Bris­tol-My­ers’ tar­nished check­point star Op­di­vo beats out Yer­voy in sur­prise PhI­II

Bris­tol-My­ers got a much-need­ed boost with the ear­li­er-than-ex­pect­ed news that Op­di­vo beat out Yer­voy in a Phase III study fo­cused on a par­tic­u­lar niche for ad­ju­vant melanoma ther­a­py. And an an­a­lyst who’s been fol­low­ing the da­ta says it could be worth a bil­lion dol­lars in added an­nu­al sales.

The big biotech says an in­ter­im analy­sis of Check­mate-238 pro­vid­ed re­searchers with proof that the PD-1 drug out­per­formed Yer­voy, Bris­tol-My­ers’ CT­LA-4 drug, among ad­vanced Stage II­Ib or IV pa­tients, cut­ting the re­cur­rence rate for those who have un­der­gone surgery. There are no bot­tom line num­bers in the state­ment, but Bris­tol-My­ers says they’ll be able to re­lease da­ta at an up­com­ing con­fer­ence to show that Op­di­vo pro­vid­ed a sig­nif­i­cant­ly low­er risk of dis­ease re­cur­rence.

Sea­mus Fer­nan­dez notes that the re­sults are like­ly to can­ni­bal­ize Bris­tol’s Yer­voy rev­enue, but will like­ly de­liv­er a $1 bil­lion boost to Op­di­vo as physi­cians steer away from the high­er dos­es of high­ly tox­ic Yer­voy. He not­ed:

This comes as a sur­prise, as top-line da­ta were not ex­pect­ed un­til the fi­nal read­out in 2H:18. While there were no de­tails in the press re­lease re­gard­ing the mag­ni­tude of ben­e­fit for Op­di­vo, we would ex­pect it to be­come the stan­dard of care in high-risk pa­tients fol­low­ing sur­gi­cal re­sec­tion giv­en its su­pe­ri­or safe­ty and tol­er­a­bil­i­ty pro­file rel­a­tive to Yer­voy. We es­ti­mate the ad­ju­vant melanoma mar­ket will ex­pand PD1 sales by ap­prox­i­mate­ly $3B glob­al­ly. Al­though this like­ly will can­ni­bal­ize sales of Yer­voy in the set­ting (we es­ti­mate cur­rent ad­ju­vant Yer­voy sales at $300-400M), the ex­pan­sion of the mar­ket should add ap­prox­i­mate­ly $1B to BMY’s net im­muno-on­col­o­gy (IO) sales de­spite as­sumed com­pe­ti­tion from MRK’s (MP) Keytru­da (pem­brolizum­ab; an­ti-PD-1).

Vic­ki Good­man

Op­di­vo’s rocky road at Bris­tol has led to end­less spec­u­la­tion that the com­pa­ny could find it­self on the auc­tion block be­fore it gets a chance to re­or­ga­nize in the clin­ic and come back in its head-to-head show­down with Mer­ck’s Keytru­da. But it is al­so rack­ing up bil­lions in an­nu­al sales of Op­di­vo, with a slate of new tri­als un­der­way.

“These topline re­sults sup­port the po­ten­tial promise of Op­di­vo as a treat­ment op­tion for pa­tients with high-risk sur­gi­cal­ly re­sect­ed melanoma. There re­mains an un­met need for ad­di­tion­al op­tions as the ma­jor­i­ty of stage III and re­sect­ed stage IV high-risk melanoma pa­tients ex­pe­ri­ence dis­ease re­cur­rence af­ter surgery,” said Vic­ki Good­man, de­vel­op­ment lead, melanoma and gen­i­touri­nary can­cers, Bris­tol-My­ers Squibb. “We are com­mit­ted to re­search­ing ther­a­pies that may bet­ter meet the needs of this pa­tient pop­u­la­tion and look for­ward to shar­ing these da­ta with health au­thor­i­ties soon.”

Jef­frey We­ber

Physi­cians in the field, in­clud­ing the high pro­file Jef­frey We­ber at NYU Lan­gone, have been wait­ing to see how this one will shake out. And they’re get­ting the read­out a year ahead of sched­ule. In a pan­el chat with ex­perts in the field in the spring of 2016, he not­ed:

On the ba­sis of my own ex­pe­ri­ence with both drugs in pi­lot ad­ju­vant tri­als, I have a sus­pi­cion that nivolum­ab is go­ing to look bet­ter than ip­il­i­mum­ab. And the next fron­tier is what we’ve al­ready pi­lot­ed when I was at Mof­fitt and we’ll con­tin­ue at NYU, which is com­bi­na­tion ad­ju­vant ther­a­py. But be­cause of the tox­i­c­i­ty, we flipped the dos­es giv­ing one of ip­il­i­mum­ab and three of nivolum­ab, which is very well-tol­er­at­ed with a pret­ty good track record, ad­mit­ted­ly, in a small study. So, I think that we’ve gone from in­ter­fer­on, we’ll go to ip­il­i­mum­ab, we’ll go to nivolum­ab, and even­tu­al­ly end up at ip­il­i­mum­ab plus nivolum­ab, over the next five years, which brings us to where we’re go­ing in metasta­t­ic treat­ment. I think we’re go­ing to see triple com­bi­na­tions. On the one hand, it’s sci­en­tif­i­cal­ly fas­ci­nat­ing, ex­treme­ly com­plex with para­dox­i­cal­ly a bar that’s now so high, it’s go­ing to be very dif­fi­cult to get com­bi­na­tions ap­proved. You’re go­ing to need to see ma­jor in­cre­men­tal ad­van­tages, which I think you prob­a­bly will see with some of the drugs my col­leagues have men­tioned. But they’re al­so go­ing to be very ex­pen­sive, so phar­ma­coeco­nom­ics is al­so go­ing to play a huge role in what we do. Right now, I would es­ti­mate that the cost of ip­il­i­mum­ab plus nivolum­ab ther­a­py for a year is about $250,000. So, I would ask where does this all end?

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.