SOPHIA ANTIPOLIS CEDEX, FRANCE
-- (Marketwired)
-- 06/19/13

Nicox Strengthens Ophthalmic
Portfolio with Immco Diagnostics' Proprietary Test
in the Dry Eye Market
Exclusive North American Agreement with rest of the world option
* Exclusive rights to promote a proprietary laboratory test targeted at
early
diagnosis of Sjögren's Syndrome, one of the most prevalent and
underdiagnosed of all auto-immune diseases, with dry eye being among
the
early signs and symptoms
* With more than 20 million patients suffering from dry eye in the US(1),
eye
care practitioners are poised to play a significant and pivotal role in
Sjögren's Syndrome identification
* 1 in 10 patients with dry eye symptoms may have undiagnosed
Sjögren's
Syndrome(2)
* Test was approved in the US in 2013 and available to doctors across
North
America. Commercial launch by Nicox expected in the second half of this
Year
* Nicox to receive majority share of revenue
June 19, 2013.
Sophia Antipolis, France.
Nicox S.A. (NYSE Euronext Paris: COX) announced today that it has entered
into
an exclusive agreement with Immco Diagnostics Inc.("Immco"), a worldwide
leader
in autoimmune diagnostic products and services, to promote a proprietary
laboratory test targeted at early detection and diagnosis of Sjögren's
Syndrome
to eye care professionals in North America. Dry eye is one of the early
primary
symptoms of the disease and the collaboration will give eye care
practitioners
and their patients' increased access to this new state-of-the-art and
unique
test which supports early diagnosis and potentially more efficient
management of
this chronic disease.
Under the terms of the agreement, Immco will grant Nicox the exclusive
rights to
promote the laboratory test to eye care practitioners in North America (US,
Canada, Puerto Rico, Mexico). Nicox will be responsible for all marketing
activities, while Immco will carry out the test in its CLIA-approved
laboratory
in Buffalo, NY, and be responsible for regulatory activities and
reimbursement.
Nicox will receive a majority share of revenue generated from eye care
practitioners and no upfront or milestones payments will be made by Nicox.
Nicox
also has a nine month option to negotiate an agreement to promote the test
in
the rest of the world. During this period, Immco and Nicox are planning to
study
and evaluate the feasibility and implementation steps for the test in other
markets, including Europe.
Sjögren's Syndrome is among the most common and underdiagnosed
autoimmune
diseases. Current diagnostic methods are only moderately effective at
diagnosing
the disease and can be used only once it has progressed to an advanced
stage
where treatment options are limited.
"This new test will facilitate faster diagnosis and we look forward to
working
in partnership with our eye care colleagues. Many early stage
Sjögren's Syndrome
patients see their Ophthalmologist or Optometrist initially with dry eye
signs
and symptoms, in some cases years before ever being formally diagnosed at
later
stage by a Rheumatologist. The eye care community is really on the "front
line"
of identifying and detecting these patients at an early stage where we can
have
a more profound impact on the course of the disease", said Julian L. Ambrus
Jr.,
M.D., Associate Professor of Medicine, Rheumatology, University of Buffalo.
Sjögren's Syndrome causes patients' immune cells to attack
moisture-producing
glands resulting in dry eye which is one of the early and hallmark symptoms
of
the disease. Sjögren's Syndrome frequently progresses into a
multisystem
disorder involving exocrine glands and other organs, and can lead to a
significant increased risk of lymphoma.
Dry eyes are among the most common reasons for patients to visit an eye
care
professionals' office today. In the US alone, it is estimated that more
than
20 million patients aged 40 years and older have dry eye disease(1).
Studies
indicate that 10% of these may have early stage, yet to be diagnosed,
Sjögren's
Syndrome(2). At present, many of these patients who develop the advanced
disease
will not be diagnosed until much later by another medical specialty.
The new laboratory test developed by Immco is a highly sensitive and
specific
diagnostic test combining three novel proprietary biomarkers (SP-1, CA-6,
PSP)
and the traditional markers (ANA, Ro, La, RF). This breakthrough test can
aid in
diagnosing Sjögren's Syndrome at an earlier stage compared to
traditional
methods therefore significantly improving management of the disease. The
test
was approved by the appropriate US regulatory authorities in 2013, and is
already available to doctors across North America.
"The convergence of Dry Eye symptoms and undiagnosed, early stage
Sjögren's
Syndrome uniquely positions Ophthalmologists and Optometrists to be able to
make
this diagnosis because these patients are coming into our offices every
day.
Clinical studies have indicated that about 1 in 10 patients with clinically
significant dry eye are positively diagnosed with Sjögren's Syndrome
which may
surprise many eye care professionals" said Gary Foulks, M.D., Emeritus
Professor
of Ophthalmology, University of Louisville School of Medicine.
Nicox has significant experience within the ocular surface disease space
and
ophthalmic diagnostic markets, and recently built its own commercial
organization in the US. The Company intends to expand its existing sales
organization to maximize the opportunity with this new test alongside
AdenoPlus®, the first and only CLIA-waived point-of-care diagnostic
test that
aids in the differential diagnosis of acute conjunctivitis, and other
point-of-care diagnostic tests.
