OVERLAND PARK, Kan., June 10 /PRNewswire/ -- CyDex, Inc., an innovator in
drug delivery technologies, today announced the first U.S. regulatory approval
of a CAPTISOL-Enabled(TM) drug -- the intravenous form of Vfend(R)
(voriconazole), a new antifungal from Pfizer Inc. CAPTISOL(R) is an advanced
formulation system that improves the solubility, stability and bioavailability
of drug compounds.
"Receiving the first FDA approval for a drug using CAPTISOL(R) is a major
milestone for CyDex and a demonstration of the value of our technologies,"
said Peter Higuchi, President and CEO of CyDex. "Pfizer is a wonderful
partner, and we congratulate our colleagues on bringing Vfend to market as an
innovative new therapy for patients with life-threatening fungal infections."
Pfizer received clearance from the U.S. Food and Drug Administration for
oral and intravenous use of Vfend in the primary treatment of acute invasive
aspergillosis and salvage therapy for rare but serious fungal infections
caused by the pathogens Scedosporium apiospermum and Fusarium spp. The
intravenous Vfend formulation combines the active ingredient voriconazole with
CAPTISOL, a proprietary CyDex molecule designed to improve the solubility of
active drug ingredients.
Pfizer licensed CAPTISOL from CyDex in 1993 for use in formulations of
antifungals and other potential new drugs. Vfend was also recently approved
in Europe, and a second CAPTISOL-Enabled compound developed by Pfizer also is
progressing through registration.
CAPTISOL enables the safe, effective delivery of medications by improving
the solubility, stability and bioavailability of drug compounds. CAPTISOL is
a donut-shaped molecule that complexes water insoluble active drugs in its
central cavity. When given by injection, a CAPTISOL-Enabled formulation helps
carry a drug into the patient's bloodstream, where CAPTISOL and the drug
disassociate, allowing the active ingredient to produce its desired
CyDex, Inc., provides innovative drug delivery solutions to pharmaceutical
and biotechnology companies and also is commercializing its own pipeline of
proprietary drug candidates. Besides Pfizer, CyDex has collaborations with
Allergan, Inc.; Bristol-Myers Squibb; Daiichi Pharmaceutical Co., Ltd., of
Japan; Genentech Inc.; OSI Pharmaceuticals, Inc; PTC Pharma AG, of
Switzerland; and Suntory Ltd., of Japan. The CAPTISOL drug delivery
technology arises from sulfobutylether beta-cyclodextrins originally
synthesized and patented by scientists at the University of Kansas Higuchi
Biosciences Center for Drug Delivery Research. CyDex is a privately owned
company in suburban Kansas City. Learn more at www.cydexinc.com .
CAPTISOL is a registered trademark and CAPTISOL-Enabled has been filed as
a trademark of CyDex, Inc.
VFEND is a registered trademark of Pfizer Inc.
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SOURCE CyDex, Inc.