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02.03.2022 07:30:00
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Nicox’s Partner Fera Pharmaceuticals Obtains Orphan Drug Designation from the U.S. FDA for Naproxcinod for the Treatment of Sickle Cell Disease
| Press Release | ||
| Nicox’s Partner Fera Pharmaceuticals Obtains Orphan Drug Designation from the U.S. FDA for Naproxcinod for the Treatment of Sickle Cell Disease | ||
March 2nd, 2022 – release at 7:30 am CET Sophia Antipolis, France Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, and Fera Pharmaceuticals, a privately-held, U.S. specialty pharmaceutical company, today announced that the United States (U.S.) Food and Drug Administration (FDA) has granted Orphan Drug Designation for naproxcinod for the treatment of sickle cell disease, which affects an estimated 100,000 Americans. Naproxcinod is a nitric oxide (NO)-donating naproxen combining the cyclooxygenase (COX) inhibitory activity of naproxen with that of nitric oxide developed by Nicox and exclusively licensed to Fera in the U.S. Nicox has tested naproxcinod in over 2,700 patients in osteoarthritis, generating a significant package of clinical safety data which is available to support Fera’s development of naproxcinod, and ultimately a New Drug Application submission for sickle cell disease. "We congratulate Fera on achieving Orphan Drug Designation for naproxcinod, which is a very important step in being able to develop this molecule as a potential treatment for sickle cell disease. Fera has already carried out pre-clinical development work on naproxcinod in models of sickle cell disease, and the extensive clinical package already developed by Nicox positions the molecule – the first that was taken into clinical development by our Company – for an accelerated development.” said Michele Garufi, Chief Executive Officer and Chairman of Nicox. "We are extremely pleased that the FDA granted Orphan Drug status for naproxcinod as it now allows us to continue our development for sickle cell disease with the benefits that come along with this designation.” said Frank DellaFera, Founder and Chief Executive Officer of Fera Pharmaceuticals. About Orphan Drug Designation The FDA Orphan Drug Designation program provides orphan status to drugs and biologics that are intended for the safe and effective treatment, diagnosis, or prevention of rare diseases that affect fewer than 200,000 people in the U.S. Among the benefits of orphan drug designation in the U.S. are seven years of market exclusivity following FDA approval, waiver or partial payment of application fees, and tax credits for expenses related to qualified clinical trials conducted after orphan designation is received. Role of nitric oxide in sickle cell disease Sickle cell disease is an inherited disorder that affects red blood cells, with a faulty version of hemoglobin causing normally oval-shaped red blood cells to assume a sickle-like shape, leading to symptoms including pain, frequent infections and anemia. Rupture of these cells in the bloodstream can lead to inflammation, a reduction in NO and a subsequent endothelial cell wall thickening, as well as platelet activation. In this inflamed environment and reduced volume, sickled red blood cells, leukocytes (white blood cells) and activated platelets aggregate to create a "vascular log-jam” (vaso-occlusion), leading to a painful vaso-occlusive crisis. Nicox-Fera Partnership Naproxcinod, a Cyclooxygenase-Inhibiting Nitric Oxide (NO)-Donating (CINOD) naproxen, is a non-steroidal anti-inflammatory product candidate engineered to release NO and naproxen, originally discovered and developed by Nicox. Nicox and Fera entered into an agreement in December 2015, amended in September 2018 and December 2020, which granted Fera exclusive rights to develop and commercialize naproxcinod for the U.S. market. Nicox is eligible to potentially receive a single $40 million sales-based milestone if naproxcinod reaches $1 billion yearly sales (for any indication) in the U.S. as well as royalties of 7% on future net sales of naproxcinod in the U.S. Fera is responsible for all clinical development, manufacturing, regulatory and commercialization activities in the U.S. Nicox retains all rights to naproxcinod outside the U.S., subject to the payment of royalties to Fera, if intellectual property developed under the agreement is used outside the U.S. | ||
| About naproxcinod | ||
| Naproxcinod is a Cyclooxygenase Inhibiting Nitric Oxide Donating, or CINOD, anti-inflammatory product candidate. While the inhibitory COX component provides the analgesic and anti-inflammatory efficacy, the NO part may play a significant role in maintaining vascular endothelial cell function and integrity, blood pressure homeostasis and microvascular circulation. A broad clinical package already exists for naproxcinod in osteoarthritis, including three Phase 3 trials with over 2,700 patients. | ||
| About Fera Pharmaceuticals | ||
| Fera Pharmaceuticals is a privately held company. The company goal is to realize opportunities via acquisitions, in-licensing, developing and marketing abbreviated new drug applications (ANDA), new drug applications (NDA) and 505(b)(2) NDA products. Areas of interest include products that could benefit from lifecycle management with a special focus on niche markets. For more information visit www.ferapharma.com. | ||
| 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 open-angle glaucoma or ocular hypertension. The company is also developing NCX 4251, a proprietary formulation of fluticasone, for dry eye disease. 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 C: 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 Dylan van Haaften Paris, France Edison Investment Research Pooya Hemami London, UK H.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. | ||
| 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 | Investors & Media United States & Europe LifeSci Advisors, LLC Sandya von der Weid T +41 78 680 05 38 svonderweid@lifesciadvisors.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 the 3rd chapter of the ‘Document d’enregistrement universel, rapport financier annuel et rapport de gestion 2020’ filed with the French Autorité des Marchés Financiers (AMF) on March 1, 2021 and in the 2nd chapter of the amendment to the "Document d’Enregistrement Universel, rapport financier annuel et rapport de gestion 2020” filed with the AMF on December 9, 2021 which are available on Nicox’s website (www.nicox.com). | ||
| 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 | ||
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