Latanoprostene bunod New Drug Application (NDA) under review by the U.S. Food & Drug Administration (FDA) with a PDUFA (Prescription Drug User Fee Act) date of July 21, 2016
AC-170 NDA to be submitted early Q2, 2016
2015 revenues €10 million, a 67% increase vs. 2014
Sophia Antipolis, France.
Nicox S.A. (Euronext Paris: FR0013018124, COX), the international ophthalmic company, today announced its financial and operating results for the year ended December 31, 2015, as approved by the Board of Directors on April 14, 2016, and provided an overview of its activities.
“During 2015, we saw strong growth in our sales revenue, integration of our acquisitions and continued progress in our development programs,” commented Michele Garufi, Chairman and Chief Executive Officer of Nicox. “We are on the brink of submitting our first ophthalmology NDA for AC-170 in allergic conjunctivitis, and are awaiting the completion of the FDA’s review of latanoprostene bunod, partnered with Bausch + Lomb, in glaucoma. Together with our expectations for our European commercial business, we expect 2016 to be a year of significant development and transformation for our company.”
2015 operational highlights
• Latanoprostene bunod NDA filed with U.S. FDA by Nicox’s licensee Bausch + Lomb. In July 2015, Bausch + Lomb (a wholly owned subsidiary of Valeant Pharmaceuticals International, Inc.) filed an NDA with the U.S. FDA seeking approval for latanoprostene bunod ophthalmic solution 0.024% as an intraocular pressure lowering single-agent eye drop dosed once daily, for patients with open angle glaucoma or ocular hypertension. The FDA accepted this NDA for review in September 2015 and set an action date of July 21, 2016 to finalize its review, as per the Prescription Drug User Fee Act (PDUFA).
• Final preparation of AC-170 NDA submission. Following two pre-NDA meetings with the FDA regarding AC 170, a novel, proprietary, cetirizine eye drop formulation developed for the treatment of ocular itching associated with allergic conjunctivitis, Nicox’s NDA for AC-170 is in final preparation. The Company expects to submit its NDA for AC-170 to the U.S. FDA early Q2, 2016. The Company is planning to seek Priority Review for AC-170, which, if obtained, could result in an FDA decision by the end of 2016 based on PDUFA performance goals.
• Corporate and pipeline update
o NCX 4251: Nicox’s nanocrystalline fluticasone propionate being developed for the treatment of blepharitis is now in formulation studies, with the goal of entering directly into Phase 2.
o New NO-donors: Nicox is advancing several nitric oxide (NO)-donating candidates including two glaucoma programs, NCX 470, a novel NO-donating bimatoprost, which is now advancing through pre-IND (Investigational New Drug) development prior to entering first-in-man clinical studies and next-generation stand-alone NO-donors which are currently in the lead optimization phase. Promising preclinical results were presented at the ARVO 2015 Annual Meeting, one of the key scientific events in the ophthalmology calendar.
o European operations: Nicox is currently evaluating a number of strategic options for its European commercial business for which discussions remain ongoing. Nicox’s European pipeline (AzaSite®, BromSite™ and NCX 4240 for which the date of dossier submission has not been decided yet) could potentially be included in these strategic discussions.
• Other 2015 and Post Reporting Period Events
o In February 2015, Nicox in-licensed the Europe, Middle East and Africa rights to AzaSite®, BromSite™ and AzaSite Xtra™ from InSite Vision Inc.
o In March 2015, Nicox completed a financing with the participation of major institutional investors specialized in life sciences, mainly from the U.S., which brought gross proceeds of €27 million.
o In November 2015, Nicox out-licensed U.S. development and commercialization rights for naproxcinod, an NO-donating anti-inflammatory drug-candidate, to Fera Pharmaceuticals.
o In December 2015, Nicox completed a 5-for-1 reverse split of its common stock, reducing the number of outstanding common shares to approximately 22.9 million.
o In January 2016, Nicox Ophthalmics, Inc. granted Ora Inc., the world’s leading ophthalmic clinical research and product development firm, exclusive worldwide rights for the development and commercialization of the OTC asset AC-120, an innovative drug-candidate for morning eyelid swelling (“puffy eyes”).
2015 Financial Summary
In accordance with IFRS5, 2014 revenues and expenses set out below do not include Nicox Inc., which was divested to Valeant in November 2014.
• Nicox’s revenues totaled €10 million in 2015, compared to €6.0 million in 2014, and were composed exclusively of European and International product sales. The growth in sales was helped by the acquisition of Doliage in France and the launch of new products in the Xailin™ range.
• Selling, Administrative and Research and Development costs amounted to €31.7 million in 2015, compared to €28.6 million in 2014, mostly due to an increase in research and development costs. The Group generated an operating loss of €28.9 million in 2015, compared to €21.6 million in 2014.
• On December 31, 2015, the Group’s cash, cash equivalents and financial instruments were €29.6 million, compared to €32.0 million on December 31, 2014.
Key upcoming milestones
• Q2, 2016: submission of AC-170 NDA to FDA
• July 21, 2016: PDUFA date for latanoprostene bunod NDA
Half-year 2016 financial results will be published on September 22, 2016.