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CyDex, Inc. Announces First U.S. Approval of a Captisol-Enabled Medication

OVERLAND PARK, KS -- June 10, 2002 -- CyDex, Inc., an innovator in drug delivery technologies, today announced the first U.S. regulatory approval of a Captisol-Enabled™ drug -- the intravenous form of Vfend® (voriconazole), a new antifungal from Pfizer Inc. Captisol® 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 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 pharmacological effect.

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 http://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.


SOURCE: CyDex, Inc.

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