NeoPharm Announces LEP-ETU Project Update.WAUKEGAN, Ill. -- NeoPharm, Inc. (Nasdaq:NEOL) has been engaged with the 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. in a dialogue to review the regulatory pathway for using section 505(b)(2) for the NeoLipid(R) drug candidate LEP-ETU (Liposomal Paclitaxel paclitaxel /pac·li·tax·el/ (pak?li-tak´sel) an antineoplastic that promotes and stabilizes polymerization of microtubules, isolated from the Pacific yew tree (Taxus brevifolia); "Easy to Use"). The FDA has now advised the Company, as part of the planning phase In amphibious operations, the phase normally denoted by the period extending from the issuance of the order initiating the amphibious operation up to the embarkation phase. The planning phase may occur during movement or at any other time upon receipt of a new mission or change in the 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 (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 marketing approval, that additional data is required to establish bioequivalence bioequivalence /bio·equiv·a·lence/ (-e-kwiv´ah-lens) the relationship between two preparations of the same drug in the same dosage form that have a similar bioavailability. 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 Side effects Effects of a proposed project on other parts of the firm. 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 castor oil, yellowish oil obtained from the seed of the castor bean. The oil content of the seeds varies from about 20% to 50%. After the hulls are removed the seeds are cold-pressed. (Cremophor(R) EL) and ethanol, which can lead to another set of debilitating de·bil·i·tat·ing adj. Causing a loss of strength or energy. Debilitating Weakening, or reducing the strength of. Mentioned in: Stress Reduction side effects including hypersensitivity reactions hypersensitivity reactions, n.pl any of several forms of overly responsive actions of the immune system to normally encountered, antigens. Also called allergic 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 Waukegan (IPA: /wɔˈkiːgən/) is a city in Lake County, Illinois. As of the 2000 census, the city had a total population of 87,901. Estimated population in 2006: 93,389 . , 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 Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 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. |
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