27 April 2017
VyzultaTM1 PDUFA date set for August 24, 2017
ZERVIATE2 PDUFA date set for September 8, 2017
NCX 4251 and NCX 470 on track to enter Phase 2
Cash position of €25 million3 as of March 31, 2017
Sophia Antipolis, France
Nicox S.A. (Euronext Paris: FR0013018124, COX), the international ophthalmic R&D company, today provided an update on its activities and cash position as of March 31, 2017.
“With the PDUFA dates now set for both VyzultaTM and ZERVIATE, we are focussing our resources on the partnering activities for ZERVIATE in the United States and on preparing for the initiation of the Phase 2 studies evaluating our promising pipeline candidates NCX 4251 in the fourth quarter of 2017 and NCX 470 in the first quarter of 2018,” said Michele Garufi, Chairman and Chief Executive Officer of Nicox. “Subject to approval by the FDA, we expect to have two revenue-generating assets and have two candidates in the clinic within the next 12 months, which would put us in a strong position as a major R&D player with an extensive clinical and preclinical pipeline in the ophthalmic space.”
First-quarter 2017 financial highlights
The Group had cash, cash equivalents and financial instruments of €25.0 million3 as of March 31, 2017, compared to €28.9 million as of December 31, 2016. The Group recorded no revenues for the first quarter 2017.
First-quarter 2017 and recent operational highlights
- Resubmission to the U.S. Food and Drug Administration (FDA) on February 24, 2017 by Nicox’s licensee, Bausch + Lomb (a wholly-owned subsidiary of Valent Pharmaceuticals Inc.), of the New Drug Application (NDA) for VyzultaTM (latanoprostene bunod ophthalmic solution) 0.024%. Latanoprostene bunod is an intraocular pressure (IOP) lowering single-agent eye drop dosed once daily, for patients with open angle glaucoma (OAG) or ocular hypertension (OHT). The FDA has set a PDUFA date of August 24, 2017 (see press release dated March 20, 2017).
- Resubmission to the U.S. FDA, by Nicox, on March 8, 2017 of the NDA for ZERVIATE (cetirizine ophthalmic solution) 0.24%, Nicox’s novel, proprietary, cetirizine eye drop formulation for the treatment of ocular itching associated with allergic conjunctivitis. The FDA has set a PDUFA date of September 8, 2017 (see press release dated April 11, 2017).
Key upcoming milestones
- August 24, 2017: Potential U.S. FDA approval of VyzultaTM NDA
- September 8, 2017: Potential U.S. FDA approval of ZERVIATE NDA
- H2 2017: Expected launch of VyzultaTM in the United States by Bausch + Lomb, subject to FDA approval
- Q4 2017: Expected start of Phase 2 clinical study for NCX 4251
- Q1 2018: Expected start of Phase 2 clinical study for NCX 470
1. VyzultaTM is the provisionally approved tradename for latanoprostene bunod ophthalmic solution, 0.024%
2. ZERVIATE is the tradename provisionally approved for cetirizine ophthalmic solution, 0.24%
3. Figures non audited