Roche and As­traZeneca set­tle years­long patent bat­tle over Ul­tomiris — re­port

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.

Big Phar­ma's Twit­ter ex­o­dus; Mer­ck wa­gers $1.35B on buy­out; $3.5M gene ther­a­py; and more

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Paul Perreault, CSL Behring CEO

CSL lands FDA ap­proval for he­mo­phil­ia B gene ther­a­py, sets $3.5M list price

The FDA has approved the world’s first gene therapy for hemophilia B, ushering into the market a treatment that’s historic in both what it promises to do and how much it will cost.

CSL will be marketing the drug, Hemgenix, at a list price of $3.5 million — which sets a new record for the most expensive single-use gene therapy in the US.

In a statement provided to Endpoints News, the Australian company noted that the current costs of treating people with moderate to severe hemophilia B can be significant over a lifetime. By some estimates, healthcare systems could spend more than $20 million per person.

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Elon Musk (GDA via AP Images)

Biggest drug com­pa­nies halt­ed Twit­ter ad buys af­ter Lil­ly in­sulin spoof

Almost all of the drug industry’s biggest advertisers cut their spending on Twitter to zero or near-zero over the last two weeks amid worries about impersonation of their brands by pranksters and the future of the social media company.

Among 18 of the biggest pharmaceutical advertisers in the US market, 12 cut their Twitter ad spending to nothing for the week beginning Nov. 14, according to Pathmatics, which tracks data on prescription drug ad spending as well as general corporate advertising. The list of drugmakers cutting spending to zero includes Merck, AstraZeneca, Eli Lilly, Novartis, Pfizer and others.

Rob Davis, Merck CEO

Up­dat­ed: No Seagen here: 'Do more' means a small $1.35B pur­chase of Ima­go for Mer­ck

Merck is making an acquisition, the Big Pharma announced before Monday’s opening bell. No, Seagen is not entering the fold, as had been speculated for quarters.

Folding under Merck’s wings will be Pfizer-backed Imago BioSciences. For nearly a year, Merck CEO Rob Davis has been saying the pharma giant needs to “do more” on the business development front after its 2021 $11.5 billion acquisition of Acceleron.

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Image: Shutterstock

MIT re­searchers re­veal DNA "Paste" tech be­hind lat­est gene edit­ing start­up

MIT scientists have developed a tool that they say can insert large gene sequences where they want in the genome.

In a paper published Thursday in Nature Biotechnology, MIT fellows Omar Abudayyeh, Jonathan Gootenberg and colleagues detail a technology they call PASTE, which they say can potentially be used to insert long strands of DNA and treat genetic diseases caused by many different mutations, such as cystic fibrosis and Leber congenital amaurosis, a rare eye disorder that causes blindness.

Dermavant Sciences' first consumer TV ad for its Vtama psoriasis med shows people ready for a new topical treatment.

Roivant’s Der­ma­vant de­buts first-ever TV com­mer­cial for pso­ri­a­sis cream Vta­ma

Dermavant Sciences has been marketing its first product, psoriasis med Vtama, to dermatologists for months, but on Tuesday it rolled out its first consumer campaign. The debut DTC effort including a streaming TV commercial encourages patients to a “Topical Uprising” in a nod to Vtama being a topical cream.

In the new commercial, a swell of people discards scarves and jacket coverings, gathering in the street to converge on a pharmacy to demand a steroid-free prescription. A moment of levity follows when a pharmacist says, “You know you can just talk to your doctor, right?” The gathered crowds collectively says, “Oh.”

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FDA preps for DMD drug gener­ics as Sarep­ta has yet to fin­ish its con­fir­ma­to­ry tri­al

The FDA typically releases guidance to help generic drug manufacturers develop new copycats of small molecule drugs, oftentimes in preparation for a brand name product’s patents or exclusivity to expire.

This week, FDA released such bioequivalence guidance for any generic drugmakers looking to take on Sarepta’s Duchenne muscular dystrophy (DMD) drug Exondys 51 (eteplirsen), even though the drug’s sponsor has yet to convert the accelerated approval to a full approval, showing clinical benefit.

Stanley Erck, Novavax CEO (Andrew Harnik/AP Images)

No­vavax pulls out of Covid-19 vac­cine al­liance with Gavi

Novavax is pulling out of its Covid-19 vaccine deal with Gavi, the Vaccine Alliance, a global partnership tasked with ensuring vaccine access in lower-income countries, following an alleged contract violation.

The Maryland-based company claimed on Friday that Gavi failed to purchase at least 350 million doses of its protein-based vaccine Nuvaxovid by the end of the year, per an advanced purchase agreement. Gavi, the World Health Organization and the Coalition for Epidemic Preparedness Innovations (CEPI) are co-leaders of COVAX, an effort to ensure that all participating countries, regardless of income levels, have access to vaccines.

Fu­ji­film to build $188M man­u­fac­tur­ing plant in North Car­oli­na’s re­search tri­an­gle

As the Japanese conglomerate Fujifilm continues to invest heavily in its CDMO arm, one of its manufacturing divisions is teeing up a major investment.

Fujifilm Irvine Scientific announced on Tuesday that parent Fujifilm is making a $188 million investment to build a cell culture media manufacturing site in the Research Triangle Park in North Carolina. The new site will mark Fujifilm Irvine’s fifth manufacturing site globally and its second in the US.