Silicon Investor (SI) -- The First Internet Community

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

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

To: Laurens who wrote (653)	2/18/1999 7:36:00 AM
From: sylvan	Read Replies (1) \| Respond to of 900

NDA Filing for EVACET(TM) Accepted by FDA PRINCETON, N.J., Feb. 18 /PRNewswire/ -- The Liposome Company (Nasdaq: LIPO - news) today announced that the FDA has accepted its New Drug Application (NDA) for EVACET(TM). ''This is an important first step in the review process,'' stated Tony Boyle, Senior VP of Medical and Regulatory Affairs. ''We are pleased that our NDA filing for Evacet has been accepted. We look forward to interacting with the FDA during the review process and to the FDA's decision later this year.'' EVACET(TM) is a proprietary liposomal formulation of the anticancer drug, doxorubicin. It has been shown to have antitumor activity equivalent to that of doxorubicin with reduced potential for cardiotoxicty. Doxorubicin's ability to cause cumulative, permanent heart damage continues to limit its utility. Data from three Phase III clinical trials of EVACET(TM) used as a first-line therapy for metastatic breast cancer, both alone and in combination with cyclophosphamide, show a statistically significant reduction in cardiotoxicity as compared with doxorubicin alone and in combination with cyclophosphamide. The Liposome Company is a biopharmaceutical company developing, manufacturing and marketing therapeutic products to treat cancer and related diseases. ABELCET® is marketed in the U.S. and 22 other countries for the treatment of severe, systemic fungal infections in patients who are refractory to or intolerant of conventional therapy and is the leading lipid-based formulation of amphotericin B in this country. The Company's product pipeline includes EVACET(TM), TLC ELL-12 and bromotaxol for the treatment of various cancers and programs focused on the development of new cancer therapies and vehicles for the delivery of gene therapy. Except for historical information, this press release contains forward-looking statements that involve risks and uncertainties, including but not limited to statements regarding future sales growth prospects for ABELCET®, the ability of ABELCET® to maintain its position as the leading lipid-based formulation of amphotericin B in the U.S., the likelihood that EVACET(TM) or any other product in the research pipeline can receive regulatory approval in the U.S. or abroad or be successfully developed, manufactured and marketed and the uncertainty of future profitability. While these statements reflect the Company's best current judgment, they are subject to risks and uncertainties that could cause actual results to vary, including the risk factors identified in the Registration Statement on Form S-3 dated October 29, 1997 and from time to time in the Company's other SEC filings.