Business
Update re Russian Marketing Authorisation
Update re Russian Marketing Authorisation.
About this update from Talisman Metals Plc
[{"type":"text","content":"\n \n \n \n RNS Number : 8444A\n Ovoca Bio PLC\n 02 October 2020\n \n \n \n \n Ovoca Bio plc\n \n \n \n \n \n (\"Ovoca\" or the \"Company\")\n \n \n \n \n \n Update on Marketing Authorisation application for BP-101 in Russian Federation\n \n \n \n \n \n \n \n \n Dublin, Ireland, 2 October, 2020 - Ovoca Bio, a biopharmaceutical company with a focus on women's health, provides an update on the Marketing Authorisation (\"MA\") application for BP-101, a novel synthetic peptide administered through a nasal spray, that was submitted to the Russian Ministry of Health (\"the Minzdrav\") in September 2019. The MA was filed for the treatment of decreased sexual desire in women, including hypoactive sexual desire disorder (or \"HSDD\"), a condition characterised by a distressing lack or loss of sexual desire.\n \n \n \n \n \n Ovoca has been informed that the Minzdrav has not granted the MA to BP-101 following the identification of certain issues relating to the chemistry, manufacturing and controls (CMC) and labelling sections of the MA submission dossier. The Company notes that no issues were highlighted by the Minzdrav regarding the safety or efficacy of BP-101 in the acquired generalized form of HSDD, which has been established by clinical data from two Phase 1 studies, a Phase 2a study and the pivotal Phase 3 study completed in 2019, all as conducted in the Russian Federation.\n \n \n \n \n \n Ovoca is undertaking an internal review of the comments received from the Minzdrav, in order to understand the changes required to the label to make approvable and the required scope of work to CMC-related processes. This will include an assessment of how best to address the identified CMC issues with the current Russia based contract manufacturer or through different suppliers. An update will be provided in due course on this review and Ovoca's plans for a full resubmission for MA in the Russian Federation.\n \n \n \n \n \n The Company is presently investigating alternative producers of active pharmaceutical ingredient (API) situated in major markets for global commercial drug supply, as well as the establishment of a CMC operational unit located in the Republic of Ireland. Clinical drug supply for Ovoca's upcoming Phase II trial of BP-101 in Australia is being provided by Swiss and British c...