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

Fewer Approvals, but Neurology Rivals Oncology and Sees Major Innovations

This report, the fourth in our Trinity Drug Index series, outlines key themes and emerging trends in the industry as we progress towards a new world of targeted and innovative products. It provides a comprehensive evaluation of the performance of novel drugs approved by the FDA in 2016, scoring each on its commercial performance, therapeutic value, and R&D investment (Table 1: Drug ranking – Ratings on a 1-5 scale).

For start-up biotechnology companies and resource stretched pharmaceutical organisations, launching a novel product can be challenging. Lean teams can make setting a launch strategy and achieving your commercial goals seem like a colossal undertaking, but can these barriers be transformed into opportunities that work to your brand’s advantage?
We spoke to Managing Consultant Frances Hendry to find out how Blue Latitude Health partnered with a fledgling subsidiary of a pharmaceutical organisation to launch an innovative product in a
complex market.
What does the launch environment look like for this product?
FH: We started working on the product at Phase II and now we’re going into Phase III trials. There is a significant unmet need in this disease area, and everyone is excited about the launch. However, the organisation is still evolving and the team is quite small – naturally this causes a little turbulence.

Every few years, a public health crisis (think Ebola, Zika) spurred by a rogue pathogen triggers a small-biotech rally, as drugmakers emerge from the woodwork with ambitious plans to treat the mounting outbreak. In most cases, that enthusiasm never quite delivers.

Things are no different, as the coronavirus outbreak in Wuhan, China takes hold. There have been close to 300 confirmed human infections in China, and at least four deaths. Coronaviruses are a large family of viruses, which include MERS and SARS. On Tuesday, the CDC reported the virus was detected in a US traveler returning from Wuhan.

Update: Nominations open through end of day, Monday, January 27

Two years ago, when we did our first Endpoints 20-under-40, we profiled a set of up-and-comers who promised to help reshape the industry as we know it. Now we’re back and once again looking for the top 20 biopharma professionals under the age of 40. We’ll be profiling folks who have accomplished a lot at a young age but seem on the verge of accomplishing so much more.

The venture tide might have subsided, the IPO window may be closing and certain listed biotechs may be having a tough time amid Neil Woodford’s well-publicized demised, but there’s still plenty to celebrate in the UK BioIndustry Association’s eyes.

Overall investment in UK biotech last year fell from the record-breaking £2.2 billion levels of 2018 to £1.3 billion — including £679 million in venture capital, a meager £64 million in IPOs plus £596 million when you add up all public financings, according to a new report from the BIA.

→ Blueprint Medicines filed an amendment to its application to get the gastrointestinal stromal tumor (GIST) drug Ayvakit approved in fourth-line GIST, the company disclosed in the prospectus for a new $325 million public offering.  Blueprint got a big accelerated OK on the drug this month in a particular mutation, but because the FDA decided to split their review in two, they didn’t hear on fourth-line GIST. They were supposed to hear before February 14, but this amendment could push that date back by 3 months. Blueprint wrote that the amendment is designed to allow the company to comply with the FDA’s request for data from the Phase III VOYAGER before they give a judgment.