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?

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

The End­points 11: They've got mad mon­ey and huge am­bi­tions. It's time to go big or go home

These days, selecting a group of private biotechs for the Endpoints 11 spotlight begins with a sprint to get ahead of IPOs and the M&A teams at Big Pharma. I’ve had a couple of faceplants earlier this year, watching some of the biotechs on my short list choose a quick leap onto Nasdaq or into the arms of a buyer.

Vividion, you would have been a great pick for the Endpoints 11. I’m sorry I missed you.

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Dave Lennon, former president of Novartis Gene Therapies

So what hap­pened with No­var­tis Gene Ther­a­pies? Here's your an­swer

Over the last couple of days it’s become clear that the gene therapy division at Novartis has quietly undergone a major reorganization. We learned on Monday that Dave Lennon, who had pursued a high-profile role as president of the unit with 1,500 people, had left the pharma giant to take over as CEO of a startup.

Like a lot of the majors, Novartis is an open highway for head hunters, or anyone looking to staff a startup. So that was news but not completely unexpected.

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Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

FDA+ roundup: Bs­U­FA III ready for show­time, court tells FDA to re-work com­pound­ing plan, new guid­ance up­dates and more

The FDA has now spelled out what exactly will be included in the third iteration of Biosimilar User Fee Act (BsUFA) from 2023 through 2027, which similarly to the prescription drug deal, sets fees that industry has to pay for submitting applications, in exchange for firm timelines that the agency must meet.

This latest deal includes several sweeteners for the biosimilar industry, which has yet to make great strides in the US market, with shorter review timelines for safety labeling updates and updates to add or remove an indication that does not contain efficacy data.

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Joshua Liang, Clover Biopharmaceuticals CEO

With world still in sore need of dos­es, Clover says its Covid-19 vac­cine is 67% ef­fec­tive in Phase III

With concerns about the Delta variant rising and much of the world still in desperate need of vaccine doses, a Chinese biotech announced Wednesday that a new shot has shown positive results in a large trial against Covid-19, including new variants.

Clover Biopharmaceuticals announced Wednesday that its vaccine candidate showed 79% efficacy against the Delta variant in a Phase II/III trial dubbed Spectra, and 67% effective against Covid-19 overall.

Jean Bennett (Brent N. Clarke/Invision/AP Images)

Lux­tur­na in­ven­tor Jean Ben­nett starts a new gene ther­a­py com­pa­ny to tack­le rare dis­eases left be­hind by phar­ma, VCs

A few years ago Jean Bennett found herself in a surprising place for a woman who invented the first gene therapy ever approved in the United States: No one, it seemed, wanted her work.

Bennett, who designed and co-developed Luxturna, approved in 2018 for a rare form of blindness, had kept building new gene therapies for eye diseases at her University of Pennsylvania lab. But although the results in animals looked promising, pharma companies and investors kept turning down the pedigreed ophthalmology professor.

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David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.