Deb­o­rah Dun­sire kicks off her new gig as Lund­beck CEO with a key PhI­II tri­al fail­ure

You have to feel al­most sor­ry for Deb­o­rah Dun­sire.

Deb­o­rah Dun­sire

No soon­er does the Mil­len­ni­um vet take the helm of Lund­beck af­ter back-to-back biotechs col­lapse on her watch than the com­pa­ny’s schiz­o­phre­nia drug can­di­date fails a Phase III study, tor­pe­do­ing the stock as shares plunge 30%.

Lu AF35700 failed to mea­sure up against con­ven­tion­al ther­a­py in its first Phase III study, like­ly elim­i­nat­ing any po­ten­tial up­side as far as reg­u­la­tors might be con­cerned. In­ves­ti­ga­tors test­ed the drug on 964 treat­ment-re­sis­tant pa­tients treat­ed over 10 weeks.

The com­pa­ny’s re­searchers based the drug de­sign on its pref­er­ence for the hu­man dopamine D1 re­cep­tor as op­posed to the dopamine D2 re­cep­tor, which they thought would give it an ad­van­tage on ef­fi­ca­cy as well as tol­er­a­bil­i­ty.

We don’t know what the hard da­ta are, but the com­pa­ny says it con­tin­ues to study the re­sults. Jef­feries had as­signed a po­ten­tial block­buster sta­tus for the drug, with peak sales pro­ject­ed at $1.2 bil­lion.

This is the com­pa­ny’s lead late-stage com­pound, shar­ing the Phase III col­umn with the Alzheimer’s drug br­ex­pipra­zole, dis­cov­ered at Ot­su­ka.

In May of last year, sev­en months af­ter Lund­beck and Ot­su­ka re­port­ed a Phase III flop for their Alzheimer’s drug idalopir­dine, the part­ners re­port­ed a hit-and-miss score on eas­ing Alzheimer’s ag­i­ta­tion for Rex­ul­ti (br­ex­pipra­zole).

Al­ready ap­proved for schiz­o­phre­nia and ma­jor de­pres­sion, the col­lab­o­ra­tors were look­ing for the first ap­proval of an an­tipsy­chot­ic specif­i­cal­ly for ag­i­ta­tion trig­gered by Alzheimer’s de­men­tia, a con­di­tion that af­flicts mil­lions of peo­ple in the US and mil­lions more world­wide. Ag­i­ta­tion can be ex­pressed in many ways, run­ning from wan­der­ing to ag­gres­sive be­hav­ior.

Now there’s a much big­ger set­back to deal with.

“This is a set­back for pa­tients with schiz­o­phre­nia, but we will con­tin­ue to ad­vance our pipeline of in­no­v­a­tive ther­a­pies to meet the needs of pa­tients suf­fer­ing from psy­chi­atric and neu­ro­log­i­cal dis­eases,” says An­ders Gersel Ped­er­sen, the head of R&D at the Dan­ish com­pa­ny.

Andre Kalil, AP Images

A 9/11-era Om­a­ha fa­cil­i­ty, an old Ebo­la drug, and the ubiq­ui­tous Dr. Fau­ci: In­side the first US nov­el coro­n­avirus tri­al

The first 11 coronavirus patients who arrived in Omaha last week, airlifted across the globe after two weeks quarantined on a cruise ship, showed only minor symptoms or none at all. And then one of them — or one of the couple of Americans who arrived later — got worse. He developed pneumonia, a life-threatening complication for coronavirus patients.

In a biocontainment room at the University of Nebraska Medical Center on Friday, doctors infused him with an experimental Gilead drug once developed for Ebola, called remdesivir. Or they gave him a placebo. For the first time in the US, neither he nor the doctors knew.

The first US novel coronavirus trial was underway and with it, a mad dash for an answer. Sponsored by the NIH, the study marked a critical point in the epidemic. Since the start of the outbreak, the agency had helped lead a global effort to contain the virus. Now, as it spread worldwide and the CDC issued warnings the US could see a major internal outbreak, they were looking at home.

“We don’t have too much time,” Andre Kalil, the trial’s lead investigator, told Endpoints News. “Everything’s moving really fast.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 73,300+ biopharma pros reading Endpoints daily — and it's free.

Grow­ing ac­cep­tance of ac­cel­er­at­ed path­ways for nov­el treat­ments: but does reg­u­la­to­ry ap­proval lead to com­mer­cial suc­cess?

By Mwango Kashoki, MD, MPH, Vice President-Technical, and Richard Macaulay, Senior Director, of Parexel Regulatory & Access

In recent years, we’ve seen a significant uptake in the use of regulatory options by companies looking to accelerate the journey of life-saving drugs to market. In 2018, 73% of the novel drugs approved by the U.S. Federal Drug Administration (FDA) were designated under one or more expedited development program categories (Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval).ᶦ

Brian Stuglik (file photo)

Turn­ing fo­cus to clin­i­cal work, Ve­rastem ax­es 31 jobs, scales back can­cer drug pro­mo­tion af­ter dis­ap­point­ing sales

Months after taking the helm at Verastem Oncology, Brian Stuglik has a plan to take the biotech in a “new strategic direction” — but not before some layoffs.

