Hus­tling to cap­ture top front­line NSCLC sta­tus, Roche scores a ‘break­through’ on Ale­cen­sa

San­dra Horn­ing, Roche CMO

The FDA has hand­ed Roche brag­ging rights to its sec­ond break­through drug des­ig­na­tion for Ale­cen­sa (alec­tinib), which is like­ly to help make the drug’s case as the new stan­dard for front-line treat­ment of ALK-pos­i­tive non-small cell lung can­cer.

BTDs are not in the least bit un­usu­al for big play­ers like Roche, which has now racked up a long string of them. But this one hits home, of­fer­ing ‘break­through’ sta­tus for this drug for pre­vi­ous­ly un­treat­ed pa­tients. Roche is fac­ing some ma­jor league com­pe­ti­tion on that score, and it won’t mind the added ben­e­fits a BTD of­fers in win­ning over reg­u­la­tors as well as in­flu­en­tial prac­ti­tion­ers.

San­dra Horn­ing ham­mered the front­line point in a state­ment. She said:

“The J-ALEX study that sup­ports the sec­ond Break­through Des­ig­na­tion for Ale­cen­sa showed su­pe­ri­or ef­fi­ca­cy ver­sus the stan­dard of care, crizo­tinib (Xalko­ri), in Japan­ese peo­ple with ad­vanced ALK-pos­i­tive dis­ease. The de­ci­sion by the FDA to grant a sec­ond break­through ther­a­py des­ig­na­tion is recog­ni­tion of the clin­i­cal­ly mean­ing­ful im­prove­ment in ef­fi­ca­cy and safe­ty that Ale­cen­sa brings to the care of peo­ple with ad­vanced ALK-pos­i­tive lung can­cer who have not re­ceived pri­or treat­ment with an ALK in­hibitor.”

A cou­ple of weeks ago No­var­tis out­lined plans to hus­tle to reg­u­la­tors with new late-stage da­ta on their can­cer drug Zyka­dia (cer­tinib), look­ing for an ap­proval to move up to first-line treat­ment of ALK-pos­i­tive non-small cell lung can­cer. In­ves­ti­ga­tors say the drug out­per­formed stan­dard chemo in pre­vi­ous­ly un­treat­ed pa­tients for pro­gres­sion-free sur­vival. There were al­so “clin­i­cal­ly mean­ing­ful” im­prove­ments in the over­all re­sponse rate and du­ra­tion of re­sponse, though that will need to be clar­i­fied when the da­ta is re­leased.

No­var­tis is look­ing to con­sid­er­ably en­hance its mar­ket for this drug, giv­en an ac­cel­er­at­ed ap­proval two years ago as a  sec­ond-line ther­a­py.

Late last year the FDA hand­ed out an ac­cel­er­at­ed first ap­proval to use Ale­cen­sa for pa­tients who had seen their dis­ease progress while on Xalko­ri.

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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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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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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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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