InSite Vision announced that it has signed an exclusive international licensing and distribution agreement for AzaSite (azithromycin ophthalmic solution) 1 percent with Nitten Pharmaceutical Co., one of the top ten Japanese ophthalmic pharmaceutical companies.
In a release, the company noted:
AzaSite contains a broad-spectrum antibiotic formulated with InSite Vision's patented DuraSite drug delivery vehicle to enhance the retention time of the antibiotic on the surface of the eye. AzaSite offers the benefit of a less frequent and more convenient dosing regimen in a safe and effective therapy for the treatment of bacterial eye infections.
Under the terms of the agreement, Nitten is responsible for securing regulatory approval and has exclusive rights to commercialize AzaSite for ocular bacterial infection in Japan and Taiwan. Nitten will pay InSite one million U.S. dollars upon the execution of the license agreement, followed by milestone payments of one million dollars upon the first regulatory submission and one million dollars upon the first regulatory approval. After approval, Nitten will also pay a double-digit royalty on net sales of AzaSite in Japan and on net royalties from Taiwan, where Nitten intends to use a partner to commercialize AzaSite. InSite Vision will initially be responsible for manufacturing AzaSite.
'Nitten has a track record of success in marketing both branded and generic ophthalmic products and is well-positioned to be our commercial partner for AzaSite in Japan and Taiwan,' said Louis Drapeau, Chief Executive Officer of InSite Vision. 'As we expand our international partnerships to bring AzaSite to patients globally, Nitten represents the type of established market leadership and commercial expertise necessary to assure commercial success for AzaSite.'
'We are pleased to license AzaSite considering the positive acceptance this ocular antibiotic has experienced in the United States. We believe there is a significant market opportunity in both Japan and Taiwan for this product, and we look forward to establishing this product in our markets as soon as possible,' said Ayumi Uetake, President of Nitten.
AzaSite was approved for bacterial conjunctivitis (pink eye) treatment by the United States Food and Drug Administration (FDA) in April 2007, and was commercially launched in the United States for the treatment of bacterial conjunctivitis by Inspire Pharmaceuticals, Inc. in August 2007. AzaSite received regulatory approval from Health Canada on March 31. Inspire Pharmaceuticals is responsible for marketing AzaSite in the U.S. and in Canada. InSite Vision is seeking additional international partners for commercialization and distribution of AzaSite outside of North America.
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