Nicox Estimates Potential Annual Global Net Sales for NCX 470 of over $300 million
July 10 2023 - 1:30AM
Nicox Estimates Potential Annual Global Net Sales for NCX 470 of
over $300 million
Press Release |
Nicox Estimates Potential Annual Global Net Sales for NCX 470 of
over $300 million |
- NCX 470 therapeutic profile
positively received
among
U.S. eye care professionals
in a market survey conducted with a
leading, independent research agency
-
Potential annual
global net sales for NCX 470
estimated to
reach at least $300
million within 8
years from the date of
launches
in U.S. and China
- Nicox
currently seeking U.S. and
Japanese commercial partners for NCX 470
July 10, 2023 – release at 7:30 am CET Sophia Antipolis,
FranceNicox SA (Euronext Growth Paris:
FR0013018124, ALCOX), an international ophthalmology company, today
provided details of a U.S. market survey evaluating the commercial
potential of NCX 470, a nitric oxide (NO)-donating bimatoprost, in
development for the lowering of intraocular pressure (IOP) in
patients with open-angle glaucoma or ocular hypertension and
estimated potential global annual net sales for NCX 470.“We
recently conducted a market survey with a leading, independent
research agency in the United States which confirmed the interest
from ophthalmologists and optometrists in the potential use of NCX
470 as a therapeutic option for patients who do not reach their
target intraocular pressure. The research also informed our
potential pricing and reimbursement strategies, which we have
factored into our assessment of the potential sales.” said
Andreas Segerros,
CEO of Nicox. “Based on this
data, and insights from our Chinese and Southeast Asian partner,
Ocumension Therapeutics, together with estimates of sales in other
territories, we believe that annual global net sales of NCX 470
could be over $300 million within 8 years of the date of launches
in the U.S. and China.”About NCX 470NCX 470, a
novel NO-donating bimatoprost eye drop, is currently in Phase 3
clinical development for the lowering of IOP in patients with
open-angle glaucoma or ocular hypertension. Results of Mont Blanc,
the first of the two Phase 3 clinical trials, were announced in
October 2022. The second Phase 3 clinical trial, Denali, is
currently ongoing, and the results are expected1 in 2025. Mont
Blanc and Denali have been designed to fulfill the regulatory
requirements for safety and efficacy Phase 3 trials to support NDA
submissions in both the U.S. and in China, where NCX 470 is
exclusively licensed to Ocumension Therapeutics.NCX 470 is
protected worldwide by composition of matter patents until 2029,
with potential extension of up to 5 years in the U.S. and Europe,
and by formulation patents to 2039 in the U.S., EU, Japan and China
as well as other territories.Basis of Estimated Sales
ForecastThe primary market research in the U.S. assumed
NCX 470 obtained U.S. FDA approval with the safety and efficacy
profile seen in the Mont Blanc Phase 3 trial. The research involved
ophthalmology key opinion leaders, prescribers and payors in a
qualitative phase, followed by 100 glaucoma prescribers in a
quantitative internet survey. Taking into account expected
genericization of the market, basing the undiscounted price on
appropriate branded references, and applying appropriate discounts,
the net annual sales potential in the U.S. alone was estimated at
between $115 and $165 million by year 8. Ocumension Therapeutics,
our exclusive licensing partner in China and Southeast Asia, has
also conducted market evaluation and provided a forecast of NCX 470
sales for their territory. We assume approval in the U.S. and China
in a similar timeframe, with the NDA submissions in both
territories made after the results of the Denali Phase 3 trial
expected in 20252. The global net sales estimate also includes
assessments of potential sales outside of the U.S. and China. We
are currently looking for U.S. and Japanese commercial partners and
would also seek partners in other territories which can use the
U.S. approval closer to that time. Our assumptions consider that
those partnerships are in place at the appropriate time to maximize
the revenue potential. We are not currently assuming revenue from
sales in Europe, which could be a potential upside pending
discussions with the European Medicines Agency on the appropriate
regulatory route to approval. |
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 Growth Paris (Ticker symbol: ALCOX)
and is part of the CAC Healthcare index.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 section 2.7 of the ‘Rapport
Annuel 2022’ which is 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 |
1 This date is based on projections of increased recruitment
which take notably into account the lifting of COVID-19
restrictions in China.2 Ibid
- EN_NCX 470 Market Potential PR_20230710_F
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