Left out of an upbeat press release spelling out its clinical plans, and buried below news of a $100 million private placement in an SEC filing, is a planned restructuring that will claim 31 jobs. Alongside some other cost-saving measures, Verastem expects to cut expenses down by $70 million to $80 million per year.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 73,300+ biopharma pros reading Endpoints daily — and it's free.

Olivier Brandicourt (AP Images)

Ex-Sanofi chief Olivi­er Brandi­court, cur­rent Black­stone ad­vi­sor, jumps on Al­ny­lam board

Former Sanofi chief Olivier Brandicourt, who departed his post with an unexpected early retirement last year, has made his move — as most C-suite executives inevitably do — to become a director on the board of a biopharma company.

RNAi player Alnylam is Brandicourt’s destination. Meanwhile, the Cambridge, Massachusetts-based drugmaker — which pioneered the first approval in the field — also disclosed the retirement of Alnylam co-founder Dr. Paul Schimmel from its board.

Sage con­firms sus­pen­sion of 2 de­pres­sion tri­als af­ter PhI­II flop; Es­pe­ri­on fol­lows up maid­en ap­proval with com­bo OK

→ In the wake of a flop in the crucial Phase III MOUNTAIN study, Sage Therapeutics confirmed in its quarterly update that it’s suspended enrollment in two other pivotal trials for the oral depression drug SAGE-217 (or zuranolone) as it awaits guidance from the FDA. While REDWOOD (measuring relapse) and RAINFOREST (for patients with both major depressive disorder and insomnia) are on hold pending amendments, though, the open-label SHORELINE has completed enrollment. CEO Jeff Jonas remained tight-lipped about what specific tweaks they are considering for the program, reiterating only there have been issues with compliance and room for a higher dose.

Dan O'Day (AP Images)

UP­DAT­ED: A name emerges out of the Gilead M&A ru­mor mill, and it’s a can­cer biotech

After months of questions and speculation about when and if Gilead will make a major acquisition, a name has emerged.

The California-based drugmaker has approached Forty Seven Inc, a cancer biotech, with a takeover offer, Bloomberg News reports. With Forty Seven’s market cap at $2.3 billion, an acquisition would likely be Gilead’s largest since they acquired Kite Pharma for $11.9 billion in 2017.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 73,300+ biopharma pros reading Endpoints daily — and it's free.

Biogen head of R&D Al Sandrock, Sangamo CEO Sandy Macrae

UP­DAT­ED: Bio­gen makes an­oth­er bold Alzheimer’s bet, drop­ping $350M up­front to part­ner with genome-edit­ing fo­cused Sang­amo

While the fate of Biogen’s resurrected Alzheimer’s drug aducanumab remains uncertain, the Cambridge, MA-based drugmaker is joining forces with genome editing company Sangamo Therapeutics to develop therapies for neurological conditions.

Sangamo is set to receive a meaty $350 million upfront in cash and stock and is eligible to receive up to $2.37 billion in milestone payments, in addition to royalties. In return, Biogen gets the rights to two Sangamo preclinical compounds: ST-501 (for use in tauopathies including Alzheimer’s disease) and ST-502 (for synucleinopathies including Parkinson’s disease).

“The partnership represents a lower-cost way to expand its work in neurologic disease,” Credit Suisse’s Evan Seigerman said in a note, referring to Biogen.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 73,300+ biopharma pros reading Endpoints daily — and it's free.

Take­da swoops in to buy lit­tle biotech part­ner and its celi­ac drug poised to 'change stan­dard of care'

Having spent three years carefully grooming PvP Biologics and its drug for celiac disease, Takeda is happy enough with the proof-of-concept data to buy it all.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 73,300+ biopharma pros reading Endpoints daily — and it's free.

Jim Wilson's gene ther­a­py start­up Pas­sage Bio bucks mar­ket sen­ti­ments, rais­ing up­sized $216M IPO

A coronavirus fear-induced bloodbath on the Nasdaq has not stopped Passage Bio from making a public debut — and an exuberant one.

By pricing an upsized offering at $18, the top of the range, the gene therapy biotech bagged $216 million from its IPO, 72% more than it’s originally penciled in.

The proceeds likely reflected confidence in Jim Wilson, who gathered all the tools he’s built over decades of gene therapy research to assemble the startup and teamed up with Frazier and OrbiMed to hone its focus on rare, monogenic disorders of the central nervous system. Just before the IPO, Deerfield partner Bruce Goldsmith took over from OrbiMed’s Stephen Squinto as CEO.