REG - Ovoca Bio PLC - Russian Marketing Authorisation for Orenetide

Ovoca BioAnnouncement

22/02/2022 15:30

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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."

 

 

 

End

 

For further information:

Ovoca Bio plc

Kirill Golovanov (Chief Executive)

Tel +353 1 661 9819

info@ovocabio.com (mailto:info@ovocabio.com)

 

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, Charlotte Densmore

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), 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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