Amphotec


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Related to Amphotec: amphotericin B, Amphotericin B Lipid Complex

Amphotec®

Amphocil Infectious disease A proprietary antifungal formulation in which toxic amphotericin B is wrapped inside a liposome envelope. See Amphotericin B, Liposome.
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SEQUUS is developing AMPHOTEC for the treatment of life threatening systemic fungal infections such as aspergillosis, candidiasis and cryptococcal meningitis in patients who have failed other therapy or are intolerant to amphotericin B.
Excluding the charges related to oritavancin and PEG-Alfacon program milestones and Amphotec impairment in 2003, the non-GAAP net loss for the nine months ended September 30, 2003 was $56.
As previously reported, a retrospective review of data from open label clinical trials, presented at the 1996 Symposium on Infections in the Immunocompromised Host, showed an overall response rate to AMPHOTEC of 53 percent in 99 patients with well-documented fungal infections who received a minimum of seven days of treatment.
AMPHOTEC was approved for market clearance by the FDA on November 22, 1996 and is indicated for the treatment of invasive aspergillosis in patients where renal impairment or unacceptable toxicity precludes the use of conventional amphotericin B therapy in effective doses, and in patients where prior amphotericin B therapy has failed.
Since we believe we are the lowest cost producer and have the best product, we have embarked on a bold pricing policy that will enable physicians and pharmacists to move toward greater use of AMPHOTEC where they believe it will provide clinical benefit and value to their patients.
The analysis included 82 patients with proven or probable aspergillosis who were treated with AMPHOTEC in one of five open-label clinical trials and 261 patients with aspergillosis treated with amphotericin B at six cancer or transplant centers from January 1990 to June 1994.
The increase in cost of goods sold as a percentage of total revenue was primarily the result of a shift in the product mix towards a higher proportion of revenue from Infergen and an inventory write-off associated with the divestiture of Amphotec in 2005.
The results of this study confirm our belief that AMPHOTEC provides the best combination of clinical benefit and value.
The divestiture of Amphotec was part of a previously announced strategy by InterMune and will not affect the Company's 2005 total revenue guidance of $140-160 million.
9, 1996 at the 38th American Society of Hematology Annual Meeting from a single, double-blind, randomized multi-center clinical trial comparing AMPHOTEC with conventional amphotericin B in the empiric treatment of 213 febrile neutropenic patients.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited, in thousands, except per share amounts) Three Months Ended March 31, 2005 and 2004 2005 2004 Revenues Actimmune $27,705 $32,921 Infergen 7,751 3,998 Amphotec and other 642 1,209 Total revenues 36,098 38,128 Costs and expenses: Cost of goods sold 9,580 9,688 Amortization of product rights 1,376 777 Research and development 19,754 18,267 Selling, general and administrative 21,829 16,686 Total costs and expenses 52,539 45,418 Loss from operations (16,441) (7,290) Interest income 1,034 845 Interest expense (308) (2,258) Other expense 670 (3,008) Net loss $(15,045) $(11,711) Basic and diluted net loss per share $(0.