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
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.
SOURCE Isotechnika Pharma Inc.
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