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.

Brian Kaspar. AveXis via Twitter

AveX­is sci­en­tif­ic founder fires back at No­var­tis CEO Vas Narasimhan, 'cat­e­gor­i­cal­ly de­nies any wrong­do­ing'

Brian Kaspar’s head was among the first to roll at Novartis after company execs became aware of the fact that manipulated data had been included in its application for Zolgensma, now the world’s most expensive therapy.

But in his first public response, the scientific founder at AveXis — acquired by Novartis for $8.7 billion — is firing back. And he says that not only was he not involved in any wrongdoing, he’s ready to defend his name as needed.

I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

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UP­DAT­ED: An em­bold­ened As­traZeneca splurges $95M on a pri­or­i­ty re­view vouch­er. Where do they need the FDA to hus­tle up?

AstraZeneca is in a hurry.

We learned this morning that the pharma giant — not known as a big spender, until recently — forked over $95 million to get its hands on a priority review voucher from Sobi, otherwise known as Swedish Orphan Biovitrum.

That marks another step down on price for a PRV, which allows the holder to slash 4 months off of any FDA review time.

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Martin Shkreli [via Getty]

Pris­on­er #87850-053 does not get to add drug de­vel­op­er to his list of cred­its

Just days after Retrophin shed its last ties to founder Martin Shkreli, the biotech is reporting that the lead drug he co-invented flopped in a pivotal trial. Fosmetpantotenate flunked both the primary and key secondary endpoints in a placebo-controlled trial for a rare disease called pantothenate kinase-associated neurodegeneration, or PKAN.

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We­bi­nar: Re­al World End­points — the brave new world com­ing in build­ing fran­chise ther­a­pies

Several biopharma companies have been working on expanding drug labels through the use of real world endpoints, combing through the data to find evidence of a drug’s efficacy for particular indications. But we’ve just begun. Real World Evidence is becoming an important part of every clinical development plan, in the soup-through-nuts approach used in building franchises.

I’ve recruited a panel of 3 top experts in the field — the first in a series of premium webinars — to look at the practical realities governing what can be done today, and where this is headed over the next few years, at the prodding of the FDA.

ZHEN SU — Merck Serono’s Senior Vice President and Global Head of Oncology
ELLIOTT LEVY — Amgen’s Senior Vice President of Global Development
CHRIS BOSHOFF — Pfizer Oncology’s Chief Development Officer

A premium subscription to Endpoints News is required to attend this webinar. Please upgrade to either an Insider or Enterprise plan for access. Already have Endpoints Premium? Please sign-in below. You can contact our Subscriptions team at help@endpointsnews.com with any issues.

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Am­gen, Al­ler­gan biosim­i­lar of Roche's block­buster Rit­ux­an clears an­oth­er US piv­otal study 

Novartis $NVS may have given up, but Amgen $AMGN and Allergan $AGN are plowing ahead with their knockoff of Roche’s blockbuster biologic Rituxan in the United States.

Their copycat, ABP 798, was found to have a clinically equivalent impact as Rituxan — meeting the main goal of the study involving CD20-positive B-cell non-Hodgkin’s lymphoma patients. This is the second trial supporting the profile of the biosimilar. In January, it came through with positive PK results in patients with rheumatoid arthritis.

BeiGene and Mus­tang nail down spe­cial FDA sta­tus for top drugs; Roche bags added cov­er­age for Hem­li­bra

→ BeiGene $BGNE is getting a boost in its drive to field a rival to Imbruvica. The FDA has offered an accelerated review to zanubrutinib, a BTK inhibitor that has posted positive results for mantle cell lymphoma. The PDUFA date lands on February 27, 2020. The drug scored breakthrough status at the beginning of the year.

→ BeiGene isn’t the only biopharma company to gain special regulatory status today. Mustang Bio $MBIO and St. Jude Children’s Research Hospital announced that MB-107, a lentiviral gene therapy for the treatment of X-linked severe combined immunodeficiency, also known as bubble boy disease, has been granted Regenerative Medicine Advanced Therapy status.

Trump ad­min­is­tra­tion re­vives bid to get drug list prices on TV ads

The Trump administration is not giving up just yet. On Wednesday, the HHS filed an appeal against a judge’s decision in July to overturn a ruling obligating drug manufacturers to disclose the list price of their therapies in television adverts — hours before it was stipulated to go into effect.

In May, the HHS published a final ruling requiring drugmakers to divulge the wholesale acquisition cost— of a 30-day supply of the drug — in tv ads in a bid to enhance price transparency in the United States. The pharmaceutical industry has vehemently opposed the rule, asserting that list prices are not what a typical patient in the United States pays for treatment — that number is typically determined by the type of (or lack thereof) insurance coverage, deductibles and out-of-pocket costs. Although there is truth to that claim, the move was considered symbolic in the Trump administration’s healthcare agenda to hold drugmakers accountable in a climate where skyrocketing drug prices have incensed Americans on both sides of the aisle.

Bob Smith, Pfizer

Pfiz­er is mak­ing a $500M state­ment to­day: Here’s how you be­come a lead play­er in the boom­ing gene ther­a­py sec­tor

Three years ago, Pfizer anted up $150 million in cash to buy Bamboo Therapeutics in Chapel Hill, NC as it cautiously stuck a toe in the small gene therapy pool of research and development.

Company execs followed up a year later with a $100 million expansion of the manufacturing operations they picked up in that deal for the UNC spinout, which came with $495 million in milestones.

And now they’re really going for it.

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Video: Putting the AI in R&D — with Badhri Srini­vasan, Tony Wood, Rosana Kapeller, Hugo Ceule­mans, Saurabh Sa­ha and Shoibal Dat­ta

During BIO this year, I had a chance to moderate a panel among some of the top tech experts in biopharma on their real-world use of artificial intelligence in R&D. There’s been a lot said about the potential of AI, but I wanted to explore more about what some of the larger players are actually doing with this technology today, and how they see it advancing in the future. It was a fascinating exchange, which you can see here. The transcript has been edited for brevity and clarity. — John Carroll