Nicox’s Partner Ocumension Therapeutics Receives Priority Review Status for ZERVIATE New Drug Application in China
2023年4月28日 - 2:30PM
Nicox’s Partner Ocumension Therapeutics Receives Priority Review
Status for ZERVIATE New Drug Application in China
Press Release |
Nicox’s Partner Ocumension Therapeutics Receives Priority Review
Status for ZERVIATE New Drug Application in China |
-
Nicox’s partner,
Ocumension Therapeutics,
announced on April 26, 2023, that they had
received Priority Review Status for
the New
Drug
Application for ZERVIATE in
China
-
Accelerates the
ZERVIATE® approval and
launch, which are
expected in China in 2024
April 28, 2023 – release at 7:30 am CET Sophia Antipolis,
FranceNicox SA (Euronext Paris: FR0013018124,
COX), an international ophthalmology company, today announced that
the New Drug Application (NDA) for approval to commercialize
ZERVIATE® (cetirizine ophthalmic solution), 0.24%, submitted in
China by its exclusive Chinese partner, Ocumension Therapeutics,
has been included in the priority review and approval process of
National Medical Products Administration of the People’s Republic
of China (“NMPA”). This will accelerate the approval process and
potentially the launch of ZERVIATE in China. ZERVIATE is the first
and only eye drop formulation of the antihistamine cetirizine, the
active ingredient in ZYRTEC®, and is currently commercialized in
the U.S. for ocular itching associated with allergic
conjunctivitis. The prescription market for allergic conjunctivitis
products in China is expected to grow to almost $500 million by
2030. Ocumension is forecasting potential annual net
sales of ZERVIATE >$100 million within 7 years.The ZERVIATE NDA
in China is supported by the data package licensed by Nicox to
Ocumension and an additional Chinese Phase 3 clinical trial of
ZERVIATE run by Ocumension. ZERVIATE was compared to emedastine
difumarate ophthalmic solution, 0.05%, an antihistamine marketed
under the brand name EMADINE®. ZERVIATE was found to be
non-inferior to emedastine difumarate in the primary efficacy
endpoint of change from baseline in the itching score in the 24
hours prior to the Day 14 visit. ZERVIATE was safe and
well-tolerated with no difference in the proportion of patients
with adverse events compared to emedastine difumarate.The priority
review and approval process of NMPA is designed to expedite the
approval of drugs that address unmet medical needs or have the
potential to offer significant improvements over existing treatment
options. The inclusion of ZERVIATE in the priority review and
approval process of NMPA will accelerate the review and approval
process of its new drug application, which is an important step
towards commercialization of ZERVIATE.ZERVIATE is exclusively
licensed to Ocumension Therapeutics for development and
commercialization in the Chinese and the majority of the Southeast
Asian markets. All costs of commercialization are borne by
Ocumension and Nicox may potentially receive sales milestones of up
to US$17.2 million together with royalties of between 5% and 9% of
net sales of ZERVIATE by Ocumension. Ocumension’s Press Release can
be found here. |
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, for lowering intraocular
pressure in patients with open-angle glaucoma or ocular
hypertension. The company is also conducting research on NCX 1728,
a nitric oxide-donating phosphodiesterase 5 inhibitor, in retinal
conditions. NCX 4251, a novel, patented, ophthalmic suspension of
fluticasone propionate nanocrystals for topical ocular application
for dry eye disease, is being developed by Ocumension Therapeutics
in China under an exclusive license agreement and is available for
partnering elsewhere. 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 (a wholly
owned subsidiary of Santen Pharmaceutical Co., Ltd.), 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 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
Eric
Yoo Paris,
FranceEdison Investment
Research Pooya
Hemami London,
UKH.C. Wainwright &
Co Yi
Chen New York,
U.S.Kepler
Cheuvreux Arsene
Guekam 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 |
|
NicoxGavin SpencerExecutive Vice President, Chief
Business Officer& Head of Corporate Development T +33 (0)4 97
24 53 00communications@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 the 3rd chapter of the
‘Document d’enregistrement universel, rapport financier annuel et
rapport de gestion 2021’ filed with the French Autorité des Marchés
Financiers (AMF) on April 29, 2022 whose first amendment has been
filed with the AMF on May 19, 2022, in the 2nd chapter of the
second amendment filed with the AMF on November 22, 2022 and in the
2nd chapter of the Securities noted filed with the AMF on November
22, 2022 which are available on Nicox’s website
(www.nicox.com) |
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 |
- EN_ZERVIATE China NDA Fastrack PR_20230428
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