NEOPHARM (NEOL) Reports Q4 Earnings, Provides Update on Status of Product Candidates

March 13, 2007 4:35 PM EDT

NEOPHARM, Inc. (Nasdaq: NEOL) announced fourth-quarter 2006 financial results and updated the status of its drug product candidates. Additionally, the Company has decided to defer the previously scheduled March 14th conference call until early April, after a scheduled late March 2006 meeting with the FDA.

NEOL reported a Q3 loss of $0.28, 3 cents better than estimates.

In December 2006, the Company announced that the Phase 3 PRECISE Clinical trial of CINTREDEKIN BESUDOTOX in the treatment of glioblastoma multiforme did not meet the primary endpoint at 215 deaths, which was a statistically significant difference, or separation, in the overall survival curves versus the Gliadel Wafer®, or Gliadel.

Since the announcement of the PRECISE trial results, the Company and our Scientific Advisory Board have been working to develop a potential regulatory path forward based on the totality of the clinical data which we currently plan to review with the FDA in late March 2007. There can be no assurance, however, that the FDA will indicate, at that time or at any time, that there is a potential regulatory path for CINTREDEKIN BESUDOTOX' use as a treatment for glioblastoma multiforme, that there is a current unmet medical need for CINTREDEKIN BESUDOTOX, that the FDA would approve a Biologics License Application, or BLA, if one were eventually to be filed, or that the FDA will not require additional data or testing which would preclude advancement of CINTREDEKIN BESUDOTOX.

Additionally, the Company indicated that it expects an interim analysis of data from a LE-SN38 Phase 2 clinical trial in second-line metastatic colorectal cancer patients being conducted by the Colorectal and Leukemia Group B (CALGB) in the second quarter of 2007. LE-SN38 is a liposomal formulation of SN-38; the active metabolite of irinotecan, or Pfizer's Camptosar®, a chemotherapeutic pro-drug used in the treatment of first- and second-line colorectal cancer.

Finally, with respect to its liposomal paclitaxel product LEP-ETU, the Company noted that it is in ongoing discussion with the FDA on clinical and regulatory plans for LEP-ETU.

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