April 6, 2016
By Alex Keown, BioSpace.com Breaking News Staff
SAN DIEGO – Following disappointing Phase IIb results for fispemifene for men for sexual dysfunction, California-based Apricus Biosciences, Inc. is slashing its employment, including members of its executive team, by 30 percent, the company announced this morning.
The company said it intends to focus its commercial and regulatory priorities on its erectile dysfunction cream Vitaros and “deprioritize all other pipeline programs.” The drug has been approved for use in Europe and Canada and Apricus said it has set its sights on regulatory approval for Vitaros in the United States. It also wants to secure footholds in parts of the Middle East, the company said. Vitaros said it plans to resubmit a New Drug Application to the U.S. Food and Drug Administration (FDA) in the third quarter of 2016 and hopes to have approval in 2017.
“After reviewing the potential for our current assets with our Board of Directors and our larger shareholders following the disappointing fispemifene Phase 2b study results, we have decided to focus only on the priorities that we believe are most likely to generate strategic value, while reducing our capital needs,” Richard Pascoe, chief executive officer of Apricus, said in a statement. “Apricus’ development priority is now focused on Vitaros, both to accelerate commercialization outside of the U.S. and to attempt to bring this novel erectile dysfunction therapy to patients in the U.S. next year, with the goal of achieving profitability in 2017.
Apricus’ stock was up in after-hours trading. Shares of Apricus took a hit following the failure of fispemifene, dropping from $1.35 per share to 71 cents per share. The stock closed Tuesday at 60 cents per share, but was up to 70 cents per share in aftermarket trading.
Apricus regained the U.S. rights from Allergan last year after entering into a marketing deal with that company in 2009. If the company is able to gain U.S. approval for Vitaros, which would likely be a significant revenue-driver for the company. Sales for erectile dysfunction products were $3 billion in the U.S. in 2014, according to data from IMS Health . It’s estimated that about 20 million men in the U.S. suffer from some form of erectile dysfunction, with more than half a million diagnosed each year. Vitaros would come up against stiff competition in Pfizer ’s Viagra and Eli Lilly ’s Cialis, but Apricus believes it has an advantage in the speed with which Vitaros works and in the tolerance patients with other diseases, such as cardiovascular and diabetes, have shown the drug during clinical trials.
While the company focuses on Vitaros, it said it will discontinue all clinical activities with fispemifene. In March, the company reported use of fispemifene for the treatment of men with secondary hypogonadism and sexual dysfunction was not statistically significant from placebo.
Although Apricus did not specify which positions were going to be most impacted by the job cuts, the company said the cuts will include decreasing the size of the board of directors and cut their cash compensation. The company will also reduce operating expenses by 30 percent this year and 60 percent in 2017.
