Aronex Pharmaceuticals Receives FDA Letter Concerning ATRAGEN
September 24, 1999 06:15 PM
THE WOODLANDS, Texas, Sept. 24 /PRNewswire/ -- Aronex Pharmaceuticals, Inc. ARNX , a biopharmaceutical company focused on proprietary medicines to treat cancer and infectious diseases, announced today that the U.S. Food and Drug Administration (FDA) has notified the Company that the information presented in its New Drug Application (NDA) for ATRAGEN(R) is inadequate and that the application is not approvable in its current form. On
August 5, 1999, Aronex had announced that the FDA had verbally informed the Company that there were deficiencies in the ATRAGEN filing.
Geoffrey F. Cox, Ph.D., Chairman and CEO of Aronex Pharmaceuticals, said, "As we have stated previously, the Company plans to work diligently with the FDA to move forward with the regulatory review of this product. We are pleased that the FDA has informed us of their issues expeditiously, and we are now in the process of discussing these issues in greater detail. We continue to believe strongly in the clinical utility of ATRAGEN in acute promyelocytic leukemia, and we will continue to update our stakeholders as we identify the appropriate actions for the future."
In December 1998, the Company filed an NDA with the FDA for ATRAGEN for the treatment of patients with acute promyelocytic leukemia, for whom therapy with tretinoin is necessary but for whom an intravenous administration is required.
Aronex Pharmaceuticals, Inc. is a biopharmaceutical company that develops and commercializes proprietary innovative medicines to treat cancer and infectious diseases. Aronex Pharmaceuticals currently has five products in clinical development, two of which (ATRAGEN(R) and NYOTRAN(R)) are in an advanced stage, as well as a pipeline of additional products.
Any statements which are not historical facts, including statements regarding the Company's clinical development programs and the expected timing of clinical trials and NDA filings, contained in this release are forward looking statements that involve risks and uncertainties, including but not limited to those relating to product demand, pricing, market acceptance, the effect of economic conditions, intellectual property rights and litigation, clinical trials, governmental regulation, competitive products, risks in product and technology development, the results of financing efforts, the ability to complete transactions and other risks identified in the Company's Securities and Exchange Commission filings.
SOURCE Aronex Pharmaceuticals, Inc.
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