TIDMOVB
RNS Number : 6341L
Ovoca Bio PLC
14 September 2021
Ovoca Bio plc
("Ovoca" or the "Company")
Interim Results for the six months ended 30 June 2021
Dublin, Ireland, 14 September, 2021 - Ovoca Bio, a
biopharmaceutical company with a focus on women's health, is
pleased to announce its interim financial statements and report
covering the six-months ending 30 June 2021.
Please click on the following link to view the full Half Year
Report:
http://www.rns-pdf.londonstockexchange.com/rns/6341L_1-2021-9-13.pdf
Highlights:
-- More than 50 per cent. of patients enrolled in the Phase II
dose ranging study assessing BP-101 being conducted in Australia
and New Zealand
-- Following a publication in the World Health Organization's
International Non-proprietary Names for Pharmaceutical Substances,
BP-101 will now be referred to as "orenetide"
-- Marketing Authorisation ("MA") application for orenetide
updated and refiled with the Russian Ministry of Health (the
"Minzdrav") and a decision is expected by the end of 2021
-- Investment in a new manufacturing process and source in Europe
-- EUR9.3 (US$11.0) million in cash and cash equivalents as at
30(th) June 2021, compared to EUR10.7 (US$13.2) million as at
31(st) December 2020.
Letter from the CEO
During the period, Ovoca has maintained its focus on the
development of novel treatments in areas of unmet medical need in
the women's health sector, continuing to make progress in the
development of BP-101, a first-in-class treatment for women with
hypoactive sexual desire disorder (HSDD), a condition characterized
by a distressing lack or loss of sexual desire.
We are pleased to report that following a publication in the
World Health Organization's International Non-proprietary Names for
Pharmaceutical Substances, orenetide has been confirmed as the new
generic name for BP-101. This recognition by the WHO marks a
welcome step forward for Ovoca as we await a decision from the
Russian Ministry of Health (Minzdrav) on approval of the product in
the Russian Federation based on data from two Phase 1 studies, a
Phase 2a study and the pivotal Phase 3 study conducted in
Russia.
In December 2020 Ovoca submitted an updated Marketing
Authorisation application for orenetide to the Minzdrav , with a
decision anticipated by the end of 2021. A positive approval will
facilitate a pathway towards commercialisation of the product
within the Russian Federation. To this end, and in line with our
stated strategy, Ovoca is pursuing potential partnering
arrangements with the manufacturer of orenetide in Russia for its
distribution and sale there. We will provide an update to the
market once those are finalised.
A previous MA submission filed with the Minzdrav in October 2020
was not approved due to concerns relating to the chemistry,
manufacturing and controls (CMC) and labelling sections of the MA
submission dossier. However, our understanding was that this was
not in any way related to the safety or efficacy of orenetide
itself, or the data provided in support of this. As previously
reported, the concerns raised by the Minzdrav have now been fully
addressed, including the CMC issues in conjunction with our product
supplier for the Russian market.
With respect to development for more profitable international
markets, in January 2021 Ovoca announced that the first patient had
been enrolled in our clinical study being undertaken in Australia
and New Zealand aimed at providing further data to validate
orenetide internationally. The Phase II, double-blind,
placebo-controlled, dose ranging study of orenetide is now more
than 50 per cent. enrolled towards the study target. Initially it
was anticipated that recruitment would be completed by the end of
2021, but with recent and restrictive measures being taken by the
Australian authorities to slow the spread of COVID-19, the
recruitment rate into the trial has been impacted. As a result of
this, our current expectation is that recruitment is now likely to
complete in the first half of 2022.
In parallel with our clinical development activities, we are
collaborating with one of the leading European peptide
manufacturers to produce orenetide under an improved manufacturing
process. In the short term, this is intended to deliver sufficient
material to support the upcoming long-term toxicological
assessments, as required by the US Food and Drug Association and
regulatory authorities in Europe and, longer term, our future
clinical work and commercialisation plans for orenetide
internationally.
With few treatments available, there remains a high unmet
medical need for patients suffering from hypoactive sexual desire
disorder (HSDD), one of the most common female sexual problems
globally, with an estimated one in ten premenopausal women
affected. As previously reported, having reviewed clinical data
from the Phase II and Phase III trials conducted in Russia,
orenetide may also be effective as a treatment for Female Orgasmic
Disorder. Research suggests that orgasmic difficulty affects 16-28%
of women in the United States, Europe, Central and South America,
and Mainland China, making it the second most frequently reported
female sexual dysfunction. The business is currently exploring how
best to investigate orenetide's potential treatment effect in this
patient population.
We are pleased to note also that the business retains a firm
capital base, with EUR9.3 (US$11.0) million in cash and cash
equivalents at 30(th) June 2021 ( compared to EUR10.7 (US$13.2 )
million as at 31(st) December 2020) and, notwithstanding the
continuing uncertainties created by the COVID pandemic, we remain
cautiously optimistic about future trading prospects and operating
conditions. The Board continues to work hard to achieve our vision
to become a leader in the research and development of, and
commercial partner of choice for, novel medicines in areas of high
unmet need that affect women. I would like to take this opportunity
to thank our shareholders for their continue support. We look
forward to providing further updated on both our corporate and
clinical activities.
End
For further information:
Ovoca Bio plc
Kirill Golovanov (Chief Executive)
Tel +353 1 661 9819
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, 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, orenetide (also referred to as
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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