Nicox Receives Confirmation of 5-year Patent Term Extension of U.S. Patent for Latanoprostene Bunod, Commercialized as VYZULTA®
January 31 2024 - 12:30AM
UK Regulatory
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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