Roche’s Chugai unit and As­traZeneca’s Alex­ion have set­tled a years­long patent bat­tle over the lat­ter’s Ul­tomiris — a rare blood dis­or­der treat­ment de­signed to suc­ceed Alex­ion’s block­buster Soliris, ac­cord­ing to re­ports.

The set­tle­ment was filed un­der seal on Mon­day, Bloomberg Law and Law 360 re­port­ed, and the terms are cur­rent­ly un­known. Alex­ion de­clined to com­ment on the case, while Chugai wasn’t avail­able as of press time.

The trou­ble dates back to 2018 (be­fore Ul­tomiris was ap­proved) when Chugai filed a com­plaint against Alex­ion al­leg­ing that the com­pa­ny used its patent­ed an­ti­body re­cy­cling tech­nol­o­gy to cre­ate the drug. The tech­nol­o­gy, Chugai says, could be used to ex­tend the half-life of an an­ti­body in the blood, and “im­prove the func­tion of C5 in­hibit­ing an­ti­bod­ies, in­clud­ing those used to treat rare blood dis­eases like PNH and aHUS.”

Like its pre­de­ces­sor Soliris, Ul­tomiris is a C5 in­hibitor — but while Soliris is dosed every two weeks dur­ing the main­te­nance pe­ri­od, Ul­tomiris can be tak­en every eight weeks. It snagged its first ap­proval in parox­ys­mal noc­tur­nal he­mo­glo­bin­uria (PNH), a rare but life-threat­en­ing blood dis­ease, in De­cem­ber 2018. Less than a year lat­er, it picked up a sec­ond ap­proval for atyp­i­cal he­molyt­ic ure­mic syn­drome (aHUS), a dis­ease that can cause pro­gres­sive in­jury to vi­tal or­gans via dam­age to the walls of blood ves­sels and blood clots.

Soliris and Ul­tomiris were key el­e­ments in As­traZeneca’s $39 bil­lion Alex­ion buy­out last sum­mer. The lat­ter raked in $688 mil­lion in 2021, ac­cord­ing to re­cent­ly re­leased Q4 re­sults.

In its 2018 com­plaint, Chugai ar­gued that Alex­ion knew of the al­leged patent in­fringe­ment be­cause the com­pa­ny made “mul­ti­ple in­quiries re­gard­ing ob­tain­ing a li­cense to Chugai’s an­ti­body tech­nol­o­gy patents” in 2012 and 2013.

“De­spite know­ing that Chugai did not give Alex­ion per­mis­sion to use Chugai’s re­cy­cling tech­nol­o­gy, and de­spite know­ing that Chugai patent­ed its re­cy­cling tech­nol­o­gy, Alex­ion know­ing­ly in­cor­po­rat­ed Chugai’s tech­nol­o­gy in­to its ALXN1210 prod­uct any­way. Alex­ion’s con­duct amounts to a will­ful dis­re­gard of Chugai’s patent rights,” the com­plaint states.

Regulators didn’t keep AstraZeneca and Daiichi Sankyo waiting long at all for their latest Enhertu approval.

The partners pulled a win on Friday in HER2-low breast cancer patients who’ve already failed on chemotherapy, just two weeks after submitting a supplemental BLA. While this isn’t the FDA’s fastest approval — Bristol Myers Squibb won an OK for its blockbuster checkpoint inhibitor Opdivo in just five days back in March — it comes well ahead of Enhertu’s original Q4 PDUFA date.

The Senate won’t return from its summer recess until Sept. 6, but when it does, it officially has 18 business days to finalize the reauthorization of the FDA user fee programs for the next 5 years, or else thousands of drug and biologics reviewers will be laid off and PDUFA dates will vanish in the interim.

FDA commissioner Rob Califf recently sent agency staff a memo explaining how, “Our latest estimates are that we have carryover for PDUFA [Prescription Drug User Fee Act], the user fee funding program that will run out of funding first, to cover only about 5 weeks into the next fiscal year.”

Rare diseases often have more than just physical effects on patients — especially when it comes to chronic conditions. In the case of the rare slow-growing blood cancer chronic lymphocytic leukemia (CLL), AbbVie wanted to try to assess the mental and emotional toll on patients.

So it surveyed more than 300 CLL patients, caregivers and physicians. While each group differed in how they felt — caregivers overwhelmingly (81%) felt positive about their role, for instance — patients described a “roller coaster” of emotions traversing diagnosis to treatment to remission and even relapse for some.

The Pharmaceutical Research and Manufacturers of America — and their fleet of drug industry lobbyists on Capitol Hill — are known for never losing.

Whenever a big drug pricing bill comes up, an army of the industry group’s lobbyists descend onto the Hill and either smash it outright or dismantle it piece by piece.

But for perhaps the largest drug pricing reforms ever enacted, after more than a decade of Congress trying and failing to allow Medicare to negotiate prescription drug prices, those same lobbyists and their biopharma clients were dealt a stunning blow on Sunday afternoon.