Eli Lil­ly ush­ers up-and-com­ing GIP/GLP-1 drug in­to PhI­II as No­vo Nordisk ri­val wows with im­pres­sive re­sults

With No­vo Nordisk’s GLP-1 drug Ozem­pic (semaglu­tide) on its tail, Eli Lil­ly has round­ed up some mid-stage da­ta to show it has the right can­di­date to fol­low on Trulic­i­ty’s block­buster suc­cess in the com­pet­i­tive di­a­betes mar­ket.

In­ves­ti­ga­tors re­port that LY3298176, a dual GIP and GLP-1 re­cep­tor ag­o­nist, out­per­formed both place­bo and Trulic­i­ty (du­laglu­tide) in terms of blood sug­ar re­duc­tion and weight loss for pat­ints with type 2 di­a­betes. And while cross-tri­al com­par­isons al­ways war­rant cau­tion, the drug ap­pears to of­fer a siz­able ad­di­tion­al ef­fect over GLP monother­a­pies.

Like GLP-1, GIP is an in­cretin hor­mone tied to in­sulin se­cre­tion.

“This drug is set­ting up to be per­haps the most crit­i­cal part of LLY’s di­a­betes strat­e­gy go­ing fwd … es­pe­cial­ly in the face of No­vo’s new launch­es,” Ever­core ISI an­a­lyst Umer Raf­fat writes in a note.

In­vestors were pay­ing close at­ten­tion. Lil­ly’s stock $LLY shot up 4%, a big deal for big-cap com­pa­ny, while No­vo’s shares $NVO slid 7%.

On the pri­ma­ry ef­fi­ca­cy mea­sure — change in HbA1c from base­line to 26 weeks — 90% of those who re­ceived the 10 mg dose of LY3298176 achieved the rec­om­mend­ed HbA1c tar­get of 7% of less; the 5 mg group record 69.1% and the 15 mg group, 77.4%. Mean­while, the sin­gle du­laglu­tide and place­bo arms had 52% and 12% of pa­tients hit­ting that tar­get.

Of note, the 15 mg group ac­tu­al­ly saw a high­er per­cent­age (30%) of pa­tients achiev­ing the most im­pres­sive re­duc­tion, which is HbA1c lev­els of less than 5.7% — what you’d ex­pect to see in non-di­a­bet­ics. Among those on the 10 mg dose, 18% got to that point.

But where LY3298176 re­al­ly stood out was in the weight loss num­bers: -4.8 kg (5 mg), -8.7 kg (10 mg) and -11.3 kg (15 mg) while pa­tients on du­laglu­tide shed an av­er­age of -2.7 kg. That trans­lates to more than a third of drug arm pa­tients los­ing 10% or more of their base­line body weight.

Source: Umer Raf­fat

Click on the im­age to see the full-sized ver­sion

Re­searchers are al­so hap­py with the safe­ty pro­file, which they say is “sim­i­lar to the GLP-1 RA class” with the most com­mon­ly re­port­ed side ef­fects be­ing nau­sea, di­ar­rhea and vom­it­ing.

“We set a high bar for this Phase II study, and the re­sults ex­ceed­ed our ex­pec­ta­tions,” said Jeff Em­mick, vice pres­i­dent of prod­uct de­vel­op­ment, Lil­ly Di­a­betes. “We’re ex­cit­ed to con­tin­ue study­ing GIP/GLP-1 RA and hope to add it to our wide range of ther­a­pies for peo­ple with di­a­betes.”

It’s now time to move in­to a larg­er Phase III tri­al dubbed SUR­PASS, which Lil­ly plans to ini­ti­ate by ear­ly 2019 and com­plete in late 2021.

If the da­ta trends hold up — as Raf­fat is bull­ish it would — he sees the drug tak­ing a key po­si­tion in a bi­fur­cat­ing GLP-1 mar­ket:

  • oral se­ma will take lots of share from short-act­ing GLP-1s (where No­vo is al­ready pulling spend from Vic­toza) as well from orals
  • per­haps there will re­main a long-act­ing niche … with No­vo’s Ozem­pic and LLY’s Trulic­i­ty … LLY will like­ly shift the spend away from Trulic­i­ty and over to this GIP/GLP.
John Hood [file photo]

UP­DATE: 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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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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ICER blasts FDA, PTC and Sarep­ta for high prices on DMD drugs Em­flaza, Ex­ondys 51

ICER has some strong words for PTC, Sarepta and the FDA as the US drug price watchdog concludes that as currently priced, their respective new treatments for Duchenne muscular dystrophy are decidedly not cost-effective.

The final report — which cements the conclusions of a draft issued in May — incorporates the opinion of a panel of 17 experts ICER convened in a public meeting last month. It also based its analysis of Emflaza (deflazacort) and Exondys 51 (eteplirsen) on updated annual costs of $81,400 and over $1 million, respectively, after citing “incorrect” lower numbers in the initial calculations.

The key dates for KRAS watch­ers through the end of the year — the trail is nar­row and risks are ex­treme

There’s nothing quite like a big patent win when it comes to burnishing your prospects in the pipeline. And for Amgen, which seems to have rescued Enbrel for a run to 2029, the cheering section on Wall Street is now fixed on AMG 510 and a key rival.

And it didn’t take much data to do it. 

There was the first snapshot of a handful of patients, with a 50% response rate. Then came word that Amgen researchers are also tracking responses in different cancers, at least one in colorectal cancer and appendiceal too. 

Bain's Or­ly Mis­han joins Pfiz­er's neu­ro spin­out Cerev­el; On­colyt­ic virus biotech taps Sil­la­Jen ex­ec He­le­na Chaye as CEO

→ Bain Capital is deploying one of its top investors to Cerevel Therapeutics, steering a $350 million-plus neuro play carved out of Pfizer. Orly Mishan — a co-founder and principal of Bain’s life sciences unit — was involved in the partnership that birthed the biotech spinout in the first place. As Cerevel’s first chief business officer, she is tasked with corporate development, program management as well as technical operations. 

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.