Iterum says FDA is in 'gen­er­al align­men­t' on pro­posed new PhI­II for re­ject­ed uU­TI drug

Iterum Ther­a­peu­tics is paint­ing a rosier pic­ture of its once-re­ject­ed an­tibi­ot­ic af­ter meet­ing with the FDA last week.

The agency was in “gen­er­al align­ment” with the Dublin and Chica­go-based biotech af­ter dis­cussing a pro­posed ad­di­tion­al Phase III clin­i­cal study of su­lopen­em for un­com­pli­cat­ed uri­nary tract in­fec­tions, or uU­TI, Iterum said Wednes­day.

Next up is an agree­ment re­quest with the reg­u­la­tor for a spe­cial pro­to­col as­sess­ment of the clin­i­cal tri­al, which will be a non-in­fe­ri­or­i­ty study com­par­ing Iterum’s oral drug to amox­i­cillin clavu­lanate, an an­tibi­ot­ic once in­volved in a le­gal dis­pute be­tween Glax­o­SmithK­line and No­var­tis over gener­ics pro­duc­tion, in adult women.

Iterum ex­pects to re­quest the agree­ment in the “com­ing weeks.” Up­on fi­nal­iza­tion, the biotech aims to kick off pa­tient en­roll­ment in the sec­ond half of this year.

The biotech, found­ed in 2015 and which de­buted on Nas­daq in May 2018, suf­fered a blow to its R&D ef­forts last Ju­ly when the FDA hand­ed down a re­jec­tion of the drug. The com­plete re­sponse let­ter added to the del­uge of dif­fi­cul­ties drag­ging down the an­tibi­otics field. A lack of clin­i­cal da­ta was the agency’s core rea­son­ing, Iterum said at the time.

Iterum was born out of an ac­qui­si­tion of the for­mer Pfiz­er an­tibi­ot­ic. With about $100 mil­lion in the cof­fers around the time of the CRL, Iterum faced a daunt­ing mid-2023 run­way.

Corey Fish­man

As of the lat­est pub­licly dis­closed tal­ly, Iterum had $81.3 mil­lion in cash, cash equiv­a­lents and short-term in­vest­ments. That’s enough to keep the lights on in­to 2024, the biotech said in late March. On March 9, the com­pa­ny re­ceived a 180-day ex­ten­sion of its Nas­daq list­ing de­fi­cien­cy, giv­ing Iterum un­til Sept. 5 to meet the min­i­mum bid price re­quire­ment.

Iterum’s shares $ITRM were down about 6%, at less than one quar­ter apiece, be­fore Wednes­day’s open­ing bell.

Ex­ec­u­tives said on a March in­vestor call that the com­pa­ny had suf­fi­cient cash to fund Iterum in­to 2024 and a “pret­ty good chance to fin­ish that study out,” re­fer­ring to the po­ten­tial new Phase III. CEO Corey Fish­man de­clined to project cost and tim­ing of the study when asked by an an­a­lyst, cit­ing on­go­ing dis­cus­sions with the FDA and a yet-to-be-fi­nal­ized tri­al de­sign.

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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