Ei­sai scores an FDA ap­proval for a home­grown sleep drug

Ei­sai’s bet on a bet­ter in­som­nia drug, whose symp­toms af­fect up to a third of all adults, has been re­ward­ed by the FDA with an ap­proval. But with safe­ty be­ing a big is­sue for sleep drugs, the new ther­a­py faces an up­hill climb to gain ac­cep­tance with doc­tors and pa­tients.

Just ear­li­er this year, the FDA im­posed black box warn­ings on a clutch of in­som­nia drugs, such as Lunes­ta, Sonata, and Am­bi­en, due to re­ports of dan­ger­ous ac­tiv­i­ty such as sleep­walk­ing and sleep-dri­ving that have led to in­juries and deaths.

The new Ei­sai drug Dayvi­go (known chem­i­cal­ly as lem­borex­ant) was de­vel­oped in-house by the Japan­ese drug­mak­er. It works by in­hibit­ing orex­in sig­nal­ing by bind­ing com­pet­i­tive­ly to both orex­in re­cep­tor sub­types (orex­in re­cep­tors 1 and 2). Orex­ins are chem­i­cals in­volved in sleep and arousal nat­u­ral­ly pro­duced by the hy­po­thal­a­mus.

“There’s still un­met need (with­in in­som­nia) as it re­lates to both ef­fi­ca­cy and safe­ty,” Tushar Pa­tel, Ei­sai’s glob­al lead for sleep-wake dis­or­ders in the neu­rol­o­gy busi­ness group, not­ed in an in­ter­view with End­points News. “And we think in Dayvi­go we have a prod­uct that ad­dress­es both (sleep) on­set and main­te­nance, and does that in a way with­out im­pair­ing pos­tur­al sta­bil­i­ty and cog­ni­tion in the morn­ing.”

Dayvi­go was test­ed in two late-stage tri­als, with safe­ty da­ta over a 12 month pe­ri­od. Un­like many old­er in­som­nia drugs, the Ei­sai drug was not as­so­ci­at­ed with re­bound in­som­nia fol­low­ing treat­ment dis­con­tin­u­a­tion. It was al­so test­ed in a trio of safe­ty stud­ies eval­u­at­ing its im­pact on the abil­i­ty to awak­en to sound, next-day pos­tur­al sta­bil­i­ty or mem­o­ry, and next-morn­ing dri­ving im­pair­ment.

Al­though there were no ma­jor dif­fer­ences be­tween Dayvi­go and place­bo on abil­i­ty to awak­en to sound, there was a dose-de­pen­dent wors­en­ing on mea­sures of at­ten­tion and mem­o­ry for the drug ver­sus place­bo. In ad­di­tion, there were no mean­ing­ful dif­fer­ences be­tween the drug and place­bo on next-day pos­tur­al sta­bil­i­ty or mem­o­ry or sta­tis­ti­cal­ly sig­nif­i­cant im­pair­ment in next-morn­ing dri­ving per­for­mance.

In­som­nia suf­fer­ers have a menu of op­tions at their dis­pos­al. They can ac­cess over-the-counter an­ti­his­t­a­mines, ben­zo­di­azepines (such as Dal­mane, Ati­van), non­ben­zo­di­azepine re­cep­tor ag­o­nists (such as Lunes­ta, Am­bi­en), tri­cyclic an­ti­de­pres­sants (such as Silenor), and mela­tonin ag­o­nists (such as Roz­erem).

The most com­mon phar­ma­co­log­i­cal treat­ments are non­ben­zo­di­azepine re­cep­tor ag­o­nists, or Non­BzRAs, which are de­signed to cause sleepi­ness by en­hanc­ing GA­BA — a wide-reach­ing in­hibito­ry neu­ro­trans­mit­ter in the brain. But not all help pa­tients main­tain sleep through the night, and some have a pletho­ra of un­sa­vory side ef­fects in­clud­ing sleep­walk­ing, sleep eat­ing, a height­ened risk of falls and ve­hic­u­lar ac­ci­dents.

