neophrm.com
February 09, 2006 07:00 AM US Eastern Timezone
NeoPharm Announces LEP-ETU Project Update
BIOWIRE2K
WAUKEGAN, Ill.--(BUSINESS WIRE)--Feb. 9, 2006--NeoPharm, Inc. (Nasdaq:NEOL) has been engaged with the FDA in a dialogue to review the regulatory pathway for using section 505(b)(2) for the NeoLipid(R) drug candidate LEP-ETU (Liposomal Paclitaxel "Easy to Use"). The FDA has now advised the Company, as part of the planning phase for a meeting to discuss NeoPharm's plans to begin a 100 patient clinical efficacy trial of LEP-ETU compared to Taxol(R) to support the submission to FDA of a 505(b)(2) New Drug Application (NDA) for marketing approval, that additional data is required to establish bioequivalence between LEP-ETU and Taxol(R). The Company is preparing to submit the additional requested data in advance of a meeting with the FDA scheduled for the second quarter of this year. As a result, initiation of the proposed clinical efficacy trial of LEP-ETU would commence, at the earliest, in the second quarter of this year, pending resolution of this issue.
About LEP-ETU
LEP-ETU is the Company's NeoLipid(R) liposomal formulation of the widely used cancer drug, paclitaxel. Paclitaxel has been approved in the U.S. as Taxol(R). Common side effects of this approved anticancer agent include nausea, vomiting, hair loss, and nerve and muscle pain. In addition, Taxol cannot be introduced into the body unless it is first formulated in a mixture of castor oil (Cremophor(R) EL) and ethanol, which can lead to another set of debilitating side effects including hypersensitivity reactions. NeoLipid(R) technology eliminates the need for Cremophor. As a result, LEP-ETU may overcome many of the current limitations of Taxol(R) treatment for cancer patients and may limit the adverse side effects.
About NeoPharm, Inc.
NeoPharm, Inc., based in Waukegan, Illinois, is a publicly traded biopharmaceutical company dedicated to the research, development and commercialization of new and innovative cancer drugs for therapeutic applications. The Company has a portfolio of cancer compounds in various stages of development. Additional information can be obtained by visiting NeoPharm's Website at www.neophrm.com.
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 LEP-ETU, future patient enrollment in the Company's LEP-ETU clinical trials, 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, obtaining 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, 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, including, but not limited to, LEP-ETU, the uncertainty of patent protection for the Company's intellectual property or trade secrets, including, but not limited to, LEP-ETU, 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.
Contacts
NeoPharm, Inc.
Paul Arndt, 847-887-0800 x 2342
parndt@neophrm.com
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