Orphan drug achieves success in Phase III trial

April 30, 2007

Novagali Pharma has reported positive results from a Phase III clinical study investigating the use of its drug candidate, Vekacia, as a treatment for paediatric Vernal Keratoconjunctivitis (VKC).

Novagali Pharma has reported positive results from a Phase III clinical study investigating the use of its drug candidate, Vekacia, as a treatment for paediatric Vernal Keratoconjunctivitis (VKC).

The study, led by Professor David Ben Ezra of the Hadassah Hebrew University Hospital, Jerusalem, Israel, showed that both symptoms and signs of VKC improved in patients receiving Vekacia.

Vekacia is a topical Cyclosporine A cationic emulsion, which enables efficient drug absorption in tissues of the eye. Novagali received EMEA orphan drug designation for Vekacia in the treatment of VKC in March 2006.

Based upon the success of the study, the company plans to file for European Marketing Authorization in the middle of 2007.

In other news, Novagali has also entered into a strategic collaboration with biopharmaceutical firm Topigen Pharmaceuticals. Under the terms of the agreement, Novagali will receive exclusive worldwide rights to develop and commercialize an ophthalmic product based on Topigen's multi-targeted, RNA-targeting platform technology for the treatment and prevention of allergic eye diseases.