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| |  Xalatan Ophthalmic Solution Cleared by FDA for Open-Angle Glaucoma KALAMAZOO, Mich., June 6, 1996 -- Pharmacia & Upjohn, Inc., (NYSE: PNU) announced today that it has received clearance to market Xalatan Ophthalmic Solution (latanoprost solution) in the United States. Xalatan will be used to treat open-angle glaucoma and ocular hypertension in patients who are either intolerant of other intraocular pressure-lowering medications or insufficiently responsive to another intraocular pressure-lowering medication. Xalatan represents a new therapeutic approach for the treatment of glaucoma, a disease that afflicts approximately two million Americans. It is expected to be available through physicians by this summer. Xalatan is also being reviewed by regulatory authorities in Europe, Japan, Australia and Canada. "Xalatan represents a major advance for these patients and an important milestone for Pharmacia & Upjohn," said Goran A. Ando, M.D., Executive Vice President, Worldwide Science and Technology. "Xalatan is an effective treatment and is well tolerated by patients. In addition, the fact that it only needs to be used once a day may help patients comply with proper treatment. Xalatan will offer physicians an important, novel option in helping them treat patients whose vision is threatened by this devastating condition," he said. Xalatan is related to a class of compounds called prostaglandins that are present in various forms throughout the body. Prostaglandins act locally in the eye to increase drainage of aqueous humor and reduce intraocular pressure. Aqueous humor, a fluid made continuously by cells inside the eye, is necessary to maintain the shape of the eye and to nourish the lens and cornea. In most forms of glaucoma, aqueous humor is produced at a normal rate, but exits the eye too slowly. Xalatan is believed to act by increasing drainage of this fluid, rather than by reducing its production, as most current treatments do, thus offering a physiologically attractive mechanism of action. "Xalatan is a unique and highly efficacious treatment approach to glaucoma that offers patients the benefits of once-a-day dosing," said Eve Higgenbotham, M.D., chair of the University of Maryland's department of glaucoma. "For the medical community, this represents a valuable therapeutic advance." In multi-center clinical trials in the U.S., the United Kingdom and Scandinavia, Xalatan-treated patients were compared to a group using the current standard glaucoma drug, timolol, a beta-blocker. The data demonstrated that once-daily Xalatan was as effective as twice-daily timolol in reducing intraocular pressure. In clinical trials, after six months of treatment, 6.8 percent of patients were reported to show a gradual change in eye color, due to an increased amount of brown pigment in the iris of the treated eye. The change in iris color occurs slowly and may not be noticeable for several months to several years. The increased pigmentation may be permanent. Therefore, patients should be examined regularly as the long-term significance of this change is currently unknown. Other local adverse effects reported in clinical trials included foreign body sensation, punctate epithelial keratopathy, stinging, conjunctival hyperemia, blurred vision, itching and burning. In controlled clinical trials the incidence of these adverse effects was similar to those seen in patients treated with timolol. Glaucoma comprises a large group of disorders which include progressive optic nerve damage associated with visual field loss and often with elevated intraocular pressure. The disease is irreversible. Once a portion of the visual field is lost, it can never be restored. It is a strongly age-related disease, and risk factors, in addition to age, include race, family history and elevated blood pressure. According to the World Health Organization, glaucoma causes more than 20 percent of the world's blindness. Glaucoma is the major cause of blindness in people over 40 years of age. Seven and one-half million people around the world are treated for glaucoma. Pharmacia & Upjohn, Inc., is a research-based, pharmaceutically focused company dedicated to helping people around the world live longer and fuller lives. The Company was formed through a merger of Pharmacia AB and The Upjohn Company and began operating in November 1995. Pharmacia & Upjohn is a provider of human health care products and related businesses, and operates on a global basis. Its corporate management center is located in London, with major research and manufacturing centers in the United States, Sweden, and Italy.
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