Eyetech Pharmaceuticals Utilizes Phase Forward's Inform EDC Solution in Macugen Clinical Trials; Macugen Approved by FDA; Launched in January 2005.WALTHAM, Mass. -- Phase Forward (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 : PFWD), a leading provider of data management solutions for clinical trials and drug safety, today announced that Eyetech Pharmaceuticals Inc. (NASDAQ: EYET) utilized the InForm(TM) electronic data capture (EDC EDC See: Export Development Corp. ) solution in clinical trials for its 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. drug 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 ), which was approved by the U.S. Food and Drug Administration (FDA FDAabbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) on December 17, 2004. Neovascular age-related macular degeneration (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. ) is the leading cause of severe vision loss in patients older than 50 years of age in the developed world. There are 15 million people in the United States living with some form of AMD and over 200,000 new cases of neovascular AMD each year - a number which is expected to increase significantly as the baby boomer generation ages and overall life expectancy Life Expectancy 1. The age until which a person is expected to live. 2. The remaining number of years an individual is expected to live, based on IRS issued life expectancy tables. increases. Presently, over 500,000 people worldwide lose their sight annually from the disease. Eyetech was founded in 2000 with the goal of developing novel therapeutics to treat diseases of the eye. On March 16, 2004, the company's application was entered into the "Pilot 1" program which allows the FDA to complete reviews of individual reviewable units within six months of submission and provide early feedback on the pre-submissions. Upon completing the eCTD filing on June 17, 2004, the application received Priority Review designation from the FDA for its AMD drug, Macugen - a designation that sets the target date for FDA action at six months and is intended for those products that address unmet medical needs. Eyetech's 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 ) was reviewed by the FDA and its Dermatologic and Ophthalmic Drugs Advisory Committee on August 27, 2004 and approved on December 17, 2004. Data for the Macugen Phase II/III pivotal clinical trials were collected electronically using Phase Forward's InForm software and subject electronic case report forms (eCRFs) were prepared for submission using InForm's CRF CRF abbr. chronic renal failure CRF Chronic renal failure Submit feature. Eyetech leveraged the InForm solution in order to reap the many benefits of EDC - faster trials with higher quality data and lower costs than traditional paper trials. CRF Submit helped Eyetech streamline the NDA submission process by automatically generating electronic versions of patient data, which allowed FDA regulators to access and analyze Macugen clinical trial data more quickly and efficiently - all contributing to a faster review process. "Fast track drugs like Macugen, developed to alleviate a condition for which no other effective treatment exists today, drive home the need for efficient and effective clinical data capture and management solutions like InForm and CRF Submit," said Robert Weiler, chief executive officer and president of Phase Forward. "By streamlining the data collection and submission process, InForm and CRF Submit continue to help our customers bring important drugs to market faster, to the benefit of all concerned." About Phase Forward Phase Forward is a leading provider of integrated data management solutions for clinical trials and drug safety. The company helps pharmaceutical, biotechnology, and medical device companies bring needed drugs and therapies to market faster and more safely. Phase Forward offers proven solutions in electronic data capture (EDC), clinical data management (CDM 1. CDM - Content Data Model 2. CDM - Code Division Multiplexing ), and adverse event reporting (AER). Phase Forward products and services have been utilized in over 10,000 clinical trials involving more than 1,000,000 clinical trial study participants at over 200 organizations worldwide including: AstraZeneca, Biogen Idec, Boston Scientific, Cedars-Sinai, Eli Lilly, GlaxoSmithKline, Guidant, Procter & Gamble, Quintiles Quintiles Transnational Corp. is a contract research organization which serves the pharmaceutical, biotechnology and healthcare industries. History Quintiles was founded in 1982 by Dennis Gillings and as of 2007 it has 18,000 employees. , Sanofi-Aventis, and Schering-Plough Research Institute. Additional information about Phase Forward is available at www.phaseforward.com. Forward Looking Statement Certain statements made in this press release that are not based on historical information are forward-looking statements which are made pursuant to the safe harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. provisions 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. This press release contains express or implied forward-looking statements relating to, among other things, the performance of Phase Forward's products and services, future business and operations plans of a Phase Forward customer, and the ability of Phase Forward's customers to realize benefits from the use of Phase Forward's products and services. These statements are neither promises nor guarantees, but are subject to a variety of risks and uncertainties, many of which are beyond Phase Forward's control, which could cause actual results to differ materially from those contemplated in these forward-looking statements. In particular, the risks and uncertainties include, among other things, the ability of Phase Forward's customers to realize benefits from the use of its products and services, and the possibility that customers' needs or plans may change over time. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Phase Forward undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise. For additional disclosure regarding these and other risks faced by Phase Forward, see the disclosure contained in Phase Forward's public filings with the Securities and Exchange Commission including, without limitation, its most recent Quarterly Report on Form 10-Q Form 10-Q See 10-Q. . |
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