Bris­tol-My­ers stag­gered by a stun­ning check­point set­back, hands Mer­ck a free pass on front­line lung can­cer com­bo

Bris­tol-My­ers Squibb $BMY fans can scratch any hopes of an ac­cel­er­at­ed fil­ing for a com­bi­na­tion of Op­di­vo and Yer­voy as a front­line ther­a­py for lung can­cer. The big biotech an­nounced in a terse state­ment late Thurs­day that it will not pur­sue an ac­cel­er­at­ed ap­proval due to the “re­view of da­ta avail­able at this time.”

More in­sight? For­get about it. Says Bris­tol-My­ers:

“In or­der to pro­tect the in­tegri­ty of on­go­ing reg­is­tra­tional stud­ies, the com­pa­ny will not be pro­vid­ing ad­di­tion­al de­tails.”

The an­nounce­ment nix­es any hopes that the com­bo can pro­vide near-term re­lief from Mer­ck’s as­sault on the front­line fran­chise with its stun­ning ear­ly fil­ing on a com­bi­na­tion of Keytru­da and chemo for first line use. Bris­tol-My­ers’s work on Check­mate-227, the key clin­i­cal pro­gram that will de­cide the fate of Op­di­vo’s fu­ture, is ex­pect­ed to last in­to 2018.

Bris­tol-My­ers’ shares plunged 10% in ear­ly trad­ing Fri­day, elim­i­nat­ing more than $9 bil­lion in mar­ket cap. Its loss was Mer­ck’s gain, which saw its stock jump 4%. And As­traZeneca was caught in this vor­tex as well, with shares drop­ping 2% in pre-mar­ket trad­ing as an­a­lysts raised doubts about its strat­e­gy for dur­val­um­ab, which will play a crit­i­cal role in CEO Pas­cal So­ri­ot’s plan to make a come­back at the phar­ma gi­ant.

Mer­ck now has plen­ty of time to grab the lead with its own ear­ly com­bo ap­proach, as As­traZeneca still looks for a come-from-be­hind win on dur­val­um­ab and treme­li­mum­ab, with pro­gres­sion-free sur­vival da­ta slat­ed to ar­rive this sum­mer — though over­all sur­vival da­ta won’t like­ly ar­rive on that ex­per­i­men­tal com­bo un­til 2018 as well.

Sea­mus Fer­nan­dez, Leerink

Sea­mus Fer­nan­dez at Leerink had some time to con­sid­er the im­pact, and he was dis­turbed by the im­pli­ca­tions for Bris­tol-My­ers as well as As­traZeneca. He not­ed:

This is a clear set­back for BMY, par­tic­u­lar­ly in light of the agency’s re­cent ac­cep­tance of MRK’s (MP) fil­ing for the Keytru­da (pem­brolizum­ab; an­ti-PD-1) + chemother­a­py reg­i­men. With the CM-227 tri­al ex­pect­ed to read­out in 1H:18, this al­so could give AZN (OP) a pot’l head start with its dur­val­um­ab (an­ti-PD-L1) + treme­li­mum­ab (an­ti-CT­LA-4) com­bi­na­tion in 1L NSCLC, as­sum­ing pos­i­tive da­ta from the MYS­TIC tri­al (ex­pect­ed in mid-2017). How­ev­er, if MRK and RHH­BY’s (NR) Phase 3 IO+Chemo tri­als are both suc­cess­ful and IO+IO com­bos fail to im­press, this would leave very lit­tle room for ei­ther BMY or AZN to dif­fer­en­ti­ate them­selves in the 1L NSCLC mar­ket. This would be par­tic­u­lar­ly sur­pris­ing and dis­ap­point­ing in the wake of our re­cent dis­cus­sions with lung can­cer KOLs.

In an­oth­er ma­jor set­back for Bris­tol-My­ers Squibb, its first piv­otal study for Op­di­vo in front­line lung can­cer failed last year, in part be­cause in­ves­ti­ga­tors de­cid­ed to tack­le a broad swathe of pa­tients. Its con­sis­tent­ly dis­ap­point­ing re­sponse on lung can­cer has ran­kled an­a­lysts and in­vestors, who once gam­bled that Bris­tol would be the king­pin in check­point drugs.

Mer­ck $MRK in the mean­time, is fol­low­ing up with dozens of stud­ies of Keytru­da com­bos. Just a few days ago the com­pa­ny turned heads once again with plans to com­bine Keytru­da with In­cyte’s IDO1 in­hibitor epaca­do­stat in lung can­cer and sev­er­al oth­er on­col­o­gy in­di­ca­tions.

