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

De­vel­op­ment of the Next Gen­er­a­tion NKG2D CAR T-cell Man­u­fac­tur­ing Process

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.

Paul Hudson, Getty Images

UP­DAT­ED: Sanofi CEO Hud­son lays out new R&D fo­cus -- chop­ping di­a­betes, car­dio and slash­ing $2B-plus costs in sur­gi­cal dis­sec­tion

Earlier on Monday, new Sanofi CEO Paul Hudson baited the hook on his upcoming strategy presentation Tuesday with a tell-tale deal to buy Synthorx for $2.5 billion. That fits squarely with hints that he’s pointing the company to a bigger future in oncology, which also squares with a major industry tilt.

In a big reveal later in the day, though, Hudson offered a slate of stunners on his plans to surgically dissect and reassemble the portfoloio, saying that the company is dropping cardio and diabetes research — which covers two of its biggest franchise arenas. Sanofi missed the boat on developing new diabetes drugs, and now it’s pulling out entirely. As part of the pullback, it’s dropping efpeglenatide, their once-weekly GLP-1 injection for diabetes.

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Roger Perlmutter, Merck

#ASH19: Here’s why Mer­ck is pay­ing $2.7B to­day to grab Ar­Qule and its next-gen BTK drug, lin­ing up Eli Lil­ly ri­val­ry

Just a few months after making a splash at the European Hematology Association scientific confab with an early snapshot of positive data for their BTK inhibitor ARQ 531, ArQule has won a $2.7 billion buyout deal from Merck.

Merck is scooping up a next-gen BTK drug — which is making a splash at ASH today — from ArQule in an M&A pact set at $20 a share $ARQL. That’s more than twice Friday’s $9.66 close. And Merck R&D chief Roger Perlmutter heralded a deal that nets “multiple clinical-stage oral kinase inhibitors.”

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Left top to right: Mark Timney, Alex Denner, Vas Narasimhan. (The Medicines Company, Getty, AP/Endpoints News)

In a play-by-play of the $9.7B Med­Co buy­out, No­var­tis ad­mits it over­paid while of­fer­ing a huge wind­fall to ex­ecs

A month into his tenure at The Medicines Company, new CEO Mark Timney reached out to then-Novartis pharma chief Paul Hudson: Any interest in a partnership?

No, Hudson told him. Not now, at least.

Ten months later, Hudson had left to run Sanofi and Novartis CEO Vas Narasimhan was paying $9.7 billion for the one-drug biotech – the largest in the string of acquisitions Narasimhan has signed since his 2017 appointment.

The deal was the product of an activist investor and his controversial partner working through nearly a year of cat-and-mouse negotiations to secure a deal with Big Pharma’s most expansionist executive. It represented a huge bet in a cardiovascular field that already saw two major busts in recent years and brought massive returns for two of the industry’s most eye-raising names.

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Paul Hudson. Sanofi

New Sanofi CEO Hud­son adds next-gen can­cer drug tech to the R&D quest, buy­ing Syn­thorx for $2.5B

When Paul Hudson lays out his R&D vision for Sanofi tomorrow, he will have a new slate of interleukin therapies and a synthetic biology platform to boast about.

The French pharma giant announced early Monday that it is snagging San Diego biotech Synthorx in a $2.5 billion deal. That marks an affordable bolt-on for Sanofi but a considerable return for Synthorx backers, including Avalon, RA Capital and OrbiMed: At $68 per share, the price represents a 172% premium to Friday’s closing.

Synthorx’s take on alternative IL-2 drugs for both cancer and autoimmune disorders — enabled by a synthetic DNA base pair pioneered by Scripps professor Floyd Romesberg — “fits perfectly” with the kind of innovation that he wants at Sanofi, Hudson said.

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Jake Van Naarden, Josh Bilenker, Nisha Nanda (Credit: Loxo, Aisling Capital)

Josh Bilenker and his Loxo crew are tak­ing the reins on on­col­o­gy R&D at Eli Lil­ly, culling the weak and map­ping a new path

Josh Bilenker, Jake Van Naarden and Nisha Nanda came out of Eli Lilly’s $8 billion Loxo Oncology buyout with a bundle of cash and plenty of choices on what they could do next. Start a new company, go public. Live on the beach in 5-star luxury. Contemplate the stars — in their own observatory.

So what are they doing?

They formed a new executive team that is taking over the management of Eli Lilly’s hundreds-strong oncology R&D group — essentially using Loxo as a base for a bold new experiment in Big Pharma R&D in an attempt to create a true biotech environment with the deep pockets of a top-15 industry player. They’ve recruited David Hyman from Memorial Sloan Kettering to join the team as chief medical officer. And the mandate includes culling out the oncology pipeline, highlighting their star prospects and going after new programs wherever they can find the best prospects.

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Game on: Re­gen­eron's BC­MA bis­pe­cif­ic makes clin­i­cal da­ta de­but, kick­ing off mul­ti­ple myelo­ma matchup with Bris­tol-My­ers

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.

FDA lifts hold on Abeon­a's but­ter­fly dis­ease ther­a­py, paving way for piv­otal study

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.

Roche faces an­oth­er de­lay in strug­gle to nav­i­gate Spark deal past reg­u­la­tors — but this one is very short

Roche today issued the latest in a long string of delays of its $4.3 billion buyout of Philadelphia-based Spark Therapeutics. The delay comes as little surprise — it is their 10th in as many months — as their most recent delay was scheduled to expire before a key regulatory deadline.

But it is notable for its length: 6 days.

Previous extensions had moved the goalposts by about 3 weeks to a month, with the latest on November 22 expiring tomorrow. The new delay sets a deadline for next Monday, December 16, the same day by which the UK Competition and Markets Authority has to give its initial ruling on the deal. And they already reportedly have lined up an OK from the FTC staff – although that’s only one level of a multi-step process.

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