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.

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.

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.

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.