#AACR18 round 1: Mer­ck takes a di­rect swing at Bris­tol-My­ers with ad­ju­vant melanoma da­ta for Keytru­da

CHICA­GO — Mer­ck $MRK came out of its cor­ner swing­ing Sun­day morn­ing, tak­ing a few di­rect jabs at the de­fend­ing cham­pi­on in check­point in­hi­bi­tion as the phar­ma gi­ant en­tered the lat­est I/O ti­tle fight with Bris­tol-My­ers Squibb $BMY at the an­nu­al meet­ing of AACR in Chica­go.

Roger Perl­mut­ter, Mer­ck

Re­searchers for Mer­ck were in Chica­go for the cur­tain open­er in what promis­es to be a bruis­ing brawl be­tween the lead­ers in the PD-1 field over a mar­ket one an­a­lyst has said is worth $3 bil­lion.

In KEYNOTE-054, Mer­ck de­ter­mined that 18 dos­es of Keytru­da pushed post-surgery pa­tients with stage 3 melanoma to a re­cur­rence-free rate of 75.4% com­pared to 61% for a com­par­i­son group get­ting a place­bo. A 43% drop in re­cur­rence rate was some­thing Mer­ck tout­ed as a ma­jor ad­vance for pa­tients.

Mer­ck is look­ing to carve away mar­ket share from Bris­tol-My­ers any way it can. And they’ll have their work cut out in Stage 3 melanoma. Bris­tol-My­ers won an ap­proval to use Yer­voy in this group three years ago, and fol­lowed up with an OK for Op­di­vo last year, mak­ing them the go-to play­er for ad­ju­vant ther­a­py.

Mer­ck, though, didn’t hes­i­tate to make its case in their out­line of the re­sults Sun­day morn­ing. Yer­voy, they note, is no­to­ri­ous­ly tox­ic for pa­tients, who may well pre­fer an al­ter­na­tive. And Op­di­vo? They have an ar­gu­ment there as well.

“Nivolum­ab was more ef­fec­tive and had few­er side ef­fects than ip­il­i­mum­ab, but it is giv­en at a dose of 3 mil­ligrams per kilo­gram every two weeks for up to a year, which is 26 dos­es in to­tal,” not­ed Alexan­der Eg­ger­ment, di­rec­tor gen­er­al of Gus­tave Roussy Can­cer Cam­pus Grand Paris, mak­ing Mer­ck’s case. “Pem­brolizum­ab may prove con­ve­nient to pa­tients and hos­pi­tals be­cause it re­quires few­er out­pa­tient hos­pi­tal vis­its and is giv­en at a flat dose.”

Mer­ck is hunt­ing ap­provals in the US and Eu­rope so they can take that pitch di­rect­ly to physi­cians.

A spokesper­son for Bris­tol-My­ers, though, fol­lowed up with me to note that “the ad­ju­vant melanoma dos­ing for nivolum­ab was up­dat­ed with the Q4W ap­proval and is now ap­proved for flat dos­ing 240 mg every two weeks or 480 mg every four weeks.”

Bris­tol-My­ers won an FDA ap­proval af­ter Check­mate-238 demon­strat­ed that Op­di­vo was bet­ter than Yer­voy in hold­ing back melanoma for post-surgery stage 3 and 4 pa­tients. In that study, the re­cur­rence rate for Op­di­vo at a me­di­an fol­low-up of 18.5 months was 66.4% for Op­di­vo and 52.7% for Yer­voy.

Whats at stake? Ac­cord­ing to Sea­mus Fer­nan­dez at Leerink, about $3 bil­lion. Here’s his com­ment on the -238 re­sults from last sum­mer:

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).

It’s not just about mon­ey, though. Ever since Bris­tol-My­ers rolled out in front of Mer­ck, Roger Perl­mut­ter’s team has been fo­cused on claim­ing the lead. A key mis­step on lung can­cer at Bris­tol-My­ers gave them an ad­van­tage they’ve been ex­ploit­ing ever since — which we’ll al­so hear more about over the next two days.

This par­tic­u­lar show­down has just be­gun.

UP­DAT­ED: Mer­ck pulls Keytru­da in SCLC af­ter ac­cel­er­at­ed nod. Is the FDA get­ting tough on drug­mak­ers that don't hit their marks?

In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders?

Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday.

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Pascal Soriot, AstraZeneca CEO (AP Images)

Pas­cal So­ri­ot cash­es in As­traZeneca’s chips on Mod­er­na for $1.2B cash in­jec­tion

While still working to prove its own Covid-19 vaccine, AstraZeneca has reportedly capitalized on the success of another.

The company has sold off its 7.7% stake in Moderna and turned it into $1.2 billion in cash, according to the Times, beefing up the reserves just as Pascal Soriot is wrapping up his $39 billion acquisition of Alexion and its rare disease pipeline.

AstraZeneca’s stock sale follows a similar move by Merck in December. But like its pharma brethren, the British giant is keeping its R&D collaborations with Moderna.

