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.

Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Vas Narasimhan (Photographer: Jason Alden/Bloomberg via Getty Images)

No­var­tis de­tails plans to axe 8,000 staffers as Narasimhan be­gins sec­ond phase of a glob­al re­org

We now know the number of jobs coming under the axe at Novartis, and it isn’t small.

The pharma giant is confirming a report from Swiss newspaper Tages-Anzeiger that it is chopping 8,000 jobs out of its 108,000 global staffers. A large segment will hit right at company headquarters in Basel, as CEO Vas Narasimhan axes some 1,400 of a little more than 11,000  jobs in Switzerland.

The first phase of the work is almost done, the company says in a statement to Endpoints News. Now it’s on to phase two. In the statement, Novartis says:

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How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

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Lina Gugucheva, NewAmsterdam Pharma CBO

Phar­ma group bets up to $1B-plus on the PhI­II res­ur­rec­tion of a once dead-and-buried LDL drug

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

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(AP Photo/Gemunu Amarasinghe)

Some phar­ma com­pa­nies promise to cov­er abor­tion-re­lat­ed trav­el costs — while oth­ers won't go that far yet

As the US Department of Health and Human Services promises to support the millions of women who would now need to cross state lines to receive a legal abortion, a handful of pharma companies have said they will pick up employees’ travel expenses.

GSK, Sanofi, Johnson & Johnson, BeiGene, Alnylam and Gilead have all committed to covering abortion-related travel expenses just four days after the Supreme Court overturned Roe v. Wade and revoked women’s constitutional right to an abortion.

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Aurobindo Pharma co-founders P. V. Ram Prasad Reddy (L) and K. Nityananda Reddy

Au­robindo Phar­ma re­ceives warn­ing let­ter from In­di­a's SEC fol­low­ing more FDA ques­tion marks

Indian-based generics manufacturer Aurobindo Pharma has been in the crosshairs of the FDA for several years now, but the company is also attracting attention from regulators within the subcontinent.

According to the Indian business news site Business Standard, a warning letter was sent to the company from the Securities Exchange Board of India, or SEBI.

The letter is related to disclosures made by the company on an ongoing FDA audit of the company’s Unit-1 API facility in Hyderabad, India as well as observations made by the US regulator between 2019 and 2022.

Bristol Myers Squibb (Alamy)

CVS re­sumes cov­er­age of block­buster blood thin­ner af­ter price drop fol­lows Jan­u­ary ex­clu­sion

Following some backlash from the American College of Cardiology and patients, Bristol Myers Squibb and Pfizer lowered the price of their blockbuster blood thinner Eliquis, thus ensuring that CVS Caremark would cover the drug after 6 months of it being off the major PBM’s formulary.

“Because we secured lower net costs for patients from negotiations with the drug manufacturer, Eliquis will be added back to our template formularies for the commercial segment effective July 1, 2022, and patient choices will be expanded,” CVS Health said in an emailed statement. “Anti-coagulant therapies are among the non-specialty products where we are seeing the fastest cost increases from drug manufacturers and we will continue to push back on unwarranted price increases.”

#Can­nes­Lions2022: Con­sumer health ex­ecs call on agen­cies to in­volve pa­tients in cre­ative process

CANNES — When Tamara Rogers joined GSK back in 2018, “science was king and R&D were the gods.” Now the global chief marketing officer of consumer healthcare wants to make room for another supreme being: the consumer.

As health and wellness becomes more relevant to consumers amid the pandemic, four health-focused executives called on marketers to involve patients in their creative process in a panel discussion at the Cannes Lions advertising creativity festival.

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Scoop: Roche scraps one of two schiz­o­phre­nia PhII tri­als af­ter fail­ing the pri­ma­ry end­point

Roche has terminated one of two Phase II trials testing its drug ralmitaront in patients with schizophrenia, the Big Pharma confirmed to Endpoints News.

The study was terminated last month, according to a June 22 update to the registry on clinicaltrials.gov. Begun in September 2020, the trial was looking at ralmitaront in patients with acute schizophrenia. The trial enrolled 286 patients out of an originally planned 308.

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