Health & Fitness
Health and Fitness
Health and Fitness
Mon, June 27, 2011
Sat, June 25, 2011
Fri, June 24, 2011 LUX BIOSCIENCES TO APPEAL EMA DECISION ON LUVENIQ&;#8482;
EDMONTON, June 24, 2011 /CNW/ - 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.
About Isotechnika Pharma Inc.
Isotechnika Pharma Inc. is a biopharmaceutical company focused on the discovery and development of immunomodulating therapeutics designed to offer key safety advantages over currently available treatments. Its lead drug, voclosporin, is a calcineurin inhibitor, and is targeted at the estimated $3.0 billion market for this class of immunosuppressants.
Isotechnika Pharma Inc. is a publicly traded company on the Toronto Stock Exchange under the symbol "ISA". More information on Isotechnika Pharma can be found at [ www.isotechnika.com ] or [ www.SEDAR.com ].
We seek safe harbor.
