Sun Phar­ma takes aim at a crowd­ed mar­ket with an­oth­er IL-23 pso­ri­a­sis drug from Mer­ck

Jes­per Jensen, Sun Phar­ma­ceu­ti­cals

In the last minute, late-stage race to the mar­ket with a new round of pso­ri­a­sis drugs, In­dia’s Sun Phar­ma­ceu­ti­cals is mak­ing its own bid with a new drug called tildrak­izum­ab. In-li­censed from Mer­ck, which agreed to han­dle the late-stage work for Sun for the for­mer MK-3222, it’s an­oth­er IL-23 drug, like J&J’s guselkum­ab.

But it didn’t per­form as well as the J&J drug in late-stage de­vel­op­ment.

Over the week­end, Sun tout­ed a late break­er at EADV which demon­strat­ed that their drug hit the pri­ma­ry end­point in the study, adding im­proved 28-week scores that demon­strat­ed it was ef­fec­tive in a ma­jor­i­ty of pa­tients.

The trou­ble, though, is that their drug was clear­ly over­shad­owed by guselkum­ab, an­oth­er IL-23 drug that’s now an­gling to hit the mar­ket to com­pete against two oth­er re­cent ar­rivals: No­var­tis’s Cosen­tyx and Eli Lil­ly’s Taltz (ix­ek­izum­ab). Both of those drugs are IL-17 ther­a­pies, a group which Valeant may well soon join af­ter its ap­pli­ca­tion for bro­dalum­ab — in-li­censed from As­traZeneca — goes through.

First, the da­ta.

An av­er­age of 64% and 78% of pa­tients re­ceiv­ing two in­jec­tions of a 200 mg dose achieved PASI 75 score af­ter 12 and 28 weeks. The da­ta fur­ther showed that a high­er num­ber of pa­tients on tildrak­izum­ab achieved PASI 90 and 100 com­pared to place­bo and En­brel (etan­er­cept). For tildrak­izum­ab, 54% and 59% of pa­tients (at 100 mg and 200 mg) achieved PASI 90 at week 28, sig­nif­i­cant­ly bet­ter than En­brel’s 31%.

But there­in lies the rub.

At week 16, the guselkum­ab pa­tients achieved a 73.3% PASI 90 rate. At week 24, the pro­por­tion of pa­tients who achieved a PASI 90 re­sponse was sig­nif­i­cant­ly high­er in the guselkum­ab group com­pared with the Hu­mi­ra group (80.2% vs. 53%, re­spec­tive­ly).

Guselkum­ab not on­ly hand­i­ly beat out Sun’s drug, the Sun ther­a­py al­so scored un­com­fort­ably close to the old main­stay Hu­mi­ra, which is — some­time in the next few years — go­ing to go gener­ic.

“I think it’s very hard to com­pare be­tween stud­ies,” says Jes­per Jensen, Sun’s ex­ec­u­tive vice pres­i­dent for bi­o­log­ics and der­ma­tol­ogy, who be­lieves that tildrak­izum­ab is well set up for its com­ing re­view by the FDA and like­ly ar­rival on the mar­ket.

Both drugs have helped demon­strate that IL-23 is a good tar­get for pso­ri­a­sis, he adds. In ad­di­tion: “We’re still see­ing many pa­tients not get­ting to goal.”

The two drugs were al­so dosed dif­fer­ent­ly, says Jensen, which could al­so ex­plain the dif­fer­ence in the out­comes.

From left to right: Lilian Kim, Associate Director Business Development; John Moller, CEO; Yooni Kim, Executive Director, Asia Operations; Michelle Park, Director South Korea Operations.

Novotech CRO sees 26% growth in Asia tri­al ac­tiv­i­ty from biotechs, but still plen­ty of ca­pac­i­ty

As the Asia-Pacific clinical trials sector continues to grow rapidly, Novotech the Asia-Pacific-based CRO is seeing biotech clinical activity up by 26%. But says there is still plenty of capacity in the region that features advanced medical facilities, supportive regulatory environments, and more than 2.3 billion people, largely treatment naïve, living in urban areas.

China, South Korea and Australia have the most studies registered as recruiting or about to recruit according to ClinicalTrials.Gov.

A preda­tor's world? Top an­a­lyst sees the 'haves' and the 'haven't­s' di­verge as biotech bub­bles form — and col­lapse

Josh Schimmer

We’ve all seen the deluge of cash that’s been pouring into biotech from every angle: VCs, IPOs and follow-ons have generated billions in capital for new and emerging drug developers with ready access to some powerful new tech. But Evercore ISI’s Josh Schimmer is asking where we’re headed from here.

His answer is neither apocalyptic nor universally blissful, but if he’s right — and this is a discussion we’re hearing much, much more about at a time of growing economic and industry uncertainty — we may well be at a crossroads that could affect valuations, M&A and the entire global industry that has formed over the past 5 years.

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Neil Kumar, Endpoints

Bridge­Bio drops bid to re­claim Ei­dos af­ter di­rec­tors spurn 3 of­fers

A couple of months ago a newly public BridgeBio turned some heads by disclosing that it had made a bid for subsidiary Eidos Therapeutics in hopes of gobbling up the 34% stake that it doesn’t already own. Two offers later, the parties are calling it off.

