There’s more bad news for the an­tibi­otics R&D field Thurs­day evening.

Ken Hillan

A few weeks af­ter the FDA green-light­ed Achao­gen’s $AKAO an­tibi­ot­ic Zem­dri (pla­zomicin) for uri­nary tract in­fec­tions but shunt­ed aside their ap­pli­ca­tion on blood­stream in­fec­tions, the biotech is lay­ing off rank-and-file re­searchers and let­ting go its top re­search ex­ecs.

Al­to­geth­er the com­pa­ny says it is cut­ting 80 jobs — 28% of the staff — as it chops spend­ing on ear­ly-stage re­search and de­vel­op­ment, tech­ni­cal op­er­a­tions and gen­er­al and ad­min­is­tra­tive ex­pens­es.

Lee Swem

Ken Hillan, pres­i­dent R&D, will leave in mid-Oc­to­ber, while CSO Lee Swem will de­part a few weeks ear­li­er.

Re­search will be nar­rowed to fo­cus on C-Scape, an oral be­ta-lac­tam/be­ta-lac­ta­mase in­hibitor com­bi­na­tion, and new amino­gly­co­side an­tibi­otics, which can count on some non-di­lu­tive fund­ing com­mit­ments to con­tin­ue the work. The main task at Achao­gen will be com­mer­cial­iz­ing their ap­proved prod­uct while hunt­ing a Eu­ro­pean OK to ex­pand that work.

For the past 10 years pub­lic health of­fi­cials have been rais­ing a hue and cry for new an­tibi­otics as old stan­dards strug­gle against a ris­ing tide of drug re­sis­tance. But the bulk of the need can still be met with cheap stand­by ther­a­pies, mak­ing it hard to prof­it by them. As a re­sult, Big Phar­ma bowed out large­ly, un­der­scored by No­var­tis’ re­cent de­ci­sion to join the ex­o­dus out of the field. As­traZeneca and oth­ers had done it years ago.

J&J’s Stelara, which is set to be in the top ten list of blockbusters come 2025, is now cleared by the FDA for use in ulcerative colitis (UC), an inflammatory disease of the large intestine.

The biologic targets interleukin (IL)-12 and IL-23 cytokines, which are known to play a key role in inflammatory and immune responses. Stelara, which generated about $4.7 billion in the first nine months of 2019, is a key player in the crowded marketplace of drugs to treat autoimmune disorders such as psoriasis, rheumatoid arthritis and Crohn’s disease. AbbVie’s star therapy, Humira, continues to dominate, despite its looming patent cliff in the United States, while others including J&J’s $JNJ own anti-IL23 Tremfya, Lilly’s $LLY anti-IL-17 Taltz and AbbVie’s $ABBV recently approved anti-IL-23 antibody Skyrizi carve out a slice of market share.

→ Hours before the first federal opioid trial was set to begin, three drug distributors and an opioid manufacturer agreed to a $260 million agreement settlement, the Wall Street Journal was the first to report. The deal — which will see McKesson, Cardinal Health and AmerisourceBergen pay $215 million to Summit and Cuyahoga counties, and Teva deal out $35 million in cash and addiction treatments — does not resolve the pending, nationwide litigation that may result in a settlement worth upwards of $40 billion. Negotiators in that case, brought by 2,300 tribes, counties and cities nationwide and led by several states’ attorneys general, worked through much of Friday without success. Josh Stein, the attorney general for North Carolina, said they were trying to put together a $48 billion deal.

GlaxoSmithKline is leaving the deep dark woods and its viruses behind.

GSK has agreed to divest its vaccines for rabies, RabAvert, and tick-born encephalitis vaccine, Encepur, to Bavarian Nordic, part of the company’s broader efforts to narrow its pipeline and focus on oncology and immunology.

The deal is worth up to nearly $1.1 billion, with a $336 million upfront payment. GSK acquired the vaccines from Novartis as part of an exchange for their late-stage oncology programs in 2015 under former chief Sir Andrew Witty.

While the FDA recently spurned an application to allow AstraZeneca’s blockbuster drug Farxiga for type 1 diabetes that cannot be controlled by insulin, citing safety concerns — the US regulator has endorsed the use of the SGLT2 treatment to reduce the risk of hospitalisation for heart failure in patients with type-2 diabetes and established cardiovascular disease or multiple CV risk factors.

Alexion has racked up a second approval for Ultomiris, the successor therapy to Soliris, as its mainstay blockbuster therapy faces a patent review process that could drastically shorten its patent exclusivity.

The FDA OK for atypical hemolytic uremic syndrome (aHUS) on Friday was widely expected after Alexion posted a full slate of positive Phase III data in January. But regulators also flagged concerns about serious meningococcal infections, slapping a black box warning on the label and mandating a REMS.

Months ago, Foamix leaned on its biggest shareholders — Perceptive Advisors and OrbiMed — to financially grease its wheels, ahead of the FDA decision date for its acne therapy. On Friday, that approval came in — and the topical formulation of the antibiotic minocycline is set for a January launch.

The therapy, Amzeeq (formerly known as FMX101), was approved to treat inflammatory lesions of non-nodular moderate-to-severe acne vulgaris in patients aged 9 and older.