Re­gen­eron and Sanofi land the big one, win­ning FDA ap­proval for their megablock­buster hope­ful Dupix­ent

George Yan­copou­los, Pres­i­dent and CSO, Re­gen­eron

The FDA has ap­proved the new eczema drug dupilum­ab from Re­gen­eron and Sanofi, of­fi­cial­ly launch­ing a new drug that is like­ly on course to cre­at­ing a megablock­buster fran­chise for these two part­ners. Wide­ly tapped as the biggest pro­gram in the in­dus­try’s pipeline this year, dupilum­ab now will be brand­ed as Dupix­ent. And the mar­ket here could be worth up­wards of $5 bil­lion a year.

“Peo­ple with mod­er­ate-to se­vere atopic der­mati­tis cope with in­tense, some­times un­bear­able symp­toms that can im­pact them for most of their lives,” said Julie Block, the CEO of the Na­tion­al Eczema As­so­ci­a­tion. “To date, there have been few op­tions avail­able to treat peo­ple with mod­er­ate-to-se­vere atopic der­mati­tis who have un­con­trolled dis­ease. That’s why to­day’s ap­proval of Dupix­ent is so im­por­tant for our com­mu­ni­ty. Now we have a treat­ment that is ex­pect­ed to help ad­dress pa­tients suf­fer­ing from this dev­as­tat­ing dis­ease.”

The drug will be priced at $37,000 a year, a shade high­er than many an­a­lysts had ex­pect­ed, but not sig­nif­i­cant­ly out of line.

“We have set a fair and re­spon­si­ble price for Dupix­ent,” says a Sanofi spokesper­son. “We are en­cour­aged by the on­go­ing con­ver­sa­tions we’ve had with health plans and phar­ma­cy ben­e­fit man­agers about cov­er­age for Dupix­ent for pa­tients, and we have a shared com­mit­ment with them to en­sure pa­tients who should re­ceive it can re­ceive it.”

Ge­of­frey Porges, Leerink

Some top an­a­lysts wouldn’t dis­agree with that re­mark. Leerink’s Ge­of­frey Porges not­ed that the dis­count price should fall right around $30,000, which should be ac­cept­able to pay­ers. He not­ed:

While pay­ers may still be­lieve Dupix­ent is an ex­pen­sive ther­a­py, the drug is cost-ef­fec­tive for the in­di­cat­ed pa­tients, ac­cord­ing to the in­flu­en­tial ICER re­port. In­deed, in to­day’s press Ex­press Scripts’ (ES­RX, MP) CMO Steven Miller com­ment­ed that the man­u­fac­tur­ers had set a “re­spon­si­ble price,” and pay­ers ap­pear to be tak­ing cred­it for in­flu­enc­ing the pric­ing de­ci­sion. Re­cent drug launch­es have been harmed by un­clear ef­fi­ca­cy, broad­ly-la­beled pa­tient pop­u­la­tions that do not match avail­able clin­i­cal tri­al da­ta, and high list prices. By con­trast, Dupix­ent’s well-de­fined la­belled in­di­ca­tion and clear out­comes ben­e­fits, as well as the com­plete lack of FDA-ap­proved med­i­cines for post-top­i­cals mod­er­ate-to-se­vere AD, should lim­it the im­pact of step-ed­its and pri­or au­tho­riza­tion re­quire­ments.

Baird’s Bri­an Sko­r­ney ran a physi­cian sur­vey and found a large num­bers of doc­tors are ea­ger to start pre­scrib­ing this drug.

Bri­an Sko­r­ney, Baird an­a­lyst

“Im­por­tant­ly, physi­cian sen­ti­ment points to a mar­ket for Dupix­ent of about 300,000-350,000 pa­tients, in line with man­age­ment’s ex­pec­ta­tions,” he not­ed Tues­day morn­ing. “We wouldn’t be sur­prised to see an ex­cep­tion­al­ly strong launch here, but we con­tin­ue to point out that con­sen­sus ex­pec­ta­tions are al­ready build­ing that in.

The two bio­phar­ma part­ners — with Re­gen­eron whip­ping up the IL-4/IL-13 an­ti­body and Sanofi weigh­ing in with its late-stage mus­cle — have divvied up the mar­ket 50/50. And they’ve al­ready fired off a pre­emp­tive le­gal blast against a liti­gious Am­gen, their arch neme­sis which is sit­ting on IP for both tar­gets.

Am­gen has ag­gres­sive­ly pur­sued a law­suit against the Re­gen­eron/Sanofi’s team for their PC­SK9 drug Pralu­ent, which com­petes against Am­gen’s Repatha. At one point, Am­gen scored a stun­ning up­set, win­ning a court rul­ing in fa­vor of shelv­ing the ri­val drug, which has since been set aside.

