OSI Pharmaceuticals Announces European Regulatory Approval for Macugen(R) (pegaptanib sodium injection); First Treatment for Neovascular (Wet) Age-related Macular Degeneration (AMD) That Targets Underlying Disease Process.MELVILLE, N.Y. -- OSI 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 : OSIP OSIP Open Source Integrated Portfolio OSIP Open Sip (session initiation protocol) OSIP Ohio Statewide Imagery Program OSIP Operational Safety Improvement Program OSIP Operational Suitability Improvement Program (aviation) ) said today that the European Commission has granted its development and marketing partner, Pfizer Inc, approval to market Macugen(R) (pegaptanib sodium injection pegaptanib sodium injection Macugen Pharmacologic class: Selective vascular endothelial growth factor (VEGF) antagonist Therapeutic class: Ophthalmic agent Pregnancy risk category B ) for the treatment of neovascular 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. (neovascular 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. ), an age-related eye disease that destroys central vision. Macugen has been proven to prevent and reduce vision loss in patients with neovascular AMD. It is the first treatment to target the underlying disease process and the first therapy approved in Europe for the treatment of all types of neovascular AMD, regardless of lesion subtype, size or baseline visual acuity. "More than 50,000 patients have been treated with Macugen in the United States, and we are pleased that our partner Pfizer will make this important medicine available to patients in Europe," said David Guyer, M.D. Executive Vice President of OSI Pharmaceuticals and Chief Executive Officer of (OSI (1) (Open System Interconnection) An ISO standard for worldwide communications that defines a framework for implementing protocols in seven layers. Control is passed from one layer to the next, starting at the application layer in one station, proceeding to the ) Eyetech, the OSI business team focused on eye disease. "In rigorous clinical studies, Macugen was effective and well-tolerated over two years, an important consideration for older patients treated for this chronic, progressive disease." Macugen has been approved by regulatory authorities in the United States, Canada, Brazil, Argentina, Peru, Pakistan and the Philippines, with filings submitted in 15 other countries, including Australia, Switzerland and Mexico. OSI and Pfizer co-promote Macugen in the United States. OSI has granted Pfizer exclusive rights to commercialize Macugen in countries outside the United States pursuant to a royalty-bearing licensing agreement. Neovascular AMD is the leading cause of irreversible severe vision loss in patients older than 50 years of age in the western world, affecting about 500,000 people worldwide each year. There are approximately 2.5 million people in the European Union living with some form of neovascular AMD. Regulatory approval of Macugen was based on the results of two pivotal clinical trials involving 1,186 patients with all subtypes of neovascular AMD. The primary efficacy endpoint of the trials was the proportion of patients protected from a three-line loss of visual acuity on the eye chart by week 54. Seventy percent of patients who had 0.3 mg of Macugen every six weeks lost fewer than three lines of vision on the eye chart, compared with 55 percent of patients in the control group, a 27 percent treatment benefit. After one year, patients were randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. to continue or discontinue treatment for another year. Two-year clinical data from the studies demonstrated a continued treatment benefit with Macugen, and Macugen was well-tolerated after two years of treatment. The safety and efficacy of Macugen beyond two years have not been demonstrated. European prescribing information for Macugen includes rare post-marketing cases of an allergic reaction reported in patients within several hours after injection with Macugen. In clinical trials, there was no evidence that Macugen was associated with allergic reactions. No direct relationship between Macugen and these post-marketing events has been established, and it is unclear whether or not the hypersensitivity is associated with Macugen or the anaesthetics and antibiotics which are co-administered with Macugen. OSI has provided U.S. regulatory authorities with updated label information for Macugen, which is currently under review. About Macugen Macugen is indicated in the United States for the treatment of neovascular age-related macular degeneration (neovascular AMD) and is administered in a 0.3-mg dose once every six weeks by intravitreal injection. Macugen is a pegylated anti-VEGF aptamer, which binds to 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 a protein that plays a critical role in angiogenesis (the formation of new blood vessels) and increased permeability (leakage from blood vessels), two pathological processes that contribute to the vision loss associated with neovascular AMD. For full prescribing information about Macugen, please visit http://www.macugen.com/. Important Safety Information Macugen is contraindicated in patients with ocular or periocular infections. Intravitreal injections including those with Macugen have been associated with endophthalmitis. Proper aseptic injection technique -- which includes use of sterile gloves, a sterile drape, and a sterile eyelid speculum (or equivalent) -- should always be utilized when administering Macugen. In addition, patients should be monitored during the week following the injection to permit early treatment, should an infection occur. Increases in intraocular pressure (IOP IOP intraocular pressure. IOP Intraocular pressure, see there ) have been seen within 30 minutes of injection with Macugen. Therefore, IOP as well as the perfusion of the optic nerve head should be monitored and managed appropriately. Serious adverse events related to the injection procedure occurring in less than 1% of intravitreal injections included endophthalmitis, retinal detachment, and iatrogenic iatrogenic /iat·ro·gen·ic/ (i-a´tro-jen´ik) resulting from the activity of physicians; said of any adverse condition in a patient resulting from treatment by a physician or surgeon. traumatic cataract. Most frequently reported adverse events in patients treated for up to two years were anterior chamber inflammation, blurred vision, cataract, conjunctival con·junc·ti·val adj. Relating to the conjunctiva. conjunctival pertaining to or emanating from conjunctiva. congenital conjunctival membrane hemorrhage, corneal edema, eye discharge, eye irritation, eye pain, hypertension, increased IOP, ocular discomfort, punctate keratitis, reduced visual acuity, visual disturbance, vitreous vitreous /vit·re·ous/ (vit´re-us) 1. glasslike or hyaline. 2. vitreous body. primary persistent hyperplastic vitreous floaters floaters /float·ers/ (flo´ters) “spots before the eyes”; deposits in the vitreous of the eye, usually moving about and probably representing fine aggregates of vitreous protein occurring as a benign degenerative change. , and vitreous opacities. These events occurred in approximately 10% to 40% of patients. About OSI Pharmaceuticals OSI Pharmaceuticals is committed to "shaping medicines and changing lives" by discovering, developing and commercializing high-quality and novel pharmaceutical products that extend life or improve the quality of life for patients with cancer, eye diseases, and diabetes. The Company operates through three business teams, (OSI) Oncology, (OSI) Eyetech and (OSI) Prosidion. (OSI) Oncology is focused on developing molecular targeted therapies designed to change the paradigm of cancer care. (OSI) Eyetech specializes in the development and commercialization of novel therapeutics to treat diseases of the eye. (OSI) Prosidion is committed to the generation of novel, targeted therapies for the treatment of type 2 diabetes type 2 diabetes n. See diabetes mellitus. and obesity. OSI's flagship product, Tarceva(R)(erlotinib), is the first drug discovered and developed by OSI to obtain 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. approval and the only EGFR EGFR Epidermal Growth Factor Receptor (a kinase enzyme) EGFR Estimated Glomerular Filtration Rate inhibitor to have demonstrated the ability to improve survival in both non-small cell lung cancer Lung Cancer, Non-Small Cell Definition Non-small cell lung cancer (NSCLC) is a disease in which the cells of the lung tissues grow uncontrollably and form tumors. Description There are two kinds of lung cancers, primary and secondary. and pancreatic cancer patients. OSI markets Tarceva through partnerships with Genentech, Inc. in the United States and with Roche throughout the rest of the world. Macugen(R) (pegaptanib sodium injection) is approved in the United States for the treatment of neovascular age-related macular degeneration. OSI commercializes Macugen in partnership with Pfizer Inc. For additional information about OSI, please visit http://www.osip.com. This news release contains forward-looking statements. These statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. Factors that might cause such a difference include, among others, the completion of clinical trials, the FDA review process and other governmental regulation, OSI's and its collaborators' abilities to successfully develop and commercialize drug candidates, competition from other pharmaceutical companies, the ability to effectively market products, and other factors described in OSI Pharmaceuticals' filings with the Securities and Exchange Commission. |
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