With the dust set­tled on an R&D spin­out, the ful­ly com­mer­cial op­er­a­tions at Iron­wood have come up with some late-stage da­ta to up its Linzess mar­ket­ing game.

Mark Mal­lon As­traZeneca

Iron­wood, along with part­ner Al­ler­gan, set out to col­lect ev­i­dence that their drug can im­prove the over­all ab­dom­i­nal symp­toms of ir­ri­ta­ble bow­el syn­drome with con­sti­pa­tion (IBS-C), not just con­sti­pa­tion. And the com­pa­nies say that’s what they found in the Phase II­Ib: Pa­tients tak­ing Linzess for 12 weeks saw a 29.7% mean de­crease from base­line in a week­ly score that mea­sured bloat­ing, pain and dis­com­fort, com­pared to 18.3% for place­bo (p<0.0001).

The tri­al al­so hit its sec­ondary end­points, in­clud­ing 40.5% of the drug arm meet­ing the cri­te­ria of a re­spon­der ver­sus 23.4% in the place­bo co­hort (p<0.0001).

The new da­ta are meant to bol­ster Iron­wood sales reps as they com­mu­ni­cate with doc­tors and pa­tients, ide­al­ly grow­ing a 7-year-old drug that brought in $785 mil­lion in 2018.

Boris Peak­er Cowen

Cowen an­a­lyst Boris Peak­er ex­plained it this way:

Linzess’ cur­rent la­bel notes re­duc­tions in “ab­dom­i­nal pain,” but not “bloat­ing” or “dis­com­fort,”, which man­age­ment stat­ed are the terms most fre­quent­ly used by pa­tients to de­scribe their symp­toms. The goal of the pro­gram was to en­able the com­pa­ny to align its mar­ket­ing with the lan­guage that physi­cians and pa­tients use day-to-day in the clin­ic

Iron­wood CMO Mike Shet­z­line added that the ab­dom­i­nal symp­toms are typ­i­cal­ly iden­ti­fied by pa­tients as the “most both­er­some.”

While the da­ta are “in­cre­men­tal­ly pos­i­tive for Linzess,” though, Peak­er sees no im­pact on his sales pro­jec­tions.

Pe­ter Hecht Cy­cle­ri­on

Linzess is one of two ap­proved prod­ucts Pe­ter Hecht kept for Iron­wood while spin­ning out the rest of the R&D work to a new com­pa­ny called Cy­cle­ri­on — un­der in­vestor pres­sure. The co-founder and long­time CEO then de­camped for the new out­fit and passed the reins to Mark Mal­lon, an As­traZeneca vet with sig­nif­i­cant in­ter­na­tion­al ex­po­sure.

Aside from a much less suc­cess­ful Tru­lance, Linzess al­so faces some de­gree of com­pe­ti­tion from Motegri­ty, a con­sti­pa­tion drug Take­da now owns cour­tesy of its Shire buy­out.

Gener­ics for the drug could be­gin to emerge in 2030, Peak­er added, at which point Iron­wood’s cur­rent­ly ex­per­i­men­tal ther­a­pies — MD-7246 for IBS with di­ar­rhea and IW-3718 for gas­troe­sophageal re­flux dis­ease — are ex­pect­ed to fill the gap.

So­cial im­age: Richard Drew, Ap Im­ages

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.