Bris­tol My­ers Squibb con­tin­ues to tout more da­ta for its ex­per­i­men­tal pso­ri­a­sis drug that it hopes will shake up the mar­ket.

The phar­ma­ceu­ti­cal gi­ant post­ed two-year re­sults from a long-term ex­ten­sion study of deu­cravac­i­tinib, show­ing the drug re­mained ef­fec­tive af­ter two years. The drug, which an­a­lysts pre­dict can bring in bil­lions in sales by 2026, is an oral TYK2 in­hibitor for adult pa­tients with mod­er­ate to se­vere plaque pso­ri­a­sis.

Ac­cord­ing to the lat­est da­ta, clin­i­cal ef­fi­ca­cy was main­tained through up to two years of treat­ment, with re­sponse rates at week 60 of 77.7% and 58.7% for PASI 75, a mea­sure of the dis­ease’s sever­i­ty. The safe­ty pro­file al­so re­mained con­sis­tent and no new is­sues popped up.

Thurs­day’s re­sults were con­sis­tent with the Phase III pso­ri­a­sis tri­als, dubbed PO­E­T­YK PSO-1 and PO­E­T­YK PSO-2 post­ed in 2021. Bris­tol My­ers may find it more dif­fi­cult to ex­pand in­to oth­er in­di­ca­tions, how­ev­er, as the drug failed a Phase II hur­dle in ul­cer­a­tive col­i­tis.

Jonathan Sadeh

Jonathan Sadeh, se­nior vice pres­i­dent of im­munol­o­gy and fi­bro­sis de­vel­op­ment at Bris­tol My­ers, said in a state­ment that the long-term fol­low-up re­sults on­ly add to the grow­ing body of ev­i­dence for the drug.

The hype start­ed ramp­ing up in Feb­ru­ary 2021 when BMS cleared an­oth­er Phase III study. Full re­sults weren’t post­ed un­til the fol­low­ing April, but Bris­tol My­ers not­ed that tri­al con­clud­ed by dis­play­ing 58.7% and 53.6% of pa­tients on deu­cravac­i­tinib achiev­ing PASI 75 re­sponse in the PO­E­T­YK-PSO-1 and PO­E­T­YK-PSO-2 stud­ies, re­spec­tive­ly. Mean­while, just 12.7% and 9.4% of place­bo pa­tients and 35.1% and 40.2% of pa­tients on Ote­zla achieved the same re­sults.

How­ev­er, de­spite the pos­i­tiv­i­ty, the drug will like­ly go un­der a fine-tooth comb at the FDA and the EMA. The FDA has pre­vi­ous­ly tak­en the ham­mer to a sim­i­lar drug class in JAK in­hibitors such as Pfiz­er’s Xel­janz, find­ing an in­creased risk of se­ri­ous heart-re­lat­ed events. The FDA al­so changed the JAK class’ la­bel af­ter a re­view of Ab­b­Vie’s Rin­voq to lim­it use to cer­tain pa­tients who are not treat­ed ef­fec­tive­ly or who ex­pe­ri­ence se­vere side ef­fects with the TNF block­ers.

Amer­i­can reg­u­la­tors have set a Sept. 10, 2022 PDU­FA date for deu­cravac­i­tinib.

Deu­cravac­i­tinib would be the first TYK2 drug ap­proved by the FDA and Bris­tol My­ers is hop­ing the dif­fer­en­ti­at­ed path­way — and os­ten­si­bly more ef­fi­ca­cious re­sults — will help in its ri­val­ry with Am­gen. Cur­rent­ly, Am­gen’s Ote­zla is the first and on­ly oral treat­ment ap­proved in adult pa­tients with plaque pso­ri­a­sis across all sever­i­ties, in­clud­ing mild, mod­er­ate and se­vere.

Early last year, Eli Lilly announced that instead of taking its blockbuster contender mirikizumab forward to the FDA for psoriasis, it would be essentially going nowhere in the indication. Instead, the pharma then announced in its Q1 ’21 earnings statement that it would be focusing on ulcerative colitis and Crohn’s disease indications in a sudden about-face.

And as the drug is before the FDA for potential approval for the first indication of ulcerative colitis, the megapharma is now ready to reveal more data to bolster its case.

Pfizer has agreed to pay $290,000 to settle allegations of questionable copay coupon practices in Arizona, Colorado, Kansas, and Vermont from 2014 to 2018.

While the company has not admitted any wrongdoing as part of the settlement, Pfizer has agreed to issue restitution checks to about 5,000 consumers.

A Pfizer spokesperson said the company has “enhanced its co-pay coupons to alleviate the concerns raised by states and agreed to a $30,000 payment to each.”

A judge in Delaware has ruled against Astellas Pharma and Gilead in a long-running patent case over Pfizer-onwed Hospira’s generic version of Lexiscan.

The case kicked off in 2018, after Hospira submitted an Abbreviated New Drug Application (ANDA) for approval to market a generic version of Gilead’s Lexiscan. The drug is used in myocardial perfusion imaging (MPI), a type of nuclear stress test.

The area of Ireland famous for Blarney Castle and its cliffsides along the Atlantic Ocean is seeing Merck KGaA expand its commitment there.

The German drug manufacturer is expanding its membrane and filtration manufacturing capabilities in Ireland. The company will invest approximately €440 million ($470 million) to increase membrane manufacturing capacity in Carrigtwohill, Ireland, and build a new manufacturing facility at Blarney Business Park, in County Cork, Ireland.

Twenty House Democrats, including Reps. Katie Porter of California and Susan Wild of Pennsylvania, are calling on Senate leaders to move quickly with a reconciliation bill (meaning they only need a simple majority for passage) with prescription drug pricing reforms, and to include adding new authority for Medicare to negotiate drug prices.

They also called on the Senate to specifically follow suit with the House passage of a $35 per month insulin cap (as Senate Majority Leader Chuck Schumer’s deadline for a vote on that provision has come and gone), and to cap Medicare Part D costs at $2,000 per year for seniors.