Nicox S.A. (0RCQ.L)
| Previous close | 4.5100 |
| Open | 4.4592 |
| Bid | 0.0000 x 0 |
| Ask | 0.0000 x 0 |
| Day's range | 4.4450 - 4.4592 |
| 52-week range | 4.4450 - 4.4592 |
| Volume | 9,230 |
| Avg. volume | N/A |
| Market cap | 128.704M |
| Beta (5Y monthly) | 1.48 |
| PE ratio (TTM) | N/A |
| EPS (TTM) | -0.6250 |
| Earnings date | N/A |
| Forward dividend & yield | N/A (N/A) |
| Ex-dividend date | N/A |
| 1y target est | N/A |
- Globe Newswire
Nicox Announces the Publication in Leading Scientific Journal of Pre-Clinical Efficacy Results on a New Class of Non-PGA NO-donating IOP-Lowering Compounds
Press ReleaseNicox Announces the Publication in Leading Scientific Journal of Pre-Clinical Efficacy Results on a New Class of Non-PGA NO-donating IOP-Lowering Compounds New class works solely through nitric oxide (NO)-mediated activityEquivalent intraocular pressure (IOP) lowering and faster onset of activity demonstrated vs. the prostaglandin analog (PGA) travoprost February 23, 2021 – release at 7:30 am CET Sophia Antipolis, France Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced the publication of pre-clinical intraocular pressure (IOP)-lowering results on a new class of non-prostaglandin analog (PGA), nitric oxide (NO)-donating compounds, in the Journal of Ocular Pharmacology and Therapeutics1. Increased IOP is one of the principal risk factors of open-angle glaucoma. The NO-mediated IOP-lowering effect in this new class of compounds is enhanced by concomitant action of phosphodiesterase type-5 (PDE5) inhibition within the same molecule. Michele Garufi, Chairman and CEO of Nicox, said “This new class of compounds, in which we optimized and enhanced the activity of nitric oxide, has been developed using the years of expertise and research in this area within Nicox. We have shown with VYZULTA and our promising Phase 3 product candidate, NCX 470, that nitric oxide can bring additional efficacy on top of a prostaglandin analog. This new class of compounds enhance the nitric oxide-mediated intraocular pressure lowering effect with the concomitant action of phosphodiesterase type-5 inhibition. We identified product candidates in this class which could potentially be used as monotherapy, or in combination with prostaglandin analogs or other intraocular pressure lowering agents, to add efficacy to existing therapies.” The published data on NCX 1741, an analog of Nicox’s development candidate NCX 1728, compared its IOP lowering effect to that of travoprost in a non-human primate model of ocular hypertension. This publication reports that NCX 1741 reduced IOP to a similar extent to travoprost, with faster onset of activity. Travoprost is a prostaglandin analog, a class of molecules which are considered standard of care for IOP lowering in humans. NCX 1728 is the first in this new class of compounds to be selected for development (See Press Release of October 23, 2020). Nicox will conduct a full characterization of the ophthalmic formulations of NCX 1728 prior to initiating non-clinical testing required for filing an IND application. Nicox owns all exclusive worldwide rights to NCX 1728 and NCX 1741. The publication can be found at https://pubmed.ncbi.nlm.nih.gov/33595367/. NO-mediated IOP lowering agents It has been established that NO plays a key role in the regulation of IOP. An NO-donating moiety can be linked to other pharmaceutical agents to improve IOP-lowering efficacy, as is the case with our lead clinical development candidate NCX 470, a novel NO-donating prostaglandin analog, and our commercialized product with the same mechanism of action, VYZULTA® (latanoprostene bunod ophthalmic solution), 0.024%. VYZULTA®, indicated for the reduction of IOP in patients with open-angle glaucoma or ocular hypertension, is exclusively licensed worldwide to our partner Bausch + Lomb, who is commercializing it in the U.S., Canada, Argentina and Mexico. The effect of NO on IOP lowering may be further increased and/or prolonged by PDE5 inhibitors, which inhibit the degradation of cyclic guanosine monophosphate (cGMP), a key intracellular messenger that is produced as a result of stimulation by NO.About NicoxNicox S.A. is an international ophthalmology company developing innovative solutions to help maintain vision and improve ocular health. Nicox’s lead program in clinical development is NCX 470, a novel nitric oxide-donating prostaglandin analog, for lowering intraocular pressure in patients with glaucoma. The company is also developing NCX 4251, a proprietary formulation of fluticasone, for acute exacerbations of blepharitis. Nicox generates revenue from VYZULTA® in glaucoma, licensed exclusively worldwide to Bausch + Lomb, and ZERVIATE® in allergic conjunctivitis, licensed in multiple geographies, including to