Nicox to receive $6 million upfront payment and up to an additional $42.5 million in future milestones, plus 8-15% in tiered royalties Eyevance targeting U.S. launch of ZERVIATETM (cetirizine ophthalmic solution) 0.24% in late 2018
September 21, 2017 - release at 7:30 am CET
Sophia Antipolis, France
Nicox S.A. (Euronext Paris: FR0013018124, COX), the international ophthalmic company, today announced that its subsidiary Nicox Ophthalmics, Inc. has entered into an exclusive licensing agreement with Eyevance Pharmaceuticals LLC, for the commercialization of ZERVIATETM (cetirizine ophthalmic solution) 0.24%, in the US.
Under the terms of the agreement, effective September 20, 2017, Eyevance will make a one-time, upfront payment of $6 million to Nicox. Nicox is eligible to receive up to an additional $42.5 million in future milestones, of which $5 million is related to near term manufacturing objectives managed by Nicox. The remaining $37.5 million are payable on Eyevance achieving pre-defined sales targets, with $30 million of these milestones being triggered by annual sales targets of $100 million and above. In addition, Nicox will also receive tiered royalties of 8-15% based on future net sales of ZERVIATE(TM). Nicox has agreed to provide pre-launch manufacturing support to Eyevance and will also be responsible, at its own cost, for completing the requisite scale-up activities for the manufacturing of the commercial product and the professional samples necessary for the launch.
“We believe that Eyevance, led by its experienced executive management team, has the financial resources and know-how to execute the planned launch of ZERVIATETM and to maximize the commercial potential of this unique product in the U.S. market,” commented Gavin Spencer, Executive Vice President of Corporate Development at Nicox. “The FDA approval of ZERVIATETM, together with the commercial experience and ophthalmic expertise of Eyevance, provides us with a strong foundation on which to begin pursuing the expansion of ZERVIATETM into additional markets.”
ZERVIATETM (formerly AC-170), approved by the U.S Food and Drug Administration (FDA) on May 30, 2017, is the first topical ocular formulation of the antihistamine cetirizine approved for the treatment of ocular itching associated with allergic conjunctivitis. Cetirizine, the active ingredient in the systemic drug Zyrtec®1, is a second-generation antihistamine which has a well-characterized systemic efficacy and safety profile with worldwide exposure resulting from 20 years of oral use2.
“ZERVIATETM is a strong first asset for Eyevance to lead off its commercial strategy focused on important ophthalmic conditions, especially given the significant awareness around cetirizine in the market and by prescribers,” stated Jerry St. Peter, Founder and Chief Executive Officer of Eyevance, “We welcome the opportunity to work with the Nicox team to bring this product to market and to providing practitioners and patients with access to ZERVIATE(TM). We look forward to further establishing Eyevance’s presence within the ophthalmic marketplace and being a trusted and respected partner.”
Important Information about ZERVIATETM
INDICATION: ZERVIATETM (cetirizine ophthalmic solution) 0.24% is indicated for treatment of ocular itching associated with allergic conjunctivitis.
DOSAGE AND ADMINISTRATION: The recommended dose is one drop in each affected eye twice daily (approximately 8 hours apart).
IMPORTANT SAFETY INFORMATION
The most commonly reported adverse reactions occurred in approximately 1-7% of patients treated with either ZERVIATETM or vehicle. These reactions were ocular hyperemia, instillation site pain, and reduction in visual acuity.
About Allergic Conjunctivitis
Allergic conjunctivitis occurs when an allergic reaction causes conjunctivitis. Conjunctivitis is an inflammation of the thin layer of tissue that lines the outside of the white surface of the eye and the inner surface of the eyelids. It may affect one or both eyes. The signs and symptoms may include eye redness, excessive watering, itchy burning eyes, discharge, blurred vision and increased sensitivity to light. It is estimated that more than 75 million people suffer from allergic conjunctivitis in the US.3 and the estimated prevalence of allergic conjunctivitis may be anywhere between 15% and 40%3. The annual U.S. market for the treatment of allergic conjunctivitis totals more than $700 million4.
