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CyDex Pharmaceuticals Receives a Key U.S. Patent for Composition of Matter and Process of Manufacturing High-Purity Captisol


Tuesday, January 05, 2010

Patent Extends Protection of Captisol Technology Until 2029

Lenexa, KS -- CyDex Pharmaceuticals Inc., a specialty pharmaceutical company, today announced that the U.S. Patent and Trademark Office (USPTO) has issued a patent to CyDex entitled "Sulfoalkyl Ether Cyclodextrin Compositions." This patent, along with other previously issued technology patents, will provide broad protection for CyDex’s Captisol® technology until 2029. The most recent of these previously issued patents – for a new Captisol that flows better, dissolves faster, and packs more densely than previous morphologies – was announced on December 9, 2009.

The patent announced today (U.S. Patent No. 7,635,773) covers a manufacturing process for producing ultra high-purity modified cyclodextrins, and specifically the beta cyclodextrin sulfobutyl ether sodium salt product known as Captisol. Captisol is CyDex’s proven enabling drug delivery technology that aids in the solubilization, stabilization and taste masking of active pharmaceutical ingredients.

"Receiving this new patent is an important achievement as we continue to license Captisol technology and develop our own products that target unmet needs in hospital intravenous therapy," said Dr. Theron Odlaug, President and Chief Executive Officer of CyDex Pharmaceuticals. "High-purity Captisol removes many impurities and degradants so that the composition can be used to increase the stability of highly sensitive active pharmaceutical ingredients. Together with the morphology patent we received earlier this month, this patent ultimately provides broader protection for our clients using Captisol and provides them with critical life-cycle management for their products."

Captisol is manufactured using a validated, patent-protected process and conforms to USP <1078> on Good Manufacturing Practices for Bulk Pharmaceutical Excipients.

About CyDex Pharmaceuticals, Inc.

CyDex Pharmaceuticals, Inc. is a specialty pharmaceutical company developing products and licensing its Captisol® technology. Captisol is currently incorporated in five FDA approved medications and marketed by three of the company’s licensees: Pfizer, Bristol-Myers Squibb and Prism Pharmaceuticals. In addition, the company is supporting drug development efforts with more than 40 other companies worldwide. The company maintains patents in the U.S. and worldwide for its Captisol technology and Captisol enabled products, and comprehensive FDA Manufacturing and Safety Drug Master Files. For additional information on business development opportunities, please contact Richard White at rwhite@cydexpharma.com or 913.685.8850. CyDex is a privately held company located in suburban Kansas City. To learn more about the company, please visit www.cydexpharma.com.



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