EYETECH GETS EXCLUSIVE LICENSE FOR GILEAD'S AMD TREATMENT.Gilead Sciences, Inc. (Nasdaq: GILD) and EyeTech Pharmaceuticals, Inc. have announced an exclusive, worldwide license of an investigational therapy for the treatment of the wet form of Age-Related Macular Degeneration Age-related macular degeneration (ARMD) Degeneration of the macula (the central part of the retina where the rods and cones are most dense) that leads to loss of central vision in people over 60. (AMD (Advanced Micro Devices, Inc., Sunnyvale, CA, www.amd.com) A major manufacturer of semiconductor devices including x86-compatible CPUs, embedded processors, flash memories, programmable logic devices and networking chips. ), the most common cause of adult-onset blindness, and Diabetic Retinopathy diabetic retinopathy n. Retinal changes occurring in long-term diabetes and characterized by punctate hemorrhages, microaneurysms, and sharply defined waxy exudates. . EyeTech has received worldwide rights to all therapeutic uses of Gilead's proprietary aptamer NX 1838, an inhibitor of vascular endothelial growth factor Vascular endothelial growth factor (VEGF) is an important signaling protein involved in both vasculogenesis (the de novo formation of the embryonic circulatory system) and angiogenesis (the growth of blood vessels from pre-existing vasculature). (VEGF VEGF vascular endothelial growth factor. ). VEGF is known to play a role in the development of both ophthalmic diseases. Currently in early clinical trials, NX 1838 will require additional studies to determine its safety and efficacy for these treatment indications. Under the terms of the deal, EyeTech has paid Gilead an up-front licensing fee of $7 million, and Gilead is entitled to additional cash payments of up to $25 million upon achievement of development milestones. EyeTech will be responsible for all research and development costs and will pay Gilead royalties on the worldwide sales of NX 1838. EyeTech also issued Gilead a warrant to purchase 833,333 shares of EyeTech Series B Convertible Preferred Stock Convertible Preferred Stock Preferred stock that includes an option for the holder to convert the preferred shares into a fixed number of common shares, usually anytime after a predetermined date. Also known as "convertible preferred shares". , exercisable over a five year period at a per share price of $6.00, the price paid by the investors participating in EyeTech's recent round of venture capital financing To start an own company or to bring a new product to the market, the venture may need to attract financial funding. There are several categories of financing possibilities. If it is a small venture, then perhaps the venture can rely on family funding, loans from friends . "EyeTech is building a strong foundation for success," said John C. Martin, Ph.D., CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. and president, Gilead Sciences. "Their work in basic research on the causes of eye disease and clinical testing of new ophthalmic drugs provides the necessary experience to rapidly and successfully develop NX 1838." A recently formed private company, EyeTech Pharmaceuticals engages in the development and commercialization of novel drugs to reduce and prevent serious vision loss caused by eye disease. NX 1838 will form the cornerstone of its ophthalmic portfolio. EyeTech's founding board members include chairman of the board, John McLaughlin, who has more than 20 years of leadership experience in the pharmaceutical and biotechnology industries. Formerly executive vice president of Genentech and president of Tularik, McLaughlin is currently president of Corgentech, a privately held pharmaceutical company. EyeTech's co-founder David Guyer, MD, who also is acting CEO and President of EyeTech, is considered one of the world's leading authorities on macular degeneration macular degeneration, eye disorder causing loss of central vision. The affected area, the macula, lies at the back of the retina and is the part that produces the sharpest vision. . Dr. Guyer is director of Residency Training at Manhattan Eye, Ear & Throat Hospital and clinical associate professor of ophthalmology at Cornell University Medical Center in New York New York, state, United States New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of . Co-founder Samir Patel, MD is the chief medical officer of EyeTech and was most recently director of the Retinal Service and Residency at the University of Chicago, where he also was an Associate Professor. Dr. Patel was the first surgeon to perform a retinal transplant in humans in the United States. "We believe that NX 1838 has the potential to be a breakthrough drug for the treatment of neovascular AMD," said Dr. Guyer. "As the lead compound in our portfolio of ophthalmics, NX 1838 will receive the full attention of our company. We are very enthusiastic about the profile of NX 1838 and plan to commence additional clinical studies this year." Mark Blumenkrantz, MD, chairman and professor of ophthalmology at Stanford, commented, "EyeTech has assembled a world class team to develop and commercialize a very promising potential drug to treat AMD." AMD May Result in Irreversible Blindness AMD is the leading cause of vision loss and blindness in people aged 65 and older. The disease is characterized by the growth of blood vessels Blood vessels Tubular channels for blood transport, of which there are three principal types: arteries, capillaries, and veins. Only the larger arteries and veins in the body bear distinct names. into the center of the