J&J may be late to the pso­ri­a­sis drug mar­ket par­ty, but it’s plan­ning to make a splash with guselkum­ab

J&J has reaped the fi­nal har­vest of Phase III da­ta it is tak­ing to reg­u­la­tors in search of a block­buster ap­proval for their pso­ri­a­sis con­tender guselkum­ab.

J&J is wide­ly ex­pect­ed to use this lat­est batch of re­li­ably pos­i­tive da­ta to clean up on ma­jor ap­provals at the FDA and EMA. But its fa­vor­able late-stage com­par­isons with Hu­mi­ra may not count for so much these days, as the phar­ma gi­ant is bring­ing up the rear of a pa­rade of new drugs that got to the mar­ket first.

No­var­tis’ Cosen­tyx got out ahead 18 months ago and the Swiss phar­ma gi­ant has fol­lowed with 4-year da­ta track­ing a sol­id suc­cess — 43.5% — in keep­ing skin cleared over the long haul. Eli Lil­ly backed its new drug Taltz in a ma­jor cam­paign last fall. And then Valeant am­bled across the fin­ish line with bro­dalum­ab — now dubbed Siliq — two weeks ago. Their drug, picked up at a dis­count from a dis­ap­point­ed As­traZeneca, al­so comes with a black box warn­ing on sui­ci­dal think­ing that will al­most cer­tain­ly squeeze its slice of the mar­ket down to a sliv­er.

Now comes J&J, a glob­al pow­er­house, with a con­tender it be­lieves is al­ready po­si­tioned for suc­cess.

As we saw in the first Phase III, VOY­AGE 1, guselkum­ab hand­i­ly outscored a place­bo on two mea­sures of com­plete or near-com­plete skin clear­ance in VOY­AGE 2. And once again their IL-23 drug slapped aside Hu­mi­ra, with guselkum­ab ver­sus adal­i­mum­ab achiev­ing an IGA 0/1 score of 84% ver­sus 67.7% and a PASI 90 of 70% com­pared to 46.8%, re­spec­tive­ly.

“The re­sults were re­mark­ably sim­i­lar, which is what you want to see,” Philippe Sza­pary, VP for der­ma­tol­ogy and gas­troen­terol­o­gy in J&J’s Im­munol­o­gy Clin­i­cal De­vel­op­ment unit, tells me about his Phase III stud­ies. “It’s very re­as­sur­ing to see such amaz­ing con­sis­ten­cy.”

J&J’s third Phase III study look­ing at pa­tients trans­ferred to guselkum­ab af­ter an in­ad­e­quate re­sponse to their oth­er pso­ri­a­sis drug Ste­lara al­so looked good. The state­ment notes:

Pa­tients who switched to guselkum­ab con­sis­tent­ly showed greater im­prove­ment in their pso­ri­a­sis be­tween weeks 28 and 40, com­pared with pa­tients who con­tin­ued to re­ceive Ste­lara, hav­ing twice as many of­fice vis­its with at least a 2 point im­prove­ment in IGA from week 16, the study’s pri­ma­ry end­point, and an IGA score of 0 or 1.

J&J gained a new ap­proval for Ste­lara last fall, adding Crohn’s to the la­bel as the com­pa­ny looked to keep its per­for­mance in block­buster ter­ri­to­ry. The new Nav­i­gate study al­so po­si­tions J&J to keep about 30% of pso­ri­a­sis pa­tients who don’t re­spond well to Ste­lara in the fold, so to speak.

In­ves­ti­ga­tors al­so reaped a sat­is­fy­ing pro­file on safe­ty, with a some­what bet­ter set of da­ta on ad­verse ef­fects com­pared to Hu­mi­ra, which re­mains a big play­er in this field as Ab­b­Vie con­tin­ues to fight off biosim­i­lar com­pe­ti­tion. There is al­so one more pso­ri­a­sis drug wait­ing in the wings. Sun Phar­ma gained con­trol of Mer­ck’s MK-3222, but it isn’t ex­pect­ed to hit the mar­ket any­time soon.

The next step is to keep gath­er­ing da­ta with ex­ten­sion stud­ies that will take the 1800 pa­tients en­rolled for VOY­AGE 1 and 2 out about five years. With a tar­get ly­ing up­stream of IL-17 and TNF, he adds, in­ves­ti­ga­tors are hope­ful that guselkum­ab will con­tin­ue to per­form well against com­pe­ti­tion long af­ter it ar­rives on the mar­ket.

Con­quer­ing a silent killer: HDV and Eiger Bio­Phar­ma­ceu­ti­cals

Hepatitis delta, also known as hepatitis D, is a liver infection caused by the hepatitis delta virus (HDV) that results in the most severe form of human viral hepatitis for which there is no approved therapy.

