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Biotech / Medical : LIPO-Liposome -- Ignore unavailable to you. Want to Upgrade?

To: Gary Mohilner who wrote (611)	5/14/1998 2:48:00 PM
From: Marc Bertoglio	Read Replies (2) \| Respond to of 900

EVACET ON TRACK FOR MID-YEAR FILING - INTERIM DATA APPEARS ROBUST: Currently underway are two Phase 3 studies - one comparing Evacet with conventional doxorubicin and the other comparing D-99 in combination with cyclophosphamide versus conventional doxorubicin with cyclophosphamide. Liposome has conducted a halfway point data analysis (as allowed in trial protocol) and initial results appear encouraging. Three abstracts have been accepted for presentation at the upcoming American Society of Clinical Oncology (ASCO) meeting. Study data comparing Evacet to doxorubicin (the subject of an oral presentation at ASCO on 5/19) demonstrated comparable response rates (33% for Evacet and 29% for doxorubicin) and statistically significant reduction in cardiotoxicity (16% for Evacet versus 25% for doxorubicin). However, the 16% rate of cardiotoxicity for patients treated with Evacet seems quite high. In addition, the data showed statistically significant reduction in other side effects (vomiting,nausea, and mucositis). Management believes that the interim data will be sufficient for an NDA filing (vs. submission of completed trial data) and will seek priority review, which could reduce review time to six months from twelve months. After the NDA filing, supplemental data to the NDA will be submitted to the FDA upon completion of both studies, if necessary. Evacet represents a large market opportunity for Liposome, given that the worldwide sales of conventional doxorubicin are currently $300-$500M. have fun