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LAKE BLUFF, Ill., Mar 10, 2010 (BUSINESS WIRE) -- NeoPharm, Inc. (Other OTC: NEOL.PK), announced today that it has filed an orphan drug application with the Office of Orphan Products Development of the United States Food and Drug Administration (FDA) to have Orphan Drug Designation granted to IL13-PE38QQR (IL13-PE) for the treatment of Idiopathic Pulmonary Fibrosis (IPF). The US Orphan Drug Act is intended to assist and encourage companies to develop safe and effective therapies for the treatment of rare diseases and disorders. IPF is the most deadly disease of the lungs in humans with very high morbidity. It is estimated that at least 55,000 patients are diagnosed with IPF each year in America and about 45,000 patients die each year with the disease. There is currently no proven effective treatment for the cure of this lethal disease.
Dr. Aquilur Rahman, President and CEO, commented, "All the studies that NeoPharm has performed in animals and in ex vivo human tissue have shown that IL13-PE works as a targeted therapy for lung fibroblasts. IL13-PE exclusively binds to the pulmonary fibroblasts, which express IL13 receptors for selective cytotoxicity, thereby ameliorating all the clinical and histopathological evidence of IPF. We are looking forward to the start of our clinical studies in humans inflicted with this disease."
Orphan Drug designation provides a seven-year term of market exclusivity for IPF upon final FDA approval. Orphan Drug designation would position NeoPharm to be able to take advantage of a wide range of financial and regulatory benefits, including government grants for conducting clinical trials, waiver of expensive FDA user fees and certain tax credits.
About NeoPharm, Inc.
NeoPharm, Inc., based in Lake Bluff, Illinois, is a publicly traded biopharmaceutical company dedicated to the research, development and commercialization of new and innovative cancer and other drugs for therapeutic applications. Additional information, including ongoing clinical trials, can be obtained by visiting NeoPharm's web site at www.neopharm.com.
This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. The Company has tried to identify such forward-looking statements by use of such words as "expects," "intends," "projects," "hopes," "anticipates," "believes," "could," "may," "evidences" and "estimates," and other similar expressions, but these words are not the exclusive means of identifying such statements. Such statements include, but are not limited to, any statements relating to the Company's drug development programs, the initiation, progress, and outcomes of clinical trials of the Company's drug product candidates including, but not limited to Cintredekin Besudotox, and any other statements that are not historical facts. Such statements involve risks and uncertainties, including, but not limited to, risks and uncertainties relating to difficulties or delays that may arise in the development, testing, regulatory approval, production, and marketing of the Company's drug and non-drug compounds, including, but not limited to, Cintredekin Besudotox, the Company's possible need to reduce its funding of certain of its development projects in order to conserve its cash resources, the ability of the Company to procure additional future sources of financing, unexpected adverse side effects or inadequate therapeutic efficacy of the Company's drug product candidates, including, but not limited to, Cintredekin Besudotox,, that could slow or prevent products coming to market, uncertainty regarding the Company's ability to commercialize any of its drug product candidates, including, but not limited to, Cintredekin Besudotox, and other risks of the type previously detailed from time to time in filings the Company formerly made with the Securities and Exchange Commission ("SEC"). Such statements are based on management's current expectations, but actual results may differ materially due to various factors, including those risks and uncertainties mentioned or referred to in this press release. At the Company's request, the Company's obligation to file reports with the SEC was suspended effective February 12, 2009. For the foregoing reasons, you should not rely on these forward-looking statements or our previously filed SEC reports as a prediction of actual future results.
SOURCE: NeoPharm, Inc.
NeoPharm, Inc.
Martin K. McCarthy
847-887-0800
Copyright Business Wire 2010
