Nicox S.A. (NYSE Euronext Paris: COX) today
announced the European launch of Xailin(TM), a new range of tear
lubricants (medical devices) for relief of dry eye symptoms, and of
AdenoPlus®, an in vitro diagnostic medical device (IVDMD) to help
the differential diagnosis of acute conjunctivitis. Nicox is now
promoting and selling the first Xailin(TM) products and AdenoPlus®
through its own sales force in the UK, Italy, Spain and France.
Commercial operations in Germany are expected to begin in the
second quarter of 2014.
Xailin(TM) - a proprietary brand of
tear lubricants
Xailin(TM) is a proprietary brand under which Nicox intends to
commercialize a range of products for dry eye, starting with the
first two products, a multi-dose preservative-free lubricating
ointment for night-time relief of dry eye sensations, and a
unit-dose preservative-free lubricant that alleviates and soothes
dry eye sensations.
The Xailin(TM) range will include medical devices developed by
Medicom Healthcare, a private UK-based pharmaceutical company
specializing in Ophthalmics, as per an exclusive supply and
distribution agreement signed in March 2013. Nicox will launch the
Xailin(TM) range of artificial tears in Europe, Middle East and
Africa. Other tear lubricants are planned to be launched throughout
the year 2014.
AdenoPlus ® for
detection of adenoviral conjunctivitis
Nicox's specialist sales force will also market AdenoPlus®, an
in vitro diagnostic medical device that aids in the identification
of adenovirus to assist in the differential diagnosis of acute
conjunctivitis. Correct diagnosis of viral conjunctivitis can help
to reduce the inappropriate use of antibiotics. Nicox in-licensed
AdenoPlus® from Rapid Pathogen Screening, Inc. in June 2012 and has
exclusive rights to commercialize AdenoPlus® to eye care
professionals in the US, as well as full exclusive rights to market
AdenoPlus® in the rest of the world. AdenoPlus® has been marketed
in the United States by Nicox since November 2012.
"The Xailin(TM) range aims to cover all aspects of dry eye
syndrome, offering healthcare professionals a wide range of eye
lubricants addressing patients' needs," said Philippe
Masquida, Executive Vice President, European and International
Operations of Nicox. "The launch of Xailin(TM) and
AdenoPlus® in Europe is an important milestone in Nicox's strategy
of building an emerging European ophthalmic Group focused on
pharmaceuticals, devices and diagnostics. Additional commercial
launches are planned in the short to mid-term, with products coming
from our internal development program as well as from acquisitions
or in-licensing agreements. We look forward to making announcements
about our infrastructure in Germany and further product agreements
and launches in due course."
Internal development program
In addition to the ophthalmic assets in-licensed or acquired
from partners, Nicox is also developing an internal range of eye
care products including medical devices, nutraceuticals and
therapeutics. In 2013, Frédéric Pilotaz joined Nicox as Director of
Pharmaceutical Operations to lead the development of these internal
projects. Nicox intends to start launching products from this
internal range in 2015.
Significant commercial infrastructure
established in Europe's five largest
markets
Nicox's strategy is to build its own infrastructure to
commercialize ophthalmic products in the United States and the five
largest European markets. The Company's European commercial team
had 73 employees at the end of February 2014, led by Philippe
Masquida, Executive Vice President, European and International
Operations. In preparation for the Xailin(TM) and AdenoPlus®
launches, Nicox has made significant progress in building its
presence in Europe's major markets both through acquisitions and
the recruitment of commercial specialists with significant
experience in the European ophthalmic market:
- UK: David Trevor was appointed Vice President, Managing
Director UK and Head of European Sales Force Effectiveness in early
2013, opening offices in Guildford and building up an experienced
sales force.
- Italy: Nicox acquired Eupharmed in December 2013, bringing an
established commercial team covering the Italian ophthalmic market.
Early 2014, Benito Guerra has been appointed Managing Director,
Italy, based near Milan.
- Spain: Davide Buffoni was appointed Managing Director, Spain,
in early 2013, building up a sales force from offices in
Madrid.
- France: Jean-François Mazelier joined Nicox in late 2013 as
Managing Director, France, based at the Company's headquarters in
Sophia Antipolis, in the Nice area.
- Germany: Torsten Cornelius will join Nicox as Managing
Director, Germany, in April 2014. Nicox expects to start to build a
sales force in Germany during the second quarter of 2014, with
offices based in Berlin.
François Ducret, Director of International Operations, is in
charge of building a network of distributors for Nicox's products
in other markets. Partnerships have been signed with distributors
in Turkey, Benelux and Switzerland, and Nicox is in advanced
discussions for distribution in a number of other key international
markets. In addition, Nicox has appointed a leading international
logistics provider for the storage and shipment of products in all
countries outside the United States.
About dry eye syndrome
Dry eye syndrome is fairly common in adults over age 40 and
covers all disorders of the tear film, the thin liquid film
protecting the exposed ocular surface of the eye. The main
functions of the tear film are metabolic, lubricant and dioptric.
For a sensation of well-being, the lacrimal system must be in
perfect condition, and any change will cause varying degrees of
ocular discomfort. The most common symptoms of dry eye syndrome are
the sensation of a foreign body in the eye, reddening, pain and
burning.
The main causes of dry eye syndrome include age (notably
menopause), environment (dry and dusty air, exposure to smoke),
contact lenses, medical conditions (including diabetes, autoimmune
diseases such as Sjögren's syndrome, eyelid diseases etc.) and
medication (including antidepressants, antihypertensives, etc.).
The treatment of dry eye is based on the restoration of the tear
film with lubricant eye drops. It is also useful to advise patients
on how to reduce eye strain, such as blinking frequently, changing
focus from near vision to distance vision, taking regular short
breaks, checking ambient light, eliminating sources of reflected
glare and regulating humidity and ventilation.
About the diagnosis of acute conjunctivitis
Acute Conjunctivitis is often misdiagnosed due to the
overlapping presentation of signs and symptoms among viral,
bacterial, and allergic conjunctivitis, the major subtypes.
Misdiagnosis represents a major problem, as adenoviral
conjunctivitis is highly contagious and associated with significant
morbidity. This includes decreased visual acuity, light
sensitivity, chronic excessive tear production, visual loss and
presence of sub-epithelial infiltrates. The majority of acute
conjunctivitis cases result in a prescription for antibiotics, even
in viral cases when antibiotics are not necessary. Inappropriate
antibiotic use may increase adverse effects, promote resistance and
add avoidable costs to the healthcare system.
...................................
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 2012 » filed with the French Autorité des Marchés
Financiers (AMF) on March 22, 2013 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 S.A. Drakkar 2 | Bât D | 2405 route des Dolines | CS 10313
| Sophia Antipolis | 06560 Valbonne | France T: +33 (0)4 97 24 53
00 | F: +33 (0)4 97 24 53 99
www.nicox.com
Nicox launches AdenoPlus® and Xailin(TM) in Europe
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