Lux Biosciences
Receives Acceptance of Luveniq™ MAA Filing from European Medicines Agency
JERSEY CITY, N.J., March 2, 2010 -- Lux Biosciences, Inc. today
announced that the European Medicines Agency (EMA) has accepted the filing
of the company’s Marketing Authorization Application (MAA) for the company’s
lead product, Luveniq™ (LX211; oral voclosporin) for the treatment of
noninfectious uveitis involving the intermediate or posterior segments of
the eye. Lux previously announced the filing of both the MAA and U.S. New
Drug Application (NDA) for LX211, which has received Orphan Drug designation
in both regions, on February 4, 2010.
“We are very pleased that our European marketing application for LX211 has
been formally accepted for review,” said Eddy Anglade, M.D., Lux
Biosciences’ Chief Medical Officer. “We now look forward to hearing from the
U.S. Food and Drug Administration on our NDA filing, for which we have also
requested priority review.”
The US FDA has up to 60 days to formally accept the completed application.
Upon acceptance, the FDA will determine if the application will be granted
priority review, which would allow for a six month review of the NDA.
About LUVENIQ™
LUVENIQ (LX211) is the oral form of a next-generation calcineurin inhibitor,
voclosporin. Like other molecules of this class, the compound reversibly
inhibits immunocompetent lymphocytes, particularly T-lymphocytes, and it
also inhibits lymphokine production and release. Lux Biosciences has
exclusive worldwide rights to voclosporin for ophthalmic use and is
cooperating with the team at Isotechnika Pharma who discovered the molecule
and develop it in psoriasis and organ transplantation.
About Uveitis
Uveitis, which represents a group of serious inflammatory eye conditions, is
inevitably associated with either severe vision loss or substantial
morbidity from steroid use. Non-infectious uveitis involving the posterior
segment of the eye is a leading cause of vision loss and long-term
disability and the fourth leading cause of legal blindness in the
industrialized world. As the majority of uveitis patients are first
diagnosed at ages under 40 years, the socio-economic burden of this disease
is higher than that of other serious ocular conditions such as AMD and
diabetic macular edema.
About Lux Biosciences
Lux Biosciences, Inc. is a privately held biotechnology company focused on
the treatment of ophthalmic diseases. Its submission stage project LUVENIQ
(LX211) is the oral formulation of a next-generation calcineurin inhibitor (voclosporin)
for which positive phase 3 data have been obtained for the treatment of
sight-threatening non-infectious uveitis. The company has several earlier
stage projects based on its mixed nanomicellar ocular formulation
technology, and based on its proprietary product-enabling bio-erodible
polymer technologies that facilitate targeted and sustained delivery of
molecules to the eye. 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
Bioscience's belief as to the medical and commercial potential of its
product candidates, Lux Bioscience's plans to pursue business and regulatory
strategy, and Lux Bioscience’s 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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