Iron­wood looks to boost gout fran­chise as FDA de­liv­ers OK for Duza­l­lo

Iron­wood Phar­ma­ceu­ti­cals $IR­WD is on track to boost­ing its gout drug fran­chise with the launch of Duza­l­lo, a com­bo ther­a­py that match­es lesin­u­rad and al­lop­uri­nol in one pill.

Pe­ter Hecht

The Cam­bridge, MA-based biotech likes to at­tach its own peak sales es­ti­mates to the prod­ucts it de­vel­ops. And CEO Pe­ter Hecht has made it clear that this com­bo ther­a­py — match­ing two ap­proach­es to hy­pe­r­uricemia (the over­pro­duc­tion and un­der­ex­cre­tion of serum uric acid) — will dri­ve the biotech’s fran­chise for un­con­trolled gout to $300 mil­lion-plus in an­nu­al sales.

Iron­wood shares jumped 7% on the news.

“Gout is a se­ri­ous and po­ten­tial­ly pro­gres­sive and de­bil­i­tat­ing in­flam­ma­to­ry dis­ease,” says Uni­ver­si­ty of Chica­go’s Michael Beck­er. “Get­ting pa­tients with gout to serum urate goal, and keep­ing them at or be­low goal, are es­sen­tial to suc­cess in treat­ing these pa­tients.”

The drug is ex­pect­ed to ar­rive on the mar­ket ear­ly in the 4th quar­ter, a date Hecht has re­peat­ed­ly promised to in­vestors as the de­ci­sion date loomed.

Ini­tial sales of Zu­rampic (lesin­u­rad), though, have been a dis­ap­point­ment to an­a­lysts so far. Once con­sid­ered a $500 mil­lion drug, the Phase III da­ta came out look­ing a bit messy — though not too messy for an ap­proval — and As­traZeneca punt­ed it along with oth­er dis­ap­point­ments in the pipeline. Iron­wood, which paid on­ly $100 mil­lion up­front for the drug, be­lieves it can po­si­tion this ther­a­py as a win­ner, with Duza­l­lo — adding the stan­dard of care al­lop­uri­nol to its new drug — lend­ing a hand with an easy once-dai­ly dose and a sin­gle co-pay for pa­tients.

Ge­off Meacham at Bar­clays isn’t ex­pect­ing any quick suc­cess here, not­ing:

Man­age­ment pre­vi­ous­ly in­di­cat­ed it an­tic­i­pates an­nu­al peak gout sales of $300M though the fran­chise is not an­tic­i­pat­ed to be­come cash ac­cre­tive un­til at least 2019.  Near-term, we ex­pect min­i­mal rev­enue con­tri­bu­tions, with Zu­rampic sales es­ti­mat­ed at $10M for 2017 and $75M in 2018.

Iron­wood al­so re­cent­ly dis­ap­point­ed an­a­lysts with the lat­est da­ta on its ex­per­i­men­tal ther­a­py IW-3718 for un­con­trolled GERD. The Phase IIb hit the pri­ma­ry end­point, but fell short of the am­bi­tious re­sults that Iron­wood ex­ecs had promised an­a­lysts.

Iron­wood founder Pe­ter Hecht, though, en­joys set­ting the bar for the biotech, con­vinced that he’s on track to achiev­ing prof­itabil­i­ty next year as he builds rev­enue for the fran­chise ther­a­py Linzess. He’s stayed up­beat through­out the ups and downs of start­ing and run­ning a biotech, mak­ing the switch from de­vel­op­ment to a full-fledged play­er with R&D and mar­ket­ing in house.

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

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Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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In a Phase III trial, patients given a 5-day dose of remdesivir were 65% more likely to show “clinical improvement” compared to an arm given standard-of-care. The trial, though, gave little indication for whether the drug had an impact on key endpoints such as survival or time-to-recovery. And in a surprising twist, a 10-day dosing arm of remdesivir didn’t lead to a statistically significant improvement over standard of care.

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Isaacs —who forged a string of high-profile Big Pharma deals along the way — has wrapped a 13-year run at the biotech with one program for kidney disease going to the new owners at Chinook Therapeutics. A host of once-heralded assets like their STING agonist program partnered with Novartis (which dumped their work on ADU-S100 after looking over weak clinical results), the Lilly-allied cGAS-STING inhibitor program and the anti-CD27 program out-licensed to Merck will all be posted for auction under a strategic review process.

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Bris­tol My­ers Squib­b's just-launched MS drug Zeposia makes the cut in key ul­cer­a­tive col­i­tis tri­al

In March, Zeposia became the third oral S1P modulator to secure US approval for multiple sclerosis. Now, the drug has succeeded in a key ulcerative colitis study.

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The Series B has landed right around the time Genor would have listed on the Hong Kong stock exchange, according to plans reported by Bloomberg late last year. Insiders had said that the company was looking to raise about $200 million.

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Fangliang Zhang (Imaginechina via AP Images)

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The company, initially called Tokai Pharmaceuticals but which subsequently changed its name to Novus Therapeutics in 2017, saw its shares more than halve on Monday after the drug — OP0201— did not pass muster as an adjunct therapy to oral antibiotics in infants and children aged 6 to 24 months with acute otitis media (OM).