close

Products

Date: 2017-05-31

Type of information: Granting of a Market Authorisation in the US

Product name: Zerviate® - AC-170

Compound: cetirizine

Therapeutic area: Allergic diseases - Immunological diseases - Ophtalmological diseases

Action mechanism: antihistamine. AC-170 is a topical ocular formulation of the second-generation histamine H1-receptor antagonist cetirizine. AC-170 has been developed for the treatment of ocular itching associated with allergic conjunctivitis by Aciex Therapeutics, which became a wholly-owned subsidiary of Nicox in October 2014.

Company: NicOx (France)

Disease: ocular itching associated with allergic conjunctivitis

Latest news:

  • • On May 31, 2017, Nicox announced that the FDA has approved the New Drug Application (NDA) for Zerviate® (cetirizine ophthalmic solution 0.24%; formerly AC-170) the first topical ocular formulation of this antihistamine, for the treatment of ocular itching associated with allergic conjunctivitis. The recommended dose is one drop in each affected eye twice daily (approximately 8 hours apart).
  • The efficacy of Zerviate® was established in three randomized, double-masked, placebo-controlled, conjunctival antigen challenge (Ora-CAC®3 model of allergic conjunctivitis) clinical trials in patients with a history of allergic conjunctivitis. Onset and duration were evaluated in two of these trials in which Zerviate® demonstrated statistically and clinically significantly less ocular itching compared to vehicle at 15 minutes and 8 hours after treatment.
  • Approval of the Zerviate® NDA on or before 1st December 2017 triggers a milestone payment in Nicox shares equivalent to $6.8 million. This payment will be made to the former shareholders of Aciex within 7 business days of the FDA approval date for Zerviate® and will result in the issuance of new shares representing approximately 2.4% of the share capital.
  • • On June 21, 2016, Nicox announced that the FDA has accepted the Company’s New Drug Application (NDA) for AC-170, a cetirizine eye drop formulation, for the treatment of ocular itching associated with allergic conjunctivitis. The FDA also granted Priority Review and has assigned a Prescription Drug User Fee Act (PDUFA) goal date of October 18, 2016.  The October PDUFA date means Nicox now has decisions expected from the FDA on two of its compounds, AC-170 and latanoprostene bunod, by the end of 2016.
  • • On April 19, 2016, Nicox announced the submission, through its American subsidiary Nicox Ophthalmics, Inc., of a New Drug Application (NDA) to the 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. 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. Two Phase 3 safety and efficacy trials have been completed using the Ora-CAC®9 (Conjunctival Allergen Challenge) model of allergic conjunctivitis. Both Phase 3 clinical trials demonstrated statistically significant results for AC-170 compared to vehicle control (placebo) for the primary endpoint of ocular itching. Treatment emergent adverse events were similar in severity and frequency within the active and placebo groups. Nicox held two pre-NDA meetings with the FDA regarding AC-170 for both its clinical development program and its chemistry, manufacturing, and controls aspects, respectively and the FDA recommended submission of the NDA. Nicox is seeking regulatory approval for AC-170 utilizing the FDA’s Section 505(b)(2) regulatory pathway, which enables the Company to rely, in part, on the FDA’s prior findings of safety and efficacy for cetirizine and on the published literature, in support of the NDA. Approval of the AC-170 NDA prior to 1st December 2016 will trigger a milestone payment of $35 million in Nicox shares to ex-Aciex shareholders or $10 million in Nicox shares if approval of the NDA is received after this date. AC-170 was developed by Aciex Therapeutics, Inc., which became a wholly-owned subsidiary of Nicox in October 2014 and was subsequently renamed Nicox Ophthalmics, Inc.
  • • On January 26, 2015, Nicox announced that it has held a positive pre-New Drug Application (NDA) meeting with the FDA regarding AC-170, a topical ocular formulation of cetirizine developed for the treatment of ocular itching associated with allergic conjunctivitis. The purpose of the meeting was to discuss the clinical package for AC-170, and based on the available efficacy and safety data, the Agency recommended submission of the NDA. Nicox will hold an additional pre-NDA meeting regarding the Chemistry, Manufacturing and Controls (CMC) data package, which is expected to take place in the first quarter of 2015. Nicox will update the market in due course on the expected NDA submission date.

Patents:

Submission of marketing authorization application USA : 2016-04-19

Submission of marketing authorization application UE:

Withdrawal of marketing authorization application USA:

Withdrawal of marketing authorization application UE:

US authorization:

UE authorization:

Favourable opinion UE:

Favourable opinion USA:

Orphan status USA:

Orphan status UE:

Pediatric exclusivit _USA:

Pediatric exclusivity UE:

OTC status:

Other news:

Is general: Yes