Isotechnika's partner Lux to appeal EMA CHMP decision against Luveniq

Isotechnika Pharma Inc. (TSX:ISA) today announced that its partner, Lux Biosciences, Inc. will appeal the European Medicines Agency's (EMA) decision not to approve Luveniq™ (voclosporin) as a treatment for noninfectious uveitis involving the intermediate or posterior segments of the eye.  The members of the Committee for Medicinal Products for Human Use (CHMP - the EMA body that prepares the opinion), adopted a negative opinion recommending that marketing authorization should not be granted for Luveniq™.

Lux remains fully committed to the potential of Luveniq™ in the treatment of noninfectious uveitis.  Lux believes that it has sufficient data to request a re-assessment of the application, and has 15 days in which to file the appeal.

In the U.S. Lux continues to address the U.S. Food and Drug Administration's (FDA) request for additional clinical information and commenced an additional pivotal trial of Luveniq™ in February of this year.

In 2006, Isotechnika granted Lux worldwide rights to develop and commercialize voclosporin for ophthalmic diseases.  In return, Isotechnika will receive development milestones payments, as well as royalties on net sales.  Voclosporin (branded as Luveniq™ by Lux) has received Orphan Drug designation in both Europe and the US for the treatment of noninfectious uveitis.