InSite Vision Regains Development Rights for AzaSite Xtra™
Potential Product to Extend AzaSite ® Ophthalmology Franchise Through 2027 and Beyond
ALAMEDA, Calif.--(BUSINESS WIRE)-- InSite Vision Incorporated (OTCBB: INSV) today announced that the company has regained North American development rights to azithromycin ophthalmic solution 2%, trademarked as AzaSite Xtra™, from Inspire Pharmaceuticals Inc., a subsidiary of Merck & Co., Inc., known as MSD outside the United States and Canada. AzaSite Xtra, formulated in InSite’s DuraSite® topical drug delivery system, is a product candidate intended for the topical treatment of ocular infections.
“We are excited for the opportunity to develop AzaSite Xtra,” said Timothy Ruane, Chief Executive Officer of InSite Vision. “We believe InSite’s capabilities as a nimble, efficient drug developer will allow us to speed the development of AzaSite Xtra.”
Under the terms of the agreement, a joint development committee composed of representatives from both companies will oversee development and submission of applications for regulatory approval in the USA and Canada for AzaSite Xtra. Merck retains an option to acquire AzaSite Xtra for a one-time payment and royalties on any product sales.
In 2007, Insite Vision licensed exclusive rights to commercialize AzaSite® and AzaSite Xtra for ocular infections in the United States and Canada to Inspire Pharmaceuticals (subsequently acquired by Merck in May 2011).
AzaSite (azithromycin ophthalmic solution) 1% is indicated for the treatment of bacterial conjunctivitis in patients one year and older caused by the following organisms: CDC cornyeform group G, Haemophilus influenzae, Staphylococcus aureus, Streptococcus mitis group, and Streptococcus pneumoniae. AzaSite is formulated using InSite Vision’s proprietary DuraSite drug delivery technology that extends the duration of drug retention on the surface of the eye. AzaSite Xtra is a higher dose (2.0%) of azithromycin ophthalmic solution formulated in DuraSite and being developed for the topical treatment of ocular infections. InSite Vision has previously completed all formulation/stability data and all GLP toxicology work to support global Investigational New Drug application filings. AzaSite Xtra has patent protection into 2027, with additional applications filed or pending.
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 the frequency of treatment and improving the efficacy of topical 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 Merck, and Besivance® (besifloxacin ophthalmic suspension) 0.6%, marketed by Bausch + Lomb. InSite Vision is also advancing three novel ophthalmic therapeutics through Phase 3 clinical studies: AzaSite Plus™ and DexaSite™ for the treatment of eye inflammation, and BromSite™ for pain and inflammation associated with ocular surgery. 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 possible development of AzaSiteXtra, possible additional AzaSiteXtra indications beyond bacterial conjunctivitis, and the possible repurchase of AzaSiteXtra by Merck at a later date. Such statements entail a number of risks and uncertainties, including but not limited to: the results of clinical trials for AzaSiteXtra and the timing thereof, InSite’s ability to obtain FDA acceptance of a New Drug Application for AzaSiteXtra and the timing thereof; InSite's reliance on third parties for the commercialization of its products; the ability of InSite to enter into corporate collaborations for its product candidates; InSite's ability to expand its product platform, including AzaSiteXtra, to include additional indications; that Merck may exercise its option to reacquire AzaSite Xtra in the future, which could limit the economic value of AzaSite Xtra to InSite; InSite's ability to compete effectively, either alone or through its partners, with other companies offering competing products or treatments; InSite's ability to maintain and develop additional collaborations and commercial agreements with corporate partners, its ability to adequately protect its intellectual property and to be free to operate with regard to the intellectual property of others; and determinations by the FDA. 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 andone 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.
BESIVANCE® is a registered trademark of Bausch & Lomb Incorporated.
Louis Drapeau, 510-747-1220
Chief Financial Officer
Media and Investor inquiries
Michelle Corral, 415-794-8662
Karen L. Bergman, 650-575-1509
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