Replies to post #141 on InSite Vision Inc. (fka INSV)

[The Rainmaker]

InSite Vision Signs International Licensing and Distribution Agreement for AzaSite® in Japan and Taiwan With Nitten Pharmaceutical Co., Ltd
ALAMEDA, Calif., Apr 02, 2009 (BUSINESS WIRE) -- InSite Vision (NYSE Amex:ISV) today announced that it has signed an exclusive international licensing and distribution agreement for AzaSite® (azithromycin ophthalmic solution) 1% with Nitten Pharmaceutical Co., Ltd., one of the top ten Japanese ophthalmic pharmaceutical companies. 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 unique 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, 2009. 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.

About Nitten

Nitten Pharmaceutical Co., Ltd, with headquarters in Nagoya, Japan, is a private company established in 1919. It is one of the ten largest ophthalmic pharmaceutical companies in Japan and employs more than 200 people with sales in excess of US $35,000,000.

[The Rainmaker]

InSite Vision Receives Regulatory Approval for AzaSite® in Canada
ALAMEDA, Calif., Mar 31, 2009 (BUSINESS WIRE) -- InSite Vision Incorporated (AMEX:ISV) today announced that the Therapeutic Products Directorate (TPD) of Health Canada has approved the company's new drug submission (NDS) for AzaSite (azithromycin ophthalmic solution) 1% for the treatment of bacterial conjunctivitis (pink eye) in adults and children one year and older. AzaSite is formulated with DuraSite®, InSite Vision's patented drug delivery vehicle that enhances the retention time of the antibiotic on the surface of the eye, offering the benefit of a less frequent and more convenient dosing regimen.

AzaSite was approved for treatment of bacterial conjunctivitis by the U.S. Food and Drug Administration (FDA) in April 2007, and commercially launched in August 2007 by Inspire Pharmaceuticals, a biopharmaceutical company based in Durham, North Carolina and exclusive licensee of AzaSite in the U.S. and Canada. Under the terms of the companies' agreement, the NDS will transfer to Inspire Pharmaceuticals and Inspire will be responsible for marketing AzaSite in Canada.

"Canadian approval of AzaSite is an important milestone for InSite, furthering our efforts to reach more patients with a product that is a clinically proven, safe and effective treatment for conjunctivitis and typically requires less than half the dosing of other ocular antibiotics," commented Lou Drapeau, InSite's Chief Executive Officer. "We are focused on supporting our marketing partner, Inspire Pharmaceuticals, on the expansion of AzaSite sales and we look forward to working closely with them to capture additional value for the product throughout North America."

Canadian regulatory approval was based on two Phase 3 clinical trials of AzaSite which demonstrated that AzaSite was safe and effective. Enrolling more than 1400 patients with bacterial conjunctivitis in the U.S. and Latin America, AzaSite was administered twice daily on the first two days, then once daily on days 3-5. Results from the Phase 3 pivotal trials demonstrated that AzaSite provided clinically and statistically significant improvements in clinical resolution of symptoms and bacterial eradication compared to placebo; and was equivalent in clinical resolution and bacterial eradication when compared to tobramycin administered four times a day for five days.