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Novagali Pharma Announces Positive Vekacia Clinical Results From,Pivotal Phase III Trial in Vernal Keratoconjunctivitis

EVRY, France, April 04, 2007 /PRNewswire/ -- Novagali Pharma, an emerging ophthalmic pharmaceutical company specialized in ophthalmology, announces today positive results from the Phase III clinical study of Vekacia(R) in children suffering from Vernal Keratoconjunctivitis (VKC). In this orphan disease, it was shown that both symptoms and signs of disease improved in patients receiving Vekacia(R). Furthermore, the tolerability to Vekacia(R) was excellent.

VKC is a severe form of chronic allergic conjunctivitis characterized by ocular discomfort, pain, itching and intense photophobia, which severely debilitates the patients. This rare disease affects mostly children and young adults living in warm climates worldwide. In March 2006, Novagali received European Medicines Agency (EMEA) orphan drug designation for Vekacia(R) in the treatment of VKC.

The study was conducted by key experts and opinion leaders in the field of ocular allergy throughout Europe and Mediterranean area and lead by Pr David Ben Ezra, Hadassah Hebrew University Hospital, Jerusalem, who first reported on the use and potential efficacy of Cyclosporine A for the treatment of VKC.

Vekacia(R) is a topical Cyclosporine A cationic emulsion enabling an efficient and unmatched-level drug absorption in tissues of the eye leading to optimal therapeutic efficacy. This proprietary ophthalmic emulsion of Cyclosporine A will be the first therapeutic product dedicated to treatment of such a severe ocular condition.

"We achieved a major corporate milestone completing our first phase III clinical trial" declares Jerome Martinez, President & CEO of Novagali, "I am very enthusiastic about the confirmation of the high potential of Novasorb(R) cationic emulsion technology through the development of Vekacia(R) and its successful use in VKC. It is very encouraging for the other ongoing projects".

"It is a great satisfaction to b
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