Eyevance Pharmaceuticals, LLC, in the U.S. and Ocumension Therapeutics in the Chinese and in the majority of South East Asian markets. Nicox is headquartered in Sophia Antipolis, France, is listed on Euronext Paris (Compartment B: Mid Caps; Ticker symbol: COX) and is part of the CAC Healthcare, CAC Pharma & Bio and Next 150 indexes. For more information on Nicox, its products or pipeline, please visit: www.nicox.com.Analyst coverage Bryan, Garnier & Co Victor Floc’h Paris, FranceCantor Fitzgerald Louise Chen New York, U.S.Edison Investment Research Pooya Hemami London, UKH.C. Wainwright & Co Yi Chen New York, U.S.Kepler Cheuvreux Damien Choplain Paris, France The views expressed by analysts in their coverage of Nicox are those of the author and do not reflect the views of Nicox. Additionally, the information contained in their reports may not be correct or current. Nicox disavows any obligation to correct or to update the information contained in analyst reports.ContactsNicoxGavin SpencerExecutive Vice President, Chief Business Officer& Head of Corporate Development T +33 (0)4 97 24 53 00communications@nicox.com Investors & MediaUnited States & Europe LifeSci Advisors, LLC Mary-Ann Chang T +44 7483 284 853mchang@lifesciadvisors.comMediaFranceLifeSci Advisors, LLCSophie BaumontM +33 (0)6 27 74 74 49 sophie@lifesciadvisors.comForward-Looking StatementsThe information contained in this document may be modified without prior notice. This information includes forward-looking statements. Such forward-looking statements are not guarantees of future performance. These statements are based on current expectations or beliefs of the management of Nicox S.A. and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Nicox S.A. and its affiliates, directors, officers, employees, advisers or agents, do not undertake, nor do they have any obligation, to provide updates or to revise any forward-looking statements. Risks factors which are likely to have a material effect on Nicox’s business are presented in the 3rd chapter of the ‘Document d’enregistrement universel, rapport financier annuel et rapport de gestion 2019’ filed with the French Autorité des Marchés Financiers (AMF) on March 6, 2020 which are available on Nicox’s website (www.nicox.com) and (ii) as restated in the 4th chapter of the half yearly financial report as of June 30, 2020, which is also available on Nicox’s website.Nicox S.A.Drakkar 2 Bât D, 2405 route des Dolines CS 10313, Sophia Antipolis 06560 Valbonne, France T +33 (0)4 97 24 53 00 F +33 (0)4 97 24 53 99 1 Bastia et al, Journal of Ocular Pharmacology and Therapeutics, 2021. doi: 10.1089/jop.2020.0126. Epub ahead of print. PMID: 33595367. Attachment EN_NCX1741 JOPT PR_20210223_F
- Globe Newswire
Nicox’s U.S. Licensee Eyevance Expands U.S. Promotion of ZERVIATE® In Agreement with Hikma
Press ReleaseNicox’s U.S. Licensee Eyevance Expands U.S. Promotion of ZERVIATE® In Agreement with Hikma February 15, 2021 – release at 7:30 am CET Sophia Antipolis, France Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced that its exclusive U.S licensee, Eyevance Pharmaceuticals, a wholly-owned subsidiary of Santen Pharmaceutical Co., Ltd, has entered into a partnership with Hikma Pharmaceuticals for the co-promotion of ZERVIATE®, indicated for the treatment of ocular itching associated with allergic conjunctivitis. Hikma will be responsible for promoting ZERVIATE to U.S. healthcare professionals working outside the eyecare specialty, with all sales continuing to be booked by Eyevance, on which Nicox will receive royalties. Hikma has strong and well-established U.S. commercial capabilities with medical sales representatives deployed across the country, serving the needs of general practitioners and family doctors. Hikma is a top-10 U.S. generic pharmaceutical company, developing, manufacturing and distributing a broad range of branded and non-branded generic medicines for customers and partners. Eyevance will continue to promote ZERVIATE to ophthalmology and optometry healthcare professionals in the U.S. Nicox and Eyevance have a license agreement for the commercialization of ZERVIATE in the U.S., where the product has been marketed since March 2020. Gavin Spencer, Chief Business Officer of Nicox, said: “This creative deal by Eyevance, executed in good time for the crucial U.S. spring allergy season, expands their reach to include healthcare professionals outside eyecare, such as allergists, general and family practitioners and pediatricians, who account for around 40% of the 1 million prescriptions for branded allergy products in the United States. The partnership may thus lead to an increase in sales and demonstrates Eyevance’s strong commitment to maximizing the value of the ZERVIATE franchise in the United