In the part­ners’ suit against Am­gen, they say that they’ve learned that Am­gen has hired coun­sel to pur­sue a claim in­volv­ing patent ‘487, which in­volves IL-4 and IL-13 drugs. Am­gen tried, and failed, to de­vel­op their own IL4/IL-13 drug — AMG317 — and failed in Phase II. And Re­gen­eron and Sanofi are seek­ing a pre­emp­tive rul­ing against Am­gen, which loves to field its ag­gres­sive le­gal team when­ev­er it suits their strat­e­gy or the lawyers be­lieve there’s some rev­enue to grab off the ta­ble.

Re­gen­eron and Sanofi have much to pro­tect here, if the an­a­lysts are right. Pfiz­er scored an ap­proval for its atopic der­mati­tis drug Eu­crisa (crisabo­role), a PDE-4 in­hibitor, which has some block­buster am­bi­tions of its own. But Dupix­ent is ex­pect­ed to be game chang­er for pa­tients.

Just a few weeks ago in­ves­ti­ga­tors spelled out a new batch of stel­lar da­ta, com­plet­ing a ma­jor Phase III ef­fort that care­ful­ly re­viewed safe­ty and ef­fi­ca­cy da­ta for a wide range of pa­tients.

In the new CHRONOS da­ta re­viewed at the an­nu­al meet­ing of the Amer­i­can Acad­e­my of Der­ma­tol­ogy in Or­lan­do ear­li­er this month, in­ves­ti­ga­tors not­ed that the se­vere itch­ing pa­tients are af­flict­ed by was re­duced by 55% and 58% in the two drug arms af­ter 16 weeks, com­pared to 29% of pa­tients on TCS alone. And the dis­ease score rat­ing for pa­tients dropped by 4 or more points among 77% of the pa­tients in the drug arms com­pared to 37% of the place­bo/top­i­cal cor­ti­cos­teroid group.

Re­gen­eron and Sanofi need to make a quick suc­cess of this drug, and they’ll like­ly roll out an ag­gres­sive mar­ket­ing ef­fort now that they have re­ceived a long-await­ed green light from the FDA. They still be­lieve that they can make a big suc­cess of Repatha, but pay­ers have kept it care­ful­ly bot­tled up, wait­ing for car­dio out­comes. Rev­enue is mar­gin­al.

Then there’s sar­ilum­ab, held up by the FDA months ago so that Sanofi could clear up some em­bar­rass­ing man­u­fac­tur­ing is­sues.

Dupix­ent is a go. And the Re­gen­eron/Sanofi team is now tak­ing the mar­ket­ing field with a care­ful­ly planned blitz. They can’t af­ford an­oth­er set­back.

Sanofi in par­tic­u­lar, which has been sad­dled with a large­ly in­ef­fec­tive French R&D group, needs to show it can de­vel­op and field a ma­jor new drug. Now they have an­oth­er shot at glo­ry.

“Dupix­ent is the re­sult of years of tire­less re­search by our sci­en­tists in­to the un­der­ly­ing caus­es of al­ler­gic and atopic dis­eases. In atopic der­mati­tis, Dupix­ent was shown to help clear the skin and man­age the in­tense itch caused by the dis­ease,” said George D. Yan­copou­los, the found­ing sci­en­tist and CSO at Re­gen­eron. “To­day’s ap­proval would not be pos­si­ble with­out the ded­i­ca­tion of the clin­i­cal in­ves­ti­ga­tors and the par­tic­i­pa­tion of the pa­tients who took part in the glob­al LIB­ER­TY AD clin­i­cal pro­gram.”

Bris­tol My­ers is clean­ing up the post-Cel­gene merg­er pipeline, and they’re sweep­ing out an ex­per­i­men­tal check­point in the process

Back during the lead up to the $74 billion buyout of Celgene, the big biotech’s leadership did a little housecleaning with a major pact it had forged with Jounce. Out went the $2.6 billion deal and a collaboration on ICOS and PD-1.

Celgene, though, also added a $530 million deal — $50 million up front — to get the worldwide rights to JTX-8064, a drug that targets the LILRB2 receptor on macrophages.

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GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.

Fangliang Zhang, AP Images

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Amid a flurry of splashy pandemic IPOs, a J&J-partnered Chinese biotech has emerged with one of the largest public raises in biotech history.

Legend Biotech, the Nanjing-based CAR-T developer, has raised $424 million on NASDAQ. The biotech had originally filed for a still-hefty $350 million, based on a range of $18-$20, but managed to fetch $23 per share, allowing them to well-eclipse the massive raises from companies like Allogene, Juno, Galapagos, though they’ll still fall a few dollars short of Moderna’s record-setting $600 million raise from 2018.

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Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

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Leen Kawas, Athira CEO (Athira)

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