No­var­tis joins forces with Al­ler­gan, push­ing a NASH com­bo in­to late-stage de­vel­op­ment

Brent Saun­ders speak­ing at an End­points News event on Jan 10, 2017 End­points News

Look­ing to leapfrog some in­tense com­pe­ti­tion to field new drugs for NASH and fat­ty liv­er dis­ease, phar­ma gi­ant No­var­tis has struck a deal to part­ner with Al­ler­gan on a new com­bo ap­proach that will start out in a Phase IIb tri­al.

No­var­tis is com­bin­ing an FXR ag­o­nist with Al­ler­gan’s ceni­crivi­roc — CVC — for the treat­ment of non-al­co­holic steato­hep­ati­tis. And they’re keep­ing the num­bers side of the arrange­ment un­der wraps.

No­var­tis be­lieves that Al­ler­gan’s CVC — which tack­les CCR2 and CCR5, a pair of in­flam­ma­to­ry chemokine re­cep­tors — is the kind of drug that will fig­ure promi­nent­ly in new cock­tails for NASH, a ma­jor mar­ket op­por­tu­ni­ty that has at­tract­ed a line­up of ri­vals like Gilead, In­ter­cept and Shire.

The deal with No­var­tis marks a quick val­i­da­tion of Al­ler­gan CEO Brent Saun­ders’ de­ci­sion to pay a huge pre­mi­um to bag To­bi­ra last fall in a deal worth up to $1.7 bil­lion — in­clud­ing a cash up­front worth 6 times the biotech’s fi­nal share price. To­bi­ra’s stock had been bat­tered by the drug’s fail­ure in a Phase IIb tri­al for NASH last sum­mer, but in­ves­ti­ga­tors gath­ered pos­i­tive da­ta for a key sec­ondary end­point that was moved up to the pri­ma­ry for a prospec­tive Phase III tri­al.

Al­ler­gan has been build­ing a port­fo­lio of new drugs for NASH, adding pre­clin­i­cal FXR ag­o­nists in a deal to ac­quire Akar­na on the same day it bagged To­bi­ra. No­var­tis’ FXR ag­o­nist is in a Phase II study, though, mov­ing the com­bo in­to a much more ad­vanced po­si­tion.

No­var­tis, mean­while, has al­so set its sights on be­com­ing a late-stage play­er in the field. The phar­ma gi­ant struck a deal to col­lab­o­rate with Cona­tus on its oral pan-cas­pase in­hibitor em­ri­c­as­an for NASH last De­cem­ber.

NASH and liv­er fi­bro­sis have be­come a ma­jor tar­get as its preva­lence spreads rapid­ly in the US and the world.

No­var­tis likes to work qui­et­ly ahead of Phase III but car­ry a big check­book for any ex­per­i­men­tal prod­ucts it may need along the way. In this case, the Big Phar­ma op­er­a­tion is go­ing af­ter a mega­mar­ket some ex­cit­ed an­a­lysts have pegged at a po­ten­tial $35 bil­lion. To get there, though, de­vel­op­ers will need to find eas­i­er ways to di­ag­nose the dis­ease to iden­ti­fy pa­tients, many of whom do not nec­es­sar­i­ly face an im­me­di­ate health threat.

Vas­ant Narasimhan No­var­tis

“Our clin­i­cal col­lab­o­ra­tion with Al­ler­gan ex­pands our de­vel­op­ment pro­grams for NASH, bring­ing to­geth­er sci­ence and ex­per­tise to in­ves­ti­gate a po­ten­tial new com­bi­na­tion ther­a­py in an ef­fort to make a pos­i­tive change for peo­ple liv­ing with this con­di­tion,” said Vas Narasimhan, No­var­tis’ CMO and head of drug de­vel­op­ment.  “We be­lieve that col­lab­o­ra­tion is key to de­vel­op­ing the best pos­si­ble treat­ments that are ur­gent­ly need­ed for NASH pa­tients.”

Roger Perlmutter. Merck via webcast

'Our lega­cy mat­ter­s': Mer­ck maps out Keytru­da king­dom while spot­light­ing ad­vances in vac­cines, hos­pi­tal care

“You can for the mo­ment stop tak­ing notes. You can put down your pens and your pad. I have no slides. I have no sub­stan­tive da­ta. I have no pitch.”

So be­gan Roger Perl­mut­ter’s brief ap­pear­ance on­stage at Mer­ck’s first in­vestor day in five years, where he dived in­to the com­pa­ny’s his­to­ry dat­ing back to 1933. The first em­ploy­ees at Mer­ck Re­search Lab­o­ra­to­ries, hand­picked by founder George W. Mer­ck, were crit­i­cal to Mer­ck’s abil­i­ty to achieve clin­i­cal and com­mer­cial suc­cess.

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.

Eli Casdin, Casdin Capital

Eli Cas­din backs Codex­is' plat­form tech with $50M eq­ui­ty buy

About a month af­ter Codex­is notched a deal with No­var­tis $NVS, the Cal­i­for­nia com­pa­ny $CDXS on Thurs­day said long-time in­vestor Cas­din Cap­i­tal is putting up $50 mil­lion in a pri­vate place­ment, which puts the New York-based in­vest­ment firm in con­trol of more than 5% of the pro­tein en­gi­neer­ing play­er’s stock.

Eli Cas­din start­ed his epony­mous in­vest­ment firm in 2012 and dates his re­la­tion­ship with Codex­is back to at least a decade. About three years ago, Cas­din Cap­i­tal be­gan in­vest­ing in the in­dus­tri­al biotech com­pa­ny, af­ter it piv­ot­ed its fo­cus to the life sci­ences — un­der the aus­pices of new chief John Nicols — away from the en­er­gy in­dus­try.

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.

In­vestors pony up $476M for the lat­est round of biotech IPOs to hit the Street

Three biotechs — and a genome se­quenc­ing play­er — have caught the lat­est tide to the Gold Coast of IPOs, round­ing out the first half of 2019 with 23 new drug de­vel­op­ers mak­ing it on Nas­daq.

Most of these com­pa­nies filed their IPOs al­most si­mul­ta­ne­ous­ly, though we’re still wait­ing on word of fel­low class­mate Bridge­Bio’s pric­ing af­ter CEO Neil Ku­mar set the terms at $14 to $16 a share on Mon­day in search of a $240 mil­lion (or so) wind­fall. If he’s suc­cess­ful, that would take the one-week haul past the $700 mil­lion mark, a fresh sign that in­vestors’ en­thu­si­asm for new­ly coined pub­lic biotechs hasn’t cooled.

Robert Forrester, Verastem

Ve­rastem CEO For­rester steps to the ex­it as the board hunts com­mer­cial-savvy ex­ec for the be­lea­guered biotech

Robert For­rester is step­ping down as CEO of Ve­rastem On­col­o­gy $VSTM just 8 months af­ter the com­pa­ny nabbed an ap­proval for du­velis­ib, a PI3K drug with a sto­ried past — and what ap­pears as not much of a fu­ture.

The biotech put out word this morn­ing that For­rester will take an ad­vi­so­ry role with Ve­rastem while COO Dan Pa­ter­son steps up to take charge of the lead­er­ship team and the board looks around for a new CEO.

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.

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