News brief­ing: Ve­rastem CMO ex­its two weeks af­ter join­ing com­pa­ny; Ther­mo Fish­er inks $550M M&A deal

Two weeks af­ter join­ing Ve­rastem On­col­o­gy as chief med­ical of­fi­cer, Frank Neu­mann is leav­ing the com­pa­ny for an­oth­er job.

Neu­mann had joined Ve­rastem af­ter leav­ing blue­bird bio, which sur­pris­ing­ly split in­to two com­pa­nies last week, one in on­col­o­gy and one in rare dis­eases. It’s not yet clear to where Neu­mann is head­ed next, but he not­ed in a state­ment that Ve­rastem’s da­ta and strat­e­gy were “tru­ly ex­cit­ing.”

“This de­ci­sion to leave is dif­fi­cult and based sole­ly on con­tin­u­ing my work in cell ther­a­py,” Neu­mann said. “I am con­fi­dent that Ve­rastem will con­tin­ue to make a pos­i­tive im­pact on pa­tients’ lives.”

Be­fore his tenure at blue­bird, Neu­mann de­vot­ed five years to Take­da, lead­ing clin­i­cal de­vel­op­ment across their cell ther­a­py spec­trum in his fi­nal year there. He was Take­da’s glob­al clin­i­cal lead for pona­tinib and med­ical team lead for ix­a­zomib. — Max Gel­man

Ther­mo Fish­er inks $550M M&A deal for rapid test­ing com­pa­ny

Ther­mo Fish­er is shelling out $450 mil­lion in cash and promis­ing $100 mil­lion in mile­stones to snap up Mesa Biotech, a di­ag­nos­tics out­fit that makes rapid tests for in­fec­tious dis­eases — in­clud­ing Covid-19.

Mesa was one of the first com­pa­nies to roll out a quick test for SARS-CoV-2.

Mark Steven­son, ex­ec­u­tive VP and COO of Ther­mo Fish­er Sci­en­tif­ic, had this to say in a pre­pared state­ment:

”The ad­di­tion of Mesa Biotech’s easy-to-use, rapid PCR-based test is high­ly com­ple­men­tary to our ex­ist­ing of­fer­ing and will fur­ther help us meet the con­tin­u­ing de­mand for COVID-re­lat­ed test­ing while we work to rapid­ly scale and de­vel­op point-of care tests for oth­er in­fec­tious dis­eases in the fu­ture.” — John Car­roll

SCO­TUS de­clines to take up Mer­ck patent ap­peal for so­fos­bu­vir

Mer­ck’s fi­nal hope to re­vive a mas­sive dam­ages award has been quashed.

The Big Phar­ma had sought in­ter­ven­tion from the US Supreme Court to re­store a de­ci­sion that would have grant­ed the com­pa­ny more than $2.5 bil­lion in dam­ages re­lat­ed to a patent fight with Gilead. But the jus­tices de­clined to take up the case, leav­ing the low­er court’s rul­ing in place and Mer­ck with­out fur­ther re­course.

Tues­day’s de­ci­sion stems from a bat­tle over Gilead’s so­fos­bu­vir, which Mer­ck had claimed in­fringed on a patent held by Mer­ck sub­sidiary Idenix Phar­ma­ceu­ti­cals. A fed­er­al court ruled in fa­vor of Mer­ck in 2016 and or­dered Gilead to pay $2.54 bil­lion in penal­ties.

But a fed­er­al judge threw out the ver­dict in 2018, de­ter­min­ing that the patent in ques­tion was in­valid. The US Court of Ap­peals for the Fed­er­al Cir­cuit up­held that rul­ing the next year, giv­ing Mer­ck one last chance to ap­peal to the Supreme Court. Their ef­forts came up short Tues­day.

So­fos­bu­vir, sold as So­val­di in the US, is used in com­bi­na­tion with rib­avirin ei­ther with or with­out in­jectable pegin­ter­fer­on al­fa to treat chron­ic he­pati­tis C in­fec­tion in pa­tients old­er than 3. — Max Gel­man

As­traZeneca, Dai­ichi’s En­her­tu earns EU nod for HER2-pos­i­tive breast can­cer

A day af­ter earn­ing the FDA’s trust for its ap­pli­ca­tion in stom­ach can­cer, As­traZeneca and Dai­ichi Sankyo’s an­ti­body-drug con­ju­gate En­her­tu has snared an EU nod for metasta­t­ic breast can­cer.

The tar­get­ed pop­u­la­tion has been di­ag­nosed with tu­mors that ex­press the HER2 gene, En­her­tu’s spe­cial­ty. The EMA based its re­view on da­ta from the piv­otal Phase II DES­TINY-Breast01 tri­al, in which En­her­tu post­ed an ob­jec­tive re­sponse rate of 61.4% at the 20.5-month fol­lowup mark, in­clud­ing a 6.5% com­plete re­sponse rate and a 54.9% par­tial re­sponse rate.

The drug al­so in­duced an es­ti­mat­ed me­di­an du­ra­tion of re­sponse of 20.8 months in pa­tients who had re­ceived at least two pre­vi­ous lines of ther­a­py.

Ear­li­er this week, En­her­tu scored an FDA nod in gas­tric can­cer to match its ear­li­er ap­proval in breast can­cer. That ap­proval made it the first ADC with the go-ahead to treat ad­vanced stom­ach can­cer, a dif­fi­cult-to-treat dis­ease with a poor prog­no­sis. — Kyle Blanken­ship

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.

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.

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.

Mesoblast gets a $110M life­line from Surg­Cen­ter De­vel­op­ment; uniQure still un­sure if gene ther­a­py spurred can­cer event

Mesoblast faced rough waters in 2020, but on Monday were thrown a financial lifeline.

The Australian stem cell therapy player has raised $110 million in a private placement, the company announced, offering 60 million shares to the US investor group SurgCenter Development. SurgCenter received the shares at a 6.5% discount from Mesoblast’s closing price on Feb. 25.

Mesoblast plans to use the funds to boost supply of its lead candidate remestemcel-L ahead of what they hope is a potential approval in pediatric GvHD when they return to the FDA, as well as advancing manufacturing and development of their rexlemestrocel-L platform for chronic heart failure and chronic low back pain.

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.

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.

Fi­bro­Gen shares skid low­er as a sur­prise ad­comm rais­es risks on roxa OK

FibroGen will likely have to delay its US rollout for roxadustat once again.

In an unexpected move, the FDA is convening its Cardiovascular and Renal Drugs Advisory Committee to review the NDA in an advisory committee meeting. The date is yet to be confirmed.

Just a few weeks ago, SVB Leerink analyst Geoffrey Porges predicted that the roxa approval could come ahead of the PDUFA date on March 20 — effusive despite already being let down once by the FDA’s extension of its review back in December. AstraZeneca, which is partnered with FibroGen on the chronic kidney disease-related anemia drug, disclosed regulators had requested further clarifying analyses of clinical data.