ISTA Pharmaceuticals, Inc. Expands Product Pipeline With Two Licensing Agreements For Exclusive North American Rights To Investigational Glaucoma Treatments; ISTA To Pay Approximately $8 Million
According to the iganidipine agreement, ISTA will pay Senju an upfront payment and aggregate development and approval milestones of approximately $8 million, in addition to royalties on future product sales. Calcium channel blockers are a new class of compounds, not approved previously for the treatment of glaucoma. Early studies on iganidipine have shown this calcium channel blocker may have the ability to enhance ocular blood flow, lower intraocular pressure, and inhibit the progression of visual field defects. Based in part on these data, ISTA plans to initiate a Phase II clinical study with this compound in the United States in 2007.
Under the terms of the agreement for the new latanoprost formulation, ISTA will pay Senju an upfront payment and development and approval milestones of approximately $8 million, as well as royalties on future product sales. Latanoprost is a member of the prostaglandin class of drugs, which are a standard treatment for glaucoma. Prostaglandins represent the largest segment of the U.S. glaucoma market, accounting for approximately $700 million in sales in 2005. ISTA plans to complete formulation development and optimization studies with latanoprost in 2007.
Under the terms of both agreements, ISTA is responsible, at its expense, for North American development for both product candidates, including clinical trials and the preparation and submission of the New Drug Applications to the U.S. Food and Drug Administration, or FDA. ISTA is also responsible for manufacturing and, if the products are approved, marketing and selling activities.
"We are very excited about filling out our glaucoma pipeline and having the opportunity to participate in new segments of the glaucoma market. If approved, and once commercialized, these products, together with Istalol, will position ISTA as a leader in providing ophthalmologists with a wide variety of treatments for this billion dollar market," said Vicente Anido, Jr., President and CEO of ISTA. "These agreements with Senju, our valued partner since 2002, represent the successful completion of a critical milestone we set for 2006."
ABOUT GLAUCOMA
Glaucoma is a chronic disease that gradually reduces eyesight without warning and often without symptoms. If undetected and untreated, glaucoma can lead to irreversible eye damage and eventual blindness. According to the Glaucoma Research Foundation, in the United States, glaucoma is the cause of an estimated 9-12% of all blindness cases and is the second leading cause of blindness. Currently, its causes are not well understood and there is no cure.
According to the Glaucoma Research Foundation, three million people in the United States suffer from the disease, with 120,000 new cases documented annually. According to prescription data compiled by IMS Health for 2005, we estimate the U.S. pharmaceutical market for the treatment of glaucoma exceeds $1.4 billion per year.
ABOUT ISTA
ISTA is a specialty pharmaceutical company focused on the development and commercialization of unique and uniquely improved ophthalmic products. ISTA's products and product candidates seek to address serious diseases and conditions of the eye, such as dry eye, vitreous hemorrhage, diabetic retinopathy, hyphema, glaucoma, ocular pain and inflammation. Building on this pipeline, ISTA's goal is to continue its growth as a specialty pharmaceutical company through a combination of its own product development efforts and by acquiring complementary products and product candidates. For additional information regarding ISTA, please visit ISTA Pharmaceuticals' Website at http://www.istavision.com.
FORWARD-LOOKING STATEMENT
Any statements contained in this press release that refer to future events or other non-historical matters are forward-looking statements. With limiting the foregoing, but by way of example, statements contained in this press release related to the expected size of the U.S. prescription glaucoma market, the opportunity anticipated by ISTA to participate in that market with iganidipine and latanoprost, the expected advantages and safety profile of iganidipine and latanoprost and our expectation to complete formulation and/or initiate clinical studies in 2007 are forward-looking statements. ISTA disclaims any intent or obligation to update any forward-looking statements. Such statements are based on ISTA's expectations as of the date of this press release and are subject to risks and uncertainties that could cause actual results to differ materially. Important factors that could cause actual results to differ from current expectations include, among others: the inherent uncertainty associated with market projections; delays, risks, and uncertainties related to ISTA's research and development programs (including the difficulty of predicting the timing or outcome of iganidipine and latanoprost development efforts, clinical testing or studies, or FDA or other regulatory agency approval or actions); uncertainties and risks regarding market acceptance of ISTA's approved products and the impact of competitive products and pricing; risks and uncertainties related to successful compliance with FDA and/or other governmental regulations applicable to ISTA's facilities, products, and/or business; uncertainties and risks related to the scope, validity, and enforceability of patents related to ISTA's products and technologies and the impact of patents and other intellectual property rights held by third parties; and such risks and uncertainties as detailed from time to time in ISTA's public filings with the U.S. Securities and Exchange Commission, including but not limited to ISTA's Annual Report on Form 10-K for the year ended December 31, 2005, and its Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2006.
Source: ISTA Pharmaceuticals