Over the past two quarters following the disappointing fispemifene clinical trial results, we have sharpened our focus on increasing value through the fostering and expansion of our Vitaros® commercial partnerships, preparing the Vitaros NDA resubmission and improving the Company’s financial position.
- Continue implementation of the U.S. regulatory approval strategy to address the safety and manufacturing issues raised by the FDA in the original Vitaros NDA submission. In November, the FDA provided clarity on the requirements needed to address the deficiencies in the 2008 Complete Response letter to include suggested additional analysis of existing clinical and non-clinical data. The FDA feedback did not indicate that new clinical studies would be required for re-submission, but the FDA did determine that Vitaros is now considered a drug-device combination. The Company intends to meet with the Office of Product Quality to confirm the necessary device engineering and compliance requirements for the NDA re-submission and then resubmit the Vitaros NDA in the second half of 2017. An FDA approval decision is expected after a six month review period;
- Continue to support the Company’s ex-U.S. partners’ efforts to build a global Vitaros brand and increase revenue by supporting new commercial launches by the Company’s partners and assisting the Company’s partners in obtaining additional regulatory approvals in their respective territories;
- Continue the Company’s efforts to license Vitaros in available countries throughout Asia to include Japan, China and India; and
- Continue to generate the required data to support delivery device improvements and related regulatory submission(s) with a priority to support the U.S. NDA resubmission of the refrigerated version of Vitaros and to deliver a commercially viable refrigerated product in Canada.
- Explore Orphan Drug Designation in the U.S. and EU; and
- Explore global or regional partnerships prior to initiating the Phase 2b study.
- Reduce operating expenses by approximately 30% in 2016 and 60% in 2017 as compared to 2015 operating expenses;
- Work with NASDAQ to try and regain compliance with the minimum $35 million market value of listed securities requirement as required for continued listing on The NASDAQ Capital Market under NASDAQ Listing Rule 5550(b)(2); and
- Grow Vitaros revenue, seek non-dilutive capital and utilize lower cost of capital financial instruments to fund operations with the goal of achieving profitability in 2018.
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 2018.
As always, thank you for your continued support and interest in Apricus Biosciences.
Richard W. Pascoe
Chief Executive Officer