Novotech CEO Dr. John Moller

Novotech CRO Award­ed Frost & Sul­li­van Best Biotech CRO Asia-Pa­cif­ic 2019

Known in the in­dus­try as the Asia-Pa­cif­ic CRO, Novotech is now lead CRO ser­vices provider for the grow­ing num­ber of in­ter­na­tion­al biotechs se­lect­ing the re­gion for their stud­ies.

Re­flect­ing this Asia-Pa­cif­ic growth, Novotech staff num­bers are up 20% since De­cem­ber 2018 to 600 in-house clin­i­cal re­search peo­ple across a full range of ser­vices, across the re­gion.

Novotech’s ca­pa­bil­i­ties have been rec­og­nized by an­a­lysts like Frost & Sul­li­van, most re­cent­ly with the pres­ti­gious Asia-Pa­cif­ic CRO Biotech of the year award for best prac­tices in clin­i­cal re­search for biotechs for the fifth year. See oth­er awards here.

Bet­ter than Am­bi­en? Min­er­va soars on PhI­Ib up­date on sel­torex­ant for in­som­nia

A month af­ter roil­ing in­vestors with what skep­tics dis­missed as cher­ry pick­ing of its de­pres­sion da­ta, Min­er­va is back with a clean slate of da­ta from its Phase IIb in­som­nia tri­al.

In a de­tailed up­date, the Waltham, MA-based biotech said sel­torex­ant (MIN-202) hit both the pri­ma­ry and sev­er­al sec­ondary end­points, ef­fec­tive­ly im­prov­ing sleep in­duc­tion and pro­long­ing sleep du­ra­tion. In­ves­ti­ga­tors made a point to note that the ef­fects were con­sis­tent across the adult and el­der­ly pop­u­la­tions, with the lat­ter more prone to the sleep dis­or­der.

Gene ther­a­py biotech sees its stock rock­et high­er on promis­ing re­sults for rare cas­es of but­ter­fly dis­ease

Shares of Krys­tal Biotech took off this morn­ing $KRYS af­ter the lit­tle biotech re­port­ed promis­ing re­sults from its gene ther­a­py to treat a rare skin dis­ease called epi­der­mol­y­sis bul­losa.

Fo­cus­ing on an up­date with 4 new pa­tients, re­searchers spot­light­ed the suc­cess of KB103 in clos­ing some stub­born wounds. Krys­tal says that of 4 re­cur­ring and 2 chron­ic skin wounds treat­ed with the gene ther­a­py, the KB103 group saw the clo­sure of 5. The 6th — a chron­ic wound, de­fined as a wound that had re­mained open for more than 12 weeks — was par­tial­ly closed. That brings the to­tal so far to 8 treat­ed wounds, with 7 clo­sures.

Alex­ion wins pri­or­i­ty re­view for Ul­tomiris' aHUS in­di­ca­tion; FDA ex­pands ap­proval of Ver­tex's Symdeko

→ Alex­ion $ALXN has scored a speedy re­view for Ul­tomiris for pa­tients with atyp­i­cal he­molyt­ic ure­mic syn­drome (aHUS) af­ter post­ing pos­i­tive da­ta from a piv­otal study in Jan­u­ary. The drug is the rare dis­ease com­pa­ny’s shot at pro­tect­ing its block­buster blood dis­or­der fran­chise that is cur­rent­ly cen­tered around its flag­ship drug, Soliris, which is a com­ple­ment in­hibitor typ­i­cal­ly ad­min­is­tered every two weeks. Ul­tomiris has a sim­i­lar mech­a­nism of ac­tion but re­quires less-fre­quent dos­ing — every eight weeks. The de­ci­sion date has been set to Oc­to­ber 19. Late last year, Ul­tomiris se­cured ap­proval for noc­tur­nal he­mo­glo­bin­uria (PNH) pa­tients.

Ab­b­Vie gets a green light to re­sume re­cruit­ing pa­tients for one myelo­ma study — but Ven­clex­ta re­mains un­der a cloud

Three months af­ter reg­u­la­tors at the FDA forced Ab­b­Vie to halt en­rolling pa­tients in its tri­als of a com­bi­na­tion us­ing Ven­clex­ta (vene­to­clax) to treat drug-re­sis­tant cas­es of mul­ti­ple myelo­ma, the agency has green-light­ed the re­sump­tion of one of those stud­ies, while keep­ing the rest on the side­lines.

