Leonard Schleifer (Photo by: Adam Jeffery/CNBC/NBCU Photo Bank via Getty Images)

Re­gen­eron inks $1B+ deal for glob­al rights to Sanofi-part­nered PD-1 Lib­tayo

Sanofi CEO Paul Hud­son made clear ear­li­er this year that his mis­sion to re­shape the com­pa­ny would in­volve some pipeline prun­ing. For the right price that ap­par­ent­ly in­cludes Lib­tayo, mere months ahead of an ex­pect­ed FDA de­ci­sion on lung can­cer.

Paul Hud­son

Re­gen­eron is putting down a whop­ping $900 mil­lion up­front for the full rights to Lib­tayo, their part­nered PD-1 treat­ment that earned Re­gen­eron $306 mil­lion last year, up 13% from the year be­fore.

The Tar­ry­town, NY-based com­pa­ny is sweet­en­ing the deal with an 11% roy­al­ty on world­wide net sales. Plus, there’s an­oth­er $100 mil­lion on the line if the drug wins ap­proval in the US or EU in com­bi­na­tion with chemother­a­py for non-small cell lung can­cer pa­tients, and $100 mil­lion in po­ten­tial sales-re­lat­ed mile­stones over the next two years.

The move is in line with Hud­son’s warn­ing ear­li­er this year that some se­ri­ous pro­gram cuts are on the way, this lat­est one sig­nal­ing a shift to next-gen can­cer meds.

Bill Si­bold

“Our ear­ly steps with Lib­tayo in im­muno-on­col­o­gy pro­vid­ed a strong foun­da­tion for our re­vi­tal­ized on­col­o­gy ef­forts. Now, we are fo­cused on lever­ag­ing our in­ter­nal ca­pa­bil­i­ties and ad­vanc­ing a new gen­er­a­tion of on­col­o­gy med­i­cines,” Sanofi’s EVP of spe­cial­ty care and North Amer­i­ca pres­i­dent Bill Si­bold said in a news re­lease.

“We con­tin­ue to main­tain a strong part­ner­ship with Re­gen­eron in im­munol­o­gy, and will work close­ly with them on the seam­less tran­si­tion of Lib­tayo to en­sure there is no im­pact for pa­tients,” Si­bold added.

Pri­or to the deal, Sanofi and Re­gen­eron co-com­mer­cial­ized Lib­tayo in the US, while Sanofi held the rights every­where else. Re­gen­eron CEO Leonard Schleifer spelled out “sev­er­al com­pelling rea­sons” for pur­su­ing the glob­al rights, per­haps most im­por­tant­ly the free­dom to ex­plore com­bi­na­tion op­por­tu­ni­ties.

“You can look at what Mer­ck and oth­ers are do­ing, and it sort of gives you a win­dow to where the world is go­ing,” he said on a call with in­vestors. “They are well aware of the loss of ex­clu­siv­i­ty that might con­front them, and they are look­ing to com­bine the drug, Keytru­da for ex­am­ple, or oth­ers, with oth­er agents that will im­prove the ben­e­fit to pa­tients while si­mul­ta­ne­ous­ly ex­tend­ing the ex­clu­siv­i­ty.”

Re­gen­eron high­light­ed a se­ries of po­ten­tial Lib­tayo com­bi­na­tions, in­clud­ing with CD3 bis­pecifics, CD28 bis­pecifics, and oth­er im­mune-mod­u­lat­ing agents like fi­an­limab, its an­ti-LAG-3 can­di­date. LAG-3 is an im­mune check­point re­cep­tor as­so­ci­at­ed with ther­a­peu­tic re­sis­tance to an­ti-PD-1 ther­a­py. There­fore, sci­en­tists be­lieve it could en­hance the an­ti-tu­mor ef­fect in melanoma pa­tients when com­bined with Lib­tayo.

George Yan­copou­los

“We be­lieve fi­an­limab is the first in a se­ries of Lib­tayo com­bi­na­tions that we can de­vel­op to im­prove treat­ment for pa­tients with can­cer,” CSO George Yan­copou­los said on the call while not­ing that new da­ta from that com­bi­na­tion won’t be avail­able un­til at least 2024.

Lib­tayo was first ap­proved in 2018 for a type of skin can­cer called metasta­t­ic cu­ta­neous squa­mous cell car­ci­no­ma, and last year won its sec­ond and third ap­provals in ad­vanced basal cell car­ci­no­ma and as a monother­a­py for cer­tain ad­vanced NSCLC pa­tients. It has a Sept. 19 PDU­FA date in com­bi­na­tion with chemo as a first-line treat­ment for ad­vanced NSCLC, and the EC is ex­pect­ed to de­cide in the sec­ond half of this year.

Ear­li­er this year, Sanofi and Re­gen­eron pulled an ap­pli­ca­tion for Lib­tayo in sec­ond-line cer­vi­cal can­cer af­ter the com­pa­nies and the FDA were not able to align on cer­tain post-mar­ket­ing stud­ies.

Robert Landry

Sanofi and Re­gen­eron’s part­ner­ship dates back to 2003. Over the last 19 years, the duo brought a hand­ful of drugs to mar­ket in a col­lab­o­ra­tion that Hud­son once called “one of the most pro­duc­tive in the in­dus­try.”

With the glob­al rights to Lib­tayo, CFO Robert Landry said Re­gen­eron isn’t afraid to ex­plore op­por­tu­ni­ties out­side of its own pipeline.

“We will con­tin­ue to ex­plore ways to bol­ster and com­ple­ment our own re­search ca­pa­bil­i­ties with ex­ter­nal­ly sourced in­no­va­tion,” he said, point­ing to the com­pa­ny’s re­cent $250 mil­lion all-cash Check­mate Phar­ma­ceu­ti­cals buy­out as an ex­am­ple.

And it cer­tain­ly has the cash to work with. Sales last year in­creased 89% to $16.07 bil­lion, $6.19 bil­lion of which was at­trib­ut­able to the com­pa­ny’s Covid-19 mon­o­clon­al an­ti­body RE­GEN-COV.

“We are not on­ly do­ing this in­ter­nal­ly,” Schleifer said. “We’re open for busi­ness.”

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Ted Love, Global Blood Therapeutics CEO

Up­dat­ed: Pfiz­er scoops up Glob­al Blood Ther­a­peu­tics and its sick­le cell ther­a­pies for $5.4B

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Just ahead of the weekend, word got out that Pfizer was close to clinching a $5 billion buyout — albeit with other potential buyers still at the table. The pharma giant, flush with cash from Covid-19 vaccine sales, apparently got out on top.

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FDA commissioner Rob Califf (Tom Williams/CQ Roll Call via AP Images)

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