ISTA Pharmaceuticals, a specialty pharmaceutical company focused on the development and commercialization ophthalmic products, announced that it has exclusively licensed from Senju Pharmaceuticals, Co., Ltd. the North American rights to two new product candidates, iganidipine, a calcium channel blocker, and a new formulation of latanoprost, a prostaglandin. Both candidates are under investigation for the treatment of glaucoma and other ophthalmic applications, and, if approved, will be complementary to Istalol, ISTA's once-daily beta blocker marketed for the treatment of glaucoma.
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 US 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 US 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."
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 per cent 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 US pharmaceutical market for the treatment of glaucoma exceeds $1.4 billion per year.