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Paul Sekhri

The next big biotech su­per­star? Paul Sekhri has some thoughts on that

It occasionally occurs to Paul Sekhri that if they pull this off, his company will be on the front page of the New York Times and a lead story in just about every major news outlet on the planet. He tries not to dwell on it, though.

“I just want to be laser-focused on getting to that point,” Sekhri says, before acknowledging, “Yes, it absolutely crossed my mind.”

Sekhri, a longtime biopharma executive with tenures at Sanofi and Novartis, is now entering year three as CEO of eGenesis, the biotech that George Church protégé Luhan Yang founded to genetically alter pigs so that they can be used for organ transplants. He led them through one megaround and has just closed another, raising $125 million from 17 different investors to push the first-ever (humanized) pig to human transplants into the clinic.

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Amit Munshi, Arena

One of Are­na's top drugs flops in a PhI­Ib study for IBS pain. But re­searchers tease out a pos­si­ble path for­ward as CEO ex­plores 's­trate­gic op­tion­s'

Four years ago, when Arena CEO Amit Munshi cut its ties to a troubled weight drug and doubled down on the pipeline, a cannabinoid receptor 2 agonist figured prominently in the biotech’s future. On Tuesday evening, however, Munshi’s high hopes for the drug took a nasty hit after it failed a Phase IIb study for patients with irritable bowel syndrome pain.

Put through a randomized pace with 273 patients, researchers said it flat failed the primary endpoint among the large group with abdominal pain. But they quickly went on to highlight subgroup data, always a tricky and controversial ploy, where they spotlighted a positive p value for patients with moderate to severe pain who received the high dose of the drug — one of 3 provided in the study.

Bob Nelsen (Photo by Michael Kovac/Getty Images)

With stars aligned and cash in re­serve, Bob Nelsen's Re­silience plans a makeover at 2 new fa­cil­i­ty ad­di­tions to its drug man­u­fac­tur­ing up­start

Bob Nelsen’s new, state-of-the-art drug manufacturing initiative is taking shape.

Just 3 months after gathering $800 million of launch money, a dream team board and a plan to shake up a field where he found too many bottlenecks and inefficiencies for the era of Covid-19, Resilience has snapped up a pair of facilities now in line for a retooling.

The company has acquired a 310,000-square-foot plant in Boston from Sanofi along with a 136,000-square-foot plant in Ontario to add to a network which CEO Rahul Singhvi says is just getting started on building his company’s operations up. The Sanofi deal comes with a contract to continue manufacturing one of its drugs.

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CEO Marco Taglietti (Scynexis)

'N­ev­er been more ur­gent:' Scynex­is looks to tack­le su­per­bug cri­sis with late-stage read­out for an­ti­fun­gal hope­ful

As the superbug crisis heats up around the world, Scynexis says it has new data from two interim analyses that prove its antifungal has the potential to treat a broad range of infections.

“The need for new anti-infectives capable of fighting the most resistant pathogens has never been more urgent as we confront the ongoing COVID-19 global pandemic,” CEO Marco Taglietti said in a statement.

A spot­light schiz­o­phre­nia drug in Neu­ro­crine's $2B Take­da deal flunks its first ma­jor test. But it's not giv­ing up yet

When Takeda spun out a pipeline of experimental psychiatry drugs to Neurocrine in a $2 billion deal amid a post-merger shakeout, R&D chief Andy Plump described the therapies as “very interesting but still difficult.”

On Tuesday, we got some idea of how difficult.

San Diego-based Neurocrine revealed that one of the three spotlight clinical programs they’d acquired failed the primary endpoint in a Phase II trial for schizophrenia, registering a negative outcome on the change from baseline in the positive and negative syndrome scale/negative symptom factor score (PANSS NSFS).

Af­ter bail­ing on Covid-19 vac­cines, Mer­ck will team up with J&J to pro­duce its shot as part of un­usu­al Big Phar­ma pact

Merck took a big gamble when it opted to jump into the Covid-19 vaccine race late, and made an equally momentous decision to back out in late January. Now, looking to chip in on the effort, Merck reportedly agreed to team up with one of the companies that has already crossed the finish line.

President Joe Biden on Tuesday is expected to announce a partnership between drugmakers Merck and Johnson & Johnson to jointly produce J&J’s recombinant protein Covid-19 vaccine that received the FDA’s emergency use authorization Saturday, the Washington Post reported.

Ab­b­Vie tees up a biotech buy­out af­ter siz­ing up their Parkin­son's drug spun out of Ke­van Shokat's lab

AbbVie has teed up a small but intriguing biotech buyout after looking over the preclinical work it’s been doing in Parkinson’s disease.

The company is called Mitokinin, a Bay Area biotech spun out of the lab of UCSF’s Kevan Shokat, whose scientific explorations have formed the academic basis of a slew of startups in the biotech hub. One of Shokat’s PhD students in the lab, Nicholas Hertz, co-founded Mitokinin using their lab work on PINK1 suggesting that amping up its activity could play an important role in regulating the mitochondrial dysfunction contributing to Parkinson’s disease pathogenesis and progression.

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