Nicox S.A. (NYSE Euronext Paris: COX), the
international ophthalmic company, today provides an update on its
first quarter 2014 revenues and cash position.
First-quarter financial summary
Revenues in the first three months of 2014 totalled €1.1
million, compared with €0.1 million in the first quarter of 2013.
The Group had cash, cash equivalents and current financial
instruments of €49.6 million as of March 31, 2014, with no bank
indebtedness. The Company will issue comprehensive six-month
financial results on July 31, 2014.
The first-quarter revenues represent the first significant
recurring revenues from Nicox's growing portfolio of ophthalmic
products, currently in the launch phase, including initial sales
from AdenoPlus® and the Xailin(TM) dry eye product range in Europe
and of Sjö(TM) in the United States. AdenoPlus® is now
commercialized in Europe and in the US for differential diagnosis
of conjunctivitis. Nicox's new range of tear lubricants for relief
of dry eye symptoms, starting with Xailin Night and Xailin Fresh,
were launched in Europe in March 2014. The Company expects to
launch the RetnaGene(TM) AMD test, for evaluation of the risk of
Age-related Macular Degeneration progression, in the US by the end
of June 2014 and to continue to roll out Sjö(TM) in the major US
markets for the early detection of Sjögren's syndrome.
First-quarter operational summary
Agreement with Sequenom in age-related macular
degeneration (AMD)
In January 2014, Nicox was granted the North American
promotional rights to the Sequenom Laboratories RetnaGene(TM) AMD
laboratory-developed test, for the evaluation of a patient's risk
of AMD disease progression within 2, 5 and 10 years. Nicox expects
to begin promoting in the United States by end June 2014 the
RetnaGene(TM) AMD test as well as an additional AMD
laboratory-developed test also covered by the agreement with
Sequenom Laboratories.
European launch of Xailin(TM) range and
AdenoPlus®
In March 2014, Nicox launched Xailin(TM), a new range of tear
lubricants for relief of dry eye symptoms, in Europe (classed as
medical devices). Other tear lubricants are planned to be launched
throughout 2014, offering ophthalmologists a full range of options.
In parallel, Nicox also launched AdenoPlus® in Europe, an in vitro
diagnostic medical device that aids in the identification of
adenovirus to assist in the differential diagnosis of acute
conjunctivitis. Nicox has already established specialist sales
teams in Italy, the UK, Spain and France. A team is currently being
built Germany, with product launches expected to begin in the
second quarter of 2014.
Expansion of the Group's U.S. commercial
team
In the first quarter of 2014, Nicox continued strengthening its
American subsidiary, Nicox Inc., to support the upcoming roll-out
of Sjö(TM) and launch of RetnaGene(TM) AMD. Nicox Inc. appointed
Mark Jasek, PhD, as Senior Director and Head, Medical &
Scientific Affairs. Dr. Jasek will serve as a key scientific
affairs expert as well as act as liaison between Nicox and the
North American ophthalmic scientific community. Dennis Pardo OD,
MPH, FAAO, was appointed to the position of Director of
Professional Affairs. In this role, Dr. Pardo will partner with key
opinion leaders in the Retina and Rheumatology areas and will serve
as the primary liaison between Nicox and the Sjögren's Syndrome
Foundation.
Presence at major international congresses
Nicox attended several key international congresses in the
ophthalmic area, including the Hawaiian Eye meeting in Hawaii,
United States, the Società Italiana Trapianto di Cornea (SITRAC)
National Congress in Padova, Italy, the International Ocular
Inflammation Society Congress (IOIS) in Valencia, Spain, the South
Eastern Congress of Optometry International (SECO) in Atlanta,
United States and the Journées Réflexions Ophtalmologiques (JRO) in
Paris, France.
Naproxcinod repositioned in Duchenne muscular dystrophy
(DMD)
In February 2014, Nicox granted an undisclosed financial partner
the right to enter into a period of exclusive evaluation to assess
the potential development of naproxcinod, a CINOD
(Cyclooxygenase-Inhibiting Nitric Oxide-Donating) anti-inflammatory
candidate, and of next generation nitric oxide-donors outside the
ophthalmology area. The evaluation will be entirely funded by the
partner and will be focused initially on DMD. Promising preclinical
results obtained with naproxcinod in models of muscular dystrophy
were published in Human Molecular Genetics in early 20141.