The CANO­VA (M13-494) study can now get back in busi­ness re­cruit­ing pa­tients to test the drug for a pop­u­la­tion that shares a par­tic­u­lar ge­net­ic bio­mark­er. To get that per­mis­sion, Ab­b­Vie — which is part­nered with Roche on this pro­gram — was forced to re­vise the pro­to­col, mak­ing un­spec­i­fied changes in­volv­ing risk mit­i­ga­tion mea­sures, pro­to­col-spec­i­fied guide­lines and an up­dat­ed fu­til­i­ty cri­te­ria.

UP­DAT­ED: In sur­prise switch, Bris­tol-My­ers is sell­ing off block­buster Ote­zla, promis­ing to com­plete Cel­gene ac­qui­si­tion — just lat­er

Apart from revealing its checkpoint inhibitor Opdivo blew a big liver cancer study on Monday, Bristol-Myers Squibb said its plans to swallow Celgene will require the sale of blockbuster psoriasis treatment Otezla to keep the Federal Trade Commission (FTC) at bay.

The announcement — which has potentially delayed the completion of the takeover to early 2020 — irked investors, triggering the New York-based drugmaker’s shares to tumble Monday morning in premarket trading.

Celgene’s Otezla, approved in 2014 for psoriasis and psoriatic arthritis, is a rising star. It generated global sales of $1.6 billion last year, up from the nearly $1.3 billion in 2017. Apart from the partial overlap of Bristol-Myers injectable Orencia, the company’s rival oral TYK2 psoriasis drug is in late-stage development, after the firm posted encouraging mid-stage data on the drug, BMS-986165, last fall. With Monday’s decision, it appears Bristol-Myers is favoring its experimental drug, and discounting Otezla’s future.

The move blindsided some analysts. Credit Suisse’s Vamil Divan noted just days ago:

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Bris­tol-My­ers star Op­di­vo fails sur­vival test in a matchup with Nex­avar aimed at shak­ing up the big HCC mar­ket

Bris­tol-My­ers Squibb has suf­fered an­oth­er painful set­back in its years-long quest to ex­pand the reach of Op­di­vo. The phar­ma gi­ant this morn­ing not­ed that their Check­mate-459 study com­par­ing Op­di­vo with Bay­er’s Nex­avar in front­line cas­es of he­pa­to­cel­lu­lar car­ci­no­ma — the most com­mon form of liv­er can­cer — failed to hit the pri­ma­ry end­point on over­all sur­vival.

This was a sig­nif­i­cant mile­stone in Bris­tol-My­ers’ tal­ly of PD-1 cat­a­lysts this year. Nex­avar (so­rafenib) has been the stan­dard of care in front­line HCC for the past decade, though Op­di­vo has been mak­ing head­way in sec­ond-line HCC cas­es, where it’s go­ing toe-to-toe with Bay­er’s Sti­var­ga (re­go­rafenib) af­ter re­cent ap­provals shook up the mar­ket.

Why would the FDA ap­prove an­oth­er con­tro­ver­sial drug to spur a woman’s li­bido with these da­ta? And why no ex­pert pan­el re­view?

AMAG Pharmaceuticals’ newly approved drug for spurring women’s sexual desire may never make much money, but it’s a big hit at sparking media attention.

The therapy — Vyleesi (bremelanotide) — got the green light from regulators on Friday evening, swiftly lighting up a range of stories around the world, from The New York Times to The Guardian. Several headlines inevitably referred to it as the “female Viagra,” invoking Pfizer’s old erectile dysfunction blockbuster.

But the two drugs have little in common.

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Fol­low­ing news of job cuts in Eu­ro­pean R&D ops, Sanofi con­firms it’s of­fer­ing US work­ers an 'ear­ly ex­it'

Ear­li­er in the week we learned that Sanofi was bring­ing out the bud­get ax to trim 466 R&D jobs in Eu­rope, re­tool­ing its ap­proach to car­dio as re­search chief John Reed beefed up their work in can­cer and gene ther­a­pies. And we’re end­ing the week with news that the phar­ma gi­ant has al­so been qui­et­ly re­duc­ing staff in the US, tar­get­ing hun­dreds of jobs as the com­pa­ny push­es vol­un­tary buy­outs with a fo­cus on R&D sup­port ser­vices.