Home » Business News » 2012 » October » October 22, 2012

Nicox launches AdenoPlus(TM) in the United States

October 22, 2012 - Sophia Antipolis Cedex, France

* 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),rapidpoint-of-care diagnostic test that aids in the differential diagnosis ofacuteconjunctivitis. AdenoPlus™ is Nicox's first product launch since itannouncedits strategy of becoming an international,late-stage development and commercialophthalmic business, reflected by a new visual identity also unveiledtoday.

Michele Garufi, Chairman and CEO of Nicox, commented: "With AdenoPlus™Nicoxhas taken a first step towards fulfilling its objective of starting acommercialbusiness in the ophthalmic space. We have established a specialized salesteamon the ground who will be marketing and selling this innovative andeasy-to-useproduct to eyecare practitioners across the US, bringing a new, fast andaccurate diagnostic option that will aid in the differential diagnosis ofacuteconjunctivitis.

The entire management team is working tirelessly to secure additionalophthalmicassets to build a comprehensive portfolio of diagnostics, therapeutics andmedical devices. With Bausch + Lomb's positive results observed in phase 2bwithour glaucoma candidate earlier this year, solid internal R&D expertise andagrowing network in the eyecare field, I believe we are in a strong positiontogrow rapidly as a specialist ophthalmic business."

AdenoPlus™ can rapidly aid in the differential diagnosis of acuteConjunctivitis

AdenoPlus™ accurately detects adenovirus, which accounts for up to 90%of allviral conjunctivitis, and approximately one out of four cases of acuteconjunctivitis seen by eyecare practitioners(2). As part of a "Red EyeProtocol", AdenoPlus™ can offer eyecare professionals an efficient andeffective method to diagnose the cause of the disease. The test, which has90%sensitivity and 96% specificity, is fast and easy-to-use. The simple,four-stepprocess takes less than two minutes to complete and provides a definiteresultin just ten minutes. An accurate diagnosis enables clinicians to makebettertherapeutic decisions based on diagnostic evidence and allows patients toleavethe clinician's office better informed and better prepared, knowing iftheir redeye is adenovirus and whether they can return to work. For more informationonAdenoPlus™, please call 1.855.MY.NICOX (from the US).

Acute Conjunctivitis is often misdiagnosed due to the overlappingpresentationof signs and symptoms among the major subtypes

It has been estimated that at least 6 million cases of acute conjunctivitisarediagnosed in the US each year(3) and studies indicate that eyecareprofessionals make an accurate clinical diagnosis approximately 50% of thetime(2). This is because viral, bacterial, and allergic conjunctivitis -themost common types - manifest similarly, making differential diagnosis usingonlysigns and symptoms challenging. Misdiagnosis represents a major problem, asadenovirus is highly contagious and associated with significant morbidity,including decreased visual acuity, light sensitivity, chronic excessivetearproduction, visual loss and presence of subepithelial infiltrates. Themajorityof acute conjunctivitis cases result in a prescription for antibiotics,even inviral cases when antibiotics are not necessary. Inappropriate antibioticuse mayincrease adverse effects, promote resistance and add avoidable costs to thehealthcare system.

Jerry St. Peter, Executive Vice President and General Manager of NicoxInc.,said: "Our first commercial launch is poised to transform the way eyecarepractitioners diagnose, and subsequently manage, acute conjunctivitis.AdenoPlus™ is accurate, fast, cost-effective, and performed at the pointofcare, making it a valuable test in seeking an immediate and accuratediagnosis.As a product, AdenoPlus™ is an embodiment of our ongoing mission: tobringeffective, efficient, and evidence-based solutions to the ophthalmicmarket."

New visual identity unveiled today

Nicox has also today unveiled a new brand identity that represents its newpositioning as an international late-stage development and commercialophthalmicgroup. The new logo, together with the tagline 'Visible Science',underlines theCompany'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) & AsiaPacificAcademy of Ophthalmology (APAO) 2012 Joint Meeting, taking place fromNovember10 to 13 in Chicago, Illinois (booth 2735). Nicox will also be present atthe91(st) Annual Meeting of the American Academy of Optometry (AAOpt) fromOctober24 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 June2012, together with other ocular diagnostic tests currently in development.Theworldwide licensing agreement grants Nicox exclusive rights tocommercializeAdenoPlus™ to eyecare professionals in the US, as well as full exclusiverights to market AdenoPlus™ in the rest of the world. RPS®maintains rightsto commercialize these ocular tests to primary and urgent careprofessionals inthe US.

Following the completion of the worldwide licensing agreement, Nicox hasbuiltup its sales infrastructure in the US. During this period, RPS® hastakenAdenoPlus™ orders for Nicox. Nicox's sales team is now actively startingthedirect marketing of AdenoPlus™ to targeted eyecare practitioners in theUS.The launch of AdenoPlus™ represents an important first step in theCompany'snew strategy but will not take Nicox to profitability on its own. Nicoxplans toexploit its new sales infrastructure to market other ophthalmic products inthefuture.

AdenoPlus™ is CE-marked and is available for sale by Nicox or itsdistributors in Europe and other countries. Nicox is focused on strategicefforts to secure AdenoPlus™ reimbursement throughout Europe.

(1) The Clinical Laboratory Improvement Amendments (CLIA) establishesqualitystandards for all laboratory testing to ensure the accuracy, reliabilityandtimeliness of patient test results regardless of where the test wasperformed. Awaiver signifies that the test has been classified as a low complexitydevice,which allows medical office personnel of CLIA-waived offices (not onlyphysicians) to perform it.

(2) O'Brien TP, Jeng BH, McDonald M, et al. Acute conjunctivitis: truthandmisconceptions. 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 aroundtherapeutics, diagnostics anddevices.

Nicox has inlicensed innovative ocular diagnostics from RPS®,includingAdenoPlus™, a test for the detection of adenoviral conjunctivitisalreadyauthorized for marketing in the United States and Europe. The Companyhas apartnership with Bausch + Lomb for the development of BOL303259X, anovelglaucoma candidate based on Nicox's proprietary nitricoxide-donating R&D


Further nitric oxide-donating compounds are under development innon-ophthalmicindications notably through partners, including Merck (known as MSDoutside the United States and Canada) andFerrer. Nicox S.A. is headquartered in France and is listed on EuronextParis (Compartment C: Small Caps). For more information please

This press release contains certain forward-looking statements. AlthoughtheCompany believes its expectations are based on reasonable assumptions,theseforward-looking statements are subject to numerous risks and uncertainties,which could cause actual results to differ materially from thoseanticipated inthe forward-looking statements.

Risks factors which are likely to have a material effect on Nicox'sbusiness arepresented in the 4th chapter of the « Document de référence,rapport financierannuel et rapport de gestion 2011 » filed with the FrenchAutorité des MarchésFinanciers (AMF) on February 29, 2012 and available on Nicox's website( and on the AMF's website

Nicox launches AdenoPlus™ in the United States:

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Source: NICOX via Thomson Reuters ONE



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