06 January 2014
- Sjö™ 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
Sophia Antipolis, France.
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™ in the United States
In November 2013, Nicox Inc., the Company’s US subsidiary, launched Sjö™, 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™ 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™ 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.
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.