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LGND > SEC Filings for LGND > Form 8-K on 14-Aug-2013All Recent SEC Filings




Entry into a Material Definitive Agreement

Item 1.01 Entry into a Material Definitive Agreement.

On August 13, 2013, our wholly-owned subsidiary CyDex Pharmaceuticals, Inc. entered into a License Agreement with privately-held CURx Pharmaceuticals, Inc. granting CURx an exclusive worldwide license for the development and commercialization of our Captisol-enabled™ Topiramate Injection for the treatment of partial onset or primary generalized tonic-clonic seizures in hospitalized epilepsy patients who are unable to take oral topiramate. Under the terms of the License Agreement, we will be eligible to receive more than $21 million in potential net milestone payments and a tiered net royalty of 6% to 7.5% on future net sales. And, we could receive revenue from the shipment of Captisol® to CURx for clinical and commercial activities.

The Captisol-enabled formulation of Topiramate Injection was initially developed at, and is exclusively licensed by CyDex from, the University of Minnesota. Topiramate is sold by Janssen Pharmaceuticals, Inc. under the trade name Topamax® and is currently only available in oral formulations. The Captisol-enabled Topiramate Injection formulation is designed to provide an intravenous or intramuscular option for hospitalized epilepsy patients unable to use oral topiramate.

A successful Phase 1 clinical trial of