Cetirizine Hydrochloride

Press Release Nicox Announces up to €3 million in Milestone Payments from Kowa in 2025 as NCX 470 Prepares to Enter Phase 3 Clinical Trials in Japan Exclusive Japanese partner Kowa has received regulatory approval to initiate Phase 3 clinical trials on NCX 470 for the treatment of ocular hypertension in Japan Milestone payments from Kowa totaling €3 million expected to be received by Nicox in 2025 Extends Nicox’s cash runway until the end of 2025 May 27, 2025 – release at 7:30 am CET Sophia Antipolis, France Nicox SA (Euronext Growth Paris: FR0013018124, ALCOX), an international ophthalmology company, today announced that its exclusive Japanese partner for NCX 470, Kowa, has received Clinical Trial Notification (equivalent of a U.S. Investigational New Drug, IND) approval to initiate Phase 3 clinical trials on NCX 470 for the treatment of ocular hypertension in Japan, triggering a €1 million milestone payment to Nicox. The clinical trials are expected to be initiated in H2 2025, which would trigger a second milestone payment of €2 million. “ This important achievement, which enables the initiation of phase 3 clinical development of NCX 470 for Japanese patients, demonstrates the effective collaboration established between the Kowa and Nicox teams and represents a significant advance by Kowa in the delivery of their accelerated development plan. As a result, we expect to receive a total of €3 million in development milestones from Kowa in 2025, extending our cash runway until at least the end of 2025 . ” said Gavin Spencer, Chief Executive Officer of Nicox. “ We congratulate our Japanese partner on the swift progress and look forward to continuing to work with them to bring NCX 470 to the Japanese market. ” Cash Runway Based on the current cash position, estimated revenue and anticipated milestone payments (including the Kowa milestones mentioned above) Nicox now estimates that it is financed until the end of 2025. If any of the assumptions around estimated income or costs change, this may impact the cash runway of the Company. Key Future Milestones Denali Phase 3 clinical trial evaluating NCX 470 in patients with open-angle glaucoma or ocular hypertension: Topline results are expected in the third quarter of 2025 NCX 470 Phase 3 clinical trial in Japan: Initiation expected in H2 2025 Kowa NCX 470 License Nicox licensed the rights to develop and commercialize NCX 470 in Japan to Kowa in February 2024. Nicox may receive a further €7 million in development and regulatory milestones, up to €17.5 million in sales milestones and tiered royalties from 7% to 12% on net sales of NCX 470 in Japan. Kowa is responsible for all development, regulatory and commercialization costs for NCX 470 in Japan. About NCX 470 NCX 470, Nicox’s lead clinical product candidate, is a novel NO-donating bimatoprost eye drop, currently in Phase 3 clinical development for the lowering of IOP in patients with open-angle glaucoma or ocular hypertension. Results of Mont Blanc, the first of the two Phase 3 clinical trials, have been extensively published and are available on our website. The second Phase 3 clinical trial, Denali, is currently ongoing. The last American patient in Denali has completed their final visit, with Chinese patients completing theirs, and the results are expected in Q3 2025. Mont Blanc and Denali have been designed to fulfil the regulatory requirements for safety and efficacy Phase 3 trials to support NDA submissions in both the U.S. and in China, where NCX 470 is exclusively licensed to Ocumension Therapeutics. NCX 470 is also licensed exclusively to Kowa for Japan. About Nicox Nicox SA 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 (bimatoprost grenod), a novel nitric oxide-donating bimatoprost eye drop, for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Nicox also has a preclinical research program on NCX 1728, a nitric oxide-donating phosphodiesterase-5 inhibitor, with Glaukos. Nicox’s first product, VYZULTA® in glaucoma, licensed exclusively worldwide to Bausch + Lomb, is available commercially in the U.S. and over 15 other territories. Nicox generates revenue from ZERVIATE® in allergic conjunctivitis, licensed in multiple geographies, including to Harrow, Inc. in the U.S., and Ocumension Therapeutics in the Chinese and in the majority of Southeast Asian markets. Nicox, headquartered in Sophia Antipolis, France, is listed on Euronext Growth Paris (Ticker symbol: ALCOX) and is part of the CAC Healthcare index. For more information www.nicox.com Analyst coverage H.C. Wainwright & Co Yi Chen New York, U.S. 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. Contacts Nicox Gavin Spencer Chief Executive Officer T +33 (0)4 97 24 53 00 communications@nicox.com Disclaimer 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 section 3 of the “ Rapport Annuel 2024 ” which is available on Nicox’s website (www.nicox.com). Finally, this press release may be drafted in the French and English languages. If both versions are interpreted differently, the French language version shall prevail. Nicox S.A. Sundesk Sophia Antipolis, Bâtiment C, Emerald Square, Rue Evariste Galois, 06410 Biot, France T +33 (0)4 97 24 53 00 Attachment EN_NCX470JapanINDApprovalMay2025_PR_FINAL Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

AUDIENCE: Consumer, Patient, Health Care Professional, Pharmacy, Dermatology ISSUE: The FDA is warning that patients stopping the oral allergy medicines cetirizine (Zyrtec) or levocetirizine (Xyzal) after long-term use may experience rare but severe itching. These medicines are available in prescription and over-the-counter (OTC) forms . The itching, also called pruritus, has been reported in patients who used these medicines daily, typically for at least a few months and often for years. Patients did not experience itching before starting the medicines. Reported cases were rare but sometimes serious, with patients experiencing widespread, severe itching that required medical intervention. As a result, we are revising the prescription cetirizine and levocetirizine prescribing information to include a new warning about this risk. We will subsequently request that manufacturers add a warning about pruritus to the Drug Facts Label of the OTC versions. BACKGROUND: Cetirizine and levocetirizine are antihistamines that block a molecule called histamine that the body releases during allergic reactions. Both medicines are approved to treat seasonal allergies, called seasonal allergic rhinitis, in adults and children 2 years and older. The medicines are also approved to treat year-round allergies, called perennial allergic rhinitis, and chronic hives, called chronic idiopathic urticaria, in patients 6 months and older. Cetirizine was approved for oral use by prescription in December 1995 under the trade name Zyrtec (no longer sold as a prescription medicine) and approved for OTC use in November 2007. Levocetirizine was approved for oral use by prescription in May 2007 under the trade name Xyzal and approved for OTC use in January 2017. RECOMMENDATIONS: Patients Contact your health care professional if you develop severe itching after stopping prescription or OTC cetirizine or levocetirizine. Patients should know that itching typically occurred within a few days of stopping these medicines after daily use for a few months to years. If you are planning on using cetirizine or levocetirizine long term, especially for more than a few months, should discuss the benefits and risks with your health care professional, who can provide advice based on your personal needs. Health Care Professionals Discuss the risk of pruritus after stopping cetirizine or levocetirizine with patients when prescribing or recommending these medicines, especially if planned for chronic use, and with those who indicate they are using OTC versions. Advise patients to contact you if they experience severe itching after stopping cetirizine or levocetirizine. [ FDA Safety Communication - 05/16/2025] Content current as of: 05/23/2025 Regulated Product(s) Topic(s) Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.