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.

Im­ple­ment­ing re­silience in the clin­i­cal tri­al sup­ply chain

Since January 2020, the clinical trials ecosystem has quickly evolved to manage roadblocks impeding clinical trial integrity, and patient care and safety amid a global pandemic. Closed borders, reduced air traffic and delayed or canceled flights disrupted global distribution, revealing how flexible logistics and supply chains can secure the timely delivery of clinical drug products and therapies to sites and patients.

Pascal Soriot (AP Images)

UP­DAT­ED: As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Vas Narasimhan, Novartis CEO (Jason Alden/Bloomberg via Getty Images)

Vas Narasimhan's 'Wild Card' drugs: No­var­tis CEO high­lights po­ten­tial jack­pots, as well as late-stage stars, in R&D pre­sen­ta­tion

Novartis is always one of the industry’s biggest R&D spenders. As they often do toward the end of each year, company execs are highlighting the drugs they expect will most likely be winners in 2021.

And they’re also dreaming about some potential big-time lottery tickets.

As part of its annual investor presentation Tuesday, where the company allows investors and analysts to virtually schmooze with the bigwigs, Novartis CEO Vas Narasimhan will outline what he thinks are the pharma’s “Wild Cards.” The slate of five experimental drugs are those that Novartis hopes can be high-risk, high-reward entrants into the market over the next half-decade or so, and cover a wide range of indications.

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Pur­due Phar­ma pleads guilty in fed­er­al Oxy­Con­tin probe, for­mal­ly rec­og­niz­ing it played a part in the opi­oid cri­sis

Purdue Pharma, the producer of the prescription painkiller OxyContin, admitted Tuesday that, yes, it did contribute to America’s opioid epidemic.

The drugmaker formally pleaded guilty to three criminal charges, the AP reported, including getting in the way of the DEA’s efforts to combat the crisis, failing to prevent the painkillers from ending up on the black market and encouraging doctors to write more painkiller prescriptions through two methods: paying them in a speakers program and directing a medical records company to send them certain patient information. Purdue’s plea deal calls for $8.3 billion in criminal fines and penalties, but the company is only liable for a fraction of that total — $225 million.

John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

UP­DAT­ED: Al­ny­lam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1. The news comes just 4 days after the European Commission took the lead in offering a green light.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

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PhRMA sues Trump gov­ern­ment over drug im­por­ta­tion rule — days be­fore it's set to be ef­fec­tive

Ever since President Donald Trump floated the idea of using state-sponsored importation to lower drug prices, PhRMA has made its opposition abundant. Not only is the proposal dangerous and futile,  but the trade group has also argued that it may even be illegal.

Now that the FDA has issued its final rule permitting states to bring certain drugs from Canada, PhRMA is taking the government to court — just a few days before the rule is slated to take effect.

The ad­u­canum­ab co­nun­drum: The PhI­II failed a clear reg­u­la­to­ry stan­dard, but no one is cer­tain what that means any­more at the FDA

Eighteen days ago, virtually all of the outside experts on an FDA adcomm got together to mug the agency’s Billy Dunn and the Biogen team when they presented their upbeat assessment on aducanumab. But here we are, more than 2 weeks later, and the ongoing debate over that Alzheimer’s drug’s fate continues unabated.

Instead of simply ruling out any chance of an approval, the logical conclusion based on what we heard during that session, a series of questionable approvals that preceded the controversy over the agency’s recent EUA decisions has come back to haunt the FDA, where the power of precedent is leaving an opening some experts believe can still be exploited by the big biotech.

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The flu virus (CDC)

Roche tacks on an­oth­er Xofluza in­di­ca­tion as flu sea­son meets pan­dem­ic

Xofluza was heralded as the first new flu drug in 20 years when it got the FDA OK back in 2018. But even so, Roche saw tough competition from cheaper Tamiflu generics that appeared to be nearly as — if not just as — effective.

Now, the pharma says the drug also can be used to prevent influenza after exposure, snagging a new approval and adding to Xofluza’s appeal as flu season meets the pandemic.

A poll sug­gests vac­cine da­ta boost­ed Pfiz­er's pub­lic im­age, but oth­er da­ta point to long road ahead

For much of the pharmaceutical industry, the pandemic presented an opportunity: to prove their value to the world and turn public opinion around on a business much of the country had come to disdain.

That theory — that helping pull the country from a pandemic could neutralize years of anger over high drug prices — was put to its biggest test this month, as three different drugmakers announced data from their Covid-19 vaccines, offering the first major evidence that industry-built inoculations could turn the tide of the outbreak in the US.