying on the road in October with our return for a live/streaming EUBIO22 in London.

Silicon Valley Bank’s Nooman Haque and I are once again jumping back into the thick of it with a slate of virtual and live events on October 12. I’ll get the ball rolling with a virtual fireside chat with Novo Nordisk R&D chief Marcus Schindler, covering their pipeline plans and BD work.

Gilead is mounting its counterfeit drug lawsuit, naming two “kingpins” and a complex network of conspirators who allegedly sold imitation bottles of its HIV meds, some of which ended up in US pharmacies.

The pharma giant on Wednesday provided an update on what it called a “large-scale, sophisticated counterfeiting conspiracy,” accusing two new defendants of “leading and orchestrating” a scheme to sell hundreds of millions of dollars in illegitimate drugs posing as meds such as Biktarvy and Descovy.

Moderna CEO Stéphane Bancel made clear on the last quarterly call that “now is not the time to slow down.” On Thursday, he made a bit more room in the cockpit.

The company unveiled a new executive role on Thursday, promoting former chief technical operations and quality officer Juan Andres to president of strategic partnerships and enterprise expansion, and poaching a former Novartis exec to take his place.