Fast biotech: Gilead hands $200M to com­pu­ta­tion­al wiz Nim­bus as it speeds in­to PhII NASH tri­al

Nim­bus CEO Don Nichol­son

When Nim­bus Ther­a­peu­tics CEO Don Nichol­son struc­tured his $1.2 bil­lion li­cens­ing deal with Gilead $GILD ear­li­er this year, he built it with the Big Biotech’s rep for fo­cus, sci­ence and clin­i­cal speed in mind.

It paid off. Fast.

To­day, Cam­bridge, MA-based Nim­bus is re­veal­ing that it grabbed a $200 mil­lion mile­stone from Gilead for its ear­ly-stage NASH drug, just 6 months af­ter nab­bing a $400 mil­lion up­front pay­ment. The pay­out now gives them $600 mil­lion this year, half of that $1.2 bil­lion deal to­tal that Gilead signed off on.

“It’s a great drug for a com­pa­ny that re­al­ly needs a pipeline,” Nichol­son tells me about his new part­ners at Gilead. “Once they sink their teeth in­to some­thing, they go af­ter it ham­mer and tong.”

Nichol­son says the pay­out is a di­rect ben­e­fit of his de­ci­sion to over­look an­oth­er of­fer for more mon­ey — no, he’s not say­ing which com­pa­ny was left at the deal ta­ble — to fa­vor a part­ner that demon­strat­ed with hep C that it will move heav­en and earth to push rapid­ly through the clin­ic. What he al­so can’t say is ex­act­ly what the mile­stone pay­ment is for, though it seems rea­son­able to as­sume on my end that it might have some­thing to do with the quick ramp up for a mid-stage clin­i­cal pro­gram.

Work­ing with a com­pu­ta­tion­al chem­istry plat­form that has at­tract­ed the back­ing of Mi­crosoft mogul Bill Gates, Nim­bus built a pro­gram for a drug that tar­gets an en­zyme called Acetyl-CoA car­boxy­lase, or ACC, in­volved in the cre­ation of en­doge­nous fat­ty acids and the reg­u­la­tion of be­ta-ox­i­da­tion, de­scribed as the process by which fat­ty acids are bro­ken down at a cel­lu­lar lev­el.

Tack­ling ACC, if it works as planned, should pre­vent the buildup of lipids in the liv­er and break down the ones al­ready present, re­duc­ing the fi­bro­sis that is char­ac­ter­is­tic of the fat­ty liv­er dis­ease. For Gilead, it’s al­so a can­di­date for the kind of com­bi­na­tion ap­proach­es that they fa­vor in look­ing to com­mand a mar­ket like NASH.

Now with $600 mil­lion in hand from the sale of a sub­sidiary, all hands on deck at Nim­bus have switched to work­ing on pre­clin­i­cal ef­forts, with lead ef­forts un­der­way for Tyk2 and STING.

The Gilead deal came along at a per­fect time, adds the CEO. In late 2015, Nim­bus was work­ing on an S-1. Then the IPO mar­ket chilled over — par­tic­u­lar­ly for ear­ly-stage, high-risk biotechs. Now he has the cash to re­ward in­vestors as well as em­ploy­ees while stock­pil­ing enough cash to pay for years of run­way.

Says Nichol­son: “It gave us an aw­ful lot of fi­nan­cial op­tions.”

And the biotech can hang on to the S-1 for a bet­ter mo­ment on the mar­ket.

In cer­tain cir­cles among the scribes that cov­er biotech, biobucks have a faint scent of the dis­rep­utable. The cash awards of­fered for de­vel­op­ment and com­mer­cial mile­stones can be writ­ten off as un­at­tain­able stacks of Mo­nop­oly mon­ey, of­ten use­ful on­ly in the realm of fan­ta­sy — Lep­rechaun gold found in the pot at the end of every rain­bow.

But Nim­bus Ther­a­peu­tics of­fers us an ex­am­ple of how wrong that view can be.

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.

Endpoints News

Basic subscription required

Unlock this story instantly and join 57,400+ biopharma pros reading Endpoints daily — and it's free.

Jim Mellon [via YouTube]

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.

Endpoints News

Basic subscription required

Unlock this story instantly and join 57,400+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Basic subscription required

Unlock this story instantly and join 57,400+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Basic subscription required

Unlock this story instantly and join 57,400+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Basic subscription required

Unlock this story instantly and join 57,400+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Basic subscription required

Unlock this story instantly and join 57,400+ biopharma pros reading Endpoints daily — and it's free.