Ovoca Bio said that its subsidiary IVIX has resubmitted a marketing application for the company’s BP-101 synthetic peptide nasal spray for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women to the Russian Ministry of Health (Minzdrav). The original application was submitted in September 2019, and Minzdrav rejected that application in October 2020, citing problems with the CMC and labelling sections of the dossier.
BP-101, also known as Libicore, was initially developed by IVIX, a Russian biopharmaceutical company. Ovoca acquired a 50.02% stake in IVIX in 2018 and then acquired the remainder in 2020. Prior to its acquisition of IVIX and changing its name to “Ovoca Bio,” the company was known as “Ovoca Gold” and was “a gold exploration and mine development company with a strong balance sheet and an exciting portfolio of gold properties.” BP-101 is the sole candidate listed on Ovoca Bio’s web site.
Ovoca Bio CEO Kirill Golovanov commented, “This is a positive development for Ovoca. We are confident that the questions raised by the Minzdrav, related to the CMC and labeling portions of the previous application rather than drug safety or efficacy, have been addressed in this new submission. Outside of Russia we are continuing to progress our clinical development program for BP-101 in high value Western markets. Preparations are advanced to start our Phase 2 dose ranging study in Australia and New Zealand, an important step towards ultimately establishing a clinical program for BP-101 in the US and EU.”
Read the Ovoca Bio press release.
