Dossier submitted, with a request for Priority Review, for the treatment of ocular itching associated with allergic conjunctivitis
SOPHIA ANTIPOLIS, France I April 19, 2016 I Nicox S.A. (Euronext Paris: FR0013018124, COX), the international ophthalmic company, today announced the submission, through its American subsidiary Nicox Ophthalmics, Inc., of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of AC-170, its novel, proprietary, cetirizine eye drop formulation, for the treatment of ocular itching associated with allergic conjunctivitis. Based on clinical pediatric data generated with AC-170, the Company also requested a Priority Review, which, if obtained, could result in an FDA decision by the end of 2016 based on PDUFA (Prescription Drug User Fee Act) performance goals.
Michele Garufi, Chairman and Chief Executive Officer of Nicox, stated. “The submission of the first U.S. NDA resulting from our acquisition of Aciex in October 2014 is a major milestone in the Company’s history and a significant step forward in our commitment to delivering new ophthalmology treatment options to patients. If successful in obtaining Priority Review, we would have two compounds – AC-170 and latanoprostene bunod, licensed to Bauch+Lomb, – potentially receiving FDA approval in the United States by the end of 2016. This would be a remarkable achievement for Nicox, and almost unique in the panorama of European biotech companies.”
“AC-170 is the first ocular product which utilizes the well-known antihistamine cetirizine,” commented Mike Bergamini, Chief Scientific Officer and Executive Vice President of Nicox. “The established safety and efficacy of this molecule, administered orally, is widely recognized by physicians, and our goal is for AC-170 to become a trusted medicine for the estimated 75 million Americans who currently suffer from allergic conjunctivitis.”
The FDA has a 60-day filing review period to determine whether the NDA is complete and acceptable for filing, and to confirm if the Priority Review has been granted. Nicox expects to communicate the Agency’s decision.
About Nicox
Nicox (Bloomberg: COX:FP, Reuters: NCOX.PA) is an international commercial-stage company focused on the ophthalmic market. With a heritage of innovative R&D, business development and marketing expertise, Nicox is building a diversified portfolio of ophthalmic products that can help people enhance their sight.
Nicox’s advanced pipeline features latanoprostene bunod for the lowering of intra-ocular pressure (IOP) in patients with open angle glaucoma or ocular hypertension, and for which a New Drug Application (NDA) was submitted to the FDA by the Company’s licensee Valeant. The Company’s pipeline also features AC-170, a pre-NDA candidate for the treatment of ocular itching associated with allergic conjunctivitis, as well as two pre-MAA candidates in Europe: AzaSite® for bacterial conjunctivitis and BromSite™ for pain and inflammation after cataract surgery. Beyond these late-stage candidates, Nicox is developing a pipeline of next generation ophthalmology-focused candidates which utilize its proprietary nitric oxide (NO)-donating research platform. The Group has operations in Europe and the United States.
Nicox is listed on Euronext Paris (Category B: Mid Caps) and is part of the CAC Healthcare, CAC Pharma & Bio and Next 150 indexes. For more information on Nicox, its commercial products or pipeline, please visit www.nicox.com.
SOURCE: Nicox
Post Views: 145
Dossier submitted, with a request for Priority Review, for the treatment of ocular itching associated with allergic conjunctivitis
SOPHIA ANTIPOLIS, France I April 19, 2016 I Nicox S.A. (Euronext Paris: FR0013018124, COX), the international ophthalmic company, today announced the submission, through its American subsidiary Nicox Ophthalmics, Inc., of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of AC-170, its novel, proprietary, cetirizine eye drop formulation, for the treatment of ocular itching associated with allergic conjunctivitis. Based on clinical pediatric data generated with AC-170, the Company also requested a Priority Review, which, if obtained, could result in an FDA decision by the end of 2016 based on PDUFA (Prescription Drug User Fee Act) performance goals.
Michele Garufi, Chairman and Chief Executive Officer of Nicox, stated. “The submission of the first U.S. NDA resulting from our acquisition of Aciex in October 2014 is a major milestone in the Company’s history and a significant step forward in our commitment to delivering new ophthalmology treatment options to patients. If successful in obtaining Priority Review, we would have two compounds – AC-170 and latanoprostene bunod, licensed to Bauch+Lomb, – potentially receiving FDA approval in the United States by the end of 2016. This would be a remarkable achievement for Nicox, and almost unique in the panorama of European biotech companies.”
“AC-170 is the first ocular product which utilizes the well-known antihistamine cetirizine,” commented Mike Bergamini, Chief Scientific Officer and Executive Vice President of Nicox. “The established safety and efficacy of this molecule, administered orally, is widely recognized by physicians, and our goal is for AC-170 to become a trusted medicine for the estimated 75 million Americans who currently suffer from allergic conjunctivitis.”
The FDA has a 60-day filing review period to determine whether the NDA is complete and acceptable for filing, and to confirm if the Priority Review has been granted. Nicox expects to communicate the Agency’s decision.
About Nicox
Nicox (Bloomberg: COX:FP, Reuters: NCOX.PA) is an international commercial-stage company focused on the ophthalmic market. With a heritage of innovative R&D, business development and marketing expertise, Nicox is building a diversified portfolio of ophthalmic products that can help people enhance their sight.
Nicox’s advanced pipeline features latanoprostene bunod for the lowering of intra-ocular pressure (IOP) in patients with open angle glaucoma or ocular hypertension, and for which a New Drug Application (NDA) was submitted to the FDA by the Company’s licensee Valeant. The Company’s pipeline also features AC-170, a pre-NDA candidate for the treatment of ocular itching associated with allergic conjunctivitis, as well as two pre-MAA candidates in Europe: AzaSite® for bacterial conjunctivitis and BromSite™ for pain and inflammation after cataract surgery. Beyond these late-stage candidates, Nicox is developing a pipeline of next generation ophthalmology-focused candidates which utilize its proprietary nitric oxide (NO)-donating research platform. The Group has operations in Europe and the United States.
Nicox is listed on Euronext Paris (Category B: Mid Caps) and is part of the CAC Healthcare, CAC Pharma & Bio and Next 150 indexes. For more information on Nicox, its commercial products or pipeline, please visit www.nicox.com.
SOURCE: Nicox
Post Views: 145
