Russian Marketing Authorisation for Orenetide

RNS Number : 4664C

Ovoca Bio PLC

22 February 2022

 

Ovoca Bio plc

("Ovoca" or the "Company")

Ovoca Bio receives marketing approval for Orenetide for the treatment of hypoactive sexual desire disorder in premenopausal women in Russian Federation

Discussions regarding partnership for commercialisation of Orenetide in the Russian Federation ongoing

Dublin, Ireland, 22 February, 2022 - Ovoca Bio, an interanational biopharmaceutical company focusing on women's health, today announces that it has received a Marketing Authorisation ("MA") approval for Orenetide (BP-101), a novel synthetic peptide, by the Russian Ministry of Health ("Minzdrav"), for the treatment of hypoactive sexual desire disorder (or "HSDD") in premenopausal women .

Minzdrav has approved the medical prescription of Orenetide, administered through a nasal spray, to patients in the Russian Federation under the trade name 'Desirix' for the treatment of HSDD, a condition characterized by a distressing lack or loss of sexual desire. The MA was approved based on data from two Phase 1 studies, a Phase 2a study and the pivotal Phase 3 study completed in 2019, conducted in Russia, which established the safety and efficacy of Orenetide.

The approved manufacturing site for Orenetide will be operated by two reputable pharmaceutical manufacturers - Nativa and OncoTarget, with commercial production of Orenetide expected to start in Spring 2022. Ovoca Bio is currently in discussions with a number of partners to explore a potential license partnerships for sales of Orenetide on the Russian market.

Kirill Golovanov, Chief Executive Officer of Ovoca Bio plc, said: "Marketing authorisation approval for Orenetide in Russia is a welcome development for HSDD patients and a major step that provides Ovoca Bio with a solid foundation to engage in distribution agreements for commercialisation of the treatment in Russia. We are currently in several partnership discussions and will provide an update on our progress in due course.  

We are also continuing our development programme for Orenetide in a wider international markets which are Ovoca's principal target. Phase II dose-ranging study assessing Orenetide being conducted in Australia and New Zealand has reached over 70% of participants' enrolment, paving the way for Ovoca Bio target to reach 100% ennrolment of participants by mid-2022." 

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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, Charlotte Densmore

[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, Orenetide (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 several key efficacy outcomes, including an increase in female sexual desire and reduction of symptoms of distress associated with HSDD.

In February 2022 Ovoca Bio has got Marketing Authorisation for Orenetide in Russia and is seeking to develop the drug for major global markets - in particular, the United States and Europe.

 

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