Updated research notes on OVB (part 1)21 Oct 2019 11:55
OVOCA BIO PLC
Ticker: #OVB
Shareprice: 11p
Shares in issue: 81.5m
Market cap: £9m
Director ownership: 52.5%
- 1,235,000 shares in FTSE listed #POLY worth £14.5m
- Cash balance at 30/06/19 was £2.7m
- No debt
- has other non-core assets up for sale
- 59.9% Investment in IVIX for $6.2m
--- IVIX has a phase III successful drug candidate (Libicore) for female sexual dysfunction disease
--- 4 successful clinical trials completed to date in Russia
--- Currently seeking approval from Russian Ministry of Health and could be on market as early as late 2020
--- In talks with potential partners about licensing for commercialisation in Russia
--- sexual dysfunction is more common in women than men
--- market size in Russia is worth $300m, and $2.25bn in USA
--- Patents approved in USA, Russia, Europe, China, Brazil, India and other countries
--- meetings planned with BfarM and FDA in 2019
--- Plans on doing a Phase 2b clinical trial in the West (US and EU) in mid 2020 and will be submitting their IND (US) and CTA (Europe) application
--- new board appointments expected to help take Libicore international
--- Libicore is already outsourced to FDA approved GMP CMOs for manufacturing:
?? API substance - Switzerland
?? Final drug product - UK
?? Vials - France (1st GL class)
?? Nasal pump - Germany
---
RNS "We are now preparing to file for the drug's marketing approval in its first country, the Russian Federation, and actively pursuing discussions with potential licensing partners to commercialize there."
RNS "Ovoca will be implementing its plans for Libicore in the rest of the world, supporting further pre-clinical and clinical studies necessary before filing for marketing authorisation in the West."
RNS "Based on planned discussions with the FDA at an upcoming Type C meeting and with the German national regulatory body, BfArM, including discussion on clinical trial protocols, Ovoca Bio anticipates pivotal clinical trials could start in the USA and European countries in the middle of 2020."
RNS "With approximately 1-in-10 adult women experiencing a distressing loss of libido and only a single FDA-approved therapy, we believe that Libicore has the potential to address a significant unmet medical need." - Kirill Golovanov, Chief Executive of Ovoca Bio ( since this RNS there are now 2 FDA approved therapies)
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