Our portfolio includes a pipeline of three programs in development, two U.S. Food and Drug Administration (FDA) approved products and research programs which could provide future product candidates. Our development pipeline consists of three programs: NCX 470 for the lowering of intraocular pressure (IOP) in patients with open angle glaucoma or ocular hypertension; NCX 4251 for patients with acute exacerbations of blepharitis and NCX 4280 (formerly AC-120) for relief of ocular redness and lid swelling due to morning ocular congestion. NCX 470 is based on our proprietary nitric oxide (NO) donating research platform and is currently in a Phase 2 clinical study. NCX 4251 and NCX 4280 are product candidates based on novel and proprietary formulations of well-established molecules that have previously been used in other indications and therapeutic areas. For NCX 4251, we plan to submit an IND application to the U.S. FDA in Q1 2019 to enable a clinical Phase 2 study, subject to successful completion of ongoing formulation and preclinical studies. NCX 4280 has been licensed to Ora Inc. who plans to advance the clinical development of NCX 4280 and subsequently sub-licence its commercialization. Our research pipeline includes future generation NO donors, including our lead stand-alone NO-donor molecules NCX 667 and NCX 1660 currently in formulation development and testing, as well as other exploratory novel NO-donating compounds targeting ophthalmic conditions including glaucoma and ocular hypertension.
In addition, we have two ophthalmology assets that have been approved by the U.S. FDA VYZULTA® (latanoprostene bunod ophthalmic solution), 0.024% and ZERVIATETM (cetirizine ophthalmic solution), 0.24%, formerly AC 170. VYZULTA, indicated for the lowering of IOP in patients with open angle glaucoma or ocular hypertension, is exclusively licensed worldwide to Bausch + Lomb, a Bausch Health Companies Inc. company, and has been commercialized by partner in the United States since December 2017. ZERVIATE, indicated for the treatment of ocular itching associated with allergic conjunctivitis, has been exclusively licensed in the United States to Eyevance Pharmaceuticals with a planned U.S. commercial launch date for the spring 2019 allergy season.
Our strategy is to become a fully integrated pharmaceutical company focused on the discovery, development and commercialization of novel ophthalmic therapeutics. This strategy includes advancing our product candidates through clinical development in the U.S. and expanding our product portfolio through internal drug discovery efforts and possible in licensing activities or acquisitions of additional ophthalmic product candidates or products.
Nicox was formed in 1996 and listed on Euronext Paris (Compartment B: Mid Caps; Ticker symbol: COX) in 1999. The Company is headquartered in Sophia Antipolis, France, has research facilities in Bresso, Italy, and U.S. development offices in Fort Worth, Texas and in Research Triangle Park, North Carolina.
Addressing a gap in the ophthalmic market
Certain areas in the ophthalmic market are expected to experience considerable growth due to a significant need for better treatments and diagnostic options. The ophthalmic market is currently dominated by large global pharmaceutical companies and much smaller national players. We see the opportunity for a targeted R&D organization in ophthalmology. Our experienced team brings together a heritage of scientific, financial, business, and corporate development expertise, strengthened by our own in-house research capabilities. Our growth strategy is based on the validated therapeutic effect of our proprietary NO-donating research platform, our other proprietary development assets and our partnered programs. We intend to develop our pipeline through outstanding international collaborations and internal focus on our proprietary developments.
IMS Health Analytics sales 2017
Partnerships accelerate the advancement of our research and development activities, allowing us to share and build our expertise and endorse our nitric oxide-donating research platform. We expect partnerships to continue to have a significant place in our future development both through the partnering of assets already advanced by us and through allowing us to access innovative science from external sources. We are always interested in hearing about potential collaborations and seek partners with complementary strengths who share our values; do not hesitate to contact us if you share our passion for visible science.
Nicox is led by a team of experienced professionals whose combined expertise covers research, clinical development, regulatory interactions, finance, business and corporate development, alliance management and communication. This experience was acquired in leading pharmaceutical and biotech companies. The team includes Michele Garufi, one of Nicox’s co-founders.
Nicox is proud to present its Board of Directors, whose members are highly experienced in the pharmaceutical and biotech industry.