8th Aug 2019 11:24
(Alliance News) - Ovoca Bio PLC on Thursday said it intends to file for the approval of its Libicore female sexual dysfunction drug later in the quarter and expects the verdict in a year's time.
Ovoca shares were down 16% at 20.20 pence in morning trade in London.
Speaking at Ovoca's annual general meeting, Chief Executive Kirill Golovanov said the company plans to file for Libicore with the Russian Ministry of Health.
"The usual length of time before an approval decision is issued by the ministry is approximately 12 months after the date of application filing," Golovanov will announce.
Ovoca was previously a mining company called Ovoca Gold, but changed to a medical firm through its acquisition of a stake in IVIX LLC in July 2018. In March 2019, Ovoca acquired the final 9.9% of IXIV it had agreed to buy, taking its stake to 60%.
Also in March, Ovoca announced positive results from its phase III Libicore trial, which met both its primary and key secondary endpoints and was completed early. Golovanov said the positive result "allowed the focus to shift to completing the filing package for marketing authorization in the first launch market", which is Russia.
"During the intervening period, 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," Golovanov will announce.
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