Eli Lil­ly wins a quick OK for new sar­co­ma drug olara­tum­ab

Richard Paz­dur, FDA

Eli Lil­ly has won an ac­cel­er­at­ed FDA ap­proval of its soft tis­sue sar­co­ma drug olara­tum­ab with set of pos­i­tive re­sults from a small mid-stage study. Lil­ly plans to sell the drug as Lartru­vo to a slice of pa­tients for front­line use  — the first such ap­proval to come along in decades for this dis­ease.

The drug tar­gets PDGF re­cep­tors which cause tu­mor growth.

The agency’s green light comes just a month af­ter the EU’s CHMP of­fered a pos­i­tive opin­ion about a sim­i­lar move in Eu­rope, set­ting up a like­ly transAt­lantic sweep for Lil­ly, which has been pour­ing re­sources in­to its on­col­o­gy pipeline in re­cent years.

The FDA ap­proved the drug, on­ly its 18th OK so far this year, in com­bi­na­tion with dox­oru­bicin among pa­tients who can’t be treat­ed by ra­di­a­tion or surgery and in a group with a type of STS that can be treat­ed with the chemo an­thra­cy­cline.

“For these pa­tients, Lartru­vo, added to dox­oru­bicin, pro­vides a new treat­ment op­tion,” said Richard Paz­dur, MD, di­rec­tor of the Of­fice of Hema­tol­ogy and On­col­o­gy Prod­ucts in the FDA’s Cen­ter for Drug Eval­u­a­tion and Re­search and act­ing di­rec­tor of the FDA’s On­col­o­gy Cen­ter of Ex­cel­lence. “This is the first new ther­a­py ap­proved by the FDA for the ini­tial treat­ment of soft tis­sue sar­co­ma since dox­oru­bicin’s ap­proval more than 40 years ago.”

Lil­ly, which has be­gun to rack up a few new drug ap­provals af­ter a long drought in the clin­ic, was able to present stats show­ing that the me­di­an sur­vival rate for pa­tients hit 26.5 months for the com­bo com­pared to 14.7 months for pa­tients who re­ceived dox­oru­bicin alone. In­ves­ti­ga­tors al­so post­ed a me­di­an pro­gres­sion-free sur­vival time of 8.2 months for the com­bo com­pared to 4.4 months for pa­tients who re­ceived on­ly dox­oru­bicin. Tu­mor shrink­age reg­is­tered at 18.2 per­cent against 7.5 per­cent.

This OK marks an­oth­er im­por­tant step for­ward for Lil­ly, which had been a peren­ni­al lag­gard in R&D. Lat­er this year Lil­ly will fol­low up with its lat­est round of Phase III da­ta for solanezum­ab, its big ex­per­i­men­tal ther­a­py for Alzheimer’s. Most an­a­lysts ex­pect mixed da­ta at best as Lil­ly looks to break the lock on new Alzheimer’s meds af­ter a decade-long run of fail­ures.

Back in March Lil­ly won an ap­proval for the pso­ri­a­sis drug Taltz (ix­ek­izum­ab) and still faces a de­ci­sion on baric­i­tinib for rheuma­toid arthri­tis as well as the CDK 4/6 drug abe­maci­clib, now sched­uled to wrap a Phase III next year as Lil­ly is forced to wait for the full da­ta set.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,300+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,300+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,300+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,300+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,300+ biopharma pros reading Endpoints daily — and it's free.