Brig­gs Mor­ri­son’s lit­tle biotech Syn­dax con­cedes 2 key tri­al set­backs for its lead drug, as shares shriv­el some more

It takes a lit­tle pa­tience, but if you bore through some com­ments about how en­thu­si­as­tic Syn­dax $SNDX CEO Brig­gs Mor­ri­son is about their on­go­ing piv­otal tri­al in breast can­cer with their lead drug, you’ll find that the ther­a­py just failed a cou­ple of key com­bi­na­tion stud­ies with two ap­proved PD-L1s.

Brig­gs Mor­ri­son

Mor­ri­son — who had a se­nior R&D post at As­traZeneca be­fore mak­ing the leap to biotech — notes that the 2 Phase Ib/II stud­ies com­bined enti­no­s­tat with Roche’s Tecen­triq and Pfiz­er/Mer­ck KGaA’s Baven­cio for triple neg­a­tive breast can­cer and ovar­i­an can­cer. But it failed to ex­tend pro­gres­sion-free sur­vival sig­nif­i­cant­ly.

As a re­sult, the Waltham, MA-based biotech is de­fer­ring the PD-1 pro­gram for enti­no­s­tat, which in­cludes a study in non-small cell lung can­cer. In­stead, the biotech is cir­cling the wag­ons around enti­no­s­tat “in HR+ breast can­cer and SNDX-5613, a Menin in­hibitor be­ing de­vel­oped for ge­net­i­cal­ly-de­fined pop­u­la­tion(s) of acute leukemias.”

Mor­ri­son, who’s kept a low pro­file since leav­ing As­traZeneca, prefers to fo­cus on the pos­i­tive. In a pre­pared state­ment, he not­ed:

We re­main high­ly en­cour­aged by the po­ten­tial for a pos­i­tive over­all sur­vival read­out in E2112, our Phase III reg­is­tra­tion tri­al of enti­no­s­tat plus ex­emes­tane in HR+, HER2- breast can­cer, and ex­pect the next in­ter­im analy­sis in the sec­ond quar­ter. As a re­minder, any pos­i­tive over­all sur­vival re­sult would al­low us to file for full reg­u­la­to­ry ap­proval in an in­di­ca­tion for which ex­ist­ing ther­a­pies have failed to show a sur­vival ben­e­fit. In ad­di­tion, we con­tin­ue to ex­pect to file an IND in the sec­ond quar­ter for our tar­get­ed ther­a­py, SNDX-5613, an in­hibitor of the Menin-MLL in­ter­ac­tion.

A fail­ure would prob­a­bly cap­size the com­pa­ny at this point.

The small-cap biotech has a lit­tle more than $80 mil­lion in re­serves, which ac­counts for close to half of its mar­ket cap of $155 mil­lion. Its stock is trad­ing at less than half of where it peaked in the spring of 2018, and slid 12% in af­ter-mar­ket trad­ing.

In starved an­tibi­ot­ic field, Melin­ta soars as FDA grants speedy drug re­view

Such is the state of af­fairs in an­tibi­ot­ic land that the FDA agree­ing to pri­or­i­ty re­view an ap­pli­ca­tion to ex­pand the use of an an­tibi­ot­ic can rock­et up a stock more than two-fold.

On Wednes­day, Melin­ta Ther­a­peu­tics said its ap­proved an­tibi­ot­ic Baxdela had been grant­ed pri­or­i­ty re­view for use in com­mu­ni­ty-ac­quired bac­te­r­i­al pneu­mo­nia (CAPB). The FDA is ex­pect­ed to make its de­ci­sion by Oc­to­ber 24. Shares of the Con­necti­cut drug­mak­er $ML­NT cat­a­pult­ed, clos­ing up near­ly 224% at $6.41.

Ken Frazier appears before the Senate Committee on Finance for a hearing on prescription drug pricing on Capitol Hill in Washington, DC, February 26, 2019. Chris Kleponis for CNP via AP Images

Who’s next in line to suc­ceed Ken Fra­zier as CEO of the Keytru­da-blessed Mer­ck?

When Mer­ck waved off a loom­ing forced re­tire­ment for Ken Fra­zier last Sep­tem­ber, the board cit­ed flex­i­bil­i­ty in CEO tran­si­tion as a key fac­tor in the de­ci­sion. Hav­ing Fra­zier — who’s al­so chair­man of the com­pa­ny — around be­yond his 65th birth­day in 2019 would en­sure they in­stall the best per­son at the best time, they said.

The board has ev­i­dent­ly be­gun that process with a clear pref­er­ence for in­ter­nal can­di­dates, sources told Bloomberg. CFO Robert Davis, chief mar­ket­ing of­fi­cer Michael Nal­ly, and chief com­mer­cial of­fi­cer Frank Clyburn are all in the run­ning, ac­cord­ing to an in­sid­er.

Brent Saunders at an Endpoints News event in 2017 — File photo

An­a­lyst call with Al­ler­gan ex­ecs stokes an­tic­i­pa­tion of a plan to split the com­pa­ny in ‘a month or two’

So what’s up at Al­ler­gan?

