Alcon Updates Filing Status of RETAANE New Drug Application; Therapy is on Track for Launch in First Half of 2005.FORT WORTH, Texas Fort Worth is the fifth-largest city in the state of Texas, 18th-largest city in the United States[1], and voted one of "America’s Most Livable Communities. -- Alcon, Inc. (NYSE NYSE See: New York Stock Exchange :ACL See access control list. 1. ACL - Access Control List. 2. ACL - Association for Computational Linguistics. 3. ACL - A Coroutine Language. A Pascal-based implementation of coroutines. ["Coroutines", C.D. ) announced that it has filed the second portion of its "rolling" New Drug Application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) with the U.S. 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. ) for RETAANE(R) 15mg (anecortave acetate for depot suspension), an investigational treatment for preserving the vision of patients with all forms of wet 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 announcement was made today during a meeting of international retinal experts in Amsterdam, Holland. RETAANE(R) depot is a fast track designated product that was also accepted into FDA's new Pilot 1 Continuous Marketing Application (CMA CMA - Concert Multithread Architecture from DEC. ) program because of its potential as a treatment for a significant unmet medical need in patients with a serious condition. The "rolling" NDA permitted under this new FDA program allows designated NDAs to be submitted in specified reviewable units as each is completed, rather than as one package when the last unit is completed. The three main reviewable units are the Chemistry, Manufacturing and Controls (CMC (Common Messaging Calls) A programming interface specified by the XAPIA as the standard messaging API for X.400 and other messaging systems. CMC is intended to provide a common API for applications that want to become mail enabled. 1. ) unit; the Pre-Clinical unit; and the Clinical unit. The fast-track designation provides a performance target for the FDA to complete its review of each unit within six months of its submission. The FDA has completed its initial review of the RETAANE(R) depot CMC reviewable unit, which was filed in 2003. Furthermore, the pre-approval inspection of Alcon's manufacturing facility has been completed with no negative findings (no 483 observations). Alcon also submitted the Pre-Clinical unit for RETAANE(R) depot in March of this year, and has responded to all questions to date. Alcon plans to complete the submission of the RETAANE(R) depot NDA with the filing of the Clinical unit in the fourth quarter of 2004. This unit will incorporate the twelve-month results from the on-going, multi-center, phase III clinical trial Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the comparing RETAANE(R) depot with photodynamic therapy (PDT) in 530 patients with wet AMD, along with results from other clinical studies completed during the development program. If approved, consistent with the spirit of the CMA Pilot, Alcon is prepared to quickly make RETAANE(R) depot available for treating wet AMD. "By piloting new review programs such as the Continuous Marketing Application program, the FDA is taking significant steps to ensure that safe and effective treatments that address significant unmet medical needs are efficiently made available to the American public," said Scott Krueger, Ph.D., Alcon's Vice President of Regulatory Affairs. "In anticipation of the upcoming twelve-month clinical safety and efficacy data from our ongoing Phase III study, we are looking forward to submitting for FDA review the final NDA unit for RETAANE(R) depot. Once we have filed this last unit, we believe the drug development program for RETAANE(R) depot will have generated a compelling database that supports its use as a treatment for wet AMD." About AMD Age-related macular degeneration causes damage to the macula - the light-sensitive cells at the center of the retina at the back of the eye. The macula is responsible for our ability to see with enough detail to read, drive, watch television and perform other activities that require focused, straight-ahead vision, as well as providing information that allows us to perceive colors; thus, allowing one to maintain independence in daily activities. There are two types of AMD - "dry," or atrophic or non-exudative, and "wet," or exudative exudative of or pertaining to a process of exudation. exudative diathesis a disease of young pigs and chickens caused by a nutritional deficiency of vitamin E. Characterized by severe edema of the subcutaneous tissues. . Although the wet form of AMD constitutes only 10-15 percent of all AMD cases, it is responsible for 90 percent of blindness attributable to this condition. Today, wet AMD is the leading cause of blindness in industrialized in·dus·tri·al·ize v. in·dus·tri·al·ized, in·dus·tri·al·iz·ing, in·dus·tri·al·iz·es v.tr. 1. To develop industry in (a country or society, for example). 