Fovea Pharmaceuticals Receives Orphan Drug Designation From EC For RdCVF For The Treatment Of Retinitis Pigmentosa
Fovea Pharmaceuticals SA, which, last
December 2007, raised $44M in a Series B financing, announced that
its product, Recombinant human rod-derived cone viability factor
(rh-RdCVF), has received designation as Orphan Sanative Product from the
European Commission, following the promising opinion from the European
Agency for the Evaluation of Medicinal Products (EMEA) Committee for the benefit of Orphan
Iatrical Product (COMP) for the treatment of retinitis pigmentosa, a
genetic ailment leading to progressive trouncing debits of vision. Fovea is currently
conducting pre-clinical studies of RdCVF and has demonstrated efficacy in
organism model of the disease.
Orphan deaden designation would entitle Fovea to exclusive marketing
rights in the European countries on ten years should Fovea be the first
company to receive marketing approval for this type of therapeutic treatment
product. In totting up, the designation would allow Fovea to tend seeking
probe funding, assess credits by reason of positive research expenses, and conduct
support. Similar orphan panacea designation is currently being assessed in
the USA by the Food and Stimulant Furnishing (FDA).
“We are pleased to have received this orphan medicate designation on the side of RdCVF
in the treatment of retinitis pigmentosa,” said Bernard Gilly, Chairman and
Chief Chief Officer of Fovea. “This designation is a admission of the
quality of our mix and last will and testament also equip us with monetary and regulatory
benefits in annex to trade in exclusivity.”
In a reading on bestial sitter of the ailment performed at INSERM U592 in
Paris (Pr. Jose Sahel’s team) RdCVF was shown to on life the survival and
the functionality of retinal cone cells that are responsible for median
envisioning and that are degenerating in patients suffering from this disease.
Fovea is conducting to boot studies to supply RdCVF and plans to start
clinical trials in 2009.
About Retinitis Pigmentosa
RP is a sustained lasting malady that slowly evolves supporting irreversible
blindness. Classically in affected people, the retinal refractory photoreceptors
ethical for night eyesight and side perspective slowly degenerate, in the beginning
leading to dusk blindness. As the breach of the peace progresses, the cone
photoreceptors go to pot also and their loss is responsible of a narrowing
of the peripheral discipline of vision which progressively worsens to befit
“tunnel-like”. During the last phase of the virus, the central vision can
decrease until the accommodating becomes heedless.
RP usually appears in teenagers and young adults but may sometimes be
present from early teens and generally progresses more than a variety of decades.
However, in extreme cases the disorder may evolve rapidly over two decades.
In the European Community, 150 000 patients are assumed by this civil disorder.
RP is a genetic hash. The birthright templet is variable and can
be either autosomal main, autosomal recessive or X-linked recessive.
Most genes for RP cause only a piddling proportion of cases, exceptions being
the rhodopsin gene, which leads to encircling 25% of dominant RP. Complete,
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 inevitable 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 big in patients with 95% cone loss.
This offers greater hope for a certain Medicine sequela usually from a strategy aimed at
preserving the residual 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 occurrence and commercialization of drugs during the
treatment of ocular diseases, with a special convergence on retinal pathologies.
Created in May 2005, Fovea has a highly sage board and management
team. Last December 2007, it raised EUR30M ($44M) in a Series B financing
from a skilled, foreign affiliate of green 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 enquiry
programs on bare AMD, glaucoma (neuroprotection) and retinal dystrophies as
well as clinical programs underway pro such indications as macular edema,
allergic conjunctivitis, and retinitis pigmentosa.
To assist the development and commercialization of its programs, FOVEA
is working both independently and through collaborators including
industrial partners liking for Novartis, Genzyme, and CombinatoRx, as well as
with academic teams, in the manner of the Inserm unit U592, the Rothschild
Ophthalmological Foundation, or the Johns Hopkins University.
For the treatment of additional information approximately FOVEA and its programs, humour visit
http://www.fovea-pharma.com
Fovea Pharmaceuticals SA
http://www.fovea-pharma.com
