Nar­can mak­er Opi­ant shelves bu­lim­ia pro­gram af­ter mid-stage flop

Nar­can mak­er Opi­ant Phar­ma­ceu­ti­cals has ad­mit­ted de­feat in a mid-stage tri­al test­ing a nasal spray ver­sion of nalox­one in pa­tients with bu­lim­ia, prompt­ing the Cal­i­for­nia-based com­pa­ny to aban­don the de­vel­op­ment of the for­mu­la­tion al­to­geth­er.

The Phase II tri­al test­ed the drug — OP­NT001 — against a place­bo in 86 pa­tients with bu­lim­ia. The po­ten­tial­ly life-threat­en­ing, ad­dic­tive eat­ing dis­or­der is typ­i­cal­ly seen in women, and is char­ac­ter­ized by a cy­cle of bing­ing and com­pen­sato­ry be­hav­iors such as self-in­duced vom­it­ing, fast­ing, ex­ces­sive ex­er­cise or mis­us­ing lax­a­tives to make up for the glut­tony. Cog­ni­tive be­hav­ioral ther­a­py is con­sid­ered the pri­ma­ry treat­ment for bu­lim­ia, ac­cord­ing to the British Med­ical Jour­nal.

The main goal of the study — to re­duce the num­ber of binge-eat­ing days by week 8 — was not met; nor were any sec­ondary end­points, Opi­ant dis­closed on Thurs­day, with­out pro­vid­ing any de­tails.

Es­ti­mates from the non-prof­it Na­tion­al As­so­ci­a­tion of Anorex­ia Ner­vosa and As­so­ci­at­ed Dis­or­ders sug­gest that 1.5% of Amer­i­can women suf­fer from bu­lim­ia in their life­time.

Roger Cyrstal

CEO Roger Crys­tal said the com­pa­ny has elect­ed to shelve the pro­gram to fo­cus its re­sources on its oth­er drugs in de­vel­op­ment: con­duct­ing a piv­otal tri­al for OP­NT003, a nasal ver­sion of nalme­fene for opi­oid over­dose; en­rolling pa­tients in­to a Phase II study for OP­NT002, nasal nal­trex­one, for use in al­co­hol use dis­or­der; and pro­gress­ing the de­vel­op­ment of OP­NT004 — which Opi­ant in-li­censed from Sanofi $SNY late last year — for acute cannabi­noid over­dose.

Amidst the rag­ing abuse, mis­use and over­dose of opi­oids in the Unit­ed States, Opi­ant’s $OP­NT Nar­can — a nasal ver­sion of nalox­one wide­ly used by first re­spon­ders, po­lice of­fi­cers and emer­gency med­ical tech­ni­cians for sus­pect­ed or emer­gency opi­oid over­dose — is sold by part­ner Adapt Phar­ma, a unit of Emer­gent BioSo­lu­tions $EBS. Two dos­es of the treat­ment, now avail­able over-the-counter, are ap­proved by the FDA for com­mu­ni­ty use, which in ef­fect means an in­di­vid­ual does not have to be med­ical­ly trained to use it.

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.

Chris Sheldon, AstraZeneca's former VP and head of investor relations

As­traZeneca files law­suit against for­mer ex­ec as he jumps to GSK

AstraZeneca and GSK are once again wrangling over talent.

The British pharma giant has filed suit against former VP and head of investor relations Chris Sheldon as he prepares to start a new job at its rival next month. AstraZeneca argued in a London court filing that Sheldon would be violating a non-compete agreement, which he was paid more than $774,000 in shares to sign back in 2021, Bloomberg reported.

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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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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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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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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