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

To: KM who wrote (856)	9/30/1999 11:01:00 AM
From: dalroi	Respond to of 900

this is the article FOR IMMEDIATE RELEASE Contact: The Liposome Company, Inc. Lawrence R. Hoffman Vice President, Finance & Chief Financial Officer (609) 452-7060 Douglas S. Farrell Director, Investor Relations (609) 951-4307 Liposome's Chairman Discusses Company's Future Direction PRINCETON, N.J., Sept. 30 /PRNewswire/ -- Charles A. Baker, Chairman and CEO of The Liposome Company made the following comments regarding the Company's future direction at the Warburg Dillon Read Life Sciences Conference in New York City yesterday afternoon. Baker said the Company was very disappointed by the Oncology Drug Advisory Committee's (ODAC) recommendation not to approve Evacet(TM) as a first line drug in the treatment of metastatic breast cancer in combination with cyclophosphamide. ``We strongly disagree with the Committee's decision,' stated Mr. Baker, ``in view of the fact that our clinical studies demonstrated that Evacet(TM) is significantly less cardiotoxic than doxorubicin. Furthermore, our combination study with Evacet(TM) and cyclophosphamide demonstrated both the efficacy of Evacet(TM) and significantly lower cardiotoxicity in the first line treatment of metastatic breast cancer which was the indication we sought.' During his presentation at the Conference, Mr. Baker made the following points: that while the setback with Evacet(TM) was disappointing, the Company has a very strong balance sheet, and has the ability to consider other product options as well as the continued development of Evacet(TM). Meanwhile, the Company will continue to focus on ways to increase shareholder value including seeking strategic alliances in the U.S. and overseas regarding the continued development of Evacet(TM) as well as merger and acquisition opportunities which may arise. The Company is committed to the continued development of Evacet(TM) in Europe and Canada. The Company has filed a marketing application with the European Medicines Evaluation Agency and the Committee for Proprietary Medicinal Products in Canada. The Company expects action on its applications in Europe and Canada in the second half of next year, Baker told the conference. The Company will pursue Evacet(TM) further with the FDA although, in the interim, it expects to receive a non-approvable letter from the FDA based on the results of the recent ODAC panel meeting. The Company has requested a meeting with the FDA to explore alternatives, and the possibilities could range from limited indications based on its existing data on the one hand, to additional studies on the other. The Company believes that Evacet(TM) is an important drug in the metastatic breast cancer setting, and that the drug will be of great value to doctors and patients. A decision on whether to pursue the approval of Evacet(TM) in the U.S. market will depend, however, on the results of the Company's discussions with the FDA. The Company will place great emphasis on identifying near term product opportunities from outside as well as to continue to develop products discovered internally. The Company intends to place greater emphasis on business development and licensing, and additional resources will be made available for this purpose. The Company's ABELCET© franchise continues to perform very well in North America and Europe. The Company will continue to aggressively support its North American sales force and its overseas marketing partners in the growth of this product. The Company expects to be profitable operationally and cash flow positive for the remainder of 1999. At the end of the second quarter of 1999, the Company had $61.8 in cash and marketable securities. The Liposome Company (Nasdaq: LIPO - news) is a biopharmaceutical company developing, manufacturing and marketing therapeutic products to treat cancer and related diseases. Abelcet© is marketed in the U.S. and 23 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 the United States. 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), TLC ELL-12 or any other product in the research pipeline can demonstrate safety and efficacy in clinical trials, receive regulatory approval in the U.S. or abroad, or be successfully developed, manufactured and marketed. The Company has incurred losses in each year since its inception and there can be no assurance of profitability in any future period. 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 Company's 1998 10-K filing and from time to time in the Company's other filings with the Securities and Exchange Commission.