AmBisome Demonstrates Superior Safety Profile Compared to Abelcet in Febrile Neutropenic Cancer Patients.

( BW)(CA-FUJISAWA-HEALTHCARE) AmBisome Demonstrates Superior Safety Profile Compared to Abelcet in Febrile Neutropenic Cancer Patients

Business Editors, Health and Medical Writers

SAN DIEGO, Calif.--(BW HealthWire)--March 23, 1999--Clinicians treating cancer patients now have direct comparative evidence to show that there is a significant difference in safety profile between two drugs they use to treat life-threatening fungal infections. The multi-center, randomized, double-blind clinical trial, designed to assess the safety of AmBisome(R) (co-marketed by Fujisawa Healthcare, Inc. and NeXstar Pharmaceuticals, Inc. (NASDAQ: NXTR)) and Abelcet(R) (produced by The Liposome Company), was conducted at 18 major cancer treatment centers in the United States, and involved 244 patients. The results were presented at the 9th annual "Focus on Fungal Infections" meeting in San Diego.

"This trial is important because it's the first time these agents have been compared in a prospective randomized double-blind fashion, which represents the highest standard for trial design," stated Dr. Ira Lawrence, vice president, Research and Development at Fujisawa Healthcare, Inc. "Although previous studies confirmed that both of these formulations were safer than amphotericin B, we did not know if there was any difference in safety between them. This trial demonstrated conclusively that compared to AmBisome, Abelcet exhibited more nephrotoxicity, more infusion related reactions, and required more premedications than AmBisome."

In the trial, neutropenic patients with unresolved fever after three days of antibacterial therapy were randomized (1:1:1) to receive either Abelcet 5 mg/kg/day (n=78), AmBisome 3 mg/kg/day (n=85), or AmBisome 5 mg/kg/day (n=81). There was no difference in efficacy or safety between the two AmBisome groups, and both were significantly less toxic than the Abelcet group. Treatment success (defined as the complete absence of protocol-specified failure criteria) was 40.0% in the AmBisome 3 mg/kg/day group, 42.0% in the AmBisome 5 mg/kg/day group, and 33.3% in the Abelcet 5 mg/kg/day group.

Patients who received AmBisome (3 mg/kg/day or 5 mg/kg/day) had a statistically significant reduction in side effects, including chills, hypertension, hypotension, tachycardia, increased creatinine, hypoxia, hyperventilation, and asthma than those who received Abelcet (5 mg/kg/day). These adverse events were 2.5 to 13 times more frequent for patients receiving Abelcet compared with those receiving AmBisome. However, patients who received 3 mg/kg/day of AmBisome experienced more confusion (13% vs 4%) than did patients receiving Abelcet. Although patients who received AmBisome observed significantly less nephrotoxicity (kidney impairment) than those patients who received Abelcet, dose limiting kidney toxicity may still be observed with AmBisome.

The investigators also discovered that there was a significant difference (p<=0.001) in drug tolerance in favor of AmBisome. "We noted that 32% of patients receiving Abelcet had to discontinue the drug prematurely due to toxicity, as compared to only 12% of the AmBisome patients," said Dr. Elias Anaissie, professor of medicine and chief, Section of Supportive Care and Oncology Emergencies, University of Arkansas Medical Sciences Center, Little Rock, AR. "The reason we need an alternative to conventional amphotericin B is because our patients are not able to tolerate it. Now that we know AmBisome is significantly less toxic than Abelcet, we can modify our treatment programs accordingly."

Commenting on the trial results, Noboru Maeda, chairman and chief executive officer of Fujisawa Healthcare, Inc. stated, "The results further differentiate AmBisome from other therapies for life-threatening fungal infections. We anticipate that with this new information, clinicians will be recommending more widespread usage of AmBisome in these clinical situations."

Fujisawa Healthcare, Inc., headquartered in Deerfield, IL, develops, manufactures and markets proprietary pharmaceutical products in the United States and abroad. Fujisawa Healthcare, Inc. is a subsidiary of Fujisawa Pharmaceutical Co., Ltd. based in Osaka, Japan. Fujisawa Pharmaceutical Co., Ltd., founded in 1894, is a leading pharmaceutical manufacturer and is actively developing its international operations in North America, Europe, and Asia. Additional information on Fujisawa Healthcare, Inc. and its products can be found on the Internet at http://www.fujisawa.com.

NeXstar Pharmaceuticals, Inc. is an integrated biopharmaceutical company engaged in the discovery, development, manufacture and commercialization of products to treat serious and life-threatening illnesses. The company currently markets two drugs in the United States and around the world, AmBisome and DaunoXome. Based in Boulder, CO, NeXstar Pharmaceuticals maintains additional research, development and manufacturing facilities in San Dimas, CA, and marketing subsidiaries worldwide. This month, Gilead Sciences, Inc. (NASDAQ: GILD) and NeXstar Pharmaceuticals announced a definitive agreement whereby Gilead will acquire NeXstar in an all-stock, tax-free pooling-of-interests transaction. The deal is expected to be completed later this year.

This press release contains forward-looking statements that involve risks and uncertainties, and actual events or results may differ materially. While these statements reflect NeXstar Pharmaceuticals' best current judgment, they are subject to risks and uncertainties that could cause actual results to vary from current projections. These risk factors are identified in NeXstar Pharmaceuticals' reports to the Securities and Exchange Commission filed on Forms 10-K and 10-Q, and in other SEC filings.

Note: This release can be obtained from: Fujisawa's website at: http://www.fujisawa.com or NeXstar's website at: http://www.nexstar.com