pSivida Corp. (NASDAQ:PSDV) (ASX:PVA), a leader in the development
of sustained release drug products and technologies, and Nicox S.A.
(Euronext Paris: FR0013018124, COX), the international ophthalmic
company, today announced their entry into a collaboration agreement
to explore the potential of combining pSivida's bioerodible
sustained release drug delivery system with Nicox's nitric oxide
(NO)-donating compounds, to develop a sustained release drug to
lower intraocular pressure (IOP) in patients with glaucoma or
ocular hypertension.
pSivida and Nicox will collaborate on the
selection of NO-donating product candidates from Nicox's research
portfolio to combine with pSivida's sustained release drug
technology. pSivida will be responsible for initial
development activities of ocular insert formulations, for which it
will receive undisclosed sums by Nicox. The companies may
then elect to proceed with further development, including more
detailed non-clinical studies to generate pre-clinical data, and
the evaluation of further compounds under the collaboration.
Nicox would make additional payments for any incremental
development activities for each implant formulation product
candidate selected by Nicox to progress in development. New
intellectual property from the collaboration relating to the
drug-device combination will be jointly owned. Nicox and
pSivida will negotiate a separate license agreement for any product
candidate that the two companies wish to further develop and
potentially commercialize as a result of this collaboration.
Expected payments from Nicox associated with this agreement
are not considered material to Nicox's financial statements at this
time.
Michael Bergamini, Executive Vice
President and Chief Scientific Officer, stated, "We have
strong pre-clinical data demonstrating the IOP lowering effect of
our novel stand-alone NO donors, such as our lead NCX 667, and
believe that their profile makes them product candidates for
potential sustained release delivery. The bioerodible
technology in development by pSivida, combined with their proven
success in developing sustained delivery devices for the eye, puts
them at the forefront of this exciting area."
"Nicox's NO-donating research platform has been
validated in both pre-clinical and human studies for the reduction
of IOP," commented Nancy Lurker, President & CEO of
pSivida. "Combining this novel approach to IOP
lowering with our bioerodible, sustained delivery device could
offer a unique therapy alternative or adjunct to existing therapies
to lower IOP in order to help prevent the development and
progression of glaucoma."
About glaucoma
Glaucoma is a group of ocular diseases in which
the optic nerve is injured, leading to peripheral and, ultimately,
central visual loss. Glaucoma can eventually lead to
blindness if not treated. Glaucoma is frequently linked to
abnormally high intraocular pressure (IOP), due to blockage or
malfunction of the eye’s aqueous humor drainage system.
Current medications are targeted at reducing IOP to slow the
progression of the disease. Numerous eye drops are available
to either decrease the amount of fluid produced in the eye or
improve its flow out of the eye. A significant portion of
patients with open-angle glaucoma require more than one medication
to lower their IOP within target levels, highlighting the need for
more effective treatments.
About Nicox’s next generation of stand-alone NO-donors
Nicox's research team has engineered a novel
chemistry for a next generation of stand-alone NO-donating
molecules with the potential to optimize NO dosing to be used alone
or in combination with existing standard-of-care drugs, either as
topical eye drops or in sustained intraocular drug-delivery
devices. The preclinical results obtained after repeat dosing
in rabbit models of glaucoma demonstrate rapid and sustained
IOP-lowering compared to vehicle following repeated dosing one hour
apart over the course of four hours with no signs of tachyphylaxis
or ocular discomfort1. Furthermore, NO-donors result in low
tolerance liability as they were found to repeatedly lower IOP on
assessed days in these models following twice daily administration
over seven days. Similar tolerance liability results were
found in non-human primates.
Notes:
- Repeated dosing of NCX 667, a new nitric oxide (NO) donor,
retains IOP-lowering activity in animal models of glaucoma, E.
Bastia, F. Impagnatiello, E. Ongini, J. Serle, M. Bergamini.
Presented at ARVO 2017
About Nicox
Nicox S.A. is an international ophthalmic
company developing innovative solutions to help maintain vision and
improve ocular health. By leveraging its proprietary expertise in
nitric oxide donation and other technologies, the Company is
developing an extensive portfolio of novel drug candidates that
target multiple ophthalmic conditions, including glaucoma.
Nicox currently has one product at the review stage with the U.S.
Food and Drug Administration (FDA), VYZULTA™ (latanoprostene
bunod ophthalmic solution) 0.024%, licensed worldwide to Bausch +
Lomb, and one product with an approved NDA,
ZERVIATE™ (cetirizine ophthalmic solution) 0.24%, licensed in
the U.S. to Eyevance. In addition, our promising
drug-candidate pipeline includes clinical stage assets based both
on our proprietary NO-donating research platform and on the
repurposing of existing molecules as well as a next-generation of
stand-alone nitric-oxide donors and exploratory novel NO-donating
compounds with the potential to offer novel approaches to treat a
range of ophthalmic conditions. Nicox is headquartered in
Sophia Antipolis, France, is listed on Euronext Paris (Compartment
B: 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.
