• Lead clinical candidates Vesneo™ and AC-170 on track for NDA submission in the United States

  • New preclinical nitric oxide-donating programs moving forward

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Sophia Antipolis, France

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™ 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™ (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™ 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™ 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:

  • Nitric oxide-donating steroids target steroid-treatable front and / or back of the eye diseases such as Diabetic Macular Edema (DME). Two potential candidate compounds, NCX 434 and NCX 422, have been selected and Nicox expects to commence pre-Investigational New Drug (IND) development activities with at least one of these candidates.
  • Next-generation stand-alone nitric oxide-donors are designed to enable the optimization of nitric oxide dosing, targeting glaucoma and other ophthalmic indications. A lead compound, NCX 667, has already shown promising preclinical results and is now being optimized. The NCX 667 results were selected by the ARVO 2015 Annual Meeting Program Committee as a ‘Hot Topic’, representing the newest and most innovative research being conducted3

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™ 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.
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References

  1. Impagnatiello F, Bastia E, Toris CB, Krauss AH, Prasanna G, Ongini E, NCX 470, a nitric oxide (NO)-donating bimatoprost lowers intraocular pressure in rabbits, dogs and non-human primate models of glaucoma, ARVO 2015 Annual Congress, Abstract No. 5809.
  2. Lumigan is a registered trademark of Allergan, Inc.
  3. Bastia E, Impagnatiello F, Almirante N, Lanzi C, Masini E, Toris C, Ongini E, NCX 667, a novel nitric oxide (NO) donor lowers intraocular pressure (IOP) in ocular normotensive and hypertensive eyes of rabbits and non-human primates, ARVO 2015 Annual Congress, Abstract No. 1999-D0242.