In an­oth­er set­back for the be­lea­guered an­tibi­otics field, Nabri­va Ther­a­peu­tics says the FDA re­ject­ed its fos­fomycin for com­pli­cat­ed uri­nary tract in­fec­tions.

Ted Schroed­er

Im­por­tant­ly, the biotech says, reg­u­la­tors are not ask­ing for any new clin­i­cal or safe­ty da­ta. The com­plete re­sponse let­ter cen­ters around “is­sues re­lat­ed to fa­cil­i­ty in­spec­tions and man­u­fac­tur­ing de­fi­cien­cies at one of Nabri­va’s con­tract man­u­fac­tur­ers,” ac­cord­ing to a brief state­ment.

Over the next few weeks Nabri­va plans to re­quest a “Type A” meet­ing to dis­cuss the FDA’s find­ings. Shares $NR­BV are down 24% pre-mar­ket.

Across the in­dus­try, an­tibi­otics de­vel­op­ers and back­ers are suf­fer­ing from a new low in morale af­ter Achao­gen filed for bank­rupt­cy de­spite notch­ing an FDA ap­proval of its cU­TI drug, due to dis­ap­point­ing sales. And that fol­lows rounds of lay­offs at both Achao­gen and oth­er an­tibi­otics com­pa­nies like Melin­ta, with Big Phar­ma large­ly out of the pic­ture al­to­geth­er.

No­body would de­ny the ur­gent need for an­tibi­otics — just two days ago the UN is­sued an­oth­er re­port warn­ing of a “silent tsuna­mi” of an­timi­cro­bial re­sis­tance that threat­ens to kill 10 mil­lion peo­ple an­nu­al­ly by 2050 — but it’s in­creas­ing­ly hard to make a case for the R&D in­vest­ment when the prod­ucts are too niche to turn a prof­it in a world dom­i­nat­ed by gener­ics.

Nabri­va’s Con­tepo (IV fos­fomycin) is an old drug that’s been used out­side the US for over 45 years. Ac­cord­ing to the com­pa­ny, it can treat a num­ber of Gram-neg­a­tive and Gram-pos­i­tive bac­te­ria in­fec­tions, ac­tive against many com­mon mul­ti-drug re­sis­tant strains.

It bagged the drug via an ac­qui­si­tion of Za­vante, whose CEO Ted Schroed­er then took the helm of the new en­ti­ty. Nabri­va’s in-house lead pro­gram for com­mu­ni­ty-ac­quired bac­te­r­i­al pneu­mo­nia, lefa­mulin, is al­so un­der re­view with a PDU­FA date in Au­gust.

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

As the global biologics market is expected to hit nearly the half-trillion-dollar mark this year, new JAMA research points to the importance of timely biosimilar entry, particularly as fewer biosimilars are entering the US than in Europe, and as monthly treatment costs for biosimilars were “substantially higher” in the US compared with Germany and Switzerland.

Among the three countries, biosimilar market share at launch was highest in Germany, but increased at the fastest rate in the US, the authors from the University of Zurich’s Institute of Law wrote in JAMA Network Open today.

The European Medicines Agency said Friday that it’s pulling from all European markets pholcodine-containing medicines, which are an opioid used in adults and children for the treatment of dry cough and in combo with other drugs as a treatment for cold and flu.

The decision to pull the medicines comes as the EMA points to the results from the recent ALPHO study, which show that use of pholcodine during the 12 months preceding anesthesia is linked to a risk of an anaphylactic reaction related to the neuromuscular blocking agents (NMBAs) used (with an adjusted OR of 4.2, and a 95% confidence interval of 2.5 to 6.9).

The Houston-based biotech Salarius Pharmaceuticals is lifting the cover on data from a Phase I/II trial for a drug currently on voluntary hold after a patient death, and the results appear to have underwhelmed investors.

Salarius’ candidate, dubbed seclidemstat, is an oral LSD1 inhibitor that is meant to treat Ewing sarcoma and FET-rearranged sarcomas in patients under 12 years old. The biotech had presented data with 13 patients with “first- and second-relapse Ewing sarcoma” who were treated in combination with topotecan and cyclophosphamide.