To: Teri Garner who wrote (28469 ) 3/19/1999 9:30:00 AM From: Chuck Respond to of 120523
Note: Negative efficacy study RE: Todays WL #10 The Liposome Company Reports Comparative Safety and Efficacy Data On Abelcet(R) PR Newswire, Friday, March 19, 1999 at 07:17 - Study Establishes ABELCET(R)'s Superior Efficacy Versus AmBisome(R) - SAN DIEGO, March 19 /PRNewswire/ -- The Liposome Company, Inc. (NASDAQ:LIPO) today announced that comparative head-to-head data on ABELCET(R) versus a competitive liposomal amphotericin B product, AmBisome(R) (NASDAQ:NXTR), was presented at the 9th Annual Focus on Fungal Infections meeting. The study, conducted by The University of Texas, M.D. Anderson Cancer Center in Houston in patients with leukemia who had diagnosed or suspected fungal infections, found ABELCET(R) to be statistically more effective than AmBisome(R). The study also documented a lower incidence of hepatic toxicity for ABELCET(R). "We believe this study has demonstrated that one of the lipid-associated formulations of amphotericin B is more effective than another," commented Dr. J. A. Boyle, Senior Vice President, Medical and Regulatory Affairs for The Liposome Company. "In this population of patients where the risk of dying from invasive fungal infections can be very high, the issue of efficacy is of primary importance. We are pleased that the research was done at one of the world's leading cancer centers, without any financial support from The Liposome Company." The prospective, open-label, randomized study compared the two lipid based formulations of amphotericin B in the treatment of leukemia patients with either suspected or confirmed fungal infections. The 75 patients developed 82 febrile episodes that were unresponsive to antibacterial therapy and were prospectively randomized to receive either ABELCET(R) (n=43) or AmBisome(R) (n=39). Both drugs were dosed as follows: 3 mg/kg/day for fever of unknown origin (FUO), 4-5 mg/kg/day for pneumonia of unknown pathogen (PUP), and 5 mg/kg/day for definite fungal infections (DFI). On an intent-to-treat basis, the overall response to therapy was 27/43 (63%) for ABELCET(R) and 15/39 (39%) for AmBisome(R) (p=0.03). Response rates for subcategories of infection were FUO (100% vs. 75%), PUP (80% vs. 56%), DFI (30% vs. 29%), ABELCET(R) vs. AmBisome(R), respectively. The response to therapy was higher for ABELCET(R) despite the fact that AmBisome(R) treated patients received higher median daily doses (4 mg/kg/day for AmBisome(R) vs. 3 mg/kg/day for ABELCET(R)) and were treated with longer courses of therapy (15 day median course for AmBisome(R) vs. a 10 day median course for ABELCET(R)). Patients randomized to receive ABELCET(R) were more likely to be neutropenic at baseline (93% vs. 79%, p=0.07) and therefore at greater risk of having a poor outcome. Although AmBisome(R) treated patients had a lower incidence of acute infusion-related toxicities (70% vs. 36%, p=NS), severe infusion-related toxicities requiring discontinuation of therapy occurred in only 3 patients (1 ABELCET(R) and 2 AmBisome(R)). The overall median increase in serum creatinine was 37.5% for ABELCET(R) and 24.3% for AmBisome(R) (p=NS). A persistent increase in serum bilirubin of >1.5 times baseline was 38% for ABELCET(R) treated patients vs. 59% for AmBisomea treated patients (p=0.05). ABELCET(R) (Amphotericin B Lipid Complex Injection), is marketed in the United States for the treatment of severe, systemic fungal infections in patients who are refractory to or intolerant of conventional therapy. In general, the adverse events most commonly reported with ABELCET(R) are transient chills and/or fever during infusion of the drug. ABELCET(R) is contraindicated in patients who have shown hypersensitivity to amphotericin B or any other component in the formulation. The Liposome Company is a biopharmaceutical company developing, manufacturing and marketing therapeutic products to treat cancer and related diseases. ABELCET(R) (Amphotericin B Lipid Complex Injection), is marketed in the United States 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. In December 1998, the Company filed a New Drug Application with the U.S. FDA for the Company's second drug, EVACET(TM) (formerly TLC D-99), liposomal doxorubicin, to treat metastatic breast cancer. TLC ELL-12 has entered Phase I clinical trials for the treatment of various cancers. The Company's product pipeline includes bromotaxol 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(R), the ability of ABELCET(R) 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 receive regulatory approval in the U.S. or abroad or be successfully developed, manufactured and marketed. 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. This press release is also available at LIPO.COM(R)