HDV is a single-stranded, circular RNA virus that requires the envelope protein (HBsAg) of the hepatitis B virus (HBV) for its own assembly. As a result, hepatitis delta virus (HDV) infection occurs only as a co-infection in individuals infected with HBV. However, HDV/HBV co-infections lead to more serious liver disease than HBV infection alone. HDV is associated with faster progression to liver fibrosis (progressing to cirrhosis in about 80% of individuals in 5-10 years), increased risk of liver cancer, and early decompensated cirrhosis and liver failure.
HDV is the most severe form of viral hepatitis with no approved treatment.
Approved nucleos(t)ide treatments for HBV only suppress HBV DNA, do not appreciably impact HBsAg and have no impact on HDV. Investigational agents in development for HBV target multiple new mechanisms. Aspirations are high, but a functional cure for HBV has not been achieved nor is one anticipated in the forseeable future. Without clearance of HBsAg, anti-HBV investigational treatments are not expected to impact the deadly course of HDV infection anytime soon.

UP­DAT­ED: In a land­mark first glimpse of hu­man da­ta from Ver­tex, CRISPR/Cas9 gene ther­a­py sig­nals ear­ly ben­e­fit

Preliminary data on two patients with blood disorders that have been administered with Vertex and partner CRISPR Therapeutics’ gene-editing therapy suggest the technology is safe and effective, marking the first instance of the benefit of the use of CRISPR/Cas9 technology in humans suffering from disease.

Patients in these phase I/II studies give up peripheral blood from which hematopoietic stem and progenitor cells are isolated. The cells are tinkered with using CRISPR/Cas9 technology, and the edited cells — CTX001 — are infused back into the patient via a stem cell transplant. The objective of CTX001 is to fix the errant hemoglobin gene in patents with two blood disorders: beta-thalassemia and sickle cell disease, by unleashing the production of fetal hemoglobin.

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UP­DAT­ED: Make that 2 ap­proved RNAi drugs at Al­ny­lam af­ter the FDA of­fers a speedy OK on ul­tra-rare dis­ease drug

Seventeen years into the game, Alnylam’s pivot into commercial operations is picking up speed.
The bellwether biotech $ALNY has nabbed their second FDA OK for an RNAi drug, this time for givosiran, the only therapy now approved for acute hepatic porphyria. This second approval came months ahead of the February deadline — even after winning priority review following their ‘breakthrough’ title earlier.
AHP is an extremely rare disease, with some 3,000 patients in Europe and the US, not all diagnosed, and analysts have projected peak revenue of $600 million to $700 million a year. The drug will be sold as Givlaari.

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David Ricks. Eli Lilly

Eli Lil­ly touts $400M man­u­fac­tur­ing ex­pan­sion, 100 new jobs to much fan­fare in In­di­anapo­lis — even though it's been chop­ping staff

Eli Lilly is pouring in $400 million to beef up manufacturing facilities at its home base of Indianapolis. The investment, which was lauded by the city’s mayor, is expected to create 100 new jobs.

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Am­gen chops 172 more staffers in R&D, op­er­a­tions and sales amid neu­ro­science ex­it, rev­enue down­turn

Neuroscience wasn’t the only unit that’s being hit by a reorganization underway at Amgen. As well as axing 149 employees in its Cambridge office, the company has disclosed that 172 others nationwide, including some from its Thousand Oaks, CA headquarters, are being let go.

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Stephen Hahn (via Senate HELP Committee)

Stephen Hahn gets through Sen­ate’s soft­ball job in­ter­view — but most­ly plays dodge­ball on the is­sues fac­ing the FDA

Anyone looking for fresh insights on what kind of FDA commissioner Stephen Hahn will be got precious few clues during Wednesday’s Senate hearing on the nomination.

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Op­di­vo/Yer­voy com­bo for melanoma fails in key pa­tient pop­u­la­tion

Bristol-Myers Squibb’s efforts to expand their checkpoint inhibitor combination have run into another recalcitrant cancer.

The NJ-based pharma announced that a combination of Yervoy and Opdivo didn’t beat out Opdivo alone in patients with resected high-risk melanoma who had very low levels of PD-L1. The drug combo couldn’t improve recurrence-free survival in these post-surgery patients.

Ver­tex's stel­lar quar­ter car­ries on with French re­im­burse­ment deal

Vertex’s golden quarter just got brighter. About a month after the US drugmaker finally clinched a deal with UK authorities to cover its slate of cystic fibrosis (CF) drugs following years of protracted negotiations, the company on Wednesday secured a deal with France for its CF therapy, Orkambi.

After the UK, France has one of the largest CF populations outside the United States. Achieving French reimbursement unlocks an ~7000-patient CF population, around ~2500-3000 of which will likely be eligible to receive (and be reimbursed for) Orkambi, Stifel’s Paul Matteis wrote in a note.

Nello Mainolfi, Kymera via Youtube

Kymera hands the helm to No­var­tis vet — and found­ing CSO — Nel­lo Main­olfi

Kymera Therapeutics is turning to a co-founder to run the company.
The protein degradation specialist with a deep-pocket syndicate behind them has opted to give the helm officially to Nello Mainolfi. The new CEO is a veteran of the Novartis Institutes for Biomedical Research. He joined Atlas Venture in their entrepreneur-in-residence program and helped launch Kymera as the CSO three years ago with Atlas’ Bruce Booth.
The boast at Kymera is that they’re angling to create a new class of protein degraders, a popular field where there’s been a variety of startups. One of its chief advocates is NIBR head Jay Bradner, who launched C4 just ahead of joining Novartis, where he’s also been doing new work in the field.