The de­layed-re­lease for­mu­la­tion of Iron­wood and Al­ler­gan’s bow­el drug Linzess will not see the light of day.

The ex­per­i­men­tal drug, MD-7246, failed to help pa­tients with ab­dom­i­nal pain as­so­ci­at­ed with ir­ri­ta­ble bow­el syn­drome with di­ar­rhea (IBS-D) in a mid-stage study, prompt­ing the part­ners to aban­don the ther­a­py.

First ap­proved in 2012, Linzess (known chem­i­cal­ly as lina­clotide) en­hances the ac­tiv­i­ty of the in­testi­nal en­zyme guany­late cy­clase-C to in­crease the se­cre­tion of in­testi­nal flu­id and then tran­sit through the in­testi­nal tract, as well as re­duce vis­cer­al pain, to re­lieve pain and con­sti­pa­tion as­so­ci­at­ed with IBS.

MD-7246 was de­signed to sim­ply deal with the pain by tar­get­ing the de­liv­ery of lina­clotide to the colon, where the ma­jor­i­ty of the ab­dom­i­nal pain as­so­ci­at­ed with IBS is be­lieved to orig­i­nate, and to lim­it flu­id se­cre­tion in the small in­tes­tine for a min­i­mal im­pact on bow­el func­tion.

Ear­li­er this week, the part­ners said MD-7246 failed both the main and sec­ondary goals of the 388 pa­tient (IBS-D) Phase II study, but did not dis­close de­tails. Back in 2016, in a tri­al of 532 ir­ri­ta­ble bow­el pa­tients with con­sti­pa­tion (IBS-C), MD-7246 did help im­prove ab­dom­i­nal pain rel­a­tive to place­bo with no ef­fect on bow­el func­tion. In April, Cred­it Su­isse’s Mar­tin Auster had mod­eled ~$300 mil­lion sales op­por­tu­ni­ty for MD-7246 for Iron­wood, based on the com­pa­ny’s sales/re­im­burse­ment ap­por­tion­ment with part­ner Al­ler­gan (now a unit of Ab­b­Vie).

Mark Mal­lon

With MD-7246 in the scrap heap, Iron­wood is left with IW-3718 as the sole clin­i­cal-stage de­vel­op­ment pro­gram, which is cur­rent­ly in late-stage de­vel­op­ment for use in re­frac­to­ry gas­troe­sophageal re­flux dis­ease. An up­date on the pro­gram was ex­pect­ed in the sec­ond half of this year, but will like­ly slide in­to 2021 due to Covid-19-re­lat­ed de­lays.

“As Linzess faces a 2029 hori­zon for gener­ics based on ex­ist­ing set­tle­ments, we an­tic­i­pate the com­pa­ny will take steps to re­place the rev­enue from that fran­chise over the next sev­er­al years by in-li­cens­ing new as­sets. We be­lieve some val­ue-fo­cused share­hold­ers may dis­like this strat­e­gy,” Cowen’s Boris Peak­er wrote in a note on Wednes­day.

Linzess gen­er­at­ed about $803 mil­lion in sales in 2019.

Pe­ter Hecht Cy­cle­ri­on

Last year, Iron­wood shed its oth­er pipeline prospects to fo­cus on GI dis­or­ders, by spin­ning out a com­pa­ny called Cy­cle­ri­on fo­cused on the sol­u­ble guany­late cy­clase (GC) — a key en­zyme in the ni­tric ox­ide sig­nal­ing path­way — busi­ness. The Boston drug­mak­er’s chief Pe­ter Hecht left to head Cy­cle­ri­on, while Iron­wood brought As­traZeneca vet­er­an Mark Mal­lon to the helm.

As concerns rise around the J&J and AstraZeneca vaccines, global attention is increasingly turning to the little, 33-year-old, productless, bankruptcy-flirting biotech that could: Novavax.

In the now 16-month race to develop and deploy Covid-19 vaccines, Novavax has at times seemed like the pandemic’s most unsuspecting frontrunner and at times like an overhyped also-ran. Although they started the pandemic with only enough cash to last 6 months, they leveraged old connections and believers into $2 billion and emerged last summer with data experts said surpassed Pfizer and Moderna. They unveiled plans to quickly scale to 2 billion doses. Then they couldn’t even make enough material to run their US trial and watched four other companies beat them to the finish line.

The FDA wrapped up its inspection of Emergent’s troubled vaccine manufacturing plant in Baltimore on Tuesday, after halting production there on Monday. By Wednesday morning, the agency already released a series of scathing observations on the cross contamination, sanitary issues and lack of staff training that caused the contract manufacturer to dispose of millions of AstraZeneca and J&J vaccine doses.

Everything came up sevens for GlaxoSmithKline on Thursday as the pharma notched the seventh PD-1 approval seven years after the first such drugs were OK’ed in Keytruda and Opdivo. But will it bring GSK good fortune?

The FDA granted accelerated approval to dostarlimab, to be branded Jemperli, to treat recurrent or advanced endometrial cancer in a specific subset of patients following platinum-based chemo. It’s a drug that came to GSK through its buyout of Tesaro, which it snapped up for $5.1 billion back in December 2018.

Although Thursday’s Senate health committee hearing was focused on how foreign countries and adversaries might be trying to steal or negatively influence biomedical research in the US, the only country mentioned by the senators and expert witnesses was China.

Committee chair Patty Murray (D-WA) made clear in her opening remarks that the US cannot “let the few instances of bad actors” overshadow the hard work of the many immigrant researchers in the US, many of which have won Nobel prizes for their work. But she also said, “There is more the NIH can be doing here.”