Apricus Biosciences Expects To Report Top-line Data For Fispemifene In Q1

(RTTNews) - Apricus Biosciences, Inc. (APRI) reviewed its 2015 corporate progress and highlighted its plans for 2016.

In 2015, the company Initiated and completed enrollment in its fispemifene Phase 2b clinical trial for the treatment of symptomatic male secondary hypogonadism.

Vitaros monthly sales in Europe tracked on a 111,000 monthly unit run rate, which is expected to grow in both existing markets and new markets with additional launches throughout 2016 by the company's commercialization partners.

Also in 2015, Apricus Biosciences completed and reported top-line data on the Phase 2a clinical trial of RayVa for Raynaud's phenomenon secondary to scleroderma, licensed the U.S. development and commercialization rights for Vitaros from Allergan plc, and expanded Vitaros partnerships to include parts of Asia, Eastern Europe and Latin America.

Looking ahead to 2016, Apricus said it will continue to leverage Vitaros as a cash-generating asset through royalty and milestone payments as well as expanding the product's market reach.

The company expects to obtain European approval for one or more variations to the approved Vitaros product with the goal of enhancing the profile of Vitaros.

The company also expects to re-submit the New Drug Application for Vitaros' approval in the U.S. in the second half of 2016, complete the Phase 2b clinical trial and report top-line data for fispemifene in symptomatic secondary hypogonadism in the first quarter 2016, and initiate a Phase 2b at-home dosing clinical trial with RayVa in the second half of 2016.