Eli Lil­ly's Taltz beats J&J's Trem­fya in pso­ri­a­sis head-to-head — but the mar­ket­ing brawl is just be­gin­ning

Eli Lil­ly has come out swing­ing at J&J, stak­ing out its chal­lenger po­si­tion in a crowd­ed bat­tle of plaque pso­ri­a­sis block­busters.

In a Phase IV head-to-head study with 1,027 pa­tients, Lil­ly says its IL-17A in­hibitor Taltz beat J&J’s IL-23/p19 drug Trem­fya on com­plete skin clear­ance at week 12 as de­fined by PASI 100. It’s the first di­rect com­par­i­son of these two class­es us­ing PASI 100 as a pri­ma­ry end­point, Lil­ly says, though it al­so shows that Taltz is con­sis­tent­ly su­pe­ri­or in mea­sures of PASI 50, PASI 75 and PASI 90 at mul­ti­ple (al­though not all) time points — com­pris­ing a num­ber of “key sec­ondary end­points.”

Lo­tus Mall­bris

The num­bers are re­served for fu­ture sci­en­tif­ic meet­ings and jour­nals. Mean­while, in­ves­ti­ga­tors are still track­ing and an­a­lyz­ing da­ta on the pro­por­tion of pa­tients main­tain­ing PASI 100 af­ter 24 weeks.

“Lil­ly’s goal is to raise the treat­ment bar for peo­ple liv­ing with pso­ri­a­sis,” said Lo­tus Mall­bris, vice pres­i­dent of im­munol­o­gy de­vel­op­ment. “And re­search shows that pa­tients want clear skin and rapid im­prove­ments.”

No­tably, J&J ran its own head-to-head against Cosen­tyx and her­ald­ed a win late last year for Trem­fya, which helped a high­er pro­por­tion of pa­tients achieve a 90% re­duc­tion in PASI scor­ing than No­var­tis’ dom­i­nant ri­val. Re­searchers said that 84.5% of the pso­ri­a­sis pa­tients tak­ing Trem­fya hit a PASI 90 score at 48 weeks, com­pared to 70% for Cosen­tyx.

Cosen­tyx, al­so an IL-17 drug, has ac­crued $1.6 so far this year. In com­par­i­son, Taltz — which was first ap­proved in 2016, a year lat­er than Cosen­tyx — has scored $606.5 mil­lion, while Trem­fya (ap­proved yet an­oth­er year lat­er) count­ed $452 mil­lion.

But the race is far from over. As the en­trance of new com­peti­tors and in­di­ca­tions com­pli­cate the pic­ture, Lil­ly will have to beat more than just J&J, which al­so has Ste­lara in its ar­se­nal. Ab­b­Vie is now in the pso­ri­a­sis game, look­ing for a come-from-be­hind win with Skyrizi. And Taltz still has a long way to prov­ing it­self in pso­ri­at­ic arthri­tis as well as non-ra­di­ograph­ic ax­i­al spondy­loarthri­tis, a key are­na Lil­ly is an­gling to en­ter.

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.

In fi­nal days at Mer­ck, Roger Perl­mut­ter bets big on a lit­tle-known Covid-19 treat­ment

Roger Perlmutter is spending his last days at Merck, well, spending.

Two weeks after snapping up the antibody-drug conjugate biotech VelosBio for $2.75 billion, Merck announced today that it had purchased OncoImmune and its experimental Covid-19 drug for $425 million. The drug, known as CD24Fc, appeared to reduce the risk of respiratory failure or death in severe Covid-19 patients by 50% in a 203-person Phase III trial, OncoImmune said in September.

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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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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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Bahija Jallal (file photo)

TCR pi­o­neer Im­muno­core scores a first with a land­mark PhI­II snap­shot on over­all sur­vival for a rare melanoma

Bahija Jallal’s crew at TCR pioneer Immunocore says they have nailed down a promising set of pivotal data for their lead drug in a frontline setting for a solid tumor. And they are framing this early interim readout as the convincing snapshot they need to prove that their platform can deliver on a string of breakthrough therapies now in the clinic or planned for it.

In advance of the Monday announcement, Jallal and R&D chief David Berman took some time to walk me through the first round of Phase III data for their lead TCR designed to treat rare, frontline cases of metastatic uveal melanoma that come with a grim set of survival expectations.

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Gen­mab ax­es an ADC de­vel­op­ment pro­gram af­ter the da­ta fail to im­press

Genmab $GMAB has opted to ax one of its antibody-drug conjugates after watching it flop in the clinic.

The Danish biotech reported Tuesday that it decided to kill their program for enapotamab vedotin after the data gathered from expansion cohorts failed to measure up. According to the company:

While enapotamab vedotin has shown some evidence of clinical activity, this was not optimized by different dose schedules and/or predictive biomarkers. Accordingly, the data from the expansion cohorts did not meet Genmab’s stringent criteria for proof-of-concept.

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.

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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