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NicOx SA (COX.PA) Focuses U S. Operations On National Launches Of Sjo™ And Retnagene™ And Restructures RPS® Licensing Agreement


7/10/2014 6:03:19 AM

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  • Nicox to focus US marketing resources on national roll-out of Sjö(TM) and launch of RetnaGene(TM)
  • Rapid Pathogen Screening (RPS®) partnership for AdenoPlus® and two other products currently in development restructured in North America

SOPHIA ANTIPOLIS, France, July 10, 2014 (GLOBE NEWSWIRE) --

Nicox S.A. (NYSE Euronext Paris: COX), the international ophthalmic company, today announced that Nicox's subsidiary, Nicox Inc, will focus its US sales force on supporting the national roll-out of Sjö(TM), an advanced diagnostic panel for the early detection of Sjögren's syndrome in patients with dry eye, and on promoting the RetnaGene(TM) portfolio including RetnaGene(TM) AMD and RetnaGene(TM) LR, specialized genetic tests which assess an individual's risk for advanced age-related macular degeneration (AMD). Nicox and Rapid Pathogen Screening (RPS®) have therefore agreed to restructure the terms of their partnership in North America. Effective August 1st, 2014, RPS® will resume responsibility for marketing AdenoPlus®, a point-of-care diagnostic test that aids in the differential diagnosis of acute conjunctivitis, to eye care professionals in North America, as well as two other diagnostic products currently in development. RPS® will pay a royalty on sales to Nicox. Nicox will continue to have rights to commercialize AdenoPlus® and the previously licensed development products in all markets outside of North America.

"With Sjö(TM) and the RetnaGene(TM) portfolio, Nicox's US sales team has a powerful combination of products that are highly complementary and target diseases with significant patient populations. In order to capitalize on this synergy, we have decided to focus our commercial efforts and resources on these products. At the same time, RPS® will take full control of marketing AdenoPlus® and two other point-of-care diagnostics covered by our agreement in the US and Canada, in exchange for a royalty to Nicox. Both companies believe this new arrangement will maximize the potential of the products in the North American market," commented Gavin Spencer, Nicox's Executive Vice President, Corporate Development. "We have a strong partnership with RPS® and will retain rights to these products in all other markets, enhancing our international offering. We have also extended our manufacturing agreement with RPS® to ensure long-term product supply at favorable prices."

Roll-out of Sjö(TM) throughout the US

Nicox recently initiated the national expansion of Sjö(TM) for the early detection of Sjögren's syndrome in patients with dry eye. Sjö(TM), which was launched in select US markets in November 2013, has already helped thousands of dry eye patients understand what may be at the root of their symptoms. Utilizing the expanded sales force put in place in June 2014 (see Press Release dated June 19th, 2014) Nicox is now marketing Sjö(TM) to eye care professionals throughout the US under an exclusive North American agreement signed with Immco Diagnostics Inc. in June 2013. Eye care practitioners are in a unique position to identify Sjögren's syndrome as dry eye is a significant and early symptom of the condition.

Restructuring of agreements with RPS®

Because of the dedicated focus on successfully commercializing Sjö(TM) and RetnaGene(TM), Nicox and RPS® have agreed to restructure the North American portion of the licensing agreement relating to AdenoPlus® and two products in development, RPS-AP, a panel test for the diagnosis of adenoviral and allergic conjunctivitis and RPS-OH, a test for the diagnosis of ocular herpes. RPS® currently markets the AdenoPlus® test to primary and urgent care professionals in the US. Effective August 1st, 2014, RPS® will assume responsibility for marketing to eye care professionals in the US and all medical practitioners in Canada. RPS® will pay Nicox single-digit royalties on sales. Nicox will no longer market these products in the US and Canada but retains a co-promotion option in these markets, with complementary therapeutics that Nicox may obtain in the future. No additional rights to other RPS® products have been transferred.

Nicox will continue to exclusively commercialize the RPS® products outside the US and Canada, and RPS® and Nicox have extended their manufacturing agreement to ensure long-term product supply at favorable prices. Nicox anticipates launching the tests in development, to be marketed by Nicox as AAT and OHT, in Europe in 2015.

Nicox entered into the worldwide licensing agreement with RPS® in June 2012 and has paid a total of $3 million to RPS® in license and option fees and contributed to half of the development costs of RPS-AP and RPS-OH to date. Under the amended agreement, Nicox will no longer contribute to development costs but may pay additional development milestones, up to a potential maximum of $525,000, related to approval of products outside North America. Nicox will pay single-digit royalties on sales of all products licensed from RPS® outside the US and Canada.

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.

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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 2013 » filed with the French Autorité des Marchés Financiers (AMF) on April 2, 2014 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
+33 (0)4 97 24 53 00 | communications@nicox.com
Media Relations
United States Justin W. Jackson | Burns McClellan, Inc.
+1 212 213 0006 | jjackson@burnsmc.com
United Kingdom Jonathan Birt
+44 7860 361 746 | jonathan.birt@ymail.com
France Caroline Courme | Communication Manager
+33 (0)4 97 24 53 43 | courme@nicox.com

Nicox press release http://hugin.info/143509/R/1819630/630040.pdf

HUG#1819630


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