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SOPHIA ANTIPOLIS, France, June 3, 2015 (GLOBE NEWSWIRE) --
Nicox S.A. (Euronext Paris: FR0000074130, COX), the international ophthalmic company, today provided an update ahead of its Ordinary and Extraordinary Shareholder Meetings, convened today, June 3, 2015, at 2 pm CET in Sophia Antipolis (France). The updated Company presentation provided at the Shareholder Meetings will be available by 12 pm CET today in the News & Media / Presentations & Webcasts section of Nicox's website (www.nicox.com).
Lead clinical candidates Vesneo(TM) and AC-170 on track for NDA submission with the FDA
Nicox's licensee Bausch + Lomb (a wholly owned subsidiary of Valeant Pharmaceuticals International Inc.) remains on track to submit a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for Vesneo(TM) (latanoprostene bunod). An announcement is expected once the NDA submission has been accepted for filing by the FDA, which normally takes place around 60 days following submission.
The NDA submission for AC-170, a novel formulation of cetirizine developed for the treatment of ocular itching associated with allergic conjunctivitis, also remains on track. Nicox's objective is to obtain FDA approval by the end of 2016.
Nicox's advanced pipeline also features two pre-MAA (Marketing Authorization Application) candidates in Europe: AzaSite® for bacterial conjunctivitis and BromSite(TM) for pain and inflammation after cataract surgery. Nicox now expects to submit European MAAs for both candidates by the end of the first half of 2016.
Preclinical programs moving forward
Based on the positive phase 3 results for Vesneo(TM) and increased interest in the potential of nitric oxide (NO)-donors in ophthalmology, Nicox's Board of Directors has selected NCX 470 as the Company's lead follow-on glaucoma candidate for internal development. NCX 470 is a novel nitric oxide-donating bimatoprost discovered in Nicox's research laboratories which showed promising results at ARVO 20151 in several preclinical models of glaucoma and ocular hypertension (see Nicox press release dated May 11, 2015). Bimatoprost, marketed under the brand name Lumigan®2, is one of the leading products in the class of prostaglandin analogs, the most widely used class of Intra-Ocular Pressure (IOP) lowering drugs. The Company will now advance NCX 470 toward clinical-stage trials.
Nicox's research team will also continue to work on two other nitric oxide donor programs:
In addition, Nicox has decided to advance its nanocrystalline fluticasone propionate, formerly known as AC-155, for the treatment of blepharitis, under the code name NCX 4251. This indication has strong commercial potential as there are currently no treatments specifically approved for the condition. Nicox believes the novel nanocrystalline form may be suited to sustained availability of the drug on the eyelid margin. Because of the extensive data already available on fluticasone, NCX 4251 would be expected to go directly into phase 2 clinical trials following toxicity studies and IND filing, pending IND approval by the FDA.
Dr. Michael Bergamini, Chief Scientific Officer and Executive Vice President at Nicox, commented: "The success of Vesneo(TM) in Phase 3 clinical studies has underlined the therapeutic interest of our nitric oxide donors in ophthalmology. Nicox's research expertise and track record in this field is now focused on discovering the next generation of compounds for glaucoma, led by NCX 470 and the next generation of stand-alone nitric oxide-donors, and for other areas of significant need in ophthalmology such as Diabetic Macular Edema."
2015 Ordinary and Extraordinary Shareholder Meetings
Based on the proxy votes which have already been registered, all the resolutions of the Ordinary and Extraordinary Shareholder Meetings are expected to be approved. The detailed resolutions can be found on Nicox's website in the Investor Information / Shareholder Meetings section. The minutes of the Ordinary and Extraordinary Shareholder Meetings, as well as the results of the vote, will be posted in the same section of the website by the end of today.
Nicox (Bloomberg: COX:FP, Reuters: NCOX.PA) is an international commercial-stage company focused on the ophthalmic market. With a heritage of innovative R&D, business development and marketing expertise, we are building a diversified portfolio of ophthalmic products that can help people to enhance their sight.
Nicox's advanced pipeline features two pre-NDA candidates (Vesneo(TM) for glaucoma, partnered with Bausch + Lomb / Valeant and AC-170 for allergic conjunctivitis) as well as two pre-MAA candidates (AzaSite® for bacterial conjunctivitis and BromSite(TM) for pain and inflammation after cataract surgery). The Group operates directly in six countries, including the United States. It has proprietary commercial operations in Europe's five largest markets complemented by an expanding international network of distributors.
Nicox is headquartered in France and has more than 120 staff worldwide. It is listed on Euronext Paris (Category B: Mid Caps) and is part of the CAC Healthcare, CAC Pharma & Bio and Next 150 indexes.
For more information on Nicox, its commercial products or pipeline, please visit www.nicox.com.
|Financial and business conferences|
|June 1-4||Jefferies Healthcare Conference||New York, US||Presentation: June 4, 2015 at 11.30 am EDT|
|June 25||Kepler Biotech Day||Paris, France|
|June 6-9||European Society of Ophthalmology (SOE)||Vienna, Austria|
|June 28-30||MaculArt||Paris, France||Booth 17|
|Bryan, Garnier & Co||Hugo Solvet||Paris|
|Invest Securities||Martial Descoutures||Paris|
|Nicox||Gavin Spencer | Executive Vice President Corporate Development|
|Caroline Courme | Communication Manager|
|Tel +33 (0)4 97 24 53 43 | firstname.lastname@example.org|
|United Kingdom||Jonathan Birt|
|Tel +44 7860 361 746 | email@example.com|
|France||NewCap | Nicolas Merigeau|
|Tel +33 (0)1 44 71 94 98 | firstname.lastname@example.org|
|United States||Argot Partners | Eliza Schleifstein|
|Tel +1 (917) 763-8106 | email@example.com|
|Europe||NewCap | Julien Perez | Valentine Brouchot|
|Tel +33 (0)1 44 71 94 94 | firstname.lastname@example.org|
|United States||Argot Partners | Melissa Forst|
|Tel +1 (212) 600-1902 | email@example.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 4 th chapter of the 'Document de référence, rapport financier annuel et rapport de gestion 2014' filed with the French Autorité des Marchés Financiers (AMF) on April 10, 2015, which is available on Nicox's website (www.nicox.com ).
Drakkar 2 | Bât D | 2405 route des Dolines | CS 10313 | Sophia Antipolis | 06560 Valbonne | France
T: +33 (0)4 97 24 53 00 | F: +33 (0)4 97 24 53 99
Press release http://hugin.info/143509/R/1925893/691065.pdf
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