TIDMOVB
RNS Number : 1383R
Ovoca Bio PLC
26 June 2020
Ovoca Bio plc
("Ovoca" or the "Company")
Publication of 2019 Annual Report
Dublin, Ireland, June 26, 2020 - Ovoca Bio, a biopharmaceutical
company with a focus on women's health, announces the publication
of its Annual Report and Financial Statements for the year ended 31
December 2019. The Annual Report and Financial Statements can be
viewed online at the following link:
http://www.rns-pdf.londonstockexchange.com/rns/1383R_1-2020-6-25.pdf
2019 Highlights
-- Successful completion of Phase III study of BP-101 in Russia
demonstrating statistically significant improvement in a number of
key efficacy outcomes in HSDD
-- Filing for approval for the marketing of BP-101 in Russia
-- Increase of its interest in the charter capital of its
subsidiary, IVIX LLC, which holds the commercial rights to BP-101,
to 100.0 per cent of outstanding equity
-- Selection of Australia as the most suitable choice for the
next stage of clinical development of BP-101, along with
identification of European regulatory needs and commissioning of
clinical trial drug supplies
-- Successful prosecution of intellectual property with granting of patents in the EU and Japan
-- Maintenance of strong financial position.
Letter from the CEO
It is my pleasure to provide you with an update on what has been
a significant and exciting year for Ovoca Bio.
With the Company's mission now focused on the women's health
sector in areas of high unmet medical need, we have been able to
make significant progress in the development of BP-101, a novel
treatment for women with hypoactive sexual desire disorder (HSDD),
a condition characterised by a distressing lack or loss of sexual
desire.
HSDD, is one of the most common female sexual problems and is
estimated to affect about one in ten premenopausal women. It
represents a significant unmet medical need and market opportunity
with an estimated 4 million premenopausal women in the US seeking
medical treatment for the condition. The prevalence of HSDD in this
population in Europe is similar to the US.
Since the initial acquisition in 2018 of IVIX LLC, the original
developer of BP-101, we have made significant progress in the
clinical and commercial development of the asset guided by
regulatory interactions with the health authorities in the Russian
Federation, Germany and the USA. Data from a Russian pivotal Phase
III trial of BP-101, which we announced in March 2019, showed that
the drug demonstrated a strong efficacy profile in patients with
HSDD. Patients reported a significant increase in the number of
satisfying sexual events when compared to a placebo controlled
group, as well as a significant improvement in sexual desire and
reduction of distress associated with low sexual desire.
In September 2019, we were pleased to announce the submission of
a marketing authorisation application for BP-101 with the Russian
Ministry of Health. If approved, BP-101 could be available for
marketing in the Russian Federation towards the end of 2020, an
exciting and significant development for the Company.
We look forward to providing further updates, including
potential partnering/ licensing opportunities for commercialisation
in the Russian Federation, in due course.
Most recently, management's focus has been on establishing
international operations in preparation for commencement of a dose
ranging study in a western population which is an important step in
the development of BP-101 for higher valued healthcare markets. We
have elected Australia as the preferred site for this Phase II
study, which is expected to further validate the results of the
Russian studies and, with completion of the concurrent preclinical
studies, provide data fully compliant with the standards of the
International Conference on Harmonisation that will ultimately
support a clinical programme in the US and EU.
Australia has so far been one of the least affected countries by
the COVID-19 pandemic, and based on the present situation there, we
are expecting to commence enrolment of patients later this calendar
year.
Finally, in March 2020, we were pleased to acquire the remaining
minority shareholding in IVIX LLC for a consideration of
approximately US$5 million, funded through existing capital
resources. This represented a further significant milestone and,
with full control of IVIX LLC, places us in a position to
accelerate the BP-101 development programme.
Reflecting the company's strategic shift, over the year there
have been a number of Board changes to support our growing status
in the international biotechnology community as a women's health
company.
We again thank Yuri Radchenko and Nikolay Myasoyedov for their
greatly valued services to the Board. We have also formalized an
advisory board of scientific experts to advise on our current and
future pipeline opportunities, and we anticipate further
announcements on this in due course.
In these economically unsettled times brought on by the COVID-19
pandemic, it is important to have sound finances, and we are
pleased to report that Ovoca Bio plc continues to have a strong
capital base. This will be used to support the exciting development
of our lead programme, BP-101 in HSDD, and selectively to expand
the pipeline where attractive opportunities are identified in
women's health. The Board remains highly optimistic for the future
of the Company and its potential to realize significant value for
our shareholders.
I would like to thank our employees and partners for enabling
the strong progress over the course of the year as we continue our
goal of addressing significant unmet needs in the women's health
sector.
Annual Report
The Annual Report and Financial Statements have been posted to
shareholders and are also available online at the
Company's website , www.ovocabio.com .
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), 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 has filed for approval for the marketing of BP-101 in
Russia and is seeking to develop the drug for major global markets
- in particular the United States and Europe.
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
ACSBLGDLGGDDGGU
(END) Dow Jones Newswires
June 26, 2020 02:00 ET (06:00 GMT)
Ovoca Bio (LSE:OVB)
Historical Stock Chart
From Mar 2024 to Apr 2024
Ovoca Bio (LSE:OVB)
Historical Stock Chart
From Apr 2023 to Apr 2024
