Ovoca is pleased to announce that IVIX has signed an agreement with Biopharma Excellence GmbH (Germany)
Ovoca is pleased to announce that IVIX has signed an agreement with Biopharma Excellence GmbH (Germany), an experienced biopharmaceutical drug development consultancy firm, to provide regulatory affairs services. Experts from Biopharma Excellence GmbH will lead the preparation of a briefing book and supporting dossier for the Scientific Advice procedure of the European Medicines Agency. During Scientific Advice, it is planned to discuss all available pre-clinical and clinical data and manufacturing operations for IVIX’S proprietary drug candidate, BP-101 ( known as “Libicore”) and to gather Agency comments on the proposed European clinical development program and Phase 2b Study design. It is the first important step to confirm a drug candidate development program that will be acceptable in Europe.
Kirill Golovanov, CEO of Ovoca, commented: “We are delighted that after the recent transaction with Ovoca, IVIX now is able to take the first step towards bringing its prospective drug candidate through the the European regulatory system.”
For further information:
Ovoca Bio plc
Kirill Golovanov (Chief Executive)
Tel +353 1 661 9819
IVIX, a Russian‐incorporated company, was formed in 2012 and since that time has sought to develop and subsequently commercialise a proprietary drug candidate, BP101 (known as "Libicore"), for the treatment of female sexual dysfunctions. Libicore is a novel synthetic peptide, administrated through a nasal spray. Clinical studies completed to-date have demonstrated statistically significant efficacy in the treatment of major forms of female sexual dysfunction. So far, IVIX has reached and completed Phase II clinical studies in Russia for Libicore. It now intends to complete the ongoing Phase III clinical trial for Libicore, following which it will seek approval for the marketing of Libicore in the Russian market, as well seek to expand its use internationally.