As­traZeneca cel­e­brates a PhI­II PARP suc­cess for Lyn­parza, putting pres­sure on Tesaro ri­val

As­traZeneca dropped one very big, tan­ta­liz­ing clue this morn­ing that will de­ter­mine the fate of its PARP in­hibitor Lyn­parza (ola­parib). As ri­val PARPs come up the pipeline from Tesaro, Clo­vis and Pfiz­er, the phar­ma gi­ant says that its Phase III ovar­i­an can­cer study came up with sta­tis­ti­cal­ly sig­nif­i­cant re­sults that beat out what we’ve seen so far.

“Im­por­tant­ly, the me­di­an PFS in the Lyn­parza arm of SO­LO-2 sub­stan­tial­ly ex­ceed­ed that ob­served in the Phase II main­te­nance study in pa­tients with plat­inum-sen­si­tive re­lapsed ovar­i­an can­cer (Study 19),” As­traZeneca $AZN said in a re­lease. In­ves­ti­ga­tors test­ed the drug as a main­te­nance monother­a­py com­pared with place­bo in pa­tients with plat­inum-sen­si­tive re­lapsed or re­cur­rent BR­CA-mu­tat­ed (BR­CAm) ovar­i­an can­cer.

And that’s all you’re go­ing to get right now, as in­ves­ti­ga­tors gath­er their da­ta for an up­com­ing sci­en­tif­ic con­fer­ence.

Lyn­parza’s ac­cel­er­at­ed ap­proval with shaky da­ta and a neg­a­tive pan­el vote is one of the best things that has hap­pened to that com­pa­ny since Pas­cal So­ri­ot took over. And they need to do bet­ter than the weak re­sults that got them over the fin­ish line if they ex­pect to pre­serve the win in the mar­ket.

The de­vel­op­ers in the field did not all go af­ter the same pa­tient pop­u­la­tion, which makes com­par­isons dif­fi­cult. How­ev­er, each new da­ta point is be­ing giv­en a care­ful eval­u­a­tion as the ri­val com­pa­nies look to divvy up the mar­ket. In par­tic­u­lar, any­thing that pol­ish­es Lyn­parza’s da­ta will be com­pared close­ly with Tesaro’s ni­ra­parib, al­so be­ing pitched as a sec­ond-line main­te­nance ther­a­py.

Jef­feries notes that the da­ta is like­ly to set up a head-to-head ri­val­ry be­tween As­traZeneca and Tesaro.

We await full re­sults SO­LO-2 at an as-yet-to-be-dis­closed med­ical meet­ing to com­pare the re­sults to those seen with TSRO’s (OP) ni­ra­parib in the gBR­CA­mut co­hort of the Phase 3 NO­VA tri­al. We ex­pect the ben­e­fit of the two drugs to be broad­ly sim­i­lar and as­sume this in our mod­el. While we cur­rent­ly ex­pect Lyn­parza and ni­ra­parib to split the mar­ket in gBR­CA­mut pa­tients, ni­ra­parib is like­ly to ben­e­fit from an ex­pand­ed in­di­ca­tion in­clud­ing ho­mol­o­gous re­com­bi­na­tion de­fi­cient (HRD) pos­i­tive pa­tients, and we al­so be­lieve like­ly HRD-neg­a­tive pa­tients as well.

Tesaro’s shares are down 3% in pre-mar­ket trad­ing.

It’s like­ly to be quite a dust­up. Pfiz­er spent $14 bil­lion to buy Medi­va­tion with its prostate can­cer drug as well as an ex­per­i­men­tal PARP, ta­la­zoparib. Clo­vis $CLVS had to grap­ple with con­sid­er­able skep­ti­cism over its re­cent batch of mixed da­ta for ru­ca­parib. And Tesaro $TSRO is al­so hunt­ing an ap­proval of ni­ra­parib for a broad sec­ond-line main­te­nance group, with­out the use of a di­ag­nos­tic.

As­traZeneca CMO Sean Bo­hen not­ed:

Sean Bo­hen

“We are pleased with the ro­bust im­prove­ment in pro­gres­sion-free sur­vival demon­strat­ed by Lyn­parza in the SO­LO-2 tri­al. We will work with reg­u­la­to­ry au­thor­i­ties to make Lyn­parza tablets avail­able as quick­ly as pos­si­ble to pa­tients with ovar­i­an can­cer. We re­main com­mit­ted to in­ves­ti­gat­ing the full po­ten­tial of Lyn­parza, both as monother­a­py and in com­bi­na­tions, and to iden­ti­fy­ing all pa­tients who may ben­e­fit from this im­por­tant med­i­cine.”

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.