Letter from the Chairman & CEO – Invitation to a shareholder information meeting on December 16, 2015 in Paris (in French)

Audio webcast recording in French 

 

Dear Fellow Nicox Shareholders,

As you are well aware, our Company’s share price has been experiencing significant downward pressure which we believe is unwarranted as we are preparing to embark on what we expect to be a transformational year for Nicox. By the end of 2016, Nicox’s portfolio could potentially have two FDA-approved products in the U.S., which we believe places Nicox in a unique position among the European specialty pharmaceutical companies.

At the same time, the growing interest around our European commercial business and the need to focus our financial and human resources on our promising and unencumbered R&D pipeline have led us to carefully evaluate certain strategic alternatives and alliances that may allow us to accelerate the growth of the European revenues while reducing our cash burn.

As a reminder, important preclinical and clinical data on latanoprostene bunod, our innovative drug candidate for the treatment of glaucoma licensed worldwide to Bausch + Lomb, have been published and presented at International Conferences in 2015 (see full list below). The FDA is expected to render a decision for this drug candidate in July 2016 and we are very eager to see its launch in the U.S. market next year should the drug be approved by the FDA.

But 2015 has not only been an important year for latanoprostene bunod:

  • We held two successful pre-NDA meetings with the FDA on AC-170, our cetirizine eye drop for which we plan to submit an NDA in the first half of 2016.
  • Our scientists are already working on other potential next-generation ophthalmic compounds with two sets of encouraging results announced at the last ARVO Annual Meeting, the world leading research conference in ophthalmology. We are particularly encouraged that results from NCX 667 were selected as a ‘Hot Topic’ by the ARVO Annual Meeting Program Committee, a distinction which was awarded to a small number of abstracts.
  • In addition, we in-licensed for the European market two ophthalmic drug candidates which have both already completed phase 3 trials: AzaSite, which is already successfully marketed in the U.S., and BromSite, which is currently under review by the FDA in the U.S.
  • We also signed a deal with Fera Pharmaceuticals which could be a new opportunity to display the full potential of naproxcinod and bring up to $35 million in milestone payments plus 7% royalties on future sales in the U.S.

In conclusion, the Nicox management team and Board believe that we will enter 2016 ready to achieve our important, value-creating milestones. We would like to invite you to a meeting on December 16, 2015, to give you the opportunity to discuss with senior members of the management team, including myself. For more information and to reserve your place, please contact Irène Lalande (lalande@nicox.com; +33.4.97.24.53.00). A live webcast will be available on our website to enable all shareholders to listen and ask questions. A recording will also be posted on our website after the meeting.

Your continued support is much appreciated.

With my best regards,

Michele Garufi, Chairman & Chief Executive Officer, Nicox SA.

 

2015 latanoprostene bunod publications

  • Araie M. Scassellati Sforzolini B, Vittitow J, Weinreb RN. Evaluation of the Effect of Latanoprostene Bunod Ophthalmic Solution, 0.024% in Lowering Intraocular Pressure over 24h in Healthy Japanese Subjects. Adv Ther 2015, in press, published online 12 November 2015.
    http://link.springer.com/article/10.1007/s12325-015-0260-y
  • Cavet ME, Vollmer TR, Harrington KL, VanDerMeid K, Richardson ME, Regulation of Endothelin-1–Induced Trabecular Meshwork Cell Contractility by Latanoprostene Bunod. Invest Ophthalmol Vis Sci. 2015, 56(6):4108-16.
    http://iovs.arvojournals.org/article.aspx?articleid=2363039

2015 latanoprostene bunod presentations in congresses

  • Liu J, Vittitow J, Sforzolini B, Weinreb R. Effect of Latanoprostene Bunod Compared with Timolol Maleate on Ocular Perfusion Pressure in Subjects with Open-Angle Glaucoma or Ocular Hypertension (CONSTELLATION). American Glaucoma Society 2015 Annual Meeting, poster PO015.
  • Scassellati Sforzolini B, Vittitow J, Weinreb R. Efficacy of Vesneo™ (Latanoprostene Bunod Ophthalmic Solution, 0.024%) Compared with Timolol Maleate Ophthalmic Solution 0.5% in Subjects with Open-Angle Glaucoma or Ocular Hypertension. 6th World Glaucoma Congress 2015, Rapid Fire Session RF-T-02-07.
  • Araie M, Scassellati Sforzolini B, Ngumah Q, Vittitow J, Weinreb R. Efficacy of Vesneo™ (Latanoprostene Bunod Ophthalmic Solution, 0.024%) in Lowering Intraocular Pressure Over 24 Hours in Healthy Japanese Subjects. 6th World Glaucoma Congress 2015, Poster P-S-056.
  • Liu J, Vittitow J, Scassellati Sforzolini B, Weinreb R. Ocular Perfusion Pressure Effects of Vesneo™ (Latanoprostene Bunod Ophthalmic Solution, 0.024%) and Timolol Maleate Ophthalmic Solution 0.5% in Subjects with Open-Angle Glaucoma or Ocular Hypertension. 6th World Glaucoma Congress 2015, Poster P-S-074.
Additional information on the Company is available on our website www.nicox.com, and in particular in the Document de Référence, Rapport Financiel Annuel et Rapport de Gestion 2014.