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.
