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SEQUUS Pharmaceuticals receives U.S. FDA market clearance for AMPHOTEC.

MENLO PARK, Calif.--(BUSINESS WIRE)--Nov. 25, 1996--SEQUUS Pharmaceuticals Inc. (NASDAQ:SEQU) today announced the receipt of U.S. Food and Drug Administration (FDA) market clearance for AMPHOTEC(TM) (amphotericin B cholesteryl sulfate complex for injection.)

This is the second SEQUUS-developed drug to be cleared for marketing in the United States in less than a year.

AMPHOTEC is indicated for the treatment invasive aspergillosis in patients where renal impairment or unacceptable toxicity precludes the use of conventional amphotericin B deoxycholate ("amphotericin B") therapy in effective doses and in patients where prior amphotericin B deoxycholate therapy has failed. It is estimated that conventional amphotericin B currently accounts for approximately 1.1 million patient days of use in the United States annually.

AMPHOTEC is a lipid-based formulation of amphotericin B, a broad-spectrum antifungal antibiotic which is widely considered to be the "gold standard" for treating progressive and potentially fatal systemic fungal infections.

The incidence of these infections, which typically occur in patients with compromised immune systems, is increasing with the more aggressive use of chemotherapy for cancer and immune-suppressive drugs for organ and bone marrow transplants as well as the growing number of AIDS patients.

Despite its therapeutic effectiveness, the use of conventional (non-lipid) amphotericin B is limited by its acute and chronic toxicities, particularly dose-limiting toxicity to the kidneys. AMPHOTEC is designed to enhance systemic antifungal therapy by reducing the dose-limiting toxicities associated with amphotericin B while maintaining its efficacy. The most common side effects associated with AMPHOTEC are fever and chills upon infusion.

"With the launch of AMPHOTEC, SEQUUS joins a select group of biopharmaceutical companies that have successfully developed two drugs for the critical U.S. market," said Dr. I. Craig Henderson, Chairman and Chief Executive Officer. "This marks a major milestone in the growth of SEQUUS and is a tribute to the dedication and excellence of our employees and colleagues in the medical community."

SEQUUS will market AMPHOTEC directly through its 45-person sales force. The product will be shipped to wholesalers and will be available to physicians before the end of the year. AMPHOTEC is supplied as a lyophilized powder in 50mg and 100mg vials. The drug is stable at room temperature (59-86 degrees F) for two years.

AMPHOTEC(TM) is marketed as AMPHOCIL(TM) in 17 countries outside of the U.S. In the literature, AMPHOTEC is frequently referred to as amphotericin B colloidal dispersion, or ABCD.

Information about AMPHOTEC, including full prescribing information, is available to health care professional by calling the SEQUUS Professional Services Group at 1-800-323-9049.

Established in 1981 and headquartered in Menlo Park, (with offices in London, England), SEQUUS is developing proprietary biopharmaceutical products to treat cancer and infectious disease.

CONTACT: SEQUUS Pharmaceuticals Inc., Menlo Park

I. Craig Henderson, M.D., Chairman and CEO

Scott Minick, President and COO

Donald J. Stewart, VP, Finance & Treasurer



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Publication:Business Wire
Date:Nov 25, 1996
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