- Sjö(TM) launched in the United States
- Acquisition of Eupharmed in Italy
- European portfolio and operations
strengthened
- Latanoprostene bunod in Phase 3 for glaucoma with
Bausch + Lomb
- AdenoPlus® roll-out
Nicox S.A. (NYSE Euronext Paris: COX) today provides a summary of
its progress in 2013. In line with the strategy announced in 2012,
Nicox is making rapid progress in building an international
ophthalmic company with a range of ophthalmic diagnostics and eye
care products marketed in the United States and in Europe. During
this important evolution year, the Company launched Sjö, a novel
diagnostic test, in the United States, acquired Eupharmed in Italy
and saw its lead R&D asset latanoprostene bunod enter Phase 3
for glaucoma. The Company intends to continue expanding its
portfolio through in-licensing, distribution and acquisition
agreements.
"We have made great progress since the announcement in March
2012 of our decision to build a new international ophthalmic
company," said Gavin Spencer, Executive Vice President
Corporate Development. "In 2013, we delivered on our
strategy to bring products in-house to strengthen our ophthalmic
portfolio both in the United States and in Europe. We look forward
to the exciting opportunities ahead of us in 2014, including the
launch of a new range of eye care products in Europe at the
beginning of the year."
Nicox Ophthalmics Diagnostics franchise expanded with
Sjö(TM) in the United States
In November 2013, Nicox Inc., the Company's US
subsidiary, launched Sjö(TM), an advanced diagnostic panel for the
early detection of Sjögren's Syndrome in patients with dry eye
symptoms. Nicox has exclusive rights to promote Sjö(TM) to eye care
practitioners in North America under an agreement signed with Immco
Diagnostics Inc. in June 2013. Nicox's US sales force also markets
AdenoPlus®, a point-of-care test in-licensed from Rapid Pathogen
Screening Inc. (RPS®) that aids in the differential diagnosis of
acute conjunctivitis. US eye care practitioners are invited to call
+1.855.MY.NICOX for more information or to order Sjö(TM) or
AdenoPlus®.
Nicox also formed a partnership with the US Sjögren's Syndrome
Foundation to raise awareness of the prevalence, seriousness and
significance of Sjögren's Syndrome to eye care specialists. For
more information, please visit www.morethandryeye.com.
European commercial infrastructure strengthened through
the acquisition of Eupharmed
In 2013, Nicox also made significant progress towards its
objective of building its own commercial infrastructure in the five
major European markets: France, Italy, United Kingdom, Germany and
Spain. Throughout the year, a number of appointments were made at
Nicox Pharma, the Company's European subsidiary.
The Company's European product portfolio was expanded in March 2013
through an exclusive agreement with an undisclosed private European
pharmaceutical company for a range of differentiated eye care
products.
Nicox plans to launch its European commercial operations in the
first quarter of 2014 with the launch of this range of eye care
products as well as with the launch of AdenoPlus®.
In Italy, Nicox acquired Eupharmed in December 2013, gaining an
established sales and marketing platform. Eupharmed commercializes
a broad portfolio of ophthalmic products in Italy, including
pharmaceuticals, medical devices and nutraceuticals, with annual
sales expected to reach €3.9 million in 2013.
NO-donating research platform confirmed its potential in
ophthalmology with the entry of latanoprostene bunod into Phase
3
In January 2013, Bausch + Lomb initiated a global Phase 3
program for latanoprostene bunod, a nitric oxide (NO)-donating
prostaglandin F2-alpha analog in development for the reduction of
intraocular pressure in patients with glaucoma and ocular
hypertension. The ongoing Phase 3 program includes two
studies, APOLLO and LUNAR. In July 2013, Bausch + Lomb
initiated two additional studies in Japan, JUPITER (Phase 3) and
KRONUS (Phase 1). For more information, please visit
www.clinicaltrials.gov.
Nicox held its first Scientific Advisory Board (SAB) meeting in
the ophthalmology field in November 2013, with the objective of
evaluating the existing data on second generation NO-donors and
discussing their potential therapeutic use in certain ophthalmic
disorders. Nicox's SAB is led by Dr. Richard L. Lindstrom, an
internationally recognized leader in corneal, cataract, refractive
and laser surgery.
Repositioning of naproxcinod
In October 2013, the European Commission granted Orphan Drug
Designation (ODD) for naproxcinod, a CINOD
(Cyclooxygenase-Inhibiting Nitric Oxide-Donating) anti-inflammatory
candidate, for the treatment of Duchenne Muscular Dystrophy (DMD).
Promising preclinical results obtained with naproxcinod in models
of muscular dystrophy were presented in several international
conferences in 2013.
Organizational changes
During 2013, Nicox conducted an international recruitment
campaign with significant appointments across its US and European
subsidiaries, including in sales, marketing, medical affairs and
logistics. In the US, Nicox Inc. had 24 employees on December 31,
2013, compared to 11 on December 31, 2012, while in Europe Nicox
Pharma's headcount stood at 45 employees at the end of 2013,
compared to none at the end of 2012.
On the Executive Committee, the Company and Eric Castaldi
mutually agreed that Eric will step down as Chief Financial Officer
of Nicox at the beginning of 2014 and Nicox has initiated the
search for a successor. The Company wishes to thank Eric for his
contribution over the past 15 years as CFO, including helping to
steer the Company from a privately-held start-up to a listing on
the French stock market.
...................................
About Nicox
Nicox (Bloomberg: COX:FP, Reuters: NCOX.PA) is
an emerging international company focused on the ophthalmic market.
With a heritage of innovative R&D, business development and
commercial expertise, the Nicox team is building a diversified
portfolio of therapies and diagnostic tools that can help people to
enhance their sight. The Company's commercial portfolio and
near-term pipeline already include several innovative diagnostic
tests intended for eye care professionals, as well as a range of
eye care products. Nicox's key proprietary asset in ophthalmology
is latanoprostene bunod, a novel compound based on Nicox's
proprietary nitric oxide (NO)-donating R&D platform, currently
in Phase 3 clinical development in collaboration with Bausch + Lomb
for the potential treatment of glaucoma and ocular hypertension.
Further NO-donors are under development, notably through
partners.
Nicox is headquartered in France, with research
capabilities in Italy, a growing commercial infrastructure in North
America and in the major European markets and an expanding
international presence through partners. Nicox S.A. is listed on
Euronext Paris (Compartment B: Mid Caps). For more information on
Nicox or its products please visit www.nicox.com.
..................................
This press release contains certain forward-looking
statements. Although the Company believes its expectations are
based on reasonable assumptions, these forward-looking statements
are subject to numerous risks and uncertainties, which could cause
actual results to differ materially from those anticipated in the
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 2012 » filed with the French Autorité des Marchés
Financiers (AMF) on March 22, 2013 and available on Nicox's website
(www.nicox.com) and on the AMF's website
(www.amf-france.org).
...................................
Contacts |
|
Nicox |
Gavin
Spencer | Executive Vice President Corporate
Development |
|
Tel +33 (0)4 97 24 53
00 | communications@nicox.com |
|
|
Media Relations |
|
|
|
United Kingdom |
Jonathan
Birt |
|
M +44 7860 361 746 |
jonathan.birt@ymail.com |
|
|
United States |
Pascale
Communications | Amy Phillips |
|
M +1 412 327
9499 | amy@pascalecommunications.com |
|
|
France |
Caroline
Courme | Communication Manager |
|
Tel +33 (0)4 97 24 53
43 | courme@nicox.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
www.nicox.com
Nicox - Major Progress in 2013
http://hugin.info/143509/R/1752702/591009.pdf
HUG#1752702
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