Re­gen­eron, Sanofi win a de­layed OK for rheuma­toid arthri­tis IL-6 heavy­weight sar­ilum­ab

It took more than six months and like­ly caused more than a few red faces, but Sanofi has dealt with the FDA’s is­sues with its man­u­fac­tur­ing ops and won a green light to start mar­ket­ing the like­ly block­buster sar­ilum­ab along­side its part­ners at Re­gen­eron.

Con­sen­sus peak sales fore­casts on the drug — to be mar­ket­ed as Kevzara — top the $1 bil­lion block­buster mark, mak­ing it a big ad­di­tion for both com­pa­nies.

George Yan­copou­los, Re­gen­eron (Get­ty/Bloomberg)

The part­ners say they set the WAC at $39,000/year for the 200 mg and 150 mg dos­es, which is ap­prox­i­mate­ly “30 per­cent low­er than the WAC for the two most wide­ly used TNF-al­pha in­hibitors.” Those two are Hu­mi­ra – which earned $16 bil­lion last year – and En­brel.

The IL-6 drug whet­ted an­a­lysts’ ex­pec­ta­tions last March when it beat out Ab­b­Vie’s Hu­mi­ra in a head-to-head show­down for rheuma­toid arthri­tis. The Hu­mi­ra da­ta weren’t in reg­u­la­tors’ pack­age for the ap­proval, but you can be sure that pay­ers will give it a good look over once the sales team hits the streets. On the down­side, sar­ilum­ab was linked to a sig­nif­i­cant­ly high­er rate of neu­trope­nia.

Leerink high­light­ed the price com­pe­ti­tion with a nod to the low­er price mod­el.

As im­por­tant­ly, Kevzara is al­so ap­prox­i­mate­ly 15% be­low the price of Actem­ra at the high­est dose and, with dis­counts, should of­fer a cost ef­fec­tive treat­ment op­tion for pay­ers in this set­ting. In a re­cent In­sti­tute for Clin­i­cal and Eco­nom­ic Re­view (ICER) analy­sis, Kevzara did not reach a typ­i­cal $100,000 per qual­i­ty-ad­just­ed life year (QALY) cost ef­fec­tive­ness thresh­old at this lev­el, but nei­ther did any of the oth­er wide­ly pre­scribed bi­o­log­i­cals for this dis­ease, in­clud­ing En­brel, Hu­mi­ra, Cimzia, Oren­cia, Actem­ra and Xel­janz.

Sar­ilum­ab now be­comes the third an­ti­body to win ap­proval from a Re­gen­eron/Sanofi part­ner­ship. The first was the PC­SK9 drug Pralu­ent, which has trig­gered a bruis­ing le­gal bat­tle with Am­gen and has yet to find any re­al trac­tion in the mar­ket, de­spite its dra­mat­ic im­pact on cho­les­terol. The part­ners are now lin­ing up car­dio out­comes da­ta from a big Phase III, hop­ing to push that out front of the com­pe­ti­tion. Then there was an OK ear­li­er this year for Dupix­ent, which a num­ber of fore­casts have pegged as a po­ten­tial megablock­buster.

Rheuma­toid arthri­tis is a tough dis­ease to beat, es­pe­cial­ly when you have to line up against some big ri­vals that are al­ready well en­trenched in the field. J&J and Glax­o­SmithK­line demon­strat­ed that when they came up with mixed re­sults in their head-to-head with sirukum­ab vs. Hu­mi­ra. But it was Eli Lil­ly that turned in the big nasty sur­prise, with the FDA stun­ning an­a­lysts with their re­jec­tion of baric­i­tinib, a drug li­censed from In­cyte.

“In the clin­i­cal tri­al pro­gram, sar­ilum­ab demon­strat­ed sta­tis­ti­cal­ly sig­nif­i­cant, clin­i­cal­ly-mean­ing­ful im­prove­ments in adult pa­tients with rheuma­toid arthri­tis by re­duc­ing signs and symp­toms and im­prov­ing phys­i­cal func­tion, re­sult­ing in sig­nif­i­cant­ly less ra­di­ograph­ic pro­gres­sion of struc­tur­al dam­age of RA,” said Alan Kivitz, an in­ves­ti­ga­tor in the glob­al SAR­IL-RA clin­i­cal pro­gram for sar­ilum­ab. “This is im­por­tant be­cause not all cur­rent­ly avail­able treat­ments work in all pa­tients, and some pa­tients may spend years cy­cling through dif­fer­ent treat­ments with­out achiev­ing their treat­ment goals. Sar­ilum­ab works dif­fer­ent­ly from the most com­mon­ly used bi­o­log­ics, such as those in the an­ti-TNF class, and is a wel­come new op­tion for pa­tients and their physi­cians.”

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His­toric drug pric­ing re­forms pass; Pfiz­er ac­quires GBT; The long search for non-opi­oid pain drugs; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

The Endpoints Weekly has officially crossed the 60,000 mark on subscribers — thanks to all of your support. As the editorial team grows, we’ve been able to do a lot more, with many of those on display this week. Be sure to check out Lei Lei Wu’s deep dive on pain R&D. If you missed it, you may also rewatch her companion panel here.

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Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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No­var­tis re­ports two pa­tient deaths af­ter treat­ment with Zol­gens­ma

Two children with spinal muscular atrophy have died after receiving Novartis’ Zolgensma, a gene therapy designed as a one-time treatment for the rare fatal disease.

The deaths, which resulted from acute liver failure, occurred in Russia and Kazakhstan, Novartis confirmed in a statement to Endpoints News. Having notified health authorities across all the markets where Zolgensma is available, it will update the drug label “to specify that fatal acute liver failure has been reported,” a spokesperson wrote.

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Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

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J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

CSL is gathering its four business units under a unified brand identity strategy (Credit: CSL company site)

CSL brings Se­qirus, Vi­for un­der par­ent um­brel­la brand in iden­ti­ty re­vamp

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

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Sanofi, GSK, Ha­le­on see stock prices dip and dive amid lit­i­ga­tion for re­called heart­burn drug

Zantac became one of the most well-known drugs on the market after being FDA-approved in 1983 — and now close to four decades later, lawsuits over safety concerns are rattling analysts and investors.

Sanofi, GSK and Haleon, GSK’s former consumer healthcare unit, have lost billions of dollars in market cap since Tuesday’s market close, according to Bloomberg. While Zantac is no longer on the market, the drop came after a suite of analysts, from Morgan Stanley and other firms, sounded the alarm on the potential impact of ongoing personal injury litigation.

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