Ab­b­Vie gets a big boost in the ma­jor league rheuma­toid arthri­tis fi­nals with promis­ing PhI­II da­ta

Ab­b­Vie passed on a big part­ner­ship it had set up with Gala­pa­gos on the promis­ing rheuma­toid arthri­tis drug fil­go­tinib so it could fo­cus all of its ef­forts on an in-house pro­gram for upadac­i­tinib (ABT-494). And to­day the block­buster gam­ble was re­ward­ed with a round of stel­lar da­ta from their first Phase III study of the oral JAK in­hibitor.

Both the 15 mg and 30 mg dos­es swept the pri­ma­ry and sec­ondary end­points in the study, with 64% and 66% re­spec­tive­ly hit­ting ACR20, with a min­i­mum 20% im­prove­ment in the dis­ease score.  ACR50 came in at 38% and 43%. Low dis­ease ac­tiv­i­ty was marked by about half of the pa­tients while on­ly 17% of the place­bo arm could say the same.

Here’s the full chart:

There have been a host of ma­jor league ri­vals go­ing af­ter RA re­cent­ly, with mixed re­sults. So how does ABT-494 stack up?

At the top of the set­back list is Eli Lil­ly’s baric­i­tinib, part­nered with In­cyte, which the FDA re­ject­ed in April for large­ly un­known rea­sons. J&J and Glax­o­SmithK­line re­cent­ly stum­bled in a head-to-head with sirukum­ab against Hu­mi­ra, a main­stay in the mar­ket. The 50 mg and 100 mg sirukum­ab num­bers hit 27% and 35% on ACR50 com­pared to 32% of the Hu­mi­ra group. But Re­gen­eron and Sanofi scored with sar­ilum­ab (Kevzara), win­ning an ap­proval for the IL-6 drug re­cent­ly af­ter be­ing de­layed over man­u­fac­tur­ing is­sues.

Ab­b­Vie has high hopes for the oral upadac­i­tinib, wide­ly tapped as a block­buster-to-be. It’s al­ready well in­to a late-stage pro­gram on pso­ri­at­ic arthri­tis fol­lowed by Crohn’s dis­ease, ul­cer­a­tive col­i­tis and atopic der­mati­tis. And Ge­of­frey Porges at Leerink was quick to of­fer the com­pa­ny ku­dos for the way this ther­a­py is be­ing po­si­tioned. He not­ed:

The place­bo-ad­just­ed ACR20 ben­e­fit rates for upadac­i­tinib with methotrex­ate of 28%-30% are nu­mer­i­cal­ly su­pe­ri­or to com­peti­tor LLY (OP)/IN­CY’s (OP) baric­i­tinib of 22-26% in the same tri­al with pa­tients who had in­ad­e­quate re­spons­es to DMARD, and the more strin­gent place­bo-ad­just­ed ACR50 and ACR70 rates for upadac­i­tinib are al­so high­er than seen in the baric­i­tinib tri­al. We cur­rent­ly mod­el $1.6bn in peak sales for upadac­i­tinib com­pared to con­sen­sus ex­pec­ta­tions of $2.5bn in 2027E, and we be­lieve that the su­pe­ri­or da­ta and re­cent FDA re­jec­tion of baric­i­tinib fa­vor­ably po­si­tion Ab­b­Vie in the JAK mar­ket seg­ment, and could lead to ma­te­r­i­al up­side to fore­casts.

The phar­ma com­pa­ny was so pumped about its prospects with this drug, with peak sales pro­jec­tions run­ning in­to the bil­lions, that it walked away from its $150 mil­lion up­front on a ri­val oral ther­a­py, which Gilead quick­ly scooped up for it­self.

Gerd Burmester

“Achiev­ing the tar­get of low dis­ease ac­tiv­i­ty in near­ly half of the pa­tients by 12 weeks and do­ing so at both high and low dose lev­els is en­cour­ag­ing,” said Gerd Burmester, pro­fes­sor of med­i­cine, De­part­ment of Rheuma­tol­ogy and Clin­i­cal Im­munol­o­gy, Char­ité Berlin, in a state­ment. “Cur­rent treat­ment rec­om­men­da­tions rec­og­nize the im­por­tance of this clin­i­cal tar­get for pa­tients, as achiev­ing low dis­ease ac­tiv­i­ty has re­mained an un­met need in rheuma­toid arthri­tis.”

Here comes the oral GLP-1 drug for di­a­betes — but No­vo Nordisk is­n't dis­clos­ing Ry­bel­sus price just yet

Novo Nordisk’s priority review voucher on oral semaglutide has paid off. The FDA approval for the GLP-1 drug hit late Friday morning, around six months after the NDA filing.

Rybelsus will be the first GLP-1 pill to enter the type 2 diabetes market — a compelling offering that analysts have pegged as a blockbuster drug with sales estimates ranging from $2 billion to $5 billion.

