Inspire Pharmaceuticals Licenses Novel Glaucoma Technology; Addition of New Ophthalmic Program Enhances Pipeline.DURHAM, N.C. -- Inspire Pharmaceuticals, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : ISPH ISPH Inspire Pharmaceuticals, Inc. ) today announced an agreement to license exclusively several patents from the Wisconsin Alumni Research Foundation The Wisconsin Alumni Research Foundation is the nonprofit technology transfer office of the University of Wisconsin-Madison. It is a significant source of research support, independent of federal grants. (WARF WARF Wisconsin Alumni Research Foundation WARF Wide Aperture Research Facility WARF Wartime Active Replacement Factors WARF weighted-average risk factor WARF Wartime Attrition and Replacement Factors WARF Whylie Animal Rescue Foundation ) for use in developing and commercializing new therapeutics for treating glaucoma, a disease that affects an estimated 2.2 million people in the United States. These patents are based upon research conducted by Dr. Paul L. Kaufman, Professor and Chairman of Ophthalmology and Visual Sciences at the University of Wisconsin, and Dr. Benjamin Geiger, Professor of Molecular Cell and Tumor Biology, and Dean Of Biology at the Weizmann Institute of Science The Weizmann Institute of Science (מכון ויצמן למדע) is a world-renowned institute of higher learning and research in Rehovot, Israel. in Israel. Under the terms of the agreement, Inspire will undertake the development of products that are covered by the licensed patents. As a result, Inspire will fund all further research, development, testing, regulatory filings and potential marketing activities related to any product developed from this license. Inspire will pay WARF potential milestone payments during the development process, including a one-time upfront payment, and royalties on sales of any regulatory approved product developed from this technology and covered by the associated patents. Inspire's previous operating expense Operating Expense The essential things that a company must purchase in order to maintain business. Notes: For example, the payment of employees wages are an operating expense. Also known as OPEX. guidance for 2004 remains unchanged. Commenting on this partnership, Dr. Kaufman said, "We are very pleased to be working with Inspire to advance treatment options for this debilitating de·bil·i·tat·ing adj. Causing a loss of strength or energy. Debilitating Weakening, or reducing the strength of. Mentioned in: Stress Reduction disease. We pursued an agreement with Inspire for several reasons, including Inspire's expertise and focus in ophthalmology, their ability to move a project effectively from discovery to commercialization, and their ability to marshal the necessary resources to make this promising program a success." Professor Geiger added, "This long term collaboration provides an excellent example for the development of a basic research project into a potentially powerful drug." Dr. Kaufman is Professor and Chair of the Department of Ophthalmology and Visual Sciences at the University of Wisconsin-Madison “University of Wisconsin” redirects here. For other uses, see University of Wisconsin (disambiguation). A public, land-grant institution, UW-Madison offers a wide spectrum of liberal arts studies, professional programs, and student activities. . He is past President and current Executive Vice President of the Association for Research in Vision and Ophthalmology (ARVO ARVO Association for Research in Vision and Ophthalmology. ), past President of the International Society for Eye Research (ISER), and has served on the United States National Advisory Eye Council and numerous foundation and corporate scientific advisory boards. He has had continuous research funding from the National Eye Institute (NEI NEI National Eye Institute (NIH) NEI Nuclear Energy Institute NEI National Emission Inventory NEI Not Enough Information NEI Netherlands East Indies NEI Nuevos Estados Independientes ) for 25 years, and has authored nearly 300 original scientific articles, 50 book chapters, and co-edited several textbooks. Dr. Geiger is Professor and former chair of the Department of Molecular Cell Biology, former Dean of the Graduate School, and present Dean of the Faculty of Biology at the Weizmann Institute of Science in Rehovot, Israel. He is a world leader in the study of cell adhesion, cellular contractility contractility /con·trac·til·i·ty/ (kon?trak-til´i-te) capacity for becoming shorter in response to a suitable stimulus. contractility a capacity for becoming short in response to suitable stimulus. and the cytoskeleton cytoskeleton System of microscopic filaments or fibres, present in the cytoplasm of eukaryotic cells (see eukaryote), that organizes other cell components, maintains cell shape, and is responsible for cell locomotion and for movement of the organelles within it. , and has authored or co-authored hundreds of publications in this area. His work has major implications in many fields of biomedicine biomedicine /bio·med·i·cine/ (bi?o-med´i-sin) clinical medicine based on the principles of the natural sciences (biology, biochemistry, etc.).biomed´ical bi·o·med·i·cine n. 1. , including cancer, cardiovascular disease Cardiovascular disease Disease that affects the heart and blood vessels. Mentioned in: Lipoproteins Test cardiovascular disease , and ophthalmology. Dr. Kaufman has worked for more than 30 years investigating the use of cytoskeleton-targeting drugs as potential glaucoma therapies, and teamed with Dr. Geiger approximately 10 years ago. Their approach targets an area in the front of the eye known technically as the trabecular meshwork Trabecular meshwork A sponge-like tissue located near the cornea and iris that functions to drain the aqueous humor from the eye into the blood. Mentioned in: Glaucoma . This tissue is responsible for the regulation of the clear liquid, or aqueous humor, which bathes and nourishes nearby tissues and is required for healthy eyesight. In the most common form of the disease, primary open angle glaucoma, the resistance of the trabecular meshwork to the drainage of aqueous humor from the eye is too high and causes pressure to build up inside the eye. The high intraocular pressure damages the optic nerve at the back of the eye, resulting in the eventual loss of vision. The cytoskeleton-targeting drugs being evaluated induce changes in the architecture of the trabecular meshwork, thereby reducing the resistance to fluid drainage from the eye, and thus reducing the intraocular pressure. "Inspire is committed to being a key player in the field of ophthalmic pharmaceuticals," said Christy L. Shaffer, Ph.D., Chief Executive Officer of Inspire. "This license broadens our pipeline beyond