The first med­i­cine tar­get­ing orex­in, Mer­ck’s Bel­som­ra, was ap­proved in 2014. Since med­i­cines fo­cused on orex­in — a neu­ro­trans­mit­ter first dis­cov­ered in 1998 — tar­get a more lo­cal­ized area of the brain, the the­o­ry is that they will cause few­er side ef­fects. How­ev­er, Bel­som­ra does car­ry a risk of im­paired dri­ving skills and can en­hance the risk of falling asleep while dri­ving.

There are oth­er drug­mak­ers de­vel­op­ing orex­in med­i­cines for in­som­nia, in­clud­ing Idor­sia and Min­er­va. So what makes Dayvi­go spe­cial?

Ivan Che­ung

“Those oth­er com­pounds are in clin­i­cal de­vel­op­ment — they have shown some­thing, and haven’t shown every­thing,” Ivan Che­ung, chief of neu­rol­o­gy of Ei­sai US, em­pha­sized to End­points, re­fer­ring to sleep on­set, sleep main­te­nance, next morn­ing safe­ty mea­sure­ments, ef­fi­ca­cy over 6 months and safe­ty over 12 months.

“Of course, I’m al­ways about more treat­ment op­tions for more pa­tients,” he said. “All I can say is that it is not an easy task even if you think you have a great mech­a­nis­tic drug to check all those box­es, and I think we’ve checked off a lot of box­es.”

Che­ung did not of­fer any de­tail on the com­pa­ny’s pric­ing plans for the drug in in­som­nia.

Orex­in sig­nal­ing is im­pli­cat­ed in oth­er phys­i­o­log­i­cal func­tions such as mem­o­ry, emo­tions, mo­ti­va­tion, and at­ten­tion. There­fore, Ei­sai is al­so test­ing the drug for use in Alzheimer’s dis­ease, in ad­di­tion to ir­reg­u­lar sleep-wake rhythm dis­or­der. The drug was pre­vi­ous­ly be­ing joint­ly de­vel­oped with Pur­due, but Ei­sai bought back all the rights to it ear­li­er this year.

IDC: Life Sci­ences Firms Must Em­brace Dig­i­tal Trans­for­ma­tion Now

Pre-pandemic, the life sciences industry had settled into a pattern. The average drug took 12 years and $2.9 billion to bring to market, and it was an acceptable mode of operations, according to Nimita Limaye, Research Vice President for Life Sciences R&D Strategy and Technology at IDC.

COVID-19 changed that, and served as a proof-of-concept for how technology can truly help life sciences companies succeed and grow, Limaye said. She recently spoke about industry trends at Egnyte’s Life Sciences Summit 2022. You should watch the entire session, free and on-demand, but here’s a brief recap of why she’s urging life sciences companies to embrace digital transformation.

Tom Barnes, Orna Therapeutics CEO

UP­DAT­ED: 'We have failed to fail': Mer­ck gam­bles $250M cash on a next-gen ap­proach to mR­NA — af­ter punt­ing its big al­liance with Mod­er­na

Merck went in deep on its collaboration with Moderna on new mRNA programs, and dropped them all over time, including their RSV partnership. But after writing off what turned out as one of the most successful infectious disease players in the business, Merck is coming in this morning with a new preclinical alliance — this time embracing a biotech that hopes to eventually outdo the famously successful mRNA in a new run at vaccines and therapeutics.

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Bayer's first DTC ad campaign for chronic kidney disease drug Kerendia spells out its benefits

Bay­er aims to sim­pli­fy the com­plex­i­ties of CKD with an ABC-themed ad cam­paign

Do you know the ABCs of CKD in T2D? Bayer’s first ad campaign for Kerendia tackles the complexity of chronic kidney disease with a play on the acronym (CKD) and its connection to type 2 diabetes (T2D).

Kerendia was approved last year as the first and only non-steroidal mineralocorticoid receptor antagonist to treat CKD in people with type 2 diabetes.