Ozempic, the once-weekly injectable formulation of semaglutide, brought in around $552 million (DKK 3.75 billion) in the first half of 2019.

As Nas­daq en­rolls the fi­nal batch of 2019 IPOs, how have the num­bers com­pared to past years?

IGM Biosciences’ upsized IPO haul, coming after SpringWorks’ sizable public debut, has revved up some momentum for the last rush of biotech IPOs in 2019.

With 39 new listings on the books and roughly two more months to go before winding down, Nasdaq’s head of healthcare listings Jordan Saxe sees the exchange marking 50 to 60 biopharma IPOs for the year.

“December 15 is usually the last possible day that companies will price,” he said, as companies get ready for business talks at the annual JP Morgan Healthcare Conference in January.

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A fa­vorite in Alex­ion’s C-suite is leav­ing, and some mighty sur­prised an­a­lysts aren’t the least bit hap­py about it

Analysts hate to lose a biotech CFO they’ve come to trust and admire — especially if they’re being blindsided by a surprise exit.

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Oxitec biologist releases genetically modified mosquitoes in Piracicaba, Brazil in 2016 [credit: Getty Images]

In­trex­on unit push­es back against claims its GM mos­qui­toes are mak­ing dis­ease-friend­ly mu­tants

When the hysteria of Zika transmission sprang into the American zeitgeist a few years ago, UK-based Oxitec was already field-testing its male Aedes aegypti mosquito, crafted to possess a gene engineered to obliterate its progeny long before maturation.

But when a group of independent scientists evaluated the impact of the release of these genetically-modified mosquitoes in a trial conducted by Oxitec in Brazil between 2013 and 2015, they found that some of the offspring had managed to survive — prompting them to speculate what impact the survivors could have on disease transmission and/or insecticide resistance.

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Pur­due threat­ens to walk away from set­tle­ment, asks to pay em­ploy­ees mil­lions in bonus­es

There are two updates on the lawsuit against Purdue Pharma over its role in fueling the opioid epidemic, as the Sackler family threatens to walk away from their pledge to pay out $3 billion if a bankruptcy judge does not stop outstanding state lawsuits against them. At the same time, the company has asked permission to pay millions in bonuses to select employees.

Purdue filed for chapter 11 bankruptcy this week as part of its signed resolution to over 2,000 lawsuits. The deal would see the Sackler family that owns Purdue give $3 billion from their personal wealth and the company turned into a trust committed to curbing and reversing overdoses.

Aerial view of Genentech's campus in South San Francisco [Credit: Getty]

Genen­tech sub­mits a big plan to ex­pand its South San Fran­cis­co foot­print

The sign is still there, a quaint reminder of whitewashed concrete not 5 miles from Genentech’s sprawling, chrome-and-glass campus: South Francisco The Industrial City. 

The city keeps the old sign, first erected in 1923, as a tourist site and a kind of civic memento to the days it packed meat, milled lumber and burned enough steel to earn the moniker “Smokestack of the Peninsula.” But the real indication of where you are and how much has changed both in San Francisco and in the global economy since a couple researchers and investors rented out an empty warehouse 40 years ago comes in a far smaller blue sign, resembling a Rotary Club post, off the highway: South San Francisco, The Birthplace of Biotech.

While No­var­tis ban­ish­es Zol­gens­ma scan­dal scars — Bio­gen goes on a Spin­raza 'of­fen­sive'

While Novartis painstakingly works to mop up the stench of the data manipulation scandal associated with its expensive gene therapy for spinal muscular atrophy (SMA) Zolgensma— rival Biogen is attempting to expand the use of its SMA therapy, Spinraza. 

The US drugmaker $BIIB secured US approval for Spinraza for use in the often fatal genetic disease in 2016. The approval covered a broad range of patients with infantile-onset (most likely to develop Type 1) SMA. 

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Eye­ing big ther­a­peu­tic push, Gink­go bags $290M to build a cell pro­gram­ming em­pire

Ginkgo Bioworks is on a roll. Days after publicizing a plan to nurture new startups via partnerships with accelerators Y Combinator and Petri, the Boston biotech says it has raised another $290 million for its cell programming platform to reach further and wider.

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UP­DAT­ED: Speak­er Nan­cy Pelosi to un­veil bill for fed­er­al­ly ne­go­ti­at­ed drug prices

After months of buzz from both sides of the aisle, Speaker Nancy Pelosi will today introduce her plan to allow the federal government to negotiate prices for 250 prescription drugs, setting up a showdown with a pharmaceutical industry working overtime to prevent it.

The need to limit drug prices is a rare point of agreement between President Trump and Democrats, although the president has yet to comment on the proposal and will likely face pressure to back a more conservative option or no bill at all. Republican Senator Chuck Grassley is reportedly lobbying his fellow party members on a more modest proposal he negotiated with Democratic Senator Ron Wyden in July.