- Collection of 0.1% dose of NCX 470 permits the second a part of Mont Blanc Part 3 trial in glaucoma and the initiation of the second Part 3 trial, Denali, anticipated by finish 2020
- Q3 2020 web income of €0.8 million and money of €42.2 million as of September 30, 2020
- VYZULTA® U.S. prescriptions in Q3 2020 elevated by 45% over Q3 2019
- ZERVIATETM U.S. prescriptions in Q3 2020 elevated by 176% over Q2 2020, the primary full quarter of gross sales
October 20, 2020 – launch at 7:30 am CET
Sophia Antipolis, France
Nicox SA (Euronext Paris: FR0013018124, COX), a world ophthalmology firm, right this moment introduced a enterprise replace and monetary highlights for Q3 2020 for Nicox SA and its subsidiaries (the “Nicox Group”), in addition to an replace on key anticipated milestones.
Key Anticipated Upcoming Milestones
·NCX 470 Mont Blanc Part 3 scientific trial: Prime-line outcomes from Mont Blanc, the primary Part 3 trial of NCX 470 for reducing of intraocular stress (IOP) in sufferers with open-angle glaucoma or ocular hypertension are presently anticipated in This autumn 2021. Mont Blanc is a 3-month security and efficacy analysis of NCX 470 ophthalmic resolution, 0.1%, in opposition to latanoprost ophthalmic resolution, 0.005%.
- NCX 470 Denali Part 3 scientific trial: The second Part 3 trial in glaucoma, Denali, which is funded equally by Nicox and our Chinese language associate Ocumension, is anticipated to begin by the top of 2020 and can consider NCX 470 ophthalmic resolution, 0.1%, versus latanoprost ophthalmic resolution, 0.005%. The Denali trial will embody scientific websites in each the U.S. and China, with the big majority of the sufferers to be recruited within the U.S. The Denali trial was designed to meet the regulatory necessities to assist New Drug Utility (NDA) filings within the U.S. and China.
- NCX 4251 Mississippi Part 2 scientific trial: A Part 2 trial, Mississippi, for the therapy of acute exacerbations of blepharitis is focused to be initiated in December 2020. This trial will embody main and secondary efficacy endpoints for blepharitis and dry eye illness respectively. Prime-line outcomes are presently anticipated in This autumn 2021. If profitable in assembly the first endpoint for blepharitis beforehand agreed upon with the U.S. Meals and Drug Administration (FDA), the trial may symbolize the primary of two pivotal trials wanted to assist an NDA within the U.S.
- ZERVIATETM China: A Part 3 scientific trial supposed to assist an utility for regulatory approval in China is anticipated to begin by the top of 2020, performed and financed by our associate Ocumension.
·Nitric oxide (NO)-donating phosphodiesterase-5 (PDE5) inhibitors for IOP reducing: IND-track candidate anticipated to be introduced shortly.
We proceed to intently watch the unfold and influence of the COVID-19 pandemic. We don’t presently anticipate delays in our scientific timelines however we’re monitoring the scenario and can present an replace when wanted.
Third Quarter 2020 and Latest Operational Highlights
- The 0.1% dose of NCX 470 was chosen within the adaptive design portion of the Mont Blanc Part 3 scientific trial. This dose continues within the second a part of Mont Blanc, a multi-regional, double-masked, 3-month, parallel group trial evaluating the efficacy and security of NCX 470 ophthalmic resolution, 0.1%, in comparison with latanoprost ophthalmic resolution, 0.005%, in sufferers with open-angle glaucoma or ocular hypertension. The 0.1% dose may even be used within the Denali trial, the second Part 3 glaucoma trial of NCX 470.
- Nicox’s associate, Ocumension Therapeutics, acquired approval from China’s Middle for Drug Analysis of the Nationwide Medical Merchandise Administration to hold out Part 3 scientific trials with ZERVIATETM (ophthalmic resolution of cetirizine), 0.24% for the therapy of ocular itching related to allergic conjunctivitis, paving the way in which for a Chinese language Part 3 trial, anticipated to begin in This autumn 2020.
- The whole variety of prescriptions1 for VYZULTA® (latanoprostene bunod ophthalmic resolution), 0.024%, within the U.S. within the third quarter of 2020 elevated by 45% in comparison with the third quarter of 2019 and by 17% in comparison with the second quarter of 2020. VYZULTA has additionally been authorized in Ukraine, bringing the entire variety of nations or territories the place VYZULTA is authorized to market to seven.
- ZERVIATETM (cetirizine ophthalmic resolution), 0.24%, U.S. prescriptions2 in Q3 2020 elevated by 176% over Q2 2020, which had been the primary full quarter of gross sales following launch within the U.S. in March 2020.
- We entered into an unique settlement with ITROM Pharmaceutical Group for the registration and commercialization of ZERVIATETM for the therapy of ocular itching related to allergic conjunctivitis in Gulf and Arab markets.
- Our associate Fera has knowledgeable us that the appliance with the U.S. FDA for an Orphan Drug Designation (ODD) for naproxcinod in sickle-cell illness has been refused however that Fera is reviewing how to answer the factors raised by the FDA and can also be contemplating different indications for the event of naproxcinod.
Third Quarter 2020 Monetary Highlights
As of September 30, 2020, the Nicox Group had money and money equivalents of €42.2 million as in contrast with €28.0 million at December 31, 2019 and €45.5 million at June 30, 2020 (together with €5 million from the divestment of our VISUfarma shareholding in July). Internet income3 for the third quarter of 2020 was €0.8 million (consisting of ZERVIATE and VYZULTA royalties and upfront funds from ITROM), in comparison with €0.5 million (consisting solely of royalty funds) for the third quarter of 2019.
As of September 30, 2020, the Nicox Group had monetary debt of €19.2 million within the type of a bond financing settlement with Kreos Capital signed in January 2019 and a €2 million credit score settlement, granted by Société Générale and LCL and assured by the French State, granted in August 2020 within the context of the COVID-19 pandemic.
Solely the determine associated to the money place of the Nicox Group as of December 31, 2019 is audited; all different figures of this press launch are non-audited.
- Bloomberg knowledge, evaluating the interval of the weeks ending July 3, 2020 to October 2, 2020 with the interval of the weeks ending April 3, 2020 to June 29, 2020 and July 5, 2019 to September 27, 2019
- Bloomberg knowledge, evaluating the interval of the weeks ending July 3, 2020 to October 2, 2020 with the interval of the weeks ending April 3, 2020 to June 29, 2020
- Internet income consists of income from collaborations much less royalty funds, which corresponds to Internet revenue within the consolidated statements of revenue or loss
Nicox is headquartered in Sophia Antipolis, France, is listed on Euronext Paris (Compartment B: Mid Caps; Ticker image: COX) and is a part of the CAC Healthcare, CAC Pharma & Bio and Subsequent 150 indexes.
For extra info on Nicox, its merchandise or pipeline, please go to: www.nicox.com.