Nicox Receives Confirmation of 5-year Patent Term Extension of U.S. Patent for Latanoprostene Bunod, Commercialized as VYZULTA®
31 Gennaio 2024 - 7:30AM
Nicox Receives Confirmation of 5-year Patent Term Extension of U.S.
Patent for Latanoprostene Bunod, Commercialized as VYZULTA®
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Press Release |
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Nicox Receives Confirmation of 5-year Patent Term Extension of U.S.
Patent for Latanoprostene Bunod, Commercialized as VYZULTA® |
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January 31, 2024 – release at 7:30 am CET Sophia Antipolis,
FranceNicox 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
VYZULTALatanoprostene 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 UpdateThe 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. |
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About Nicox |
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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. |
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Analyst coverage |
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Bryan, Garnier & Co
Eric
Yoo Paris,
FranceH.C. Wainwright &
Co Yi
Chen New York,
U.S. |
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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. |
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Contacts |
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NicoxGavin SpencerExecutive Vice President, Chief
Business Officer& Head of Corporate Development T +33 (0)4 97
24 53 00communications@nicox.com |
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Forward-Looking Statements |
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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). |
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Nicox S.A.Drakkar 2Bât D, 2405 route des
Dolines06560 Valbonne, FranceT +33 (0)4 97 24 53 00F +33 (0)4 97 24
53 99 |
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Grafico Azioni Nicox (TG:NXOA)
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Grafico Azioni Nicox (TG:NXOA)
Storico
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