Clo­vis soars as its PARP drug ru­ca­parib lines up for FDA re­view with pos­i­tive da­ta

Clo­vis On­col­o­gy stock $CLVS shot up 30% Tues­day af­ter­noon af­ter the biotech laid out com­pet­i­tive piv­otal da­ta for its PARP in­hibitor ru­ca­parib, which has now been ac­cept­ed by the FDA for a pri­or­i­ty re­view. The biotech says it is now start­ing the clock for a re­view that should wrap with a for­mal de­ci­sion by Feb­ru­ary 23 as sev­er­al late-stage ri­vals look to steal its thun­der. The move comes just a day af­ter Pfiz­er com­plet­ed a deal to buy Medi­va­tion and its Phase III PARP in­hibitor ta­la­zoparib for $14 bil­lion.

In­ves­ti­ga­tors for Clo­vis post­ed an over­all ob­jec­tive re­sponse rate of 54% from two small stud­ies with 106 pa­tients suf­fer­ing from ad­vanced ovar­i­an can­cer with BR­CA mu­ta­tions. The me­di­an du­ra­tion of re­sponse was 9.2 months with a 9% com­plete re­sponse rate. Clo­vis added that the “ORR was sim­i­lar for pa­tients with germline BR­CA-mu­tant ovar­i­an can­cer or so­mat­ic BR­CA-mu­tant ovar­i­an can­cer and for pa­tients with a BR­CA1 gene mu­ta­tion or BR­CA2 gene mu­ta­tion.”

That com­pares fa­vor­ably with As­traZeneca’s pi­o­neer­ing PARP Lyn­parza (ola­parib), which was ap­proved with a 34% ORR for an av­er­age of 7.9 months. The FDA over­ruled an FDA pan­el vote against Lyn­parza in 2014, de­spite frets over the drug’s ef­fi­ca­cy.

There’s a long way to go, though, be­fore Clo­vis can lay any claims to hav­ing a best-in-class drug. First, there’s a lot more da­ta to con­sid­er be­fore any fi­nal de­ci­sion ar­rives. Sec­ond, Tesaro $TSRO has al­ready laid out some im­pres­sive pos­i­tive ovar­i­an can­cer da­ta of its own for its PARP ni­ra­parib. Their da­ta high­light­ed a clear im­pact for the tar­get­ed drug in a pop­u­la­tion of germline BR­CA mu­ta­tion car­ri­ers, with a me­di­an PFS of 21 months in the drug group com­pared to 5.5 months in the con­trol arm — a 15.5-month ad­van­tage.

And, third, Pfiz­er has to fol­low up with a much clos­er look at ta­la­zoparib while Ab­b­Vie hus­tles along veli­parib in the clin­ic.

Tesaro shares were down 6% af­ter Clo­vis’s news hit, but the stock had slipped ahead of the news.

Clo­vis al­so has some lin­ger­ing cred­i­bil­i­ty is­sues to deal with. Its oth­er big can­cer drug, rocile­tinib, was scut­tled ear­li­er this year af­ter the FDA forced it to re­cal­cu­late the da­ta used in its sub­mis­sion. Ques­tion­able meth­ods were used to claim an im­pact that the fi­nal da­ta couldn’t sup­port. The ap­proval at­tempt im­plod­ed as an FDA ad­vi­so­ry pan­el turned thumbs down on the trou­bled drug and the biotech was forced to re­struc­ture in the wake of the de­ba­cle. And Clo­vis has re­port­ed in SEC fil­ings that it is un­der in­ves­ti­ga­tion by fed­er­al agen­cies ex­am­in­ing the tim­ing of the biotech’s da­ta sub­mis­sions and cor­rec­tions.

Clo­vis, though, re­tained the com­mer­cial in­fra­struc­ture it had built up, grim­ly de­ter­mined to fol­low through on ru­ca­parib. The biotech has ig­nored re­peat­ed re­quests for in­ter­views in re­cent months.

“Re­cur­rent ovar­i­an can­cer re­mains a very dif­fi­cult dis­ease to treat, even among women who car­ry, or whose tu­mors have a mu­ta­tion in the BR­CA genes. De­spite the avail­able treat­ment op­tions, few ef­fec­tive ther­a­pies are at our dis­pos­al. Thus, the op­por­tu­ni­ty to treat women with germline or so­mat­ic BR­CA mu­ta­tions with ru­ca­parib af­ter two pri­or lines of plat­inum-based ther­a­py, rep­re­sents a mean­ing­ful step for­ward for our pa­tients,” said Robert L. Cole­man, a pro­fes­sor at Uni­ver­si­ty of Texas MD An­der­son Can­cer Cen­ter in Hous­ton and one of the prin­ci­pal in­ves­ti­ga­tors in the ARIEL clin­i­cal tri­al pro­gram.

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.