SOPHIA ANTIPOLIS, France, March 17, 2014 (GLOBE NEWSWIRE) -- 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:
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.
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).
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Nicox launches AdenoPlus® and Xailin(TM) in Europe http://hugin.info/143509/R/1769012/601463.pdf