Ironwood Pharmaceuticals, Inc. (IRWD - Free Report) presented efficacy and safety data from two phase III extension studies on its marketed drug Zurampic (lesinurad) at the American College of Rheumatology (ACR) Annual Meeting in Washington, D.C.
The company also presented pooled analysis of the extension studies and data from three pivotal phase III studies on Zurampic at the meeting. Note that Zurampic was launched in the U.S. this October as a once-daily oral tablet for the treatment of hyperuricemia, in combination with a xanthine oxidase inhibitor (XOI). Hyperuricemia or high serum uric acid (sUA) level in the blood is associated with gout.
Ironwood has a licensing agreement with AstraZeneca PLC (AZN - Free Report) for the exclusive U.S. rights to Zurampic and all products containing lesinurad, including the fixed-dose combination of lesinurad and allopurinol. The fixed-dose combination was submitted for FDA approval in October and is expected to be launched by late 2017, if approved.
Data from these extension studies identified no new safety signals in patients continuing treatment with Zurampic plus allopurinol in the CLEAR extension study compared with the safety profile observed in the CLEAR 1 and CLEAR 2 studies.
The pooled analysis found that patients treated with Zurampic, combined with an XOI, for up to two years exhibited continued increase in the rate of complete reduction in the tophus area (deposit of crystalline uric acid and other substances), as well as decreased rates of gout flares. Moreover, data were pooled from patients enrolled in the CLEAR 1, CLEAR 2 and CRYSTAL trials to evaluate renal-related and kidney stone safety in patients. The study demonstrated a comparable rate of renal adverse events to XOI alone.
We remind investors that the approval of Zurampic was based on data from the CLEAR 1 and CLEAR 2 studies.
The company estimates peak sales potential of the uncontrolled gout market in the U.S. to be more than $300 million.
Zacks Rank & Key Picks
Ironwood currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the health care sector include Cambrex Corporation (CBM - Free Report) and Vanda Pharmaceuticals, Inc. (VNDA - Free Report) . Both the stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Cambrex’s earnings estimates increased from $2.46 to $2.55 for 2016 and from $2.91 to $3.06 for 2017 over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 19.78%. Its share price gained 13.3% year to date.
Vanda’s loss estimates narrowed from 68 cents to 56 cents for 2016 while its earnings estimates increased from 16 cents to 17 cents for 2017 over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 56.65%. Its share price surged 82.1% year to date.
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