August 2, 2016
Dear Nicox Shareholder,
As you may have noticed this has been without doubt an intense few weeks for Nicox, with the US FDA granting Priority Review for our New Drug Application (NDA) for AC-170 on June 18th, followed by the signing of an innovative agreement with GHO Capital for the future development of our European Commercial operations on July 4th. Two weeks later, on July 21st, our partner Valeant / Bausch + Lomb received a Complete Response Letter (CRL) from the FDA concerning the NDA for latanoprostene bunod, our highly promising new intraocular pressure lowering eye drop, citing some concerns related to a Bausch + Lomb manufacturing facility in Tampa.
While we are of course disappointed not to have received the NDA approval yet because of these very specific concerns, we were pleased that the FDA’s Letter did not identify any efficacy or safety concerns or the need for any additional clinical trials for the approval of the NDA. The only reasons identified for the delay in the approval were the concerns raised by the FDA pertaining to a Current Good Manufacturing Practices (CGMP) inspection at Bausch + Lomb’s manufacturing facility in Tampa, Florida.
We understand that Valeant will be meeting with the FDA to discuss the CRL. We have been told that Valeant is working diligently to satisfy the observations made by the FDA for the Tampa plant. In the meantime, Valeant continues to manufacture other products in the Tampa plant and distribute them to the market. Valeant plans to provide updates as appropriate. We expect latanoprostene bunod will receive FDA approval and we will continue to support Bausch + Lomb. We are also confident that approval will validate Nicox’s proprietary nitric oxide (NO)-donating research platform in the reduction of intraocular pressure (IOP) and we are committed to progressing our innovative development programs in this area.
I am as well particularly delighted that a number of specialist healthcare investors share our optimism about the potential for latanoprostene bunod and AC-170, as well as for the rest of our highly promising pipeline, enabling us to complete an additional financing of € 18 million (gross proceeds) to pursue our focused R&D strategy. The funds raised give us the financial strength to proceed with the development of our other key pipeline assets without delay. We plan to accelerate the development of our extensive R&D pipeline including NCX 4251 for blepharitis, NCX 470 for the treatment of elevated IOP – both of which we expect will start in phase 2 clinical studies by the second half of 2017 – and the next generation of promising stand‐alone NO donors.
I want to thank you all once more for your continued support and we look forward to updating you on our progress.
Chairman and CEO