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31.01.2024 07:30:00
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Nicox Receives Confirmation of 5-year Patent Term Extension of U.S. Patent for Latanoprostene Bunod, Commercialized as VYZULTA®
| Press Release | ||
| Nicox Receives Confirmation of 5-year Patent Term Extension of U.S. Patent for Latanoprostene Bunod, Commercialized as VYZULTA® | ||
January 31, 2024 – release at 7:30 am CET Sophia Antipolis, France Nicox SA (Euronext Growth Paris: FR0013018124, ALCOX), an international ophthalmology company, today announced that the United States Patent and Trademark Office (USPTO) has determined that U.S. Patent No. 7,629,345, which covers latanoprostene bunod, commercialized by Bausch + Lomb under the trademark VYZULTA®, is eligible for patent term extension of five years. Nicox has also applied for patent term extension of two other patents covering latanoprostene bunod, U.S. patent Nos. 7,273,946 and 8,058,467. Nicox, in collaboration with Bausch + Lomb, must now elect which patent will be the subject of the patent term extension, and, depending on the choice of the patent, this may lead to an extension to either 2029 or 2030. "We are close to the final step in the process for obtaining a Patent Term Extension for latanoprostene bunod, which would ensure royalty payments to Nicox on sales of VYZULTA until at least 2029. The majority of our licensing revenues currently come from VYZULTA, and at €4.2 million in 2023, showed a year-on-year increase of 29%.” said Gavin Spencer, EVP, Chief Business Officer of Nicox. About Latanoprostene Bunod and VYZULTA Latanoprostene bunod, the pharmaceutical active ingredient in VYZULTA (latanoprostene bunod ophthalmic solution), 0.024%, was invented and patented by Nicox, and is the first product from the Company’s proprietary nitric oxide-donating research platform to be approved for commercialization. Under the patent restoration provisions of the Drug Price Competition and Patent Term Restoration Act of 1984 (also known as the "Hatch-Waxman Act”) certain patents for pharmaceutical products in the U.S. may be extended by up to 5 years once product approval from the FDA has been obtained. VYZULTA, exclusively licensed worldwide to Bausch + Lomb, is commercialized in more than 15 countries, including the U.S., and is also approved in a number of other countries. VYZULTA is indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Under the terms of the exclusive global license agreement with Bausch + Lomb, Nicox is eligible to receive a $5 million net ($20 million before deductions to Pfizer) milestone on VYZULTA net sales reaching $100 million and are receiving tiered net royalties from Bausch + Lomb of 6% to 12%, after deduction of payments due to Pfizer under the 2009 agreement. Nicox Corporate Status Update The Company estimates it is financed until June 2024, based exclusively on the development of NCX 470. The Company is pursuing licensing and other business development discussions, exploring multiple strategic options and is also discussing with its creditors to restructure its debt. | ||
| 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, a novel nitric oxide-donating bimatoprost eye drop, for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Nicox generates revenue from VYZULTA® in glaucoma, licensed exclusively worldwide to Bausch + Lomb, and 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 | ||
Bryan, Garnier & Co Eric Yoo Paris, France 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 Executive Vice President, Chief Business Officer & Head of Corporate Development T +33 (0)4 97 24 53 00 communications@nicox.com | ||
| 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 section 2.7 of the "Rapport Annuel 2022” and in section 4 of the "Rapport semestriel financier et d’activité 2023” which are available on Nicox’s website (www.nicox.com). | ||
| Nicox S.A. Drakkar 2 Bât D, 2405 route des Dolines 06560 Valbonne, France T +33 (0)4 97 24 53 00 F +33 (0)4 97 24 53 99 | ||
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