Mer­ck’s Keytru­da com­bo wows again, ac­ing PhI­II over­all sur­vival goal for lung can­cer ear­ly

Mer­ck’s Keytru­da team can chalk up an­oth­er big win in the race for PD-1/L1 dom­i­nance.

Their check­point in­hibitor added to chemo in a piv­otal study de­liv­ered “sig­nif­i­cant” ben­e­fits in over­all sur­vival as well as pro­gres­sion-free sur­vival among front­line non-small cell lung can­cer pa­tients — one of the big prizes in the ri­val­ry over a mega-block­buster mar­ket.

Roger Perl­mut­ter

They are de­clar­ing this suc­cess at an ear­ly, in­ter­im point —well ahead of ex­pec­ta­tions. The fi­nal OS read­out wasn’t ex­pect­ed un­til ear­ly next year. The new re­sults come just a few months af­ter Mer­ck rat­tled in­vestors with its de­ci­sion to yank a Eu­ro­pean ap­pli­ca­tion for Keytru­da for front­line use in the face of reg­u­la­to­ry re­sis­tance to the Phase II da­ta that were be­ing of­fered.

Mer­ck’s shares moved steadi­ly up­wards on the news, jump­ing 6% by mid-morn­ing with Roche stock skid­ding 3.7% and Bris­tol-My­ers shares down 2.7% as in­vestors placed their bets.

“The fact that MRK hit in KN-189 al­ready means Roche won’t get that leg up over MRK that was be­ing talked about post IMP-150 (al­so in 1L lung),” not­ed Ever­core ISI’s Uber Raf­fat.

Re­searchers at Mer­ck are stick­ing with the top-line re­sults for now, with hard num­bers on their KEYNOTE-189 study be­ing held for a sci­en­tif­ic con­fer­ence. But this is the first time that a check­point study has demon­strat­ed an over­all sur­vival ben­e­fit for this group.

Their will­ing­ness to in­clude OS to the study — which added Keytru­da to Eli Lil­ly’s Al­im­ta — un­der­scored Mer­ck’s con­fi­dence in their big can­cer drug, which has been mak­ing steady ad­vances since Bris­tol-My­ers Squibb stum­bled bad­ly last year with a clin­i­cal set­back that it has yet to re­cov­er from. There are now 5 of these PD-1/L1 drugs on the mar­ket, with a 6th on the way soon, and hun­dreds of com­bi­na­tion stud­ies like this have been mount­ed to find the best ap­proach, of­ten cen­ter­ing on chemo or in-house ther­a­pies like the CT­LA-4 drugs.

Leerink’s Sea­mus Fer­nan­dez says Mer­ck was able to keep its lead to­day, but the race isn’t over yet. His note:

We see these re­sults as fur­ther so­lid­i­fy­ing MRK’s cur­rent lead po­si­tion in the 1L NSCLC race; how­ev­er, full da­ta (to be pre­sent­ed at an up­com­ing meet­ing) will be nec­es­sary to com­pare with RHH­BY’s (NR) IM­pow­er150 tri­al of Tecen­triq (ate­zolizum­ab; an­ti-PD-L1) + Avastin (be­va­cizum­ab; an­ti-VEGF) + chemo, as well as up­com­ing read­outs from BMY’s (OP) Check­Mate-227 tri­al of Op­di­vo (nivolum­ab; an­ti-PD-1) + Yer­voy (ip­il­i­mum­ab; an­ti-CT­LA-4) and OS re­sults from AZN’s (MP) MYS­TIC tri­al of Imfinzi (dur­val­um­ab; an­ti-PD-L1) + treme­limuamb (an­ti-CT­LA-4).

“KEYNOTE-189 showed sig­nif­i­cant im­prove­ment in over­all sur­vival and pro­gres­sion-free sur­vival for pa­tients re­ceiv­ing Keytru­da in the first-line set­ting in com­bi­na­tion with tra­di­tion­al chemother­a­py, com­pared with those re­ceiv­ing chemother­a­py alone,” said Mer­ck R&D chief Roger Perl­mut­ter.

Brent Saunders [Getty Photos]

UP­DAT­ED: Ab­b­Vie seals $63B deal to buy a trou­bled Al­ler­gan — spelling out $1B in R&D cuts

Brent Saunders has found his way out of the current fix he’s in at Allergan $AGN. He’s selling the company to AbbVie for $63 billion in the latest example of the hot M&A market in biopharma.

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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.

FDA re­jects Ac­er's rare dis­ease drug, asks for new tri­al — shares crater

Ac­er Ther­a­peu­tics’ bid to re­pur­pose celipro­lol — a be­ta-block­er on the mar­ket for hy­per­ten­sion — as a treat­ment for a rare, in­her­it­ed con­nec­tive tis­sue dis­or­der has hit a se­vere set­back. The New­ton, Mass­a­chu­setts-based com­pa­ny on Tues­day said the FDA re­ject­ed the drug and has asked for an­oth­er clin­i­cal tri­al.

The com­pa­ny’s shares $AC­ER cratered near­ly 77% to $4.47 in Tues­day morn­ing trad­ing.

Richard Gonzalez testifying in front of Senate Finance Committee, February 2019 [AP Images]

Ab­b­Vie's $63B buy­out spot­lights the re­turn of ma­jor M&A deals — de­spite the back­lash

Big time M&A is back. But for how long?

Over the past 18 months we’ve now seen three major buyouts announced: Takeda/Shire; Bristol-Myers/Celgene and now AbbVie/Allergan. And with this latest deal it’s increasingly clear that the sharp fall from grace suffered by high-profile players which have seen their share prices blasted has created an opening for the growth players in big pharma to up their game — in sharp contrast to the popular bolt-on deals that have been driving the growth strategy at Novartis, Merck, Roche and others.

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Suf­fer­ing No­var­tis part­ner Cona­tus grabs the ax and packs it in on NASH af­ter a se­ries of set­backs

The NASH par­ty is over at No­var­tis-backed Cona­tus. And this time they’re turn­ing off the lights.

More than 2 years af­ter No­var­tis sur­prised the biotech in­vest­ment com­mu­ni­ty with its $50 mil­lion up­front and promise of R&D sup­port to part­ner with the lit­tle biotech on NASH — ig­nit­ing a light­ning strike for the share price — Cona­tus $CNAT is back with the lat­est bit­ter tale to tell about em­ri­c­as­an, which once in­spired con­fi­dence at the phar­ma gi­ant.

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.

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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