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

The breakthrough therapy designation Pfizer and Merck KGaA notched for Bavencio in bladder cancer has quickly paved way for a full approval.

The PD-L1 drug is now sanctioned as a first-line maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma, applicable in cases where cancer hasn’t progressed after platinum-containing chemotherapy.

Petros Grivas, the principal investigator of the supporting Phase III JAVELIN Bladder 100, called the approval “one of the most significant advances in the treatment paradigm in this setting in 30 years.”

Merck has notched an approval for using Keytruda to treat a biomarker-based subset of first-line colorectal cancer patients with unresectable or metastatic tumors, as the pharma giant continues to find new niches for its blockbuster PD-1 star.

The OK is significant in a number of ways. Not only does it build on an accelerated approval for all tumors characterized as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR); it also marks the first single treatment for colorectal cancer that doesn’t contain chemotherapy.

Novartis has reached another large settlement to resolve misconduct allegations, agreeing to pay more than $678 million to settle claims that it had spent hundreds of millions of dollars on lavish dinners, so-called speaking fees and expensive alcohol “that were nothing more than bribes” to get doctors to prescribe Novartis medications.

The top-shelf alcohol and lavish meals included a $3,250 per person night at Nobu in Dallas, a $672-per person dinner at Washington DC’s Smith & Wollensky and a $314 per person meal at Sushi Roku in Pasadena, according to the Justice Department complaint. There were at least 7 trips to Hooters and fishing trips in Alaska and off the Florida coast. Each of these events were supposed to be “speaker programs” where doctors educated other doctors on a drug, but the DOJ alleged many were “bogus” wine-and-dine events where the drug was barely mentioned, if at all.  (“Nobody presented slides on the fishing trips,” the complaint says.)

A new court ruling has strengthened Amgen’s grip on the IP estate around Enbrel, keeping biosimilars of the autoimmune and inflammatory drug at bay until 2029.

Novartis, the patent challenger, isn’t throwing in the towel yet. In a statement noting the failed appeal, its generics division Sandoz noted its reviewing options, “including potential appeal to US Supreme Court.”

It’s been almost four years since the FDA approved Erelzi, Sandoz’s copycat version of Enbrel. While sales of the Pfizer-partnered drug in the US — the market Amgen is in charge of — have dipped slightly during that time, it remains a solid megablockbuster with 2019 revenue slightly above $5 billion.