Naproxcinod was granted orphan drug designation in Europe in
October 2013 for the treatment of DMD.
Management team
In February 2014, Evelyne Nguyen was appointed Chief Financial
Officer (CFO) of Nicox, succeeding Eric Castaldi.
Post-first quarter events
Clinical and preclinical results obtained with latanoprostene
bunod were presented by Bausch + Lomb at the Association for
Research in Vision and Ophthalmology (ARVO) Annual meeting in
Orlando, Florida (May 4-8), including results from two clinical
studies (CONSTELLATION and KRONUS) as well as some preclinical
results on the effect of latanoprostene bunod on primary human
trabecular meshwork cell contractility and underlying signaling
pathways2. Latanoprostene bunod is a nitric oxide-donating
prostaglandin F2-alpha analog currently in Phase 3 clinical
development with Bausch + Lomb for the reduction of intraocular
pressure in patients with glaucoma and ocular hypertension.
Top-line Phase 3 data are expected during the fourth quarter of
2014.
Nicox attended the 2014 ASCRS (American Society of Cataract and
Refractive Surgery) · ASOA (American Society of Ophthalmic
Administrators) Symposium & Congress in Boston, Massachusetts
(April 25-29), as well as the Société Française d'Ophtalmologie
(SFO) Congress in Paris, France (May 10-13).
...................................
References: 1 Long-term treatment with naproxcinod significantly
improves skeletal and cardiac disease phenotype in the mdx mouse
model of dystrophy, Uaesoontrachoon K, Quinn JL, Tatem KS, Van der
Meulen JH, Yu Q, Phadke A, Miller BK, Gordish-Dressman H, Ongini E,
Miglietta D, Nagaraju K. Hum Mol Genet. 2014, Early online
publication Jan 23, 2014. 2 The abstracts are available on the
ARVO 2014 Online Planner
(http://www.arvo.org/ARVO_2014_Mobile_App/).
...................................
About Nicox
Nicox (Bloomberg: COX:FP, Reuters: NCOX.PA) is
an emerging international company focused on the ophthalmic market.
With a heritage of innovative R&D, business development and
commercial expertise, the Nicox team is building a diversified
portfolio of therapies and diagnostic tools that can help people to
enhance their sight. The Company's commercial portfolio and
near-term pipeline already include several innovative diagnostic
tests intended for eye care professionals, as well as a range of
eye care products. Nicox's key proprietary asset in ophthalmology
is latanoprostene bunod, a novel compound based on Nicox's
proprietary nitric oxide (NO)-donating R&D platform, currently
in Phase 3 clinical development in collaboration with Bausch + Lomb
for the potential treatment of glaucoma and ocular hypertension.
Further NO-donors are under development, notably through
partners.
Nicox is headquartered in France, with research
capabilities in Italy, a growing commercial infrastructure in North
America and in the major European markets and an expanding
international presence through partners. Nicox S.A. is listed on
Euronext Paris (Compartment B: Mid Caps). For more information on
Nicox or its products please visit www.nicox.com.
...................................
This press release contains certain forward-looking
statements. Although the Company believes its expectations are
based on reasonable assumptions, these forward-looking statements
are subject to numerous risks and uncertainties, which could cause
actual results to differ materially from those anticipated in the
forward-looking statements.
Risks factors which are likely to have a material effect
on Nicox's business are presented in the 4th chapter of the «
Document de référence, rapport financier annuel et rapport de
gestion 2013 » filed with the French Autorité des Marchés
Financiers (AMF) on April 2, 2014 and available on Nicox's website
(www.nicox.com) and on the AMF's website
(www.amf-france.org).
...................................
Contacts |
|
Nicox |
Gavin
Spencer | Executive Vice President Corporate
Development |
|
Tel +33 (0)4 97 24 53 00 |
communications@nicox.com |
|
|
Media
Relations |
|
|
|
United
Kingdom |
Jonathan
Birt |
|
M +44 7860 361 746 |
jonathan.birt@ymail.com |
|
|
France |
Caroline
Courme | Communication Manager |
|
Tel +33 (0)4 97 24 53 43 |
courme@nicox.com |
Nicox: first quarter 2014 financial information
http://hugin.info/143509/R/1785957/612599.pdf
HUG#1785957
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