retina. Over time, the leakage from these small blood vessels causes the formation of scar tissue on the retina. A patient's central vision gradually deteriorates as the disease destroys the retina, ultimately resulting in irreversible blindness. The two common types of AMD are atrophic ("dry") and neovascular ("wet"). Wet macular degeneration accounts for approximately 10 percent of all cases but is a more serious threat to complete vision loss than the dry form. Growing Incidence of AMD Each year, approximately 200,000 Americans are diagnosed with the wet form of AMD. The incidence is slightly higher in Europe with 220,000 new cases diagnosed annually and Japanese officials estimate 78,000 new cases this year. As the population ages, the incidence of AMD is expected to increase dramatically. In the United States alone, approximately 1.2 million individuals have been afflicted with this devastating dev·as·tate tr.v. dev·as·tat·ed, dev·as·tat·ing, dev·as·tates 1. To lay waste; destroy. 2. To overwhelm; confound; stun: was devastated by the rude remark. disease, which is considered the leading cause of legal blindness in people aged 65 and older. Currently, there is no effective therapeutic for the treatment of AMD. Recently approved by the U.S. Food and Drug Administration, photodynamic therapy (PDT PDT abbr. Pacific Daylight Time PDT Pacific Daylight Time PDT n abbr (US) (= Pacific Daylight Time) → hora de verano del Pacífico PDT ) will soon be a commercially available treatment for the condition. An important first step in the care of patients with AMD, experts believe that PDT is not a cure and does not prevent recurring bleeding in the eye -- the underlying cause of wet AMD. Experts in the field believe that medical intervention with a drug to inhibit neovascularization would represent the next major breakthrough in this area and may be complementary to PDT. NX 1838 Inhibits VEGF Extensive preclinical and clinical research has attributed the sudden abnormal growth of ocular blood vessels to the over-production of vascular endothelial growth factor (VEGF), a protein that stimulates the growth of the endothelial cells that make new blood vessels (a process called angiogenesis angiogenesis /an·gio·gen·e·sis/ (-jen´e-sis) vasculogenesis; development of blood vessels either in the embryo or in the form of neovascularization or revascularization. an·gi·o·gen·e·sis n. ). In animal and human models, NX 1838 has been shown to bind to to contract; as, to bind one's self to a wife s>. See also: Bind VEGF and inhibit its function, thus preventing the abnormal growth of ocular blood vessels and vessel leakage in the eye. NX 1838 is a compound from a class of drugs called aptamers. Made of chemically synthesized short strands of RNA RNA: see nucleic acid. RNA in full ribonucleic acid One of the two main types of nucleic acid (the other being DNA), which functions in cellular protein synthesis in all living cells and replaces DNA as the carrier of genetic (oligonucleotides), aptamers assume three-dimensional shapes that allow high affinity binding to the targets for which they are designed, a characteristic that may enhance therapeutic benefit. Anthony Adamis, MD, associate professor of ophthalmology at Harvard Medical School Harvard Medical School (HMS) is one of the graduate schools of Harvard University. It is a prestigious American medical school located in the Longwood Medical Area of the Mission Hill neighborhood of Boston, Massachusetts. and director of EyeTech's preclinical development program noted, "Given the requisite role of VEGF in ocular neovascularization and the aptamers' high specificity for VEGF, this aptamer is a logical choice for the inhibition of choroidal cho·roi·dal adj. Of or relating to the choroid. choroidal pertaining to or emanating from the choroid. choroidal hypoplasia neovascularization secondary to AMD." Following execution of the licensing agreement, EyeTech intends to initiate a multiple dose Phase I trial to further define the safety profile of NX 1838. About Gilead Sciences and EyeTech Gilead Sciences, Inc., headquartered in Foster City, CA, is an independent biopharmaceutical company that seeks to provide accelerated solutions for patients and the people who care for them. Gilead discovers, develops, manufactures and commercializes proprietary therapeutics for challenging infectious diseases (viral, fungal and bacterial infections) and cancer. Gilead maintains research, development or manufacturing facilities in Foster City, CA; Boulder, CO; San Dimas, CA; Cambridge, UK and Dublin, Ireland and sales and marketing organizations in the United States, Europe and Australia. For more information about Gilead, visit www.gilead.com. EyeTech Pharmaceuticals, Inc. is a private, Manhattan-based pharmaceutical company recently formed to develop and commercialize novel drugs to reduce and prevent serious vision loss caused by eye disease. The Company's primary goal is to develop and commercialize the first breakthrough antiangiogenic an·ti·an·gi·o·gen·ic adj. Inhibiting the growth of blood vessels. antiangiogenic drug to reduce vision loss caused by neovascular age-related macular degeneration. The EyeTech team combines world-renowned thought-leaders in ophthalmology, strong relationships with leading academic institutions such as Harvard and Stanford, and extensive experience designing and implementing clinical trials to test drugs to treat diseases of the eye. For more information, call (650)522-5715 or (516)773-0319. |
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