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.”

John Hood [file photo]

UP­DAT­ED: Cel­gene and the sci­en­tist who cham­pi­oned fe­dra­tinib's rise from Sanofi's R&D grave­yard win FDA OK

Six years after Sanofi gave it up for dead, the FDA has approved the myelofibrosis drug fedratinib, now owned by Celgene.

The drug will be sold as Inrebic, and will soon land in the portfolio at Bristol-Myers Squibb, which is finalizing a deal to acquire Celgene.

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Health­i­er, longer lifes­pans will be a re­al­i­ty soon­er than you think, Ju­ve­nes­cence promis­es as it clos­es $100M round

Earlier this year, an executive from Juvenescence-backed AgeX predicted the field of longevity will eventually “dwarf the dotcom boom.” Greg Bailey, the UK-based anti-aging biotech’s CEO, certainly hopes so.

On Monday, Juvenescence completed its $100 million Series B round of financing. The company is backed by British billionaire Jim Mellon — who wrote his 400-page guide to investing in the field of longevity shortly after launching the company in 2017.  Bailey, who served as a board director for seven years at Medivation before Pfizer swallowed the biotech for $14 billion, is joined by Declan Doogan, an industry veteran with stints at Pfizer and Amarin.

UP­DAT­ED: AveX­is sci­en­tif­ic founder was axed — and No­var­tis names a new CSO in wake of an ethics scan­dal

Now at the center of a storm of controversy over its decision to keep its knowledge of manipulated data hidden from regulators during an FDA review, Novartis CEO Vas Narasimhan has found a longtime veteran in the ranks to head the scientific work underway at AveXis, where the incident occurred. And the scientific founder has hit the exit.

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Ab­b­Vie gets its FDA OK for JAK in­hibitor upadac­i­tinib, but don’t look for this one to hit ex­ecs’ lofty ex­pec­ta­tions

Another big drug approval came through on Friday afternoon as the FDA OK’d AbbVie’s upadacitinib — an oral JAK1 inhibitor that is hitting the rheumatoid arthritis market with a black box warning of serious malignancies, infections and thrombosis reflecting fears associated with the class.

It will be sold as Rinvoq — at a wholesale price of $59,000 a year — and will likely soon face competition from a drug that AbbVie once controlled, and spurned. Reuters reports that a 4-week supply of Humira, by comparison, is $5,174, adding up to about $67,000 a year.

The top 10 fran­chise drugs in bio­phar­ma his­to­ry will earn a to­tal of $1.4T (tril­lion) by 2024 — what does that tell us?

Just in case you were looking for more evidence of just how important Amgen’s patent win on Enbrel is for the company and its investors, EvaluatePharma has come up with a forward-looking consensus estimate on what the list of top 10 drugs will look like in 2024.

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UP­DAT­ED: Sci­en­tist-CEO ac­cused of im­prop­er­ly us­ing con­fi­den­tial in­fo from uni­corn Alec­tor

The executive team at Alector $ALEC has a bone to pick with scientific co-founder Asa Abeliovich. Their latest quarterly rundown has this brief note buried inside:

On June 18, 2019, we initiated a confidential arbitration proceeding against Dr. Asa Abeliovich, our former consulting co-founder, related to alleged breaches of his consulting agreement and the improper use of our confidential information that he learned during the course of rendering services to us as our consulting Chief Scientific Officer/Chief Innovation Officer. We are in the early stage of this arbitration proceeding and are unable to assess or provide any assurances regarding its possible outcome.

There’s no explicit word in the filing on what kind of confidential info was involved, but the proceeding got started 2 days ahead of Abeliovich’s IPO.

Abeliovich, formerly a tenured associate professor at Columbia, is a top scientist in the field of neurodegeneration, which is where Alector is targeted. More recently, he’s also helped start up Prevail Therapeutics as the CEO, which raised $125 million in an IPO. And there he’s planning on working on new gene therapies that target genetically defined subpopulations of Parkinson’s disease. Followup programs target Gaucher disease, frontotemporal dementia and synucleinopathies.

But this time Abeliovich is the CEO rather than a founding scientist. And some of their pipeline overlaps with Alector’s.

Abeliovich and Prevail, though, aren’t taking this one lying down.

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Chi­na has be­come a CEO-lev­el pri­or­i­ty for multi­na­tion­al phar­ma­ceu­ti­cal com­pa­nies: the trend and the im­pli­ca­tions

After a “hot” period of rapid growth between 2009 and 2012, and a relatively “cooler” period of slower growth from 2013 to 2015, China has once again become a top-of-mind priority for the CEOs of most large, multinational pharmaceutical companies.

At the International Pharma Forum, hosted in March in Beijing by the R&D Based Pharmaceutical Association Committee (RDPAC) and the Pharmaceutical Research and Manufacturers of America (PhRMA), no fewer than seven CEOs of major multinational pharmaceutical firms participated, including GSK, Eli Lilly, LEO Pharma, Merck KGaA, Pfizer, Sanofi and UCB. A few days earlier, the CEOs of several other large multinationals attended the China Development Forum, an annual business forum hosted by the research arm of China’s State Council. It’s hard to imagine any other country, except the US, having such drawing power at CEO level.

As dis­as­ter struck, Ab­b­Vie’s Rick Gon­za­lez swooped in on Al­ler­gan with an of­fer Brent Saun­ders couldn’t say no to

Early March was a no good, awful, terrible time for Allergan CEO Brent Saunders. His big lead drug had imploded in a Phase III disaster and activists were after his hide — or at least his chairman’s title — as the stock price continued a steady droop that had eviscerated share value for investors.

But it was a perfect time for AbbVie CEO Rick Gonzalez to pick up the phone and ask Saunders if he’d like to consider a “strategic” deal.

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CEO Pascal Soriot via Getty Images

As­traZeneca's jug­ger­naut PARP play­er Lyn­parza scoops up an­oth­er dom­i­nant win in PhI­II as the FDA adds a 'break­through' for Calquence

AstraZeneca’s oncology R&D group under José Baselga keeps churning out hits.

Wednesday morning the pharma giant and their partners at Merck parted the curtains on a successful readout for their Phase III PAOLA-1 study, demonstrating statistically significant improvement in progression-free survival for women with ovarian cancer in a first-line maintenance setting who added their PARP Lynparza to Avastin. This is their second late-stage success in ovarian cancer, which will help stave off rivals like GSK.

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