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

Biohaven is at risk of making a habit of disappointing its investors. 

Late Friday the biotech $BHVN reported that the FDA had rejected its application for riluzole, an old drug that they had made over into a sublingual formulation that dissolves under the tongue. According to Biohaven, the FDA had a problem with the active ingredient used in a bioequivalence study back in 2017, which they got from the Canadian drugmaker Apotex.

Let the long battle for biosimilars in the cancer space begin.

Amgen has launched its Avastin and Herceptin copycats — licensed from the predecessors of Allergan — almost two years after the FDA had stamped its approval on Mvasi (bevacizumab-awwb) and three months after the Kanjinti OK (trastuzumab-anns). While the biotech had been fielding biosimilars in Europe, this marks their first foray in the US — and the first oncology biosimilars in the country.

→ On the same day it announced a $17.5 million Series C, life sciences and health data company Seer unveiled that it had lured former FDA commissioner and ex-CMS administrator Mark McClellan on to its board. “Mark’s deep understanding of the health care ecosystem and visionary insights on policy reform will be crucial in informing our thinking as we work to bring our liquid biopsy and life sciences products to market,” said Seer chief and founder Omid Farokhzad in a statement.

Gilead CEO Daniel O’Day’s new task hunting up a CSO for the company isn’t stopping the industry’s dominant antiviral player from doing pipeline deals.

The big biotech today snapped up 3 preclinical antiviral programs from pharma giant Novartis, with drugs promising to treat human rhinovirus, influenza and herpes viruses. We don’t know what the upfront is, but the back end has $291 million in milestones baked in.