Ovoca Bio plc`s goal is to become a leader in the development and commercialisation of novel product candidates for the treatment of female sexual dysfunctions.
The key elements of this strategy include:
Complete the clinical development of IVIX`s product candidates to approval Ovoca Bio plc Ovoca Bio plc is focused on completing the development of its clinical product candidate, Libicore. Ovoca Bio plc Ovoca Bio plc intends to complete the Russian Phase III clinical trial for Libicore in Q3 2019 and expects to have the results available by Q2 2019.
Subject to the results of the Phase III trial, Ovoca Bio plc intends to submit applications for marketing approval for Libicore within Russia and Eurasian Economic Union countries in Q3 2019.
In the United States, IVIX has had a pre-IND meeting with the FDA to discuss requirements for conducting clinical trials in the United States in order to obtain marketing authorization. IVIX received instructions from the FDA on the studies that will need to be conducted to obtain authorization to conduct a Phase IIb clinical trial in United States. Ovoca Bio plc intends to fulfil the FDA’s requirements and to progress the clinical trials of Libicore in order to ultimately obtain marketing authorisation for Libicore from the FDA. Submission of the IND application to the FDA and obtaining approval for the Phase IIb clinical trial is expected to take place in 2019.
Establish commercialisation partnerships with third parties Ovoca Bio plc intends to license commercialisation rights or collaborate with regional partners, global pharmaceutical companies or other qualified potential partners with the aim of promoting its current and future product candidates in an effective way with a targeted sales and marketing group.
Continue to invest in and strengthen its intellectual property portfolio Ovoca Bio plc owns a patent portfolio that provides broad effective protection of its technology and current product candidate. Ovoca Bio plc intends to continue to leverage this patent portfolio to develop and commercialise its product candidate and potential future product candidates. Ovoca Bio plc intends to continue to generate and file new patent applications and take other steps to expand and strengthen its intellectual property position. In addition, Ovoca Bio plc may also expand its intellectual property portfolio through in-licensing and acquisition.