Lag­ging fur­ther be­hind, As­traZeneca adds fresh de­tails to its check­point come­back strat­e­gy

As­traZeneca has sketched out some fresh de­tails on its mis­sion crit­i­cal piv­otal study on its check­point drug ap­proach to non-small cell lung can­cer, map­ping an­oth­er like­ly de­lay as the phar­ma gi­ant looks for its first big open­ing in the megablock­buster can­cer mar­ket.

The MYS­TIC study has been en­rolling lung can­cer pa­tients re­gard­less of PD-L1 ex­pres­sion sta­tus. In its state­ment to­day the phar­ma gi­ant says it will eval­u­ate pro­gres­sion-free sur­vival as well as over­all sur­vival for dur­val­um­ab com­bined with treme­li­mum­ab — its all-im­por­tant I/O + I/O matchup that will look to out­per­form the ther­a­pies al­ready ap­proved for front­line and sec­ond line pa­tients — for all com­ers as well as PD-L1 ex­pressers. And it will al­so now ex­plore the da­ta for dur­val­um­ab as a monother­a­py.

Sea­mus Fer­nan­dez, Leerink

Da­ta are ex­pect­ed now mid-year for PFS and no lat­er than some­time in 2018 for OS, which Sea­mus Fer­nan­dez at Leerink counts as a three-month de­lay:

“In the wake of MRK’s (MP) sur­prise fil­ing an­nounce­ment for its Keytru­da (pem­brolizum­ab; an­ti-PD-1) + chemother­a­py com­bi­na­tion, AZN’s de­ci­sion to fo­cus on MYS­TIC’s best chance of suc­cess with ei­ther mono- or com­bo ther­a­py is ra­tio­nal, in our view,” Fer­nan­dez not­ed. “In ad­di­tion, the com­pa­ny’s strate­gic up­date on im­muno-on­col­o­gy (IO) monother­a­py (PEARL study) and com­bo ther­a­py (ex­pand­ed NEP­TUNE re­cruit­ment) pro­vides an­oth­er sub­stan­tial shot on goal for the com­pa­ny’s glob­al IO ef­forts.”

The NEP­TUNE study will be used to seek an OK in Chi­na for first-line use based on ear­li­er PFS da­ta while the new­ly launched PEARL will go af­ter PD-L1 ex­pressers in Asian mar­kets, where the rate of NSCLC runs high.

Mer­ck stunned the mar­ket re­cent­ly when it sped through a fil­ing for a com­bi­na­tion of Keytru­da with chemother­a­py in front­line NSCLC, putting some fresh dis­tance be­tween its big check­point and Bris­tol-My­ers Squibb’s ri­val Op­di­vo. Roche was the third play­er on the mar­ket with Tecen­triq, which is al­so in­volved in mul­ti­ple stud­ies.

As­traZeneca, which stum­bled through a se­ries of mishaps last year, des­per­ate­ly needs to do some­thing right with dur­val­um­ab to at least par­tial­ly sat­is­fy some big promis­es CEO Pas­cal So­ri­ot has made to in­vestors. A late ar­rival to the check­point mar­ket, ei­ther along­side or right be­hind Pfiz­er, leaves As­traZeneca with shrink­ing op­por­tu­ni­ties for mak­ing a splash.

It’s still pos­si­ble, though, and an­a­lysts aren’t count­ing the com­pa­ny out.

“While Keytru­da is now ap­proved in 1L pa­tients with PD-L1 ex­pres­sion of 50% or high­er, there re­mains “white space” for dur­va in PD-L1+ pa­tients with low­er (but still pos­i­tive) ex­pres­sion,” re­ports Fer­nan­dez.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 60,200+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 60,200+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 60,200+ biopharma pros reading Endpoints daily — and it's free.

[via AP Images]

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. 

Jason Kelly. Mike Blake/Reuters via Adobe

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 60,200+ biopharma pros reading Endpoints daily — and it's free.

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.