Nicox Receives Complete Response Letter from the FDA Related to GMP on NDA for AC-170
October 10, 2016
Sophia Antipolis, France
Nicox S.A. (Euronext Paris: FR0013018124, COX), the international ophthalmic R&D company, today announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for AC-170, its novel, proprietary, cetirizine eye drop formulation, for the treatment of ocular itching associated with allergic conjunctivitis. The FDA's stated reason for the CRL pertains solely to a Good Manufacturing Practice (GMP) inspection at a third party facility producing the active pharmaceutical ingredient (API) cetirizine and supplying it to the manufacturer of the finished product. The safety and efficacy data submitted by Nicox in the AC-170 NDA have not resulted in the FDA requesting any further clinical or non-clinical testing for the approval of the AC-170 NDA. Furthermore, the CRL did not include any concerns related to the finished product manufacturing facility.
Since the receipt of the CRL, Nicox has been contacting its suppliers to assess the timeline for the API manufacturer to address the FDA's concerns. Once these have been addressed, Nicox will then resubmit the AC-170 NDA.
AC-170 is a novel formulation of cetirizine, the active ingredient in Zyrtec ®1 , which has been developed for the first time for topical application in the eye for the treatment of ocular itching associated with allergic conjunctivitis. Cetirizine is a second generation antihistamine and mast cell stabilizer that binds competitively to histamine receptor sites to reduce swelling, itching and vasodilation. Cetirizine, as an approved oral drug, has a well-characterized systemic safety and efficacy profile with worldwide exposure representing more than 300 million patient-years 2-3-4 . AC-170 is covered by two granted U.S. patents expiring in 2030 and 2032.
Approval of the AC-170 NDA prior to 1 st December 2016 will trigger a milestone payment of $35 million in Nicox shares to ex-Aciex shareholders or $10 million in Nicox shares if approval of the NDA is received after this date. AC-170 was developed by Aciex Therapeutics, Inc., which became a wholly-owned subsidiary of Nicox in October 2014 and was subsequently renamed Nicox Ophthalmics, Inc.
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 white surface of the eye and the inner surface of the eyelids. It is a common eye disease, especially in children, and 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. Conjunctivitis can be caused by a viral or bacterial infection, or can be the result of an allergic reaction.
It is estimated that more than 75 million people suffer from allergic conjunctivitis in the U.S. 5 and the prevalence ranges from 20% to 40% 6-7 . The annual U.S. market for the treatment of allergic conjunctivitis totals more than $800 million 8 .
Nicox (Bloomberg: COX:FP, Reuters: NCOX.PA) is an international R&D company focused on the ophthalmic market. For more information on Nicox, its products or pipeline, please visit: www.nicox.com.
Bryan, Garnier & Co Hugo Solvet Paris, France
Invest Securities Martial Descoutures Paris, France
Gilbert Dupont Damien Choplain Paris, France
Stifel Olivia Manser London, UK
Upcoming financial and business conferences
November 14-15 Bryan Garnier & Co 4 th European Healthcare conference Paris, France
November 15-16 Stifel 2016 Healthcare Conference New York, US
November 18-19 Salon Actionnaria Paris, France
November 21-23 Deutsches Eigenkapitalforum Frankfurt, Germany
December 13 Guggenheim Securities 4th Annual Boston Healthcare Conference Boston, US
Nicox Gavin Spencer
| Executive Vice President Corporate Development
Tel +33 (0)4 97 24 53 00 | firstname.lastname@example.org
Tel +44 7860 361 746 | email@example.com
| Nicolas Merigeau
Tel +33 (0)1 44 71 94 98 | firstname.lastname@example.org
| Eliza Schleifstein
Tel +1 (917) 763-8106 | email@example.com
| Julien Perez | Valentine Brouchot
Tel +33 (0)1 44 71 94 94 | firstname.lastname@example.org
| Melissa Forst
Tel +1 (212) 600-1902 | email@example.com
The information contained in this document may be modified without former 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.
Last updated on: 11/10/2016
PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.