ALAMEDA, Calif. -- (BUSINESS WIRE) -- InSite Vision Incorporated (OTCBB:INSV) and Senju Pharmaceutical Co., Ltd. today announced that they have entered into a collaboration and license agreement to develop and market InSite’s azithromycin ophthalmic solution using DuraSite® including AzaSite® 1% and AzaSite XtraTM 2% ocular antibiotics in Japan. Senju has agreed to pay InSite an upfront license fee, additional development milestones fees, and a percentage royalty on net sales.
“We are pleased to enter this strategic partnership with one of the leading ophthalmic pharmaceutical companies in Japan,” said Timothy Ruane, Chief Executive Officer of InSite Vision. “We look forward to the approval of these important ocular antibiotics for the benefit of the Japanese people.”
About Senju Pharmaceutical Co., Ltd.
Established in 1947 and headquartered in Osaka, Japan, Senju Pharmaceutical Co., Ltd. is a company that develops, manufactures and commercializes a variety of innovative products on a global basis, specializing in ophthalmic preparations.
About InSite Vision
InSite Vision is advancing new ophthalmologic products for unmet eye care needs based on its innovative DuraSite platform technologies. The DuraSite® and DuraSite® 2 drug delivery systems extend the duration of drug retention on the surface of the eye, thereby reducing frequency of treatment and improving the efficacy of topically delivered drugs.
The DuraSite® platform is currently leveraged in two commercial products for the treatment of bacterial eye infections, AzaSite® (azithromycin ophthalmic solution) 1%, marketed in the U.S. by Akorn Pharmaceuticals, and Besivance® (besifloxacin ophthalmic suspension) 0.6%, marketed by Bausch & Lomb, a subsidiary of Valeant Pharmaceuticals. BromSite™ (ISV-303) for pain and swelling associated with ocular surgery has completed its Phase 3 clinical studies and InSite expects to file the New Drug Application for BromSite with the U.S. Food and Drug Administration in the second half of 2014. InSite Vision is also advancing two novel ophthalmic therapeutics through Phase 3 clinical studies: AzaSite Plus™ (ISV-502) and DexaSite™ (ISV-305) for the treatment of eye infections. For further information on InSite Vision, please visit www.insitevision.com.
This news release contains certain statements of a forward looking nature relating to future events, including the development and commercialization of the Products in Japan, the payment of development milestone fees, and the payment of a percentage royalty on net sales Such statements entail a number of risks and uncertainties, including but not limited to: that InSite must raise significant additional funding, in addition to any payments under the Senju agreement, in order to continue its operations beyond September 2014; that the products that are the subject of the Senju agreement must still be approved by regulatory authorities in Japan prior to commercialization thereof and such approval may take longer than expected or may never be obtained; that InSite may not receive royalties, milestones or other payments under the agreement in the amount, within the timeframe that it expects, or at all; that InSite must rely on Senju to obtain marketing approval of the subject products in Japan and thereafter to for all sales, marketing and commercialization efforts in Japan and there can be no assurance that Senju will be effective in selling the subject products, which would reduce the royalties and milestone payments payable to InSite; the ability of InSite to enter and retain corporate collaborations for its product candidates, including with Senju in Japan. Reference is made to the discussion of these and other risk factors detailed in InSite Vision's filings with the Securities and Exchange Commission, including its annual report on Form 10-K and its quarterly reports on Form 10-Q, under the caption "Risk Factors" and elsewhere in such reports. Any forward-looking statements or projections are based on the limited information currently available to InSite Vision, which is subject to change. Although any such forward-looking statements or projections and the factors influencing them will likely change, InSite Vision undertakes no obligation to update the information. Such information speaks only as of the date of its release. Actual events or results could differ materially and therefore the reader should not unduly rely on such statements and one should not assume that the information provided in this release is still valid at any later date.
AzaSite® and DuraSite® are registered trademarks of InSite Vision Incorporated.
AzaSite Plus™, BromSite™, DexaSite™ and AzaSite Xtra™ are trademarks of InSite Vision Incorporated.
BESIVANCE® is a registered trademark of Bausch + Lomb Incorporated.