Once picked as a $500M win­ner, bank­rupt Achao­gen auc­tions off its an­tibi­ot­ic for a frac­tion of that

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

A new chap­ter in the de­cen­tral­ized clin­i­cal tri­al ap­proach

Despite the promised decentralized trial revolution, we haven’t yet moved the needle in a significant way, although we are seeing far bolder commitments to this as we continue to experience the pandemic restrictions for some time to come. The vision of grandeur is one thing, but operationalizing and execution are another and recognising that change, particularly mid-flight on studies, is worthy of thorough evaluation and consideration in order to achieve success. Here we will discuss one of the critical building blocks of a Decentralized and Remote Trial strategy: TeleConsent; more than paper under glass, it is a paradigm change and key digital enabler.

Su­per-se­cre­tive an­ti-ag­ing biotech Cal­i­co tees up the first vis­i­ble clin­i­cal tri­al of an ex­per­i­men­tal drug. And it’s for can­cer?

Over the past 7 years, Calico has been so much more than your average, run-of-the-mill secretive biotech players. It’s a riddle, wrapped in a mystery, inside an enigma, to repurpose an old Winston Churchill line dating from the time he confronted the Iron Curtain surrounding Stalin’s thoughts.

Launched by industry legend Art Levinson of Genentech fame, with the infinitely deep pockets of Google for support, one of the few big headlines the anti-aging biotech has sparked focused on a major alliance with AbbVie — a giant outfit that conversely likes to show off its drug prospects whenever it can. Together, they’ve been focused on diseases that limit life span — quite an arc of ailments.

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RBC's Bri­an Abra­hams holds a mock ad­comm on Bio­gen's iffy ad­u­canum­ab da­ta — and most of these ex­perts don't see a path to an ap­proval

As catalysts go, few loom larger than the aducanumab adcomm slated for Nov. 6.

With its big franchise under assault, Biogen is betting the ranch that its mixed late-stage Alzheimer’s data can squeak past the experts and regulators and get onto the market. And the topic — after a decade of Alzheimer’s R&D disasters in what still represents the El Dorado of drug markets — remains in the center ring of discussions around late-stage pipeline prospects.

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Joe Biden (Carolyn Kaster, AP Images)

What about the Ger­man ne­go­ti­a­tion mod­el? Biden steers drug pric­ing de­bate to a show­down

From an ill-fated proposal to ban rebates for pharmacy benefit managers to an executive order demanding a “most-favored-nation price” for Medicare, if nothing else President Donald Trump has introduced Americans to a flurry of ideas to rein in pharma, an industry he once accused of “getting away with murder.” And now we’re getting the first glimpse of what a Joe Biden presidency might mean for prescription drug pricing.

Covid-19 roundup: Pars­ing Bourla, a top an­a­lyst sees im­proved chances for Pfiz­er vac­cine; Fau­ci: No sur­prise that Trump was hit by Covid-19

With a medley of adverse events hobbling the late-stage development of vaccines and drugs, Pfizer CEO Albert Bourla’s latest — extended — timeline for the mRNA approach they’re working on with BioNTech is giving some top analysts added confidence that the pharma giant can come up with the regulatory goods next month.

Parsing Bourla’s language in his comments last week, SVB Leerink’s Geoffrey Porges notes that Bourla’s decision to say they “may” be able to nail down the positive efficacy of their vaccine in a matter of days — a big change from his earlier certainty — may also indicate a delay on that to early November.

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IN8bio CEO William Ho (IN8bio)

Bring­ing their ge­net­i­cal­ly mod­i­fied gam­ma delta T cells to Nas­daq, IN8bio files for $86M IPO

The biotech IPO parade continues marching forward as 2020 turns toward the fourth quarter.

IN8bio, a New York-based company focused on genetically modified gamma delta T cell therapies, filed to go public Friday seeking an $86 million raise. The company has two clinical-stage candidates being studied in glioblastoma and leukemia, respectively.

By any stretch of the imagination, 2020 has already been a huge year for biotech, and nowhere does it appear more obvious than the vast amounts of companies hitting the public market.

News brief­ing: Ab­b­Vie and Roche's Ven­clex­ta scores an­oth­er FDA OK; Im­muno­Gen nabs Chi­na deal with $40M cash

AbbVie and Roche’s Venclexta has gotten a new FDA thumbs up.

The pair announced Monday that regulators have approved the drug in combination with azacitidine or low-dose cytarabine for newly-diagnosed acute myeloid leukemia in adults who are 75 or older or those who can’t undergo intensive chemotherapy. This follows the drug’s accelerated approval in 2018 and positive data from two Phase III confirmatory trials.

James Sabry (Roche)

Roche's James Sabry inks his sec­ond AI deal in back-to-back pacts — this time part­ner­ing Genen­tech with Stan­ford spin­out Gen­e­sis Ther­a­peu­tics

Less than a week after Roche joined forces with Dyno Therapeutics to develop gene therapies using artificial intelligence, its giant subsidiary Genentech is hopping on the AI bandwagon with a different player.

Genentech has inked a deal with Stanford spinout Genesis Therapeutics to harness its AI power for drug development and discovery. Genesis is getting an upfront payment and milestones, but the companies are keeping the details under wraps for now. The Burlingame, CA-based biotech also stands to earn future royalties on any approved Genentech drugs that come from the deal.

En­do pays $658M in a fur­ther bet on col­la­gen-based med­i­cines, buy­ing out long­time bio­phar­ma part­ner

A little less than two years after Endo Pharmaceuticals’ deal to purchase Somerset Therapeutics fell through, the Irish drugmaker is returning to the well with a much bigger acquisition.

Endo has agreed to buy BioSpecifics Technologies for a whopping $658 million, the two companies announced Monday, in the culmination of a research agreement signed all the way back in 2004. Endo will purchase all of BioSpecifics’ outstanding stock for about $540 million, valuing the company at $88.50 per share — a 45% premium on the $61.02 share price at which the company closed on Friday.