2. nations in people over the age of 50, primarily because there is a lack of effective treatments for the disease. Currently, there is no approved treatment for dry AMD. The two currently approved treatments for wet AMD - laser photocoagulation photocoagulation /pho·to·co·ag·u·la·tion/ (-ko-ag?u-la´shun) condensation of protein material by the controlled use of an intense beam of light (e.g. and photodynamic therapy - are appropriate for only a percentage of patients. About RETAANE(R) Depot Anecortave acetate, the active ingredient in RETAANE(R) 15 mg (anecortave acetate for depot suspension), is an angiostatic cortisene that inhibits the abnormal growth of blood vessels - a process scientifically known as angiogenesis. Angiostatic cortisenes were derived from the steroid class and engineered to remove chemical groups responsible for unwanted glucocorticoid glucocorticoid /glu·co·cor·ti·coid/ (-kor´ti-koid) 1. any of the group of corticosteroids predominantly involved in carbohydrate metabolism, and also in fat and protein metabolism and many other activities (e.g. effects, such as the development of cataracts and elevated intraocular pressure leading to glaucoma, while preserving angiostatic (or anti-neovascular) potency. Some investigational therapies attempt to block only one growth factor such as 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. ), thus still allowing other growth factors, such as basic fibroblast growth factor Basic fibroblast growth factor, also known as bFGF or FGF2, is a member of the fibroblast growth factor family. In normal tissue, basic fibroblast growth factor is present in basement membranes and in the subendothelial extracellular matrix of blood (bFGF), to signal the endothelial cells and commence the angiogenesis process. Angiostatic cortisenes are able to block signals from multiple growth factors because they act downstream and independent of the initiating angiogenic stimuli thus inhibiting angiogenesis subsequent to the angiogenic stimulation. RETAANE(R) depot is the only therapy for AMD that uses the unique delivery system of posterior juxtascleral depot (PJD). During the procedure, RETAANE(R) 15 mg is drawn into a blunt-tipped, curved cannula cannula /can·nu·la/ (kan´u-lah) a tube for insertion into a vessel, duct, or cavity; during insertion its lumen is usually occupied by a trocar. can·nu·la or can·u·la n. pl. and then delivered in direct contact with the outer surface of the sclera sclera: see eye. without puncturing the eyeball. This method of delivery for RETAANE(R) depot avoids the risk of intraocular infection and retinal detachment, the most common side effects associated with frequently injecting therapeutic agents directly into the eye. RETAANE(R) depot requires less frequent administration (once every six months) compared to some other investigational angiogenesis inhibitors, which are injected into the eye as often as nine to 12 times a year. According to an independent safety panel, no clinically relevant side effects were associated with RETAANE(R) depot or the PJD procedure. About Alcon Alcon, Inc. is the world's leading eye care company. Alcon, which has been dedicated to the ophthalmic industry for over 50 years, develops, manufactures and markets pharmaceuticals, surgical equipment and devices, contact lens solutions and other vision care products that treat diseases, disorders and other conditions of the eye. Alcon has been conducting retinal research for more than 15 years and is the world's leading provider of surgical equipment used by vitreoretinal specialists who treat patients with AMD and other retinal diseases. Caution Concerning Forward-Looking Statements. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995, relating principally to our ability to complete clinical trials for Anecortave Acetate and file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) and the expected benefits of Anecortave Acetate in treating exudative age-related macular degeneration (AMD). These statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by our forward-looking statements. These statements reflect the views of our management as of the date of this press release with respect to future events and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward- looking statements. Factors that might cause future results to differ include, but are not limited to, the following: we may never submit an NDA for anecortave acetate to the FDA, or submission and/or approval of the NDA may take longer than we expect; treatments developed by other companies may reach the market sooner or prove to be more effective than anecortave acetate; challenges inherent in new product marketing; and government regulation and legislation. You should read this press release with the understanding that our actual future results may be materially different from what we expect. Except to the extent required under the federal securities laws and the rules and regulations promulgated by the Securities and Exchange Commission, we undertake no obligation to publicly update or revise any of these forward- looking statements, whether to reflect new information or future events or circumstances or otherwise. |
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