NeoPharm Announces LEP-ETU Project Update
LAKE FOREST, Ill.--(BUSINESS WIRE)--Sept. 29, 2005--NeoPharm, Inc. (Nasdaq:NEOL - News):
Bioequivalency Study Meets Endpoint
Development For NDA Submission via 505(b)(2) Pathway Planned
NeoPharm, Inc. (Nasdaq:NEOL - News) today announced that, based on the results of its recently completed bioequivalence study, the Company's NeoLipid® drug candidate LEP-ETU (Liposome Entrapped Paclitaxel "Easy to Use") has met the study criteria, established by FDA, for demonstrating bioequivalence. LEP-ETU is NeoPharm's easy-to-use liposomal formulation of paclitaxel (Taxol®), which is a widely-used and approved treatment for advanced cancers, including ovarian, breast, and lung cancer.
Based on this initial bioequivalence study, NeoPharm is accelerating the clinical program of LEP-ETU to support submission to FDA of a 505(b)(2) New Drug Application (NDA) for marketing approval.
The Company is currently preparing to submit an abstract in December of the bioequivalence study data to the American Society of Clinical Oncology (ASCO) for consideration for the program of the 2006 ASCO Annual Meeting in Atlanta, Georgia, June 2-6, 2006.
"We are pleased that our LEP-ETU drug candidate has demonstrated bioequivalence to Taxol," said Ronald G. Eidell, NeoPharm's President and Chief Executive Officer.
"According to written guidance provided by the FDA, after completion of a 100-patient comparator study, we may be able to file an NDA for LEP-ETU as early as the fourth quarter of 2007."
Under the 505(b)(2) pathway, and guidance from the FDA on LEP-ETU, in addition to the bioequivalence study, the Company will need to initiate a 100-patient comparator study in metastatic breast cancer.
The Company estimates the 100-patient comparator study, in which 50 patients would receive LEP-ETU and 50 patients would receive Taxol, will take approximately eight to ten months to enroll with a six-month treatment period.
The Company is finalizing preparations for such a study to expedite patient enrollment, and currently expects to commence enrollment in the first quarter of 2006.
The rationale for developing a liposomal formulation of paclitaxel is to attempt to improve the safety profile of paclitaxel by eliminating the drug formulation component polyoxyethylated castor oil (Cremophor® EL), which is associated with toxicities, while maintaining or enhancing efficacy.
In addition to the LEP-ETU comparator study, a Phase II study for another of the Company's NeoLipid drug candidates, LE-SN38 for colorectal cancer, is being planned with the Cancer and Leukemia Group B (CALGB), an NCI funded clinical study group, with protocol submission and acceptance to NCI CTEP and FDA, currently anticipated in the fourth quarter of this year.
About LEP-ETU
LEP-ETU is the Company's NeoLipid® liposomal formulation of the widely used cancer drug, paclitaxel. Paclitaxel has been approved in the U.S. as Taxol. 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® EL) and ethanol, which can lead to another set of debilitating side effects including hypersensitivity reactions. NeoLipid® technology eliminates the need for Cremophor. As a result, LEP-ETU may overcome many of the current limitations of Taxol treatment for cancer patients and may limit the adverse side effects.
About NeoPharm, Inc.
NeoPharm, Inc., based in Lake Forest, 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 and LE-SN38, future patient enrollment in the Company's LEP-ETU comparator study, or LE-SN38 clinical study, 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 and LE-SN38, 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 and LE-SN38 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 and LE-SN38, the uncertainty of patent protection for the Company's intellectual property or trade secrets, including, but not limited to, LEP-ETU and LE-SN38, 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.
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