Nicox and Kowa Enter into Agreement for NCX 470 Development and Commercialization in Japan
08 Febbraio 2024 - 7:30AM
UK Regulatory
Nicox and Kowa Enter into Agreement for NCX 470 Development and
Commercialization in Japan
Press Release |
Nicox and Kowa Enter into Agreement for NCX 470 Development and
Commercialization in Japan |
- €3 million upfront payment
and a total of a further potential €27.5 million in
milestones
- Tiered royalties on net
sales of 7% to 12%
- Kowa to be responsible for
all development and commercialization costs for NCX 470 in
Japan
- Upfront payment extends
Nicox cash runway to September 2024
February 8, 2024 – release at 7:30 am CET
Sophia Antipolis, France
Nicox SA (Euronext Growth Paris: FR0013018124,
ALCOX), an international ophthalmology company, today announced the
signature of an agreement granting Kowa Company, Ltd., a Japanese
company with a global pharmaceutical business engaged in
ground-breaking research, development and marketing, exclusive
Japanese rights to develop and commercialize NCX 470, Nicox’s
nitric oxide (NO)-donating bimatoprost eye drop, for the lowering
of intraocular pressure (IOP) in patients with glaucoma or ocular
hypertension.
“We are very pleased to welcome Kowa as an exclusive partner
for our lead asset, NCX 470, for the Japanese market. The interest
of such an established ophthalmology player confirms the scientific
and commercial opportunity for NCX 470 specifically for Japanese
patients.” said Emmet Purtill, Vice President of
Business Development at Nicox. “Japan
represents one of the largest regional markets for ophthalmic
therapeutics and therefore this collaboration significantly
strengthens the global potential revenue for NCX 470, which we
estimate to be over $300 million in peak annual net
sales.”
Terms of the Exclusive License Agreement
Under the terms of the exclusive licensing agreement, Kowa has the
rights to develop and commercialize NCX 470 in Japan. Kowa shall
make a non-refundable upfront payment of €3 million to Nicox, with
a further potential €10 million in development and regulatory
milestones, €17.5 million in sales milestones and tiered royalties
from 7% to 12% on net sales. Kowa shall be responsible for all
development, regulatory and commercialization costs for NCX 470 in
Japan.
The collaboration will be managed by a Joint Steering Committee.
Kowa expects to conduct additional clinical trials in Japanese
patients as required for regulatory approval of NCX 470 in Japan in
addition to the development data from Nicox.
Nicox Corporate Status Update
Including the upfront payment from the Japanese licensing deal for
NCX 470, the Company estimates it is currently funded until
September 2024, exclusively based on the development of NCX 470.
The Company is pursuing business development discussions which
could further extend the cash runway, exploring multiple strategic
options and is also discussing with its creditors to restructure
its debt.
About NCX 470
NCX 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 expected in 2025, based on
current recruitment rates. 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. In addition to the Japanese and Chinese
licensees for NCX 470, Nicox is also looking for a commercial
partner in the United States.
NCX 470 is protected worldwide by a composition of matter patent
until 2029, with potential extension of up to 5 years in the U.S.
and Europe, and by a patent covering the eye drops formulation
until 2039 in the U.S., EU, Japan and China as well as other
territories. |
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.
Sundesk Sophia Antipolis, Bâtiment C
Emerald Square,
Rue Evariste Galois, 06410 Biot, France
T +33 (0)4 97 24 53 00 |
- EN_Kowa Japan NCX470 Licensing PR_20240208_F
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