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AstraZeneca's Gout Drug in Focus with Phase III Data Readout

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Investors in the pharma/biotech sector eagerly wait for pipeline updates as they play an important role in deciding whether or not to invest in a particular company. Pipelines are of prime importance as far as pharma/biotech companies are concerned. These companies spend a significant amount in advancing their pipelines.

AstraZeneca (AZN) announced top-line results from three phase III studies (CLEAR1, CLEAR2 and CRYSTAL) on gout candidate lesinurad. The multi-center, randomized, placebo-controlled and 12-month CLEAR1 and CLEAR2 studies evaluated the efficacy and safety of lesinurad (200 mg and 400 mg once daily) in combination with the xanthine oxidase (:XO) inhibitor allopurinol, in symptomatic gout patients not achieving sufficient benefit on their current allopurinol dose.

Lesinurad in both doses in combination with allopurinol met the primary endpoint in the CLEAR1 and CLEAR2 studies. Top-line data from the studies revealed that a statistically significant higher proportion of patients under lesinurad met the serum uric acid (sUA) level goal (<6.0 mg/dL) at six months compared to patients under allopurinol alone.

Meanwhile, the company also announced data from the CRYSTAL study on lesinurad (200 mg and 400 mg once daily) in combination with Takeda Pharmaceuticals' (TKPYY) XO inhibitor Uloric (febuxostat) in gout patients with tophi. In the study, lesinurad 400 mg in combination with febuxostat met the primary endpoint, while lesinurad 200 mg failed to do so at 6 months.

The company plans to make regulatory submissions for the lesinurad (200 mg) combination therapy. We remind investors that lesinurad was added to AstraZeneca’s pipeline with the acquisition of Ardea Biosciences, Inc. We expect investor focus to remain on AstraZeneca’s pipeline going forward.

AstraZeneca presently carries a Zacks Rank #2 (Buy). Some better-ranked stocks in the healthcare sector include Endo International (ENDP) and Allergan (AGN). Both Allergan and Endo are Zacks Rank #1 (Strong Buy) stocks.

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