A special committee of independent directors at the smaller biotech led by RA Capital’s Rajeev Shah and ex-Portola CEO William Lis first rejected the parent company’s initial offer — which would swap 1.3 BridgeBio shares for each Eidos share — on September 12. In the latest announcement, BridgeBio revealed that it eventually raised the offer to 1.5 shares and made $110 million available for all-cash or mixed consideration options, but Eidos still wasn’t interested.

Mark Foley, Revance

HR vi­o­la­tion push­es Re­vance co-founder out, vault­ing for­mer Zel­tiq chief to the helm

Months after Revance amended the terms of its Botox biosimilar collaboration with Mylan, the Newark, California-based drug developer disclosed its co-founder Dan Browne is stepping down, in what appears to be mysterious circumstances.

The company — which is also developing a rival to Allergan’s formidable Botox franchise — on Monday said Browne is departing “due to misjudgment in handling an employee matter,” that has also culminated in his resignation from Revance’s board of directors.

In-house FDA re­view flags a sus­pi­cious im­bal­ance in deaths as Sh­iono­gi hunts an OK for an­tibi­ot­ic

Shionogi has some big questions to answer if they plan to win an FDA panel’s backing for their new antibiotic.

While investigators have provided positive efficacy data for their new product to treat cases of complex urinary tract infections, an FDA review has flagged an imbalance of deaths between the antibiotic and a control arm. And they want the agency’s outside advisers to take a good hard look at that when they meet on Wednesday.

Pfizer, South San Francisco — Jeff Rumans for Endpoints News

UP­DAT­ED: Pfiz­er takes aim at a flag­ship fran­chise at Sanofi and Re­gen­eron — and scores a few di­rect hits

Count Pfizer in as a top player in the blockbuster game of JAK1 inhibitors.

Over the weekend the pharma giant posted some stellar Phase III efficacy data for their heavyweight contender abrocitinib in atopic dermatitis (eczema) that lines up ahead of a booming Dupixent (dupilumab), a blockbuster in the portfolios of Regeneron and Sanofi. And they put some real distance ahead of Eli Lilly’s trailing Olumiant, which made a delayed initial arrival on the market for rheumatoid arthritis after the FDA hobbled it with some additional hurdles on safety concerns.

JADE-MONO-1 scores well for Pfizer, teeing up what will be an intensely followed breakdown of the JADE MONO-2 data, which the pharma giant recently top-lined as “similar” to the first Phase III when tested against a placebo — a control group that has been easily outclassed by all the drugs in this market niche.

As of now, Pfizer looks to be equipped to run into the review stage — advantaged by a breakthrough therapy designation that is intended to speed up the regulatory process.

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Cell ther­a­py start­up rais­es $16 mil­lion to fund its quest for the Holy Grail in re­gen­er­a­tive med­i­cine

In 2006, Shinya Yamanaka shook stem cell research with his discovery that mature cells can be converted into stem cells, relieving a longstanding political-ethical blockage and throwing open medical research on everything from curbing eye degeneration to organ printing.

But that process still has pitfalls, including in risk and scalability, and some researchers are exploring another way first hinted at years ago: new technology to convert mature cells directly into other mature cells without the complex and time-consuming process of first making them into stem cells.

Eye­ing $86M, Galera leads a pack of three mod­est biotech IPOs push­ing past high pro­file stum­bles

Exactly one year after kicking off a pivotal Phase III study for its lead drug — a companion for cancer patients receiving radiotherapy — Galera is looking to the Nasdaq for some new cash to complete the clinical work and fuel its commercial drive.

CEO Mel Sorensen has penciled in an $86 million ask, which was filed on the same day as liver disease company 89bio and rare disease diagnostics shop Centogene. The trio marks the first batch of IPO filings in the wake of two highly anticipated but ultimately disappointing public debuts by BioNTech and Vir, signaling dwindling biotech fervor on Wall Street. 89bio and Centogene are seeking $70 million and $69 million, respectively.

UP­DAT­ED: Pelosi drug pric­ing bill promis­es sav­ings, but could gag R&D — CBO analy­sis

The Democrats’ drug pricing bill — unveiled by Speaker Nancy Pelosi last month — could save Medicare spending by $345 billion over a seven-year period, a new analysis suggests. But the venomous climate of impeachment proceedings and the intensifying discord between the Democrat-controlled House and Republican-majority Senate portends the bill will unlikely ever become law.

Technically, both sides of the aisle agree drug prices in the United States need some lowering. The Democrats’ bill, H.R.3 – Lower Drug Costs Now Act of 2019, is engineered to empower the HHS to negotiate prices for the 125 most expensive prescription drugs without at least two competitors — the Trump administration has already backed such a measure for the Veterans Association. Under the bill, prices for this category of medicines are not intended to exceed 120% of the average price in certain other countries (Australia, Canada, France, Germany and the United Kingdom), akin to a proposal floated by Trump earlier this year, which suggested prices be pegged against what other nations were paying as part of an “international pricing index”.