FDA Grants Orphan Drug Status for IntraDose.Medical & Health Writers FREMONT, Calif.--(BW HealthWire)--April 13, 2000 Matrix Pharmaceutical, Inc., (NNM NNM Network Node Manager NNM NASDAQ National Market (financial) NNM National Nutrition Month (March; American Dietetic Association) NNM Naryan-Mar (Russia) NNM Net New Money : MATX MATX Micro Advanced Technology Extended (motherboard type) MATX Micro ATX ) today announced that 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. ) has granted orphan drug orphan drug, drug developed under the U.S. Orphan Drug Act (1983) to treat a disease that affects fewer than 200,000 people in the United States. The orphan drug law offers tax breaks and a seven-year monopoly on drug sales to induce companies to undertake the status to its cisplatin/epinephrine product candidate for the treatment of squamous cell carcinoma squamous cell carcinoma n. A carcinoma that arises from squamous epithelium and is the most common form of skin cancer. Also called cancroid, epidermoid carcinoma. of the head and neck. Matrix is developing this product under the trade name of IntraDose(R). Products designated as Orphan Drugs gain seven years of marketing exclusivity for the designated indications once they receive FDA approval. Earlier this year, Matrix announced that it had completed enrollment in two 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. , double-blind, placebo controlled trials using IntraDose to treat head and neck cancer. "Receiving orphan drug designation for IntraDose further strengthens the competitive position of this product," said Michael Casey, Chairman and Chief Executive Officer of Matrix. "We plan to report results from our Phase III trials by the end of May and remain on schedule to file an 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 for IntraDose during the fourth quarter." The Orphan Drug Act provides financial incentives to stimulate the development of drugs for diseases that affect 200,000 people or less in the United States. In addition to seven years of marketing exclusivity for the designated indications, orphan drug designation also enables the Company to obtain research funding, tax credits for certain research expenses, and a waiver of the application user fee. Located in Fremont, California, Matrix Pharmaceutical, Inc. is developing novel local and systemic treatments for cancer. In addition to IntraDose Injectable Gel, the Company is also developing FMdC, a systemically administered new chemical entity, and MPI MPI - Message Passing Interface 5020, a radiopotentiator. This press release contains, in addition to historical statements, certain forward looking statements relating to the Company's timing and plans to file an NDA for IntraDose. Such statements are based on management's current expectations and are subject to a number of factors and uncertainties including the risk that IntraDose may not be effective in the pivotal trials and the Company may decide to not file an NDA. Further, Orphan Drug designation does not imply any greater or lesser likelihood of receiving approval to market IntraDose from the FDA. Additional factors and uncertainties which could cause actual results to differ materially from those described in the forward looking statements are set forth under the heading "Risk Factors" in the Company's Annual Report on From 10-K for the year ended December 31, 1999. Matrix news releases are available on the World Wide Web on the Matrix web site at www.matx.com. |
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