This strategic re-positioning will focus on clearing regulatory and commercialization hurdles so that it can achieve profitability via Vitaros.
It comes after news last month that a Phase 2b trial for its Fispemifen drug, a possible treatment for patients with hypogonadism and sexual dysfunction, failed to meet the primary endpoint (of ‘erectile function’) or the secondary endpoint (related to low libido).
Richard Pascoe, Apricus chief executive, described the recent fispemifene results as disappointing and said the priority now was on products that the company believe are most likely to generate ‘strategic value’.
He added: “Apricus’s development priority is now focused on Vitaros, both to accelerate commercialization outside of the US and to attempt to bring this novel erectile dysfunction therapy to patients in the US next year, with the goal of achieving profitability in 2017.”
The San Diego based drugs developer today said it will re-submit a new drugs application for Vitaros with the US Food & Drugs Administration in the third quarter of 2016, so that the drug can potentially be approved in the first half of next year.
Vitaros is already available in Europe and the Middle East and the company said it will aim to expand the drug’s availability in those territories with around ten new country launches through 2016 and the first half of 2017.
Apricus said it will discontinue all ongoing clinical activities relating to fispemifene for hypogonadism, and will deprioritise work on the drugs other potential indications.
The company also intends to significantly reduce operating costs. Staffing will reduce by 30%, including the executive team. It plans to cut overall operating expenses by 30% in 2016, and up to 60% next year.