Fovea Pharmaceuticals Receives Orphan Drug Designation from EC for RdCVF for the...

Fovea Pharmaceuticals Receives Orphan Drug Designation from EC for RdCVF for
the Treatment of Retinitis Pigmentosa

PARIS, Jan. 7 /PRNewswire/ -- Fovea Pharmaceuticals SA, which, last
December 2007, raised $44M in a Series B financing, today announced that its
product, Recombinant human rod-derived cone viability factor (rh-RdCVF), has
received designation as Orphan Medicinal Product from the European Commission,
following the positive opinion from the European Agency for the Evaluation of
Medicinal Products (EMEA) Committee for Orphan Medicinal Product (COMP) for
the treatment of retinitis pigmentosa, a genetic disease leading to
progressive loss of vision. Fovea is currently conducting pre-clinical studies
of RdCVF and has demonstrated efficacy in animal model of the disease.
Orphan drug designation would entitle Fovea to exclusive marketing rights
in the European countries for ten years should Fovea be the first company to
receive marketing approval for this type of therapeutic drug product. In
addition, the designation would allow Fovea to apply for research funding, tax
credits for certain research expenses, and protocol assistance. Similar orphan
drug designation is currently being assessed in the USA by the Food and Drug
Administration (FDA).
"We are pleased to have received this orphan drug designation for RdCVF in
the treatment of retinitis pigmentosa," said Bernard Gilly, Chairman and Chief
Executive Officer of Fovea. "This designation is a recognition of the quality
of our work and will also provide us with financial and regulatory benefits in
addition to market exclusivity."
In a study on animal model of the disease performed at INSERM U592 in
Paris (Pr. Jose Sahel's team) RdCVF was shown to improve the survival and the
functionality of retinal cone cells that are responsible for central vision
and that are degenerating in patients suffering from this disease. Fovea is
conducting further studies to produce RdCVF and plans to start clinical trials
in 2009.
About Retinitis Pigmentosa
RP is a long lasting disease that slowly evolves towards irreversible
blindness. Classically in affected people, the retinal rod photoreceptors
responsible for night vision and side vision slowly degenerate, first leading
to night blindness. As the disorder progresses, the cone photoreceptors
degenerate also and their loss is responsible of a narrowing of the peripheral
field of vision which progressively worsens to become "tunnel-like". During
the last phase of the disease, the central vision can decrease until the
patient becomes blind.
RP usually appears in teenagers and young adults but may sometimes be
present from early childhood and generally progresses over several decades.
However, in extreme cases the disease may evolve rapidly over two decades. In
the European Community, 150 000 patients are affected by this disorder.
RP is a genetic disorder. The inheritance pattern is variable and can be
either autosomal dominant, autosomal recessive or X-linked recessive. Most
genes for RP cause only a small proportion of cases, exceptions being the
rhodopsin gene, which leads to about 25% of dominant RP. Overall,
approximately 40% of cases of RP are due to genes that are as yet
undiscovered.
About RdCVF
RdCVF (Rod derived Cone Viability Factor) is a protein that is produced by
the rods and is necessary for the functionality and the survival of the cones.
RdCVF was first identified by Pr. José Sahel's team at INSERM U592. The
original work was published in Nature Genetics in 2004.
In RP, preventing cone cell death is a very promising therapeutic approach
as vision can remain substantial in patients with 95% cone loss. This offers
greater hope for a positive outcome from a strategy aimed at preserving the
remaining cones in RP patients and simultaneously broadens the window for
therapeutic intervention.
About FOVEA Pharmaceuticals
Fovea Pharmaceuticals SA (Fovea) is a privately-held biopharmaceutical
company specialized in development and commercialization of drugs for the
treatment of ocular diseases, with a special focus on retinal pathologies.
Created in May 2005, Fovea has a highly experienced board and management team.
Last December 2007, it raised EUR30M ($44M) in a Series B financing from a
strong, international syndicate of new and existing investors led by Forbion
Capital Partners (Naarden, The Netherlands). All existing institutional
investors participated in the round including Sofinnova Partners, Abingworth,
GIMV, The Wellcome Trust and Credit Agricole Private Equity (CAPE).
Fovea has built a project portfolio including internal research programs
on dry AMD, glaucoma (neuroprotection) and retinal dystrophies as well as
clinical programs underway for such indications as macular edema, allergic
conjunctivitis, and retinitis pigmentosa.
To advance the development and commercialization of its programs, FOVEA is
working both independently and through collaborators including industrial
partners like Novartis, Genzyme, and CombinatoRx, as well as with academic
teams, like the Inserm unit U592, the Rothschild Ophthalmological Foundation,
or the Johns Hopkins University.
For additional information about FOVEA and its programs, please visit
www.fovea-pharma.com

Fovea Pharmaceuticals
Bernard Davitian
Chief Financial Officer
+33144164261
info@fovea-pharma.com

Press Contacts:
France
Marie-Carole de Groc
EuroRSCG C&O
+33158479507
marie-carole.de-groc@eurorscg.fr

US
Wendy Lau
Russo Partners, LLC
+1-212-845-4272
wendy.lau@russopartnersllc.com

SOURCE Fovea Pharmaceuticals SA

Bernard Davitian, Chief Financial Officer of Fovea Pharmaceuticals,
+33144164261, info@fovea-pharma.com; Press Contacts: France, Marie-Carole de
Groc, EuroRSCG C&O, +33158479507, marie-carole.de-groc@eurorscg.fr, US, Wendy
Lau, Russo Partners, LLC, +1-212-845-4272, wendy.lau@russopartnersllc.com