Achao­gen has just about wrapped up its go­ing-out-of-busi­ness sale, with a small group of buy­ers from around the globe pick­ing up its main an­tibi­ot­ic as­sets for a song. And they’re just one short tele­phone auc­tion away from sell­ing their last re­main­ing clin­i­cal pro­gram.

Bank­rupt and run­ning out of cash $AKAO af­ter go­ing $186 mil­lion in the red last year, the biotech has now sold off the glob­al rights to Zem­dri (pla­zomicin for mul­tidrug-re­sis­tant, gram-neg­a­tive pathogens) along with its lab equip­ment for just $16 mil­lion. Her­itage Glob­al Part­ners got the lab equip­ment. Cipla USA got all glob­al rights to Zem­dri out­side of Chi­na, while QiLu An­tibi­otics Phar­ma­ceu­ti­cal bagged the roy­al­ty-free Chi­na rights. 

This is an an­tibi­ot­ic that Leerink once con­fi­dent­ly pre­dict­ed would reap $500 mil­lion a year in peak sales. In the heady days of spring, 2017, its stock reached a peak price of $27 a share. It’s vir­tu­al­ly worth­less now. The dra­mat­ic fall from mar­ket grace came as the FDA re­ject­ed the biotech’s pitch to use their an­tibi­ot­ic against blood­stream in­fec­tions, lim­it­ing the OK to drug-re­sis­tant uri­nary tract in­fec­tions while adding a black box warn­ing on safe­ty.

Once on the mar­ket, the an­a­lysts found that hos­pi­tals al­ready had a fa­vorite brand to turn to, and lit­tle Achao­gen made lit­tle head­way on its own. In founder­ing, the biotech of­fered one of the more re­cent cau­tion­ary ex­am­ples of the haz­ards of an­tibi­ot­ic de­vel­op­ment. In a field dom­i­nat­ed by gener­ics, star­tups are find­ing their way blocked by es­tab­lished prod­ucts, with lit­tle prospect for a turn­around, even though the threat of drug-re­sis­tant bac­te­ria grows with every pass­ing year.

In­vestors have not ig­nored the im­pli­ca­tions for the rest of the tiny op­er­a­tors in the field, as most of Big Phar­ma shuns the space.

Any­one in­ter­est­ed in buy­ing Achao­gen’s last as­set — the C-Scape pro­gram — can di­al in for their last sale on Mon­day, June 10.

Their last 10-K notes that C-Scape is be­ing de­vel­oped for “cU­TI, in­clud­ing pyelonephri­tis, caused by ES­BL-pro­duc­ing En­ter­obac­te­ri­aceae. C-Scape is a b-lac­tam/b-lac­ta­mase in­hibitor com­bi­na­tion com­prised of ceftibuten, an ap­proved third gen­er­a­tion cephalosporin, and clavu­lanate, an ap­proved b-lac­ta­mase in­hibitor. The FDA award­ed Qual­i­fied In­fec­tious Dis­ease Prod­uct (QIDP) sta­tus to C-Scape for the treat­ment of cU­TI in 2017. QIDP sta­tus pro­vides in­cen­tives for the de­vel­op­ment of new an­tibi­otics, in­clud­ing pri­or­i­ty re­view and an ex­ten­sion by an ad­di­tion­al five years of any ex­ist­ing non-patent mar­ket ex­clu­siv­i­ty the prod­uct may be award­ed up­on ap­proval. Our C-Scape pro­gram is fund­ed in part by a con­tract with BAR­DA for up to $18.0 mil­lion, of which $12.0 mil­lion is com­mit­ted.”

What’s it worth on the mar­ket?

Im­age: Shut­ter­stock

Celyad’s view on developing and delivering a CAR T-cell therapy with multi-tumor specificity combined with cell manufacturing success
Overview
Transitioning potential therapeutic assets from academia into the commercial environment is an exercise that is largely underappreciated by stakeholders, except for drug developers themselves. The promise of preclinical or early clinical results drives enthusiasm, but the pragmatic delivery of a therapy outside of small, local testing is most often a major challenge for drug developers especially, including among other things, the manufacturing challenges that surround the production of just-in-time and personalized autologous cell therapy products.

As J&J attempts to jostle past Bristol-Myers Squibb and bluebird for a landmark approval of its anti-BCMA CAR-T — and while GlaxoSmithKline maps a quick path to the FDA riding on its own BCMA-targeting antibody-drug conjugates — the bispecifics are arriving on the scene to stake a claim for a market that could cross $10 billion per year.

The main rivalry in multiple myeloma is shaping up to be one between Regeneron and Bristol-Myers, which picked up a bispecific antibody to BCMA through its recently closed $74 billion takeover of Celgene. Both presented promising first-in-human data at the ASH 2019 meeting.

It’s been a difficult few years for gene and cell therapy startup Abeona Therapeutics. Its newly crowned chief Carsten Thiel was forced out last year following accusations of unspecified “personal misconduct,” and this September, the FDA imposed a clinical hold on its therapy for a form of “butterfly” disease. But things are beginning to perk up. On Monday, the company said the regulator had lifted its hold and the experimental therapy is now set to be evaluated in a late-stage study.