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.

Earlier this year, an executive from Juvenescence-backed AgeX predicted the field of longevity will eventually “dwarf the dotcom boom.” Greg Bailey, the UK-based anti-aging biotech’s CEO, certainly hopes so.

On Monday, Juvenescence completed its $100 million Series B round of financing. The company is backed by British billionaire Jim Mellon — who wrote his 400-page guide to investing in the field of longevity shortly after launching the company in 2017.  Bailey, who served as a board director for seven years at Medivation before Pfizer swallowed the biotech for $14 billion, is joined by Declan Doogan, an industry veteran with stints at Pfizer and Amarin.

Another big drug approval came through on Friday afternoon as the FDA OK’d AbbVie’s upadacitinib — an oral JAK1 inhibitor that is hitting the rheumatoid arthritis market with a black box warning of serious malignancies, infections and thrombosis reflecting fears associated with the class.

It will be sold as Rinvoq — at a wholesale price of $59,000 a year — and will likely soon face competition from a drug that AbbVie once controlled, and spurned. Reuters reports that a 4-week supply of Humira, by comparison, is $5,174, adding up to about $67,000 a year.

After a “hot” period of rapid growth between 2009 and 2012, and a relatively “cooler” period of slower growth from 2013 to 2015, China has once again become a top-of-mind priority for the CEOs of most large, multinational pharmaceutical companies.

At the International Pharma Forum, hosted in March in Beijing by the R&D Based Pharmaceutical Association Committee (RDPAC) and the Pharmaceutical Research and Manufacturers of America (PhRMA), no fewer than seven CEOs of major multinational pharmaceutical firms participated, including GSK, Eli Lilly, LEO Pharma, Merck KGaA, Pfizer, Sanofi and UCB. A few days earlier, the CEOs of several other large multinationals attended the China Development Forum, an annual business forum hosted by the research arm of China’s State Council. It’s hard to imagine any other country, except the US, having such drawing power at CEO level.