(Alliance News) - Ovoca Bio PLC on Friday said the Russian Ministry of Health has not granted marketing authorisation for BP-101 after identifying issues with chemistry, manufacturing and controls.
Shares in Ovoca dropped 23% to 10.15 pence in London in morning trading.
BP-101 is Ovoca's novel synthetic peptide administered through a nasal spray intended to treat decreased sexual desire in women. The Women's health-focused biopharmaceutical company submitted its application in September 2019.
The ministry, known as the Minzdrav, identified issues relating to CMC and labelling sections of the marketing authorisation submission dossier that led to its decision not to grant the application.
However, Ovoca pointed out that no issues had been highlighted in terms of safety of efficacy for BP-101.
The company is undertaking an internal review of the Minzdrav's comments so as to understand what changes would be needed to make BP-1010 approvable in Russia and understand the scope of work needed to achieve this. This will include assessing how to fix the CMC issues with its current Russia-based contract manufacturer, or with different suppliers.
Ovoca plans to release an update in due course with the outcome of this review and its plans for full resubmission in Russia.
It is investigating alternative producers of the active pharmaceutical ingredient in major markets for global drug supply, as well as establishment of a CMC operational unit in the Republic of Ireland.
The clinical drug supply for the company's upcoming phase 2 trial of BP-101 in Australia comes from Swiss and British contract manufacturers.
Chief Executive Kirill Golovanov said: "This is a disappointing outcome for Ovoca but we are confident that the questions raised by Minzdrav, related to the CMC and labelling portions of the application, can be addressed to the satisfaction of the regulator. 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.
"This has no implications for the drug product being supplied for our primary goal, the ongoing clinical development programme for BP-101 in high value Western markets, where we are working with well-established drug manufacturers in Switzerland and the UK. Preparations are currently underway to start our phase II dose ranging study in Australia, an important step towards ultimately establishing a clinical programme for BP-101 in the US and EU."
By Anna Farley; annafarley@alliancenews.com
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