About pSivida
pSivida Corp. (www.psivida.com), headquartered
in Watertown, MA, is a leader in the development of sustained
release drug products for treating eye diseases. pSivida has
developed three of only four FDA-approved sustained-release
treatments for back-of-the-eye diseases. The most recent,
ILUVIEN®, a micro-insert for diabetic macular edema, licensed to
Alimera Sciences, is currently sold directly in the U.S. and three
EU countries. Retisert®, an implant for posterior uveitis, is
licensed to and sold by Bausch & Lomb. pSivida’s lead
product candidate, Durasert™ micro-insert for posterior segment
uveitis, is being independently developed. Two pivotal Phase
3 studies with Durasert achieved their primary efficacy endpoint of
prevention of recurrence of uveitis at six months of follow-up with
statistical significance, and the Company plans to file an NDA by
late December 2017/early January 2018. pSivida’s pre-clinical
development program is focused on using its core platform
technology Durasert™ to deliver drugs to treat wet age-related
macular degeneration, glaucoma, osteoarthritis and other
diseases. To learn more about pSivida, please visit
www.psivida.com and connect on Twitter, Linkedin, Facebook and
Google+.
Nicox Disclaimer
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 4th
chapter of the ‘Document de référence, rapport financier annuel et
rapport de gestion 2016’ filed with the French Autorité des Marchés
Financiers (AMF) on March 29, 2017, and in the updated and
additional risk factors as of August 14, 2017, which are available
on Nicox’s website (www.nicox.com).
pSivida Disclaimer
SAFE HARBOR STATEMENTS UNDER THE PRIVATE
SECURITIES LITIGATION REFORM ACT OF 1995: Various statements made
in this release are forward-looking, and are inherently subject to
risks, uncertainties and potentially inaccurate assumptions. All
statements that address activities, events or developments that we
intend, expect or believe may occur in the future are
forward-looking statements. Some of the factors that could cause
actual results to differ materially from the anticipated results or
other expectations expressed, anticipated or implied in our
forward-looking statements include uncertainties with respect to:
our ability to achieve profitable operations and access to needed
capital; fluctuations in our operating results; successful
commercialization of, and receipt of revenues from, ILUVIEN® for
diabetic macular edema ("DME"), which depends on Alimera's ability
to continue as a going concern and the effect of pricing and
reimbursement decisions on sales of ILUVIEN; the successful
development and, if approved, commercialization of Durasert (under
the ILUVIEN trademark) for posterior segment uveitis in Europe, the
Middle East and Africa ("EMEA") by Alimera; the number of clinical
trials and data required for the Durasert three-year uveitis
marketing approval applications in the U.S. and EU; our ability to
file and the timing of filing and acceptance of the Durasert
three-year uveitis marketing approval applications in the U.S.; our
ability to use data in a U.S. NDA from clinical trials outside the
U.S.; our ability to successfully commercialize Durasert three-year
uveitis, if approved; potential off-label sales of ILUVIEN for
uveitis; consequences of fluocinolone acetonide side effects;
potential declines in Retisert® royalties; efficacy and our future
development of an implant to treat severe osteoarthritis; our
ability to successfully develop product candidates, initiate and
complete clinical trials and receive regulatory approvals; our
ability to market and sell products; the success of current and
future license agreements, including our agreement with Alimera;
termination or breach of current license agreements, including our
agreement with Alimera; our dependence on contract research
organizations, vendors and investigators; effects of competition
and other developments affecting sales of products; market
acceptance of products; effects of guidelines, recommendations and
studies; protection of intellectual property and avoiding
intellectual property infringement; retention of key personnel;
product liability; industry consolidation; compliance with
environmental laws; manufacturing risks; risks and costs of
international business operations; effects of the potential U.K.
exit from the EU; legislative or regulatory changes; volatility of
stock price; possible dilution; absence of dividends; and other
factors described in our filings with the Securities and Exchange
Commission. You should read and interpret any forward-looking
statements in light of these risks. Should known or unknown risks
materialize, or should underlying assumptions prove inaccurate,
actual results could differ materially from past results and those
anticipated, estimated or projected in the forward-looking
statements. You should bear this in mind as you consider any
forward-looking statements. Our forward-looking statements speak
only as of the dates on which they are made. We do not undertake
any obligation to publicly update or revise our forward-looking
statements even if experience or future changes makes it clear that
any projected results expressed or implied in such statements will
not be realized.
Contacts |
NicoxGavin Spencer,Executive Vice President
Corporate Development T +33 (0)4 97 24 53
00communications@nicox.com |
Investor
RelationsEurope NicoxCorporate
Communications Department T +33
(0)4 97 24 53 00communications@nicox.com |
Media Relations
United Kingdom Jonathan BirtT +44 7860 361
746jonathan.birt@ymail.com |
United
States Argot Partners Melissa ForstT +1 (212)
600-1902melissa@argotpartners.com |
France
NewCapNicolas MerigeauT +33 (0)1 44 71 94 98nicox@newcap.eu |
|
United
States Argot Partners Eliza SchleifsteinT +1 (917)
763-8106eliza@argotpartners.com |
pSivida |
Investor RelationsEVC Group Michael Polyviou/Doug
Sherk212.850.6020; 646-445-4800 mpolyviou@evcgroup.com;
dsherk@evcgroup.com Media
Relations 201-476-0322
tom@tomgibsoncommunications.com |
Nicox S.A.Drakkar 2 Bât D, 2405 route des
Dolines CS 10313, Sophia Antipolis 06560 Valbonne, France T +33
(0)4 97 24 53 00 F +33 (0)4 97 24 53 99
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