(Sharecast News) - Biopharmaceutical company Ovoca Bio updated shareholders on Friday on its marketing authorisation application for BP-101, a novel synthetic peptide administered through a nasal spray, that was submitted to the Russian Ministry of Health (Minzdrav) in September 2019.
The AIM-traded firm said the authorisation was filed for the treatment of decreased sexual desire in women, including hypoactive sexual desire disorder, a condition characterised by a distressing lack or loss of sexual desire.
It said it had been informed that the Minzdrav had not granted the authorisation to BP-101, following the identification of certain issues relating to the chemistry, manufacturing and controls (CMC) and labelling sections of the submission dossier.
The company said no issues were highlighted by the Minzdrav regarding the safety or efficacy of BP-101 in the acquired generalised form of hypoactive sexual desire disorder, which had 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.
Ovoca said it was undertaking an internal review of the comments received from the Minzdrav, in order to understand the changes required to the label to make it approvable and the required scope of work to CMC-related processes.
That would include an assessment of how best to address the identified CMC issues with the current Russia-based contract manufacturer, or through different suppliers.
The board said an update would be provided on the review, and its plans for a full resubmission for marketing authorisation in the Russian Federation.
Ovoca said it was currently 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 2 trial of BP-101 in Australia was being provided by Swiss and British contract manufacturers with "extensive experience" in supplying clinical trials.
"This is a disappointing outcome for Ovoca but we are confident that the questions raised by Minzdrav, related to the CMC and labeling portions of the application, can be addressed to the satisfaction of the regulator," said chief executive officer Kirill Golovanov.
"We are currently undertaking an internal review to determine how best to proceed, including next steps for CMC in Russia and will update in due course."
Golovanov said the outcome had no implications for the drug product being supplied for the company's primary goal, which was the ongoing clinical development programme for BP-101 in high-value Western markets, where it was working with drug manufacturers in Switzerland and the UK.
"Preparations are currently underway to start our phase 2 dose ranging study in Australia, an important step towards ultimately establishing a clinical programme for BP-101 in the US and EU."
At 1006 BST, shares in Ovoca Bio were down 18.87% at 10.75p.
Ovoca Bio (OVB)23 Nov 2023 15:53