Update re Russian Marketing Authorisation

RNS Number : 8444A

Ovoca Bio PLC

02 October 2020

 

Ovoca Bio plc

("Ovoca" or the "Company")

Update on Marketing Authorisation application for BP-101 in Russian Federation

Dublin, Ireland, 2 October, 2020 - Ovoca Bio, a biopharmaceutical company with a focus on women's health, provides an update on the Marketing Authorisation ("MA") application for BP-101, a novel synthetic peptide administered through a nasal spray, that was submitted to the Russian Ministry of Health ("the Minzdrav") in September 2019. The MA was filed for the treatment of decreased sexual desire in women, including hypoactive sexual desire disorder (or "HSDD"), a condition characterised by a distressing lack or loss of sexual desire.

Ovoca has been informed that the Minzdrav has not granted the MA to BP-101 following the identification of certain issues relating to the chemistry, manufacturing and controls (CMC) and labelling sections of the MA submission dossier. The Company notes that no issues were highlighted by the Minzdrav regarding the safety or efficacy of BP-101 in the acquired generalized form of HSDD, which has been established by clinical data from two Phase 1 studies, a Phase 2a study and the pivotal Phase 3 study completed in 2019, all as conducted in the Russian Federation.

Ovoca is undertaking an internal review of the comments received from the Minzdrav, in order to understand the changes required to the label to make approvable and the required scope of work to CMC-related processes. This will include an assessment of how best to address the identified CMC issues with the current Russia based contract manufacturer or through different suppliers. An update will be provided in due course on this review and Ovoca's plans for a full resubmission for MA in the Russian Federation.

The Company is presently investigating alternative producers of active pharmaceutical ingredient (API) situated in major markets for global commercial drug supply, as well as the establishment of a CMC operational unit located in the Republic of Ireland. Clinical drug supply for Ovoca's upcoming Phase II trial of BP-101 in Australia is being provided by Swiss and  British contract manufacturers with extensive experience in supplying clinical trials.

Kirill Golovanov, Chief Executive Officer of Ovoca Bio plc, said: "This is a disappointing outcome for Ovoca but we are confident that the questions raised by Minzdrav, related to the CMC and labeling portions of the application, can be addressed to the satisfaction of the regulator. We are currently undertaking an internal review to determine how best to proceed, including next steps for CMC in Russia and will update in due course.

This has no implications for the drug product being supplied for our primary goal, the ongoing clinical development programme for BP-101 in high value Western markets, where we are working with well-established drug manufacturers in Switzerland and the UK. Preparations are currently underway to start our Phase II dose ranging study in Australia, 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 [phone]

[e-mail]

Davy (Nominated Adviser, Euronext Growth Advisor and Broker)

John Frain / Daragh O'Reilly

Tel: [phone]

Consilium Strategic Communications

Chris Gardner, Chris Welsh, Carina Jurs

[e-mail]

Tel: [phone]

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), a condition characterized by a distressing lack or loss of sexual desire affecting an estimated ~4 million premenopausal women in the US alone.

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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