In the TV commercial launched this week, A is for awareness, B is for belief and C is for cardiovascular, explained in the ad as awareness of the connection between type 2 and kidney disease, belief that something can be done about it, and cardiovascular events that may be reduced with treatment.

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James Mock, incoming CFO at Moderna

Mod­er­na taps new CFO from PerkinElmer af­ter for­mer one-day CFO oust­ed

When Moderna hired a new CFO last year,  it didn’t expect to see him gone after only one day. Today the biotech named his — likely much more vetted — replacement.

The mRNA company put out word early Wednesday that after the untimely departure of then brand-new CFO Jorge Gomez, it has now found a replacement in James Mock, the soon-to-be former CFO at diagnostics and analytics company PerkinElmer.

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Kate Haviland, Blueprint Medicines CEO

Blue­print met all its end­points in bid for ex­pand­ed Ay­vak­it la­bel — but stock trends low­er any­way

Blueprint Medicines announced this morning that the second part of its study on Ayvakit in non-advanced systemic mastocytosis (SM) — a rare disease in which a type of white blood cells known as mast cells builds up — met all endpoints, but the biopharma left key questions unanswered.

In 212 patients, with 141 in the treatment arm and 71 in the control arm, patients who got Ayvakit saw an average 15.6-point decrease in their symptom scores compared to a 9.2-point decrease in the placebo arm at 24 weeks. In an extension study, those on Ayvakit saw their symptom scores drop by 20.2 points by week 48.

Paul Hudson, Sanofi CEO (Eric Piermont/AFP via Getty Images)

Up­dat­ed: Hit by an­oth­er PhI­II flop, Sanofi culls breast can­cer drug — sound­ing alarm for the class

Sanofi is officially giving up on its oral SERD.

The French drugmaker put out word Wednesday morning that it will discontinue the global development program of amcenestrant, the selective estrogen receptor degrader once billed as a top late-stage prospect. Having already failed a Phase II monotherapy test earlier this year, a combo with the drug also missed the bar in a second trial for breast cancer, triggering the decision to drop the whole program.

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Etleva Kadilli, director of UNICEF’s supply division

GSK lands first-ever UNICEF con­tract for malar­ia vac­cine worth $170M

GSK has landed a new first from UNICEF the first-ever contract for malaria vaccines, worth up to $170 million for 18 million vaccine doses distributed over the next three years.

The vaccine, known as Mosquirix or RTS,S, won WHO’s backing last October after a controversial start, but UNICEF said these doses will potentially save thousands of lives every year.

“We hope this is just the beginning,” Etleva Kadilli, director of UNICEF’s supply division, said. “Continued innovation is needed to develop new and next-generation vaccines to increase available supply, and enable a healthier vaccine market. This is a giant step forward in our collective efforts to save children’s lives and reduce the burden of malaria as part of wider malaria prevention and control programmes.”

Joe Jonas (Photo by Anthony Behar/Sipa USA)(Sipa via AP Images)

So­lo Jonas broth­er car­ries Merz's new tune in Botox ri­val cam­paign

As the lyrics of his band’s 2019 pop-rock single suggest, Joe Jonas is only human — and that means even he gets frown lines. The 33-year-old singer-songwriter is Merz’s newest celebrity brand partner for its Botox rival Xeomin, as medical aesthetics brands target a younger audience.

Merz kicked off its “Beauty on Your Terms” campaign on Tuesday, featuring the Jonas brother in a video ad for its double-filtered anti-wrinkle injection Xeomin.

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Paul Perreault, CSL Behring CEO

CSL CEO Paul Per­reault de­ter­mined to grow plas­ma col­lec­tion af­ter full-year sales dip

As the ink dries on CSL’s $11.7 billion Vifor buyout, the company posted a dip in profits, due in part to a drop in plasma donations amid the pandemic.

However, CEO Paul Perreault assured investors and analysts on the full-year call that the team has left “no stone unturned” when assessing options to grow plasma volumes. The chief executive also spelled out positive results for the company’s monoclonal antibody garadacimab in hereditary angioedema (HAE), though he isn’t revealing the exact numbers just yet.