Latest news with #ocularhypertension
Yahoo
6 days ago
- Business
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Nicox's Partner Kowa Initiates NCX 470 Phase 3 Clinical Trial in Japan
Press Release Nicox's Partner Kowa Initiates NCX 470 Phase 3 Clinical Trial in Japan Exclusive Japanese partner Kowa has initiated a Phase 3 safety clinical trial of NCX 470 for the treatment of ocular hypertension in Japan Triggers a €2 million milestone payment to Nicox August 5, 2025 – release at 7:30 am CET Sophia Antipolis, FranceNicox SA (Euronext Growth Paris: FR0013018124, ALCOX), an international ophthalmology company, today announced that its exclusive Japanese partner, Kowa, has initiated a Phase 3 safety clinical trial of NCX 470 (also known as K-911) in Japan for the treatment of ocular hypertension, triggering a €2 million milestone payment to Nicox. Only one Phase 3 confirmatory clinical trial in Japanese patients, which will start shortly, plus this safety trial, is required for submission for marketing approval of NCX 470 in Japan. Kowa is responsible for financing and managing the trials under the February 2024 license agreement with Nicox.'Thanks to our continuing collaborative efforts after Kowa received approval to initiate this trial, we are very pleased to announce that the first patient has been enrolled. The Phase 3 trials in Japan are being managed and financed by Kowa, and only one confirmatory Phase 3 trial is expected to be needed to make a submission for marketing approval of NCX 470 in Japan.' said Doug Hubatsch, EVP Scientific Officer of Nicox. The trial announced today is a safety trial and is detailed here: JRCT Safety Trial NCX 470. The 500 patient confirmatory trial is expected to start shortly and is detailed here: JRCT Confirmatory Trial NCX NCX 470NCX 470, Nicox's lead clinical product candidate, is a novel NO-donating bimatoprost eye drop, currently in Phase 3 clinical development programs in the U.S., China and Japan for the lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Results of Mont Blanc, the first of the Phase 3 clinical trials, have been extensively published and are available on our website. All patients have completed the second Phase 3 clinical trial, Denali, and topline results are expected mid-August to mid-September 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. A separate Phase 3 clinical program is underway to support Japanese approval. NCX 470 is exclusively licensed to Ocumension Therapeutics in China, Korea and Southeast Asia and to Kowa in the rest of the world. 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, licensed to Ocumension Therapeutics for the Chinese, Korean and Southeast Asian markets and to Kowa elsewhere. 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 Analyst coverage H.C. Wainwright & Co Yi Chen New York, 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 NicoxGavin SpencerChief Executive OfficerT +33 (0)4 97 24 53 00communications@ 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 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 ( 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 Sophia Antipolis, Bâtiment C, Emerald Square, Rue Evariste Galois, 06410 Biot, FranceT +33 (0)4 97 24 53 00 Attachment EN_NCX470KowaFPFVAugust2025_PR_FINAL
Yahoo
27-05-2025
- Business
- Yahoo
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
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 JapanExclusive 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, FranceNicox 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 RunwayBased 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 LicenseNicox 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 NCX 470NCX 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 Analyst coverage H.C. Wainwright & Co Yi Chen New York, 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 NicoxGavin SpencerChief Executive OfficerT +33 (0)4 97 24 53 00communications@ 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 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 ( 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 Sophia Antipolis, Bâtiment C, Emerald Square, Rue Evariste Galois, 06410 Biot, FranceT +33 (0)4 97 24 53 00 Attachment EN_NCX470JapanINDApprovalMay2025_PR_FINALError in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
