NeoPharm Announces Preliminary Phase I Clinical Trial Data for LEP-ETU; Data Presented at the 29th Congress of the European Society for Medical Oncology.

LAKE FOREST, Ill. -- NeoPharm (Nasdaq:NEOL) announced today that preliminary data from a Phase I clinical trial of the Company's NeoLipid(TM) compound LEP-ETU were presented on October 30 at the 29th Congress of the European Society for Medical Oncology (ESMO), held in Vienna, Austria, from October 29 to November 2, 2004. Results from this dose-escalation study provide preliminary evidence on the safety and tolerability of LEP-ETU in patients with advanced cancers. LEP-ETU is NeoPharm's "Easy to Use" liposomal formulation of paclitaxel, a chemotherapeutic drug in wide use for the treatment of several forms of advanced cancer, including ovarian cancer and metastatic breast cancer.

"NeoPharm is pleased with the progress made in the development of LEP-ETU and the safety profile of the drug observed in the Phase I study," said Gregory P. Young, CEO of NeoPharm.

In a scientific poster session at the ESMO meeting, initial results were presented from 25 patients who received doses of LEP-ETU ranging from 135 mg/m2 to 375 mg/m2 as a 90 minute intravenous infusion once every three weeks. LEP-ETU appeared to be well tolerated in terms of typical paclitaxel side effects by the majority of patients, including those receiving the higher doses of drug, as well as those who were not premedicated with antihistamines and steroids. Antitumor activity was observed, with three patients experiencing partial responses (shrinkage of tumor by 50% or more). Eleven other patients evidenced stable disease and were able to complete 4 or more 3-week cycles of LEP-ETU treatment. Patients previously treated with taxanes were among those who responded to LEP-ETU. The poster can be viewed and downloaded from NeoPharm's corporate website at http://www.neophrm.com/Abstracts/LEP-ETU-101%20Fishman%20Pstr%2010.26. 04.pdf (Due to its length, this URL may need to be copied/pasted into your Internet browser's address field. Remove the extra space if one exists.)

"The observation that higher doses of paclitaxel could be given safely in this Phase I study is encouraging and suggests that further studies to assess the safety and efficacy of LEP-ETU are warranted," commented Mayer Fishman, MD, PhD, Assistant Professor in the Department of Interdisciplinary Oncology at the H. Lee Moffitt Cancer Center and Research Institute, University of South Florida, and one of the lead investigators in this study.

About LEP-ETU

LEP-ETU is the Company's NeoLipid(TM) liposomal non-sonicated formulation of the widely used cancer drug, paclitaxel. Paclitaxel has been approved in the U.S. for the treatment of ovarian, breast, and lung cancers. It is sold by Bristol-Myers Squibb as Taxol. Common side effects of this approved anticancer agent include neutropenia, nerve and muscle pain, nausea, vomiting, and hair loss. In addition, Taxol cannot be introduced into the body unless it is first formulated in a mixture of castor oil (Cremophor) and ethanol, which often leads to another set of debilitating side effects including hypersensitivity reactions. NeoLipid(TM) technology is designed to eliminate the need for Cremophor. As a result, LEP-ETU may overcome many of the current limitations of Taxol treatment for cancer patients, as well as its subsequent side effects.

About NeoLipid(TM) Drug Delivery Technology

NeoLipid technology uses an innovative liposome-based system to deliver anticancer drugs to tumors. Liposomes are microscopic membrane-like structures created from lipids (fats). NeoLipid(TM) technology combines drugs or other compounds with the Company's proprietary lipids and allows for the creation of a stable liposome. Because tumor cells need to consume large amounts of fats to sustain their extremely rapid growth, they recognize the liposomal drug as a potential source of nutrition.

About NeoPharm

NeoPharm is a publicly traded biopharmaceutical company dedicated to the research, discovery, and commercialization of new and innovative cancer drugs for therapeutic applications. NeoPharm has built its drug portfolio based on its two novel proprietary technology platforms: a tumor-targeting platform and the NeoLipid(TM) drug delivery system. The Company has a portfolio of anticancer compounds in various stages of development. Additional information about NeoPharm, recent news releases, and scientific abstracts related to the Company's drug compounds can be obtained by visiting NeoPharm's Website at www.neophrm.com, or calling Paul Arndt at 847-295-8678x215.

Forward Looking Statements - 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," "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 program, including, but not limited to the initiation, progress and outcomes of clinical trials of the Company's drug product candidates, including, but not limited to, LEP-ETU, and any other statements that are not historical facts. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to difficulties or delays in financing, development, testing, regulatory approval, production and marketing of the Company's drug and non-drug compounds, including, but not limited to, LEP-ETU, uncertainty regarding the availability of third party production capacity, uncertainty regarding the outcome of damage claims made by or against the Company, the Company's financial guidance and projections, the Company's ability to cut back on its funding of certain of its development projects, including, but not limited to, LEP-ETU, 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 and non-drug compounds, including, but not limited to, LEP-ETU, that could slow or prevent products coming to market, uncertainty regarding the Company's ability to market its drug and non-drug products directly or through independent distributors, the uncertainty of patent protection for the Company's intellectual property or trade secrets, including, but not limited to, LEP-ETU, uncertainty regarding the efforts of John N. Kapoor to obtain consent for, among other things, removal of four of the Company's current independent directors, and other risks detailed from time to time in filings the Company makes with the Securities and Exchange Commission including its annual reports on Form 10-K and quarterly reports on Forms 10-Q. 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. Accordingly, you should not rely on these forward-looking statements as a prediction of actual future results.