Tesaro rock­ets up af­ter PARP in­hibitor aces PhI­II study and R&D ri­val­ry in­ten­si­fies

Tesaro’s close­ly-watched PARP in­hibitor ni­ra­parib has aced its first Phase III chal­lenge, rack­ing up a slate of promis­ing out­comes for pro­gres­sion-free sur­vival for ad­vanced, re­cur­ring ovar­i­an can­cer that will take it straight to the FDA — which has al­ready ap­proved a ri­val with much worse da­ta.

Mary Lynne Hed­ley, Tesaro Pres­i­dent & COO

“This is the first ran­dom­ized Phase III of a PARP in­hibitor to be suc­cess­ful,” says Mary Lynne Hed­ley, the pres­i­dent and COO of Waltham, MA-based Tesaro ($TSRO).

“The hope would be that fol­low­ing sub­mis­sions from the NO­VA study, we could be in a po­si­tion to launch ni­ra­parib next year,” says CEO Lon­nie Moul­der, who views the Phase III da­ta as a ma­jor mile­stone for Tesaro.

In­vestors, who watched the biotech’s shares slide 8% yes­ter­day, drove a 112% spike in the com­pa­ny’s share val­ue in pre-mar­ket trad­ing Wednes­day morn­ing. Tesaro start­ed the day with a $1.7 bil­lion mar­ket cap.

The da­ta high­light 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.

But it al­so did bet­ter than that, sur­pris­ing some doubters in two oth­er tar­get­ed pa­tient groups.

For pa­tients who were not germline BR­CA mu­ta­tion car­ri­ers but whose tu­mors were de­ter­mined to be HRD pos­i­tive, the ni­ra­parib arm hit the pri­ma­ry end­point with a me­di­an PFS of 12.9 months com­pared to 3.8 months for the con­trol arm. And in the over­all non-germline BR­CA mu­tant co­hort, which in­clud­ed pa­tients with both HRD-pos­i­tive and HRD-neg­a­tive tu­mors, the PFS was 9.3 months for ni­ra­parib com­pared to 3.9 months for con­trol.

Lon­nie Moul­der, Tesaro CEO

“From the out­set, we’ve been quite bull­ish on the tri­al de­sign,” Moul­der added. “Peo­ple an­tic­i­pat­ed ni­ra­parib would be suc­cess­ful in germline BR­CA mu­ta­tion.” But there was some con­tro­ver­sy over what in­ves­ti­ga­tors would like­ly see in the oth­er two groups, with con­sid­er­able skep­ti­cism about the nongermline group re­gard­less of HRD sta­tus.

Run­ning the board with pos­i­tive out­comes was not ex­pect­ed.

“It’s as good as we could ever hope for,” says the CEO. “It is pret­ty com­pelling.”

To pro­vide some added con­text for the da­ta, the FDA ap­proved As­traZeneca’s Lyn­parza (ola­parib) af­ter an ad­vi­so­ry board turned their thumbs down on an ap­proval for ovar­i­an can­cer in 2014. The phar­ma gi­ant’s drug failed a Phase III study on over­all sur­vival, but the turn­around team at AZ felt they had a clear shot at an ap­proval any­way.

“This tri­al (for ola­parib) has prob­lems,” FDA can­cer chief Richard Paz­dur con­ced­ed in the pan­el dis­cus­sion at the time. If in­ves­ti­ga­tors had “pris­tine ev­i­dence of a 7-month ad­van­tage in PFS, we wouldn’t be here.”

Now ni­ra­parib takes the lead among a group of PARP in­hibitors jock­ey­ing for a lead po­si­tion in sev­er­al can­cer types, with J&J tak­ing over the de­vel­op­ment of the drug for prostate can­cer and Tesaro pur­su­ing new in­di­ca­tions for oth­er can­cer types. As­traZeneca has new da­ta com­ing out soon, but there’s al­so con­sid­er­able at­ten­tion for Medi­va­tion’s ta­la­zoparib, which Sanofi has been an­gling to snatch in a $9.3 bil­lion takeover at­tempt. (Sanofi tried and failed, in this field with ini­parib) Then there’s ru­ca­parib, Clo­vis’ newest lead drug in the wake of ro­ci’s im­plo­sion at the FDA’s doorsteps. And Ab­b­Vie has veli­parib in the clin­ic.

Clo­vis will be put to the test once again, as all the play­ers in this field look to po­si­tion them­selves in a hy­per-com­pet­i­tive field.

For Tesaro, a new drug launch for ni­ra­parib would give the biotech a sec­ond drug to mar­ket, fol­low­ing ro­lap­i­tant’s ap­proval, as it beefs up staff from 300 to about 400 em­ploy­ees.

“Next year with a ni­ra­parib launch, we’ll in­crease our com­mer­cial pres­ence 25-30%,” Moul­der told me in a re­cent con­ver­sa­tion. “Then we’ll be ful­ly scaled for mul­ti­ple prod­ucts.”

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.

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.

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.

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.

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.

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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