States.” Under Nicox’s licensing agreement with Eyevance, Nicox is eligible for up to $37.5 million in milestones payable on Eyevance achieving pre-defined sales targets, with $30 million of these milestones being triggered by annual sales of $100 million and above. Nicox also receives tiered royalties1 of 8% to 15% on net sales of ZERVIATE in the U.S., including those made as a result of promotion by HIKMA. Eyevance is responsible for all manufacturing, regulatory and commercialization activities for ZERVIATE in the United States, where ZERVIATE is protected by patents expected to remain in force until 2030 and 2032. About Hikma Hikma helps put better health within reach every day for millions of people in more than 50 countries around the world. For more than 40 years, we've been creating high-quality medicines and making them accessible to the people who need them. Headquartered in the UK, we are a global company with a local presence across the United States (US), the Middle East and North Africa (MENA) and Europe, and we use our unique insight and expertise to transform cutting-edge science into innovative solutions that transform people's lives. We're committed to our customers, and the people they care for, and by thinking creatively and acting practically, we provide them with a broad range of branded and non-branded generic medicines. Together, our 8,600 colleagues are helping to shape a healthier world that enriches all our communities. We are a leading licensing partner, and through our venture capital arm, are helping bring innovative health technologies to people around the world. For more information, please visit: www.hikma.com. About ZERVIATE ZERVIATE® (cetirizine ophthalmic solution), 0.24% is a novel formulation of cetirizine developed and approved for the first time for topical application in the eye for the treatment of ocular itching associated with allergic conjunctivitis. Cetirizine, the active ingredient in ZYRTEC®, is a second-generation antihistamine (H1 receptor antagonist) that binds competitively to histamine receptor sites. Cetirizine, in approved oral formulations, has a well-characterized systemic efficacy and safety profile with worldwide exposure resulting from 20 years of oral use. ZERVIATE was developed by Nicox as the first and only formulation of cetirizine for topical application in the eye. For further details of ZERVIATE in the U.S., please go to www.myzerviate.com. ZERVIATE is also licensed exclusively to Ocumension Therapeutics in the Chinese and South East Asian markets, Samil Pharmaceutical in South Korea and ITROM Pharmaceutical Group for Gulf and Arab Markets. About Allergic Conjunctivitis Allergic conjunctivitis occurs when an allergic reaction causes conjunctivitis. Conjunctivitis is an inflammation of the thin layer of tissue that lines the outside of the white surface of the eye and the inner surface of the eyelids. It may affect one or both eyes. The signs and symptoms may include eye redness, excessive watering, itchy burning eyes, discharge, blurred vision and increased sensitivity to light.About NicoxNicox S.A. is an international ophthalmology company developing innovative solutions to help maintain vision and improve ocular health. Nicox’s lead program in clinical development is NCX 470, a novel nitric oxide-donating prostaglandin analog, for lowering intraocular pressure in patients with glaucoma. The company is also developing NCX 4251, a proprietary formulation of fluticasone, for acute exacerbations of blepharitis. Nicox generates revenue from VYZULTA® in glaucoma, licensed exclusively worldwide to Bausch + Lomb, and ZERVIATE™ in allergic conjunctivitis, licensed in multiple geographies, including to Eyevance Pharmaceuticals, LLC, in the U.S. and Ocumension Therapeutics in the Chinese and in the majority of South East Asian markets. Nicox is headquartered in Sophia Antipolis, France, is listed on Euronext Paris (Compartment B: Mid Caps; Ticker symbol: COX) and is part of the CAC Healthcare, CAC Pharma & Bio and Next 150 indexes. For more information on Nicox, its products or pipeline, please visit: www.nicox.com.Analyst coverage Bryan, Garnier & Co Victor Floc’h Paris, FranceCantor Fitzgerald Louise Chen New York, U.S.Edison Investment Research Pooya Hemami London, UKH.C. Wainwright & Co Yi Chen New York, U.S.Kepler Cheuvreux Damien Choplain Paris, France The views expressed by analysts in their coverage of Nicox are those of the author and do not reflect the views of Nicox. Additionally, the information contained in their reports may not be correct or current. Nicox disavows any obligation to correct or to update the information contained in analyst reports.ContactsNicoxGavin SpencerExecutive Vice President, Chief Business Officer& Head of Corporate