Ovoca Bio PLC Filing of Marketing Authorisation Application (0458M)

TIDMOVB

RNS Number : 0458M

Ovoca Bio PLC

12 September 2019

12 September 2019

Ovoca Bio plc

("Ovoca" or the "Company")

Ovoca Announces filing of Marketing Authorisation Application with Russian Ministry of Health for BP-101

DUBLIN, 12 September 2019 - Ovoca Bio plc (LSE: OVB; ISE:OVXA), a biopharmaceutical company focused on identifying and developing novel therapeutics targeting the large unmet needs in the treatment of female sexual dysfunction, today announces that a Marketing Authorisation ("MA") application for BP-101, a novel synthetic peptide administered through a nasal spray, has been filed by its subsidiary, IVIX LLC ("IVIX"), with the Russian Ministry of Health ("Minzdrav").

IVIX submitted the BP-101 MA application for the treatment of hypoactive sexual desire disorder (or "HSDD"), a condition characterized by a distressing lack or loss of sexual desire, in premenopausal women. The MA application is based on data from two Phase 1 studies, a Phase 2a study and the pivotal Phase 3 study completed earlier this year, conducted in Russia, which establish the safety and efficacy of BP-101 in the proposed indication.

Upon confirmation that the submission is complete, the Minzdrav will automatically commence a review process. If approved, BP-101 could be available for marketing in the Russian Federation towards the end of 2020.

Kirill Golovanov, Chief Executive Officer of Ovoca Bio plc, said: "The submission of the BP-101 MA application marks an important milestone on our journey to ensure that this innovative therapy is available to patients as quickly as possible. I would like to take this opportunity to recognize the hard work of our colleagues at IVIX and at our manufacturing, regulatory and other partners who have made this filing possible. We are committed to advancing BP-101 in the Russian Federation and then globally as a new treatment option for patients with HSDD and look forward to receiving the outcome of our submission to the Minzdrav."

ENDS

For further information:

Ovoca Bio plc

Kirill Golovanov (Chief Executive)

Tel [phone]

[e-mail]

Davy (Nominated Adviser, Euronext Growth Advisor and Broker)

John Frain / Daragh O'Reilly

Tel: [phone]

About IVIX:

IVIX, a Russian--incorporated company, was formed in 2012 and since that time has sought to develop and subsequently commercialize a proprietary drug candidate, BP-101, for the treatment of female sexual dysfunction. BP-101 is a novel synthetic peptide, administered through a nasal spray. Clinical studies completed to-date have demonstrated statistically significant efficacy in the treatment of a major form of female sexual dysfunction. So far, IVIX has reached and completed Phase II and Phase III clinical studies in Russia for BP-101. It is now seeking approval for the marketing of BP-101 in the Russian market, as well seeking to expand its use internationally.

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September 12, 2019 02:01 ET (06:01 GMT)