Boston, MA — Aciex Therapeutics, Inc. today announced that the United States Patent and Trademark Office (USPTO) has issued a U.S. Patent (No. 8,829,005) covering AC-170 Cetirizine Ophthalmic Compositions and a U.S. Patent (No. 8,765,725) covering AC-155 Fluticasone Propionate Nano-crystalline Compositions. Aciex is a private, US-based ophthalmic development pharmaceutical company with a strong near-term pipeline of therapeutics addressing major segments of the ophthalmic market, including allergy and inflammation.
On July 1, 2014, Nicox S.A. (NYSE Euronext Paris: COX) signed an agreement to acquire Aciex Therapeutics, Inc. For more information, see Nicox press release dated July 2, 2014 available on Nicox’s website.
U.S. Patent No. 8,829,005 contains method of treatment claims that cover Aciex’s cetirizine product candidate (cetirizine ophthalmic solution, 0.24%). U.S. Patent No. 8,765,725 contains both composition of matter and method of uses claims that broadly cover Aciex’s novel nanocrystalline formulations of fluticasone propionate.
AC-170 is a novel formulation of cetirizine (an oral antihistamine, available under brand names including Zyrtec®) being evaluated for the treatment of allergic conjunctivitis. Pending FDA approval, it could become the first topical application of cetirizine in the eye available to patients. Two phase 3 safety and efficacy studies have demonstrated statistically significant results for AC-170 over vehicle control for the primary endpoint of ocular itching. Treatment-emergent adverse events were similar in severity and frequency in the active and vehicle groups. An AC-170 pre-NDA meeting with the U.S. FDA is expected to be held by the end of Q1 2015.
AC-155 is a novel nanocrystalline form of fluticasone (a market leading nasal corticosteroid available/sold under brand names including Flonase® and Flovent®) and is also being developed for the first time for topical ocular administration. It uses Aciex’s proprietary manufacturing process and is being developed for post-operative inflammation and pain. Based on fluticasone’s approximately ten-fold greater affinity for the glucocorticoid receptor, AC-155 will be evaluated at a reduced dosing frequency compared to dexamethasone. AC-155 is expected to move into a phase 2 clinical trial in 2015, subject to agreement by the U.S. FDA, completion of toxicity studies, and IND filing.
Zyrtec® is a trademark of UCB Pharma SA or GlaxoSmithKline; Flonase® and Flovent® are trademarks of Glaxo Group Limited.
Aciex Therapeutics, Inc., located in Boston, MA, is a venture-backed ophthalmic pharmaceutical company focused on developing first-in-class products to treat ocular diseases. Aciex’s extensive pipeline includes a number of clinical and pre-clinical programs that principally target ocular allergy, ocular inflammation and blepharitis and which offer opportunities for both in-house development and external collaborations. The pipeline has been developed through a close partnership with Ora, Inc., a leading ophthalmic Contract Research Organization (CRO) and development company. Existing investors in Aciex include Akorn, Inc., Bay City Capital, HealthCare Ventures, New Enterprise Associates and Ora Investment Group. Aciex’s product pipeline, which includes both clinical stage and pre-IND assets, is designed to fill significant unmet therapeutic needs and allow the Company to build a sustainable ophthalmic franchise. For more information about Aciex, visit www.aciexrx.com.
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 VESNEO (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.
Aciex’s Forward-looking Statements
This news release contains certain statements of a forward looking nature relating to future events, including statements and projections regarding the development of clinical trials relating to and potential approval for marketing of Aciex’s product candidates. Such statements entail a number of risks and uncertainties. Any forward-looking statements or projections are based on the limited information currently available to the Company, which is subject to change. Although any such forward-looking statements or projections and the factors influencing them will likely change, Aciex Therapeutics, Inc. undertakes no obligation to update the forward-looking statements or projections contained herein. Such statements and projections speak only as of the date of this news release. Actual events or results could differ materially and one should not unduly rely on such statements or information nor assume that the information provided in this release is still valid at any later date.