Development T +33 (0)4 97 24 53 00communications@nicox.com Investors & MediaUnited States & Europe LifeSci Advisors, LLC Mary-Ann Chang T +44 7483 284 853mchang@lifesciadvisors.comMediaFranceLifeSci Advisors, LLCSophie BaumontM +33 (0)6 27 74 74 49 sophie@lifesciadvisors.comForward-Looking StatementsThe information contained in this document may be modified without prior notice. This information includes forward-looking statements. Such forward-looking statements are not guarantees of future performance. These statements are based on current expectations or beliefs of the management of Nicox S.A. and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Nicox S.A. and its affiliates, directors, officers, employees, advisers or agents, do not undertake, nor do they have any obligation, to provide updates or to revise any forward-looking statements. Risks factors which are likely to have a material effect on Nicox’s business are presented in the 3rd chapter of the ‘Document d’enregistrement universel, rapport financier annuel et rapport de gestion 2019’ filed with the French Autorité des Marchés Financiers (AMF) on March 6, 2020 which are available on Nicox’s website (www.nicox.com) and (ii) as restated in the 4th chapter of the half yearly financial report as of June 30, 2020, which is also available on Nicox’s website.Nicox S.A.Drakkar 2 Bât D, 2405 route des Dolines CS 10313, Sophia Antipolis 06560 Valbonne, France T +33 (0)4 97 24 53 00 F +33 (0)4 97 24 53 99 1 Nicox committed to pay to Eyevance certain manufacturing costs, which will be deducted from these royalty payments, reducing the effective royalty initially to 5% net until such costs are paid Attachment EN_ZERVIATEEyevanceNonOphthaCoPromote_PR_20210215_F
- Globe Newswire
Bausch Health Announces Vyzulta® (latanoprostene Bunod Ophthalmic Solution), 0.024%, is Now Approved in South Korea
Nicox Investors & Media Contact: Gavin Spencer communications@nicox.com +33 (0)4 97 24 53 00 Mary-Ann Chang mchang@lifesciadvisors.com +44 7483 284 853 Nicox Media France Contact: Sophie Baumont sophie@lifesciadvisors.com +33 6 27 74 74 49 Investor Contact: Art Shannonarthur.shannon@bauschhealth.com(514) 856-3855 (877) 281-6642 (toll free) Media Contact:Lainie Kellerlainie.keller@bauschhealth.com (908) 927-1198 BAUSCH HEALTH ANNOUNCES VYZULTA® (LATANOPROSTENE BUNOD OPHTHALMIC SOLUTION), 0.024%, IS NOW APPROVED IN SOUTH KOREA SOPHIA ANTIPOLIS, France, and LAVAL, Quebec, Feb. 9, 2021 – Bausch Health Companies Inc. (NYSE/TSX: BHC) (“Bausch Health” or the “Company”), Bausch + Lomb, a leading global eye health business, and Nicox (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced that VYZULTA® (latanoprostene bunod ophthalmic solution), 0.024%, has received regulatory approval from the Ministry of Food and Drug Safety in South Korea. VYZULTA is indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension in the United States and other territories that have the same indication.1 “VYZULTA is an important treatment option for people suffering from glaucoma, and we are committed to securing additional regulatory approvals for VYZULTA in countries around the world,” said Thomas J. Appio, president, Bausch + Lomb/International. “Bausch + Lomb remains focused on bringing forward innovative eye health treatment options to help address unmet medical needs around the world.” VYZULTA is now approved in nine markets, including Argentina, Canada, Colombia, Hong Kong, Mexico, South Korea, Taiwan, Ukraine and the United States. Indication and Important Safety Information about VYZULTA INDICATION AND USAGEVYZULTA® (latanoprostene bunod ophthalmic solution), 0.024% is indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. IMPORTANT SAFETY INFORMATION Increased pigmentation of the iris and periorbital tissue (eyelid) can occur. Iris pigmentation is likely to be permanentGradual changes to eyelashes, including increased length, increased thickness, and number of eyelashes, may occur. These changes are usually reversible upon treatment discontinuationUse with caution in patients with a history of intraocular inflammation (iritis/uveitis). VYZULTA should generally not be used in patients with active intraocular inflammationMacular edema, including cystoid macular edema, has been reported during treatment with prostaglandin analogs. Use with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edemaThere have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products that were inadvertently contaminated by patientsContact lenses should be removed prior to the administration of VYZULTA and may be reinserted 15 minutes after administrationMost common ocular adverse reactions with incidence ≥2% are conjunctival hyperemia (6%), eye irritation (4%), eye pain (3%), and instillation