Lux Biosciences, Inc.
JERSEY CITY, N.J., (August 4, 2010)
-- Lux Biosciences, Inc. today announced that
the U.S. Food and Drug Administration’s Center of Drug Evaluation and
Research has issued a Complete Response letter regarding the New Drug
Application (NDA) for Luveniq™ (oral voclosporin) for the treatment of
non-infectious uveitis.
FDA issues a Complete Response letter when the review of a file is completed
and questions remain that preclude the approval of the NDA in its current
form. Lux Biosciences and its partner Isotechnika Pharma are evaluating the
Complete Response letter, in which the FDA has indicated that it regards the
data from one of the two pivotal studies submitted in the NDA as positive.
Lux Biosciences plans to conduct an additional pivotal trial of Luveniq,
expected to begin before the end of 2010.
“We continue to work with FDA to address their outstanding questions
regarding the safety and efficacy of Luveniq™, and the Lux Biosciences’
board of directors is supportive of our starting the additional trial,” said
Dean Mitchell, Lux Biosciences’ President and Chief Executive Officer. “At
the same time, the European Medicines Agency review of the Marketing
Authorization Application for Luveniq remains on course for completion in
the first quarter of 2011.”
Lux Biosciences announced submission of both the NDA and MAA for Luveniq on
February 3, 2010.
About Lux Biosciences
Lux Biosciences, Inc. is a privately held biotechnology company focused on
the treatment of ophthalmic diseases. Lux Biosciences has exclusive
worldwide rights to voclosporin for all ophthalmic indications and is
cooperating with the team at Isotechnika Pharma who discovered the molecule.
For more information on Lux Biosciences, please visit the company’s website
at www.luxbio.com.
Lux Biosciences cautionary statement regarding forward-looking
statements
This press release may contain forward-looking statements, including Lux
Biosciences’ belief as to the medical and commercial potential of its
product candidates, Lux Biosciences’ plans to pursue business and regulatory
strategy, and Lux Biosciences’ expectations regarding actions and decisions
solely within the control and purview of other parties. These
forward-looking statements involve important known and unknown risks and
uncertainties, which could cause actual results to differ materially from
those in the forward-looking statements. Such risks and uncertainties
include, among others, the exercise of discretion by regulatory agencies and
other parties, the availability to Lux Biosciences of funds and resources to
pursue research and development projects, the performance of activities and
generation of scientific data by parties other than Lux Biosciences, the
ability of Lux Biosciences to economically manufacture and commercialize its
products once approved, acceptance by the medical community of Lux
Biosciences’ products once approved and the availability of alternative
therapeutic agents, approval for reimbursement by third-party payors of Lux
Biosciences’ products once approved, the success and timely completion of
clinical trials and other scientific studies, the ability of Lux Biosciences
and its licensors to defend its and their patents from infringement by third
parties, and the risk that such patents may be subsequently shown to be
invalid or that the practice of such patents may infringe the patents of
others. Further, Lux Biosciences disclaims any undertaking to issue further
press releases or otherwise advice about changes to these beliefs, plans and
expectations.
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