On May 24, 2006 Isotechnika Inc. signed a distribution and license agreement with Lux Biosciences Inc. (“Lux”) granting them worldwide rights to develop and commercialize voclosporin for the treatment and prophylaxis of all ophthalmic diseases. Under the terms of the agreement, Lux will make upfront and milestone payments. Assuming all development milestones are achieved, the amount of this deal will be US$32.7 million. Isotechnika Inc. received an upfront payment of $3.32 million (US$3.0 million) upon signing the agreement. Lux will also pay royalties based on a percentage of net sales. Lux is responsible for the clinical development, registration, and marketing of voclosporin for all ophthalmic indications. Regulatory approvals in the U.S. and Europe, of the first indication, will trigger milestone payments of US$7.04 million and US$3.52 million, respectively, to the Company. Lux is investigating voclosporin for the treatment of uveitis and dry eye syndrome.
In February, 2010, Lux filed a New Drug Application (“NDA”) with the FDA and a Marketing Authorization Application (“MAA”) with the European Medicines Agency (“EMA”) for voclosporin for the treatment of non-infectious uveitis.
On August 4, 2010, the Company announced that Lux received a Complete Response Letter (“CRL”) from the FDA regarding their NDA for voclosporin. A CRL is issued by the FDA when the review of a file is completed and questions remain that prevent the approval of the NDA in its current form. The FDA has requested additional information and recommended that an additional clinical trial be conducted in order to consider a future approval of voclosporin for this indication.
In February, 2011, Lux commenced the required additional pivotal Phase 3 trial. The study is a 6-month randomized trial of voclosporin versus placebo in 150 patients in North America and Europe with active non-infectious intermediate, posterior, or pan-uveitis. See the Lux website (http://www.luxbio.com/) for further information.
In March, 2010, the EMA validated the MAA and the dossier was distributed to members of the Committee for Medicinal Products for Human Use (“CHMP”) for formal review. On June 27, 2011 the Company announced that Lux appealed the EMA’s decision not to approve voclosporin as a treatment for noninfectious uveitis involving the intermediate or posterior segments of the eye.
On October 20, 2011, the Company announced that Lux had decided to modify its European regulatory strategy by withdrawing its MAA of Luveniq™ but to resubmit the application supplemented with data from the ongoing Phase 3 trial.