site pain (2%) Please see full prescribing information here. About Nicox Nicox S.A. is an international ophthalmology company developing innovative solutions to help maintain vision and improve ocular health. Nicox’s lead program in clinical development is NCX 470, a novel nitric oxide-donating prostaglandin analog, for lowering intraocular pressure in patients with glaucoma. The company is also developing NCX 4251, a proprietary formulation of fluticasone, for acute exacerbations of blepharitis. Nicox generates revenue from VYZULTA® in glaucoma, licensed exclusively worldwide to Bausch + Lomb, and ZERVIATE™ in allergic conjunctivitis, licensed in multiple geographies, including to Eyevance Pharmaceuticals, LLC, in the U.S. and Ocumension Therapeutics in the Chinese and in the majority of South East Asian markets. Nicox is headquartered in Sophia Antipolis, France, is listed on Euronext Paris (Compartment B: Mid Caps; Ticker symbol: COX) and is part of the CAC Healthcare, CAC Pharma & Bio and Next 150 indexes. For more information on Nicox, its products or pipeline, please visit: www.nicox.com. About Bausch + Lomb Bausch + Lomb, a leading global eye health business of Bausch Health Companies Inc., is solely focused on helping people see. Its core businesses include over-the-counter products, dietary supplements, eye care products, ophthalmic pharmaceuticals, contact lenses, lens care products, ophthalmic surgical devices and instruments. Bausch + Lomb develops, manufactures and markets one of the most comprehensive product portfolios in the industry, which is available in more than 100 countries. For more information, visit www.bausch.com. About Bausch Health Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global company whose mission is to improve people's lives with our health care products. We develop, manufacture and market a range of pharmaceutical, medical device and over-the-counter products, primarily in the therapeutic areas of eye health, gastroenterology and dermatology. We are delivering on our commitments as we build an innovative company dedicated to advancing global health. More information can be found at www.bauschhealth.com. Nicox Forward-looking Statements The information contained in this document may be modified without prior notice. This information includes forward-looking statements. Such forward-looking statements are not guarantees of future performance. These statements are based on current expectations or beliefs of the management of Nicox S.A. and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Nicox S.A. and its affiliates, directors, officers, employees, advisers or agents, do not undertake, nor do they have any obligation, to provide updates or to revise any forward-looking statements. Risks factors which are likely to have a material effect on Nicox’s business are presented in the 3rd chapter of the ‘Document d’enregistrement universel, rapport financier annuel et rapport de gestion 2019’ filed with the French Autorité des Marchés Financiers (AMF) on March 6, 2020 which are available on Nicox’s website (www.nicox.com) and (ii) as restated in the 4th chapter of the half yearly financial report as of June 30, 2020, which is also available on Nicox’s website. Bausch Health Forward-looking Statements This news release may contain forward-looking statements, which may generally be identified by the use of the words “anticipates,” “expects,” “intends,” “plans,” “should,” “could,” “would,” “may,” “believes,” “estimates,” “potential,” “target,” or “continue” and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties discussed in Bausch Health’s most recent annual report on Form 10-K and detailed from time to time in Bausch Health’s other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. They also include, but are not limited to, risks and uncertainties caused by or relating to the evolving COVID-19 pandemic, and the fear of that pandemic and its potential effects, the severity, duration and future impact of which are highly uncertain and cannot be predicted, and which may have a material adverse impact on Bausch Health, including but not limited to its project development timelines, and costs (which may increase). Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. Bausch Health undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this news release or to reflect actual outcomes, unless required by law. ### VYZULTA is a trademark of Bausch & Lomb Incorporated or its affiliates. All other product/brand names and/or logos are trademarks of the respective owners. © 2021 Bausch & Lomb Incorporated or its affiliates. 1 VYZULTA® [prescribing information]. Bridgewater, NJ: Bausch & Lomb Incorporated; 2019. Attachment EN_ Joint PR_VYZULTA approval South Korea_20210209_ F2
