November 6, 2017
Dear Nicox Shareholder,
It is an important moment for all of us, perhaps the most important since the foundation of Nicox. The first drug generated by our proprietary NO-donating research platform has been approved for launch in the world’s largest, most prestigious and challenging pharmaceutical market, the United States.
As I am sure you are aware, the FDA issued on November 2 a positive opinion to our global licensee Bausch + Lomb on the commercialization of VYZULTA® (latanoprostene bunod ophthalmic solution), 0.024% in the US. Latanoprostene bunod was invented in our Nicox Research Institute Laboratories in Milan and is the first new molecular entity with a potential of more than $500 million yearly sales invented by a ‘’start up’’ French R&D Company to receive FDA approval. The drug will be marketed by Bausch + Lomb under the brand VYZULTA® and its launch in the U.S. market is expected before the end of the year.
We expect VYZULTA® to become an important new treatment option for the reduction of intraocular pressure in patients with open angle glaucoma or ocular hypertension. It is also expected to provide a significant long-term revenue stream for Nicox as we are eligible to receive milestone payments linked to certain sales targets, royalties on future sales and potential additional market approvals.
This is an exciting time at Nicox and I would like to thank all of our shareholders who have supported us, especially as we faced and navigated through some difficult times, including those encountered by cutting edge life science companies focused on the research and development of innovative new drugs. A special thank you goes to all of the dedicated Nicox employees who have worked so hard, demonstrating their tireless commitment through the highs and lows in recent years to build Nicox into a leading player in the ophthalmology space, ensuring that our first major product is brought to the market.
Today a new chapter starts for Nicox, one that is full of new opportunities and fresh challenges. This exciting news comes less than 2 months after the licensing agreement signed with Eyevance Pharmaceuticals for the commercialization of ZERVIATETM (cetirizine ophthalmic solution) 0.24% in the US which is targeted in late 2018, coinciding with the fall allergy season.
We continue to drive our Company forward thanks to our extensive and promising R&D pipeline including clinical-stage assets, NCX 4251 for blepharitis and NCX 470 for the treatment of IOP lowering in patients with open-angle glaucoma or ocular hypertension. IND submissions are planned in H2 and H1 2018, respectively, to support Phase 2 studies. We are also focused on advancing a new generation of stand-alone nitric oxide donors and novel NO-donating compounds in the glaucoma field, which are currently under exploratory evaluation in sustained release implant formulations with partners.
The approval of VYZULTA® is the most important “gold medal” we have won so far but we are confident it will not be the last. We look forward to many more successes in the future with your continuing support.
Chairman and CEO