SOPHIA ANTIPOLIS CEDEX, FRANCE--(Marketwire - Oct 22, 2012) -
* Innovative device for differential diagnosis of acute conjunctivitis is
Nicox's first commercial launch
* New visual identity unveiled to present Nicox as a specialty ophthalmic
group
Nicox S.A. (PARIS: COX) today announces its United States (US)
launch of AdenoPlus™, the first and only FDA-cleared, CLIA-waived(1),
rapid
point-of-care diagnostic test that aids in the differential diagnosis of
acute
conjunctivitis. AdenoPlus™ is Nicox's first product launch since it
announced
its strategy of becoming an international,
late-stage development and commercial
ophthalmic business, reflected by a new visual identity also unveiled
today.
Michele Garufi, Chairman and CEO of Nicox, commented: "With AdenoPlus™
Nicox
has taken a first step towards fulfilling its objective of starting a
commercial
business in the ophthalmic space. We have established a specialized sales
team
on the ground who will be marketing and selling this innovative and
easy-to-use
product to eyecare practitioners across the US, bringing a new, fast and
accurate diagnostic option that will aid in the differential diagnosis of
acute
conjunctivitis.
The entire management team is working tirelessly to secure additional
ophthalmic
assets to build a comprehensive portfolio of diagnostics, therapeutics and
medical devices. With Bausch + Lomb's positive results observed in phase 2b
with
our glaucoma candidate earlier this year, solid internal R&D expertise and
a
growing network in the eyecare field, I believe we are in a strong position
to
grow rapidly as a specialist ophthalmic business."
AdenoPlus™ can rapidly aid in the differential diagnosis of acute
Conjunctivitis
AdenoPlus™ accurately detects adenovirus, which accounts for up to 90%
of all
viral conjunctivitis, and approximately one out of four cases of acute
conjunctivitis seen by eyecare practitioners(2). As part of a "Red Eye
Protocol", AdenoPlus™ can offer eyecare professionals an efficient and
effective method to diagnose the cause of the disease. The test, which has
90%
sensitivity and 96% specificity, is fast and easy-to-use. The simple,
four-step
process takes less than two minutes to complete and provides a definite
result
in just ten minutes. An accurate diagnosis enables clinicians to make
better
therapeutic decisions based on diagnostic evidence and allows patients to
leave
the clinician's office better informed and better prepared, knowing if
their red
eye is adenovirus and whether they can return to work. For more information
on
AdenoPlus™, please call 1.855.MY.NICOX (from the US).
Acute Conjunctivitis is often misdiagnosed due to the overlapping
presentation
of signs and symptoms among the major subtypes
It has been estimated that at least 6 million cases of acute conjunctivitis
are
diagnosed in the US each year(3) and studies indicate that eyecare
professionals make an accurate clinical diagnosis approximately 50% of the
time(2). This is because viral, bacterial, and allergic conjunctivitis -
the
most common types - manifest similarly, making differential diagnosis using
only
signs and symptoms challenging. Misdiagnosis represents a major problem, as
adenovirus is highly contagious and associated with significant morbidity,
including decreased visual acuity, light sensitivity, chronic excessive
tear
production, visual loss and presence of subepithelial 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.
Jerry St. Peter, Executive Vice President and General Manager of Nicox
Inc.,
said: "Our first commercial launch is poised to transform the way eyecare
practitioners diagnose, and subsequently manage, acute conjunctivitis.
AdenoPlus™ is accurate, fast, cost-effective, and performed at the point
of
care, making it a valuable test in seeking an immediate and accurate
diagnosis.
As a product, AdenoPlus™ is an embodiment of our ongoing mission: to
bring
effective, efficient, and evidence-based solutions to the ophthalmic
market."
New visual identity unveiled today
Nicox has also today unveiled a new brand identity that represents its new
positioning as an international late-stage development and commercial
ophthalmic
group. The new logo, together with the tagline 'Visible Science',
underlines the
Company's strong R&D heritage now leveraged in the ophthalmic field.
Nicox to attend AAOpt and AAO annual meetings
Nicox will attend the American Academy of Ophthalmology (AAO) & Asia
Pacific
Academy of Ophthalmology (APAO) 2012 Joint Meeting, taking place from
November
10 to 13 in Chicago, Illinois (booth 2735). Nicox will also be present at
the
91(st) Annual Meeting of the American Academy of Optometry (AAOpt) from
October
24 to 27, 2012, in Phoenix, Arizona (booth 517).
Worldwide licensing agreement between Nicox and RPS®
AdenoPlus™ was in-licensed from Rapid Pathogen Screening, Inc
(RPS®) in June
2012, together with other ocular diagnostic tests currently in development.
The
worldwide licensing agreement grants Nicox exclusive rights to
commercialize
AdenoPlus™ to eyecare professionals in the US, as well as full exclusive
rights to market AdenoPlus™ in the rest of the world. RPS®
maintains rights
to commercialize these ocular tests to primary and urgent care
professionals in
the US.
Following the completion of the worldwide licensing agreement, Nicox has
built
up its sales infrastructure in the US. During this period, RPS® has
taken
AdenoPlus™ orders for Nicox. Nicox's sales team is now actively starting
the
direct marketing of AdenoPlus™ to targeted eyecare practitioners in the
US.
The launch of AdenoPlus™ represents an important first step in the
Company's
new strategy but will not take Nicox to profitability on its own. Nicox
plans to
exploit its new sales infrastructure to market other ophthalmic products in
the
future.
AdenoPlus™ is CE-marked and is available for sale by Nicox or its
distributors in Europe and other countries. Nicox is focused on strategic
efforts to secure AdenoPlus™ reimbursement throughout Europe.
(1) The Clinical Laboratory Improvement Amendments (CLIA) establishes
quality
standards for all laboratory testing to ensure the accuracy, reliability
and
timeliness of patient test results regardless of where the test was
performed. A
waiver signifies that the test has been classified as a low complexity
device,
which allows medical office personnel of CLIA-waived offices (not only
physicians) to perform it.
(2) O'Brien TP, Jeng BH, McDonald M, et al. Acute conjunctivitis: truth
and
misconceptions. Curr Med Res Opin. 2009 Aug; 25(8):1953-61.
(3) 2005 Thomson Healthcare Medstat
About Nicox
Nicox (Bloomberg: COX:FP, Reuters: NCOX.PA) is creating an international,
late-stage development and commercial ophthalmic group based around
therapeutics,
diagnostics and
devices.
Nicox has inlicensed innovative ocular diagnostics from RPS®,
including
AdenoPlus™, a test for the detection of adenoviral conjunctivitis
already
authorized for marketing in the United States and Europe. The Company
has a
partnership with Bausch + Lomb for the development of BOL303259X, a
novel
glaucoma candidate based on Nicox's proprietary nitric
oxide-donating R&D
platform.
Further nitric oxide-donating compounds are under development in
non-ophthalmic
indications notably through partners, including Merck (known as MSD
outside the
United States and Canada) and
Ferrer.
Nicox S.A. is headquartered in France and is listed on Euronext
Paris
(Compartment C: Small Caps). For more information 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 2011 » filed with the French
Autorité des Marchés
Financiers (AMF) on February 29, 2012 and available on Nicox's website
(www.nicox.com) and on the AMF's website www.amf-france.org).
Nicox launches AdenoPlus™ in the United States:
http://hugin.info/143509/R/1650774/532398.pdf
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Source: NICOX via Thomson Reuters ONE
[HUG#1650774]