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 be able to anticipate providing a product addressing such an unmet therapeutic need in a paediatric population" says Florence Binlich Novagali's Medical Director who adds "we are also impressed by the high level of motivation and enthusiasm of the experts who participated in the trial".

"As practicing clinicians, we are very pleased to observe that Vekacia(R) brought significant benefits even in severe forms of the disease" declared Pr Ben Ezra, study lead investigator "It can confidently be said that now, the treating ophthalmologists may have, finally, a new and efficient tool for the management of VKC".

Based upon the results of the study, Novagali plans to file European Marketing Authorization mid-2007.

About Novagali Pharma: http://www.novagali.com

Novagali Pharma SA is an emerging ophthalmic pharmaceutical company based in the Genopole biocluster in Evry, France, that develops innovative products for all segments of the eye. Thanks to its proprietary technology platforms Novasorb(R) and Eyeject(R), the company has developed a broad pipeline of 6 innovative products addressing main ocular conditions as well as orphan diseases. Most advanced products include Vekacia(R), an orphan product for treatment of vernal keratoconjunctivitis; Cationorm(R), a CE marking product for dry eye relief; and Nova22007, a product for the treatment of moderate-to-severe dry eye syndrome. Founded in 2000, the firm has raised a total amount of Euro 44 million in 3 series of financing.

CONTACT: Press Contact: Genevieve Garrigos, +33(0)6-82-85-58-99, genevieve.garrigos@novagali.com

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Posted: April 2007

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