our core P2 receptor programs to an attractive therapeutic market that is highly synergistic with our current research and development, sales and marketing resources, and expertise. The patents are based upon a first-in-class, novel mechanism that targets the underlying cause of the disease. Building on Drs. Kaufman and Geiger's extensive research, we plan to work rapidly to identify an optimal compound to advance into clinical development and are targeting 2006 for an Investigational New Drug (IND) filing with the Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. )." Kim Brazzell, Ph.D., Senior Vice President of Ophthalmic Research and Development at Inspire said, "We are pleased to be working with Drs. Kaufman and Geiger on this exciting new program. If successful, this program could lead to a breakthrough in the treatment of glaucoma, as it would become the first pharmacologic treatment to target the trabecular meshwork and address the true pathophysiology pathophysiology /patho·phys·i·ol·o·gy/ (-fiz?e-ol´ah-je) the physiology of disordered function. path·o·phys·i·ol·o·gy n. 1. of primary open angle glaucoma. Drs. Kaufman and Geiger have done substantial research in this area, having demonstrated preclinical efficacy of a number of model compounds and have published extensively on this approach in prominent peer reviewed journals." Drs. Kaufman and Geiger's research focus has been on inhibitors of actomyosin actomyosin /ac·to·my·o·sin/ (ak?to-mi´o-sin) the complex of actin and myosin occurring in muscle fibers. ac·to·my·o·sin n. contractility or actin microfilament microfilament /mi·cro·fil·a·ment/ (-fil´ah-ment) any of the submicroscopic filaments composed chiefly of actin, found in the cytoplasmic matrix of almost all cells, often with the microtubules. assembly that can effectively relax and alter the shape of the cells and tissue architecture within the trabecular meshwork, working to improve the flow of aqueous humor out of the eye. These drugs act directly on the trabecular outflow pathway, which is the site of abnormal flow resistance in glaucoma. Currently available therapies are targeted at decreasing aqueous humor formation and/or increasing fluid drainage by uveoscleral outflow, which plays a lesser role in outflow dysfunction than does the trabecular meshwork. Inspire's ophthalmology franchise currently includes Elestat(TM), which was approved by the FDA for the prevention of itching associated with allergic conjunctivitis, and is being co-promoted by Inspire with Allergan, Inc. Additionally, Inspire co-promotes Restasis(R) with Allergan, which was approved by the FDA for the treatment of dry eye disease. The Company's pipeline also includes diquafosol tetrasodium for the treatment of dry eye. Inspire received an approvable letter from the FDA in December 2003 for diquafosol and is conducting an additional Phase 3 clinical study on diquafosol. Additionally, INS INS abbr. 1. Immigration and Naturalization Service 2. International News Service Noun 1. INS 37217 Ophthalmic is an investigational new drug under evaluation for the treatment of retinal diseases associated with pathological sub-retinal or intra-retinal accumulation of fluid. Inspire will provide additional information on this new program during its quarterly earnings conference call scheduled for Thursday, November 4th at 10:00 AM ET (revised time). To access the conference call, U.S. participants may call (877) 780-2276. International participants may call (973) 582-2757. The call will be webcast live on Inspire's website at www.inspirepharm.com. About Glaucoma Glaucoma is a group of diseases that can damage the eye's optic nerve and result in vision loss and blindness. Glaucoma currently affects more than 2.2 million people in the United States and represents the largest market in ophthalmic pharmaceuticals with estimated annualized annualized Of or relating to a variable that has been mathematically converted to a yearly rate. Inflation and interest rates are generally annualized since it is on this basis that these two variables are ordinarily stated and compared. 2004 sales of $1.5 billion in the U.S. In the most common form of the disease, primary open angle glaucoma, patients exhibit elevated intraocular pressure within the eye that over time causes stress and damage to the optic nerve. There are no early symptoms of the disease, so it is primarily diagnosed during eye exams. As the disease progresses, a person with glaucoma may notice peripheral vision gradually failing. As the disease worsens, the field of vision narrows and blindness results. If diagnosed in early stages, glaucoma can be controlled and vision loss slowed or halted by various treatments, including medications, laser procedures and surgery. However, any vision lost to glaucoma cannot currently be restored. In general, glaucoma is more common in African Americans, Hispanics and with increasing age. As the U.S. population ages, the condition will likely become more prevalent. About Inspire Inspire is a biopharmaceutical company dedicated to discovering, developing and commercializing novel prescription products for diseases with significant unmet medical needs. Inspire has significant technical and scientific expertise in the therapy areas of ophthalmology and respiratory and is a leader in the field of P2 receptors which are important drug targets in various therapeutic areas, including ophthalmology, respiratory disease, cardiovascular disease and pain. Inspire's specialty sales force promotes Elestat(TM) and Restasis(R), ophthalmology products developed by Inspire's partner, Allergan, Inc. Forward-Looking Statements The forward-looking statements in this news release relating to management's expectations and beliefs are based on preliminary information and management assumptions. Such forward-looking statements are subject to a wide range of risks and uncertainties that could cause results to differ in material respects, including those relating to product development, revenue and earnings expectations, intellectual property rights and litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. , competitive products, results of clinical trials, the need for additional research and testing, delays in manufacturing, funding and the timing and content of decisions made by regulatory authorities, including the United States Food and Drug Administration United States Food and Drug Administration (FDA), n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. . Further information regarding factors that could affect Inspire's results is included in Inspire's filings with the Securities and Exchange Commission. Inspire undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof. |
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