[Available On-Demand]
Ixaltis USA is bringing together a valuable set of late stage clinical assets into a dedicated Urology/Women's Health Care US based specialty pharma. Its pipeline includes litoxetine, the oral NCE for the treatment of Stress/Mixed Urinary Incontinence (SMUI), and Alenura, an anesthetic formulation for Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS). Both products are in phase 2b/3, are coming off recent discussions of new clinical data with FDA, and will fulfill unmet needs in their markets. Alenura, a 505(b)(2)NDA offers a near term US approval in 2023 and sales potential of several hundred million dollars in the IC/BPS market. The litoxetine NDA will be the first in class product in the US incontinence market to treat SMUI and will enter this market with a true blockbuster profile and US sales potential sales of over $1B. International opportunity is significant as both products are covered by extensive IP portfolios, and the company has a seasoned international management team
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Ixaltis USA