"Immco is a well-established and innovative organization with a reputation
for
cutting edge science and high quality products. The addition of this new
test
into our portfolio synergizes well with our existing point-of-care
offering, and
will contribute to the momentum we are building in the marketplace with
AdenoPlus®", said Jerry St Peter, Executive Vice President and General
Manager
of Nicox Inc.
"Nicox is one the few eye care specialists in the world with an already
existing marketing and sales infrastructure in the ophthalmic diagnostic
space.
This expertise makes Nicox an ideal partner to deliver Sjögren's
diagnostic
solutions", said Bill Maggio, President and CEO of Immco Diagnostics.
About the laboratory test
The development of this new diagnostic test is based on the discovery of
novel
antibodies in Sjögren's Syndrome by researchers at the University at
Buffalo and
Immco Diagnostics, Inc.: SP-1 (salivary gland protein-1), CA-6 (carbonic
anhydrase-6) and PSP (parotid secretory protein). Traditional tests use
ANA, Ro,
La and RF antibodies which have significant limitations of sensitivity
and/or
specificity and are associated with later-stage disease. During studies,
these
novel antibodies were found in 45% of patients meeting the criteria for
Sjögren's Syndrome who lacked the traditional antibodies for Ro or La.
In
patients diagnosed with idiopathic xerostomia and xerophthalmia for less
than
two years, 76% had antibodies to SP-1 and/or CA-6 while only 31% had
antibodies
to Ro or La(3).
The new test combines novel and traditional markers supporting an accurate
and
early diagnosis with high sensitivity and specificity. US eye care
practitioners
can obtain more information on the test by calling 1.855.MY.NICOX.
About Sjögren's Syndrome
Sjögren's Syndrome is a systemic chronic autoimmune disorder of the
exocrine
glands with associated lymphocytic infiltrates in affected glands. It is
one of
the most common and underdiagnosed autoimmune disorders affecting more than
4
million Americans(4). Involvement of the lacrimal and salivary glands
leads to
the classic symptoms of dryness of the eyes and mouth.
Ocular signs and symptoms of Sjögren's Syndrome are consistent with
the
presentation of dry eye syndrome. Patients often complain of ocular
irritation
with the accompanying symptoms: burning, stinging, itching, foreign body
sensation, lid irritation and swelling, photophobia, ocular fatigue, mucoid
discharge. As disease progression advances, patients experience
significant
morbidity, diminished gland performance, and eventual atrophy.
Damage to other body parts (joints, thyroid, kidneys, liver etc.), and
increased
dental damage (tooth loss, infection) is also common in advanced disease,
along
with an increased risk of developing lymphoma.
(1 )2010 Datamonitor report
(2) Prevalence and predictors of Sjögren's syndrome in a prospective
cohort of
patients with aqueous-deficient dry eye - Melissa (Shiao Hui) Liew, Min
Zhang,
Elizabeth Kim, Esen K Akpek
Evaluation of Patients with Dry Eye for Presence of Underlying
Sjögren's
Syndrome - Esen Karamursel Akpek, MD, Alena Klimava, BS, Jennifer E.
Thorne, MD,
PhD, Don Martin, MD, Kaevalin Lekhanont, MD, and Ann Ostrovsky, MD
(3 )Novel autoantibodies in Sjogren's syndrome - Long Shen, Lakshmanan
Suresh,
Matthew Lindemann, Jingxiu Xuan, Przemek Kowal, Kishore Malyavantham,
Julian L.
Ambrus Jr.
(4)Sjögren's Syndrome Foundation
About Nicox
Nicox (Bloomberg: COX:FP, Reuters: NCOX.PA) is creating a new
mid-sized
international player in the ophthalmic market by building a
diversified
portfolio of innovative therapies and diagnostic tools. With a
heritage of
scientific, business development and commercial expertise, the Nicox
team is
focused on developing and marketing novel pharmaceuticals and diagnostic
devices
that can help people to enhance their sight. In the United States, Nicox
markets
AdenoPlus®, a test for the differential diagnosis of acute
conjunctivitis
in-licensed from RPS®.
The Company's pipeline includes latanoprostene bunod, a novel
drug-candidate
based on Nicox's proprietary nitric oxide (NO)-donating R&D platform,
developed
in collaboration with Bausch + Lomb for the potential treatment of
glaucoma and
ocular hypertension. Further NO-donating compounds are under development in
non-ophthalmic indications, notably through partners, including Merck
(known as MSD
outside the United States and Canada).
Nicox S.A. is headquartered in France and is listed on Euronext
Paris
(Compartment B: Small Caps). For more information please visit
www.nicox.com.
This communication may contain 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).
Exclusive agreement with Immco Diagnostics Inc.:
http://hugin.info/143509/R/1710335/567048.pdf
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Source: NICOX via Thomson Reuters ONE
[HUG#1710335]
Contacts
Nicox
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Executive Vice President Corporate Development
Tel +33 (0)4 97 24 53 00
Email Contact
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Europe
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M +44 (0)7876 444 977
Email Contact
United States
Robert Stanislaro
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M +1 (917) 968 9795
Email Contact
Nicox S.A.
Drakkar 2
Bat 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
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