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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.

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