About Eyevance Pharmaceuticals
Eyevance Pharmaceuticals is a U.S. based company committed to developing and commercializing innovative and impactful ophthalmic products that enable optimal vision and better quality of life for all patients. Eyevance seeks to establish a portfolio of products that address significant unmet needs, including rare and orphan conditions, while also focusing on products with a legacy of proven safety and efficacy. The company’s strategy will leverage the deep knowledge of its management team within Ophthalmology and Optometry.
Notes:
Zyrtec® is a trademark of UCB Pharma SA or GlaxoSmithKline https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020346, accessed, 10Aug17 Rosario N, Bielory L. Epidemiology of allergic conjunctivitis. Curr Opin Allergy Clin Immunol. 2011;11:471-476 IMS Health Analytics About Nicox Nicox S.A. is an international ophthalmic company developing innovative solutions to help maintain vision and improve ocular health. By leveraging its proprietary expertise in nitric oxide donation and other technologies, the Company is developing an extensive portfolio of novel drug candidates that target multiple ophthalmic conditions, including glaucoma. Nicox currently has one product at the review stage with the U.S. Food and Drug Administration (FDA), VYZULTATM (latanoprostene bunod ophthalmic solution) 0.024%, licensed worldwide to Bausch + Lomb, and one product with an approved NDA, ZERVIATETM (cetirizine ophthalmic solution) 0.24%, licensed in the U.S. to Eyevance. In addition, our promising drug-candidate pipeline includes clinical stage assets based both on our proprietary NO-donating research platform and on the repurposing of existing molecules as well as a next-generation of stand-alone nitric-oxide donors and exploratory novel NO-donating compounds with the potential to offer novel approaches to treat a range of ophthalmic conditions. Nicox is headquartered in Sophia Antipolis, France, is listed on Euronext Paris (Compartment B: Mid Caps; Ticker symbol: COX) and is part of the CAC Healthcare, CAC Pharma & Bio and Next 150 indexes.
For more information on Nicox, its products or pipeline, please visit: www.nicox.com. Analyst coverage Bryan, Garnier & Co Hugo Solvet Paris, France
Invest Securities Martial Descoutures Paris, France
Gilbert Dupont Damien Choplain Paris, France The views expressed by analysts in their coverage of Nicox are those of the author and do not reflect the views of Nicox. Additionally, the information contained in their reports may not be correct or current. Nicox disavows any obligation to correct or to update the information contained in analyst reports. Upcoming financial and business conferences
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Contacts Nicox
Gavin Spencer,
Executive Vice President Corporate Development
T +33 (0)4 97 24 53 00
communications@nicox.com Investor Relations
Europe
Nicox
Corporate Communications Department
T +33 (0)4 97 24 53 00
communications@nicox.com
Media Relations
United Kingdom
Jonathan Birt
T +44 7860 361 746
jonathan.birt@ymail.com United States
Argot Partners
Melissa Forst
T +1 (212) 600-1902
melissa@argotpartners.com France
NewCap
Nicolas Merigeau
T +33 (0)1 44 71 94 98
nicox@newcap.eu United States
Argot Partners
Eliza Schleifstein
T +1 (917) 763-8106
eliza@argotpartners.com Disclaimer The information contained in this document may be modified without prior notice. This information includes forward-looking statements. Such forward-looking statements are not guarantees of future performance. These statements are based on current expectations or beliefs of the management of Nicox S.A. and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Nicox S.A. and its affiliates, directors, officers, employees, advisers or agents, do not undertake, nor do they have any obligation, to provide updates or to revise any 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 2016’ filed with the French Autorité des Marchés Financiers (AMF) on March 29, 2017, and in the updated and additional risk factors as of August 14, 2017, which are available on Nicox’s website (www.nicox.com). Nicox S.A.
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