Ear­li­er this week the ubiq­ui­tous Ever­core ISI an­a­lyst Umer Raf­fat was on the line with com­pa­ny ex­ec­u­tives to probe in­to the lat­est on the num­bers as well as CEO Brent Saun­ders’ re­cent de­c­la­ra­tion that he’d be do­ing some­thing de­fin­i­tive to help long-suf­fer­ing in­vestors who have watched their shares dwin­dle in val­ue.

He came away with the im­pres­sion that a sig­nif­i­cant com­pa­ny split is on the way. And not on some dis­tant time hori­zon.

John Reed at JPM 2019. Jeff Rumans for Endpoints News

Sanofi's John Reed con­tin­ues to re­or­ga­nize R&D, cut­ting 466 jobs while boost­ing can­cer, gene ther­a­py re­search

The R&D reorganization inside Sanofi is continuing, more than a year after the pharma giant brought in John Reed to head the research arm of the Paris-based company.
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The top 10 block­buster drugs in the late-stage pipeline — Eval­u­ate adds 6 new ther­a­pies to heavy-hit­ter list

Vertex comes in for a substantial amount of criticism for its no-holds-barred tactical approach toward wresting the price it wants for its commercial drugs in Europe. But the flip side of that coin is a highly admired R&D and commercial operation that regularly wins kudos from analysts for their ability to engineer greater cash flow from the breakthrough drugs they create.

Both aspects needed for success in this business are on display in the program backing Vertex’s triple for cystic fibrosis. VX-659/VX-445 + Tezacaftor + Ivacaftor — it’s been whittled down to 445 now — was singled out by Evaluate Pharma as the late-stage therapy most likely to win the crown for drug sales in 5 years, with a projected peak revenue forecast of $4.3 billion.

The latest annual list, which you can see here in their latest world preview, includes a roster of some of the most closely watched development programs in biopharma. And Evaluate has added 6 must-watch experimental drugs to the top 10 as drugs fail or go on to a first approval. With apologies to the list maker, I revamped this to rank the top 10 by projected 2024 sales, instead of Evaluate's net present value rankings.

It's how we roll at Endpoints News.

Here is a quick summary of the rest of the top 10:

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How small- to mid-sized biotechs can adopt pa­tient cen­tric­i­ty in their on­col­o­gy tri­als

By Lucy Clos­sick Thom­son, Se­nior Di­rec­tor of On­col­o­gy Pro­ject Man­age­ment, Icon

Clin­i­cal tri­als in on­col­o­gy can be cost­ly and chal­leng­ing to man­age. One fac­tor that could re­duce costs and re­duce bar­ri­ers is har­ness­ing the pa­tient voice in tri­al de­sign to help ac­cel­er­ate pa­tient en­roll­ment. Now is the time to adopt pa­tient-cen­tric strate­gies that not on­ly fo­cus on pa­tient needs, but al­so can main­tain cost ef­fi­cien­cy.

In­vestor day prep at Mer­ck in­cludes a new strat­e­gy to pick up the pace on M&A — re­port

Mer­ck’s re­cent deals to buy up two bolt-on biotechs — Ti­los and Pelo­ton — weren’t an aber­ra­tion. In­stead, both ac­qui­si­tions mark a new strat­e­gy to beef up its dom­i­nant can­cer drug op­er­a­tions cen­tered on Keytru­da while look­ing to ad­dress grow­ing con­cerns that too many of its eggs are in the one I/O bas­ket for their PD-1 pro­gram. And Mer­ck is go­ing af­ter more small- and mid-sized buy­outs to calm those fears.

John Chiminski, Catalent CEO - File Photo

'It's a growth play': Catal­ent ac­quires Bris­tol-My­er­s' Eu­ro­pean launch pad, ex­pand­ing glob­al CD­MO ops

Catalent is staying on the growth track.

Just two months after committing $1.2 billion to pick up Paragon and take a deep dive into the sizzling hot gene therapy manufacturing sector, the CDMO is bouncing right back with a deal to buy out Bristol-Myers’ central launchpad for new therapies in Europe, acquiring a complex in Anagni, Italy, southwest of Rome, that will significantly expand its capacity on the continent.

There are no terms being offered, but this is no small deal. The Anagni campus employs some 700 staffers, and Catalent is planning to go right in — once the deal closes late this year — with a blueprint to build up the operations further as they expand on oral solid, biologics, and sterile product manufacturing and packaging.

This is an uncommon deal, Catalent CEO John Chiminski tells me. But it offers a shortcut for rapid growth that cuts years out of developing a green fields project. That’s time Catalent doesn’t have as the industry undergoes unprecedented expansion around the world.

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Right back at you, Pfiz­er: BeiGene and a Pfiz­er spin­out launch a new­co to de­vel­op a MEK/BRAF in­hibitor that could ri­val $11.4B com­bo

A day af­ter Pfiz­er bought Ar­ray and its ap­proved can­cer com­bo, BeiGene and Pfiz­er spin­out Spring­Works have part­nered in launch­ing a new biotech that has an eye on the very same mar­ket the phar­ma gi­ant just paid bil­lions for. And they’re plan­ning on us­ing an ex-Pfiz­er drug to do it.

In a nut­shell, Chi­na’s BeiGene is toss­ing in a pre­clin­i­cal BRAF in­hibitor — BGB-3245, which cov­ers both V600 and non-V600 BRAF mu­ta­tions — for a big stake in a new, joint­ly con­trolled biotech called Map­Kure with Bain-backed Spring­Works.