Can strug­gling Iterum turn the cor­ner to an an­tibi­ot­ic suc­cess sto­ry? They will know in six months

More than five years af­ter Corey Fish­man and Michael Dunne dust­ed su­lopen­em off Pfiz­er’s shelves — the sec­ond castoff an­tibi­ot­ic they’ve brought out of the phar­ma gi­ant — and found­ed Iterum Ther­a­peu­tics around that sin­gle drug, they have lined up a quick shot at ap­proval with pri­or­i­ty re­view from the FDA.

The de­ci­sion, six months from now, will mark a make-or-break mo­ment for a strug­gling biotech that has just enough cash to keep the lights on un­til the third quar­ter.

Corey Fish­man

Reg­u­la­tors will be look­ing at the oral for­mu­la­tion of su­lopen­em as a treat­ment of un­com­pli­cat­ed uri­nary tract in­fec­tions (uU­TI), specif­i­cal­ly in pa­tients with a quinolone non-sus­cep­ti­ble pathogen.

The in­di­ca­tion was the on­ly one, out of three, that had yield­ed pos­i­tive re­sults in piv­otal tri­als. The drug had hit the pri­ma­ry end­point for the pop­u­la­tion with base­line pathogens re­sis­tant to quinolones but not the one on the pa­tients with or­gan­isms sus­cep­ti­ble to quinolones — still enough to pro­vide a po­ten­tial path to mar­ket, the com­pa­ny had re­port­ed in June.

“We es­ti­mate that there are over 6 mil­lion quinolone-re­sis­tant uri­nary tract in­fec­tions an­nu­al­ly in the U.S., many of which are al­so mul­ti-drug re­sis­tant, and su­lopen­em has demon­strat­ed su­pe­ri­or­i­ty ver­sus ciprofloxacin in treat­ing these in­fec­tions,” Fish­man, the CEO, not­ed.

In oth­er stud­ies, though, su­lopen­em didn’t look as promis­ing.

A reg­i­men of the in­tra­venous for­mu­la­tion fol­lowed by tablets failed to prove non-in­fe­ri­or to oth­er es­tab­lished an­tibi­otics in com­pli­cat­ed in­tra-ab­dom­i­nal in­fec­tions (cIAI) or com­pli­cat­ed uri­nary tract in­fec­tion (cU­TI). Even though Dunne, the for­mer CSO and cur­rent strat­e­gy ad­vi­sor, sug­gest­ed there were sil­ver lin­ings if you fo­cus on pa­tients with mul­tidrug-re­sis­tant pathogens, an­a­lysts saw slim chances of ap­proval based on the avail­able da­ta. Iterum’s web­site sug­gests the pro­grams are still un­der de­vel­op­ment.

Michael Dunne

With on­ly $8.7 mil­lion re­main­ing in the banks as of Sept. 30, the com­pa­ny sore­ly needs the ap­proval in uU­TI to push the drug any fur­ther — even though in a com­mer­cial en­vi­ron­ment as un­for­giv­ing as the an­tibi­otics space, there will be no guar­an­tee of suc­cess.

By putting the oral pro­drug for­ward first, Iterum will be try­ing to skirt the tricky hos­pi­tal re­im­burse­ment and go­ing straight for the out­pa­tient set­ting.

Or it could be test­ing the wa­ters for Big Phar­ma M&A. Fish­man and Dunne, af­ter all, had been known for their work at Du­ra­ta flip­ping dal­ba­vancin, which they then sold to Ac­tavis for $675 mil­lion. The acute bac­te­r­i­al skin and skin struc­ture in­fec­tion treat­ment is now in the port­fo­lio of Ab­b­Vie by way of its Al­ler­gan buy­out.

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.

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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.

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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.

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.

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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: Feds clear the road for J&J to start de­liv­er­ing mil­lions of dos­es of their Covid-19 vac­cine — but frets linger about run­ner-up sta­tus

All the pieces needed to trigger a third wave of Covid-19 vaccine supply to start washing over the US fell neatly into place over the weekend.

After providing for a brief mime of regulatory judiciousness, the FDA stamped their emergency approval on J&J’s Covid-19 vaccine Saturday, adding to the Biden administration’s plan aimed at ending the pandemic in the near term — at least in the US. The CDC came through on Sunday with its stamp of approval and J&J is reportedly expected to start delivering vaccine sometime in the next few days.

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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.

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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.

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