Re-Filing of Marketing Authorisation Application
Source: RNS
Ovoca Bio plc
("Ovoca" or the "Company")
Ovoca Bio plc Announces resubmission of Marketing Authorisation Application with Russian Ministry of Health for BP-101
Dublin, Ireland, 05 January 2021 - Ovoca Bio plc (LSE: OVB; ISE: OVXA), a biopharmaceutical company with a focus on women's health, today announces that a new Marketing Authorisation ("MA") application for BP-101, a novel synthetic peptide administered through a nasal spray, was filed by its subsidiary, IVIX LLC ("IVIX"), with the Russian Ministry of Health (the "Minzdrav") on 30 December 2020.
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 conducted in Russia, which establish the safety and efficacy of BP-101 in the proposed indication.
In October 2020 IVIX's previous MA submission filed with the Minzdrav for BP-101 was not granted following the identification of issues relating to the chemistry, manufacturing and controls (CMC) and labelling sections of the MA submission dossier. Ovoca is satisfied that the concerns raised by the Minzdrav have now been fully addressed.
Upon confirmation that the submission is complete, the Minzdrav will automatically commence a review process, which is expected to be a minimum of nine months duration.
Kirill Golovanov, Chief Executive Officer of Ovoca Bio plc, said: "This is a positive development for Ovoca. We are confident that the questions raised by the Minzdrav, related to the CMC and labeling portions of the previous application rather than drug safety or efficacy, have been addressed in this new submission.
"Outside of Russia we are continuing to progress our clinical development programme for BP-101 in high value Western markets. Preparations are advanced to start our Phase II dose ranging study in Australia and New Zealand, an important step towards ultimately establishing a clinical programme for BP-101 in the US and EU."
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For further information:
Ovoca Bio plc
Kirill Golovanov (Chief Executive)
Tel +353 1 661 9819
Davy (Nominated Adviser, Euronext Growth Advisor and Broker)
John Frain / Daragh O'Reilly
Tel: +353 1 679 6363
Consilium Strategic Communications
Chris Gardner, Chris Welsh, Carina Jurs
ovocabio@consilium-comms.com
Tel: +44 (0)20 3709 5700
About Ovoca Bio
Ovoca Bio is a European-based biopharmaceutical company with a focus on women's health. The Company is currently developing a novel treatment for women with hypoactive sexual desire disorder (HSDD).
The Company's lead product, BP-101, a novel synthetic peptide administered through a nasal spray, is clinically validated, with Phase II and Phase III studies conducted in Russia demonstrating statistically significant improvement in a number of key efficacy outcomes, including an increase in female sexual desire and reduction of symptoms of distress associated with HSDD.
Ovoca Bio is seeking to develop the drug for major global markets - in particular the United States and Europe, as well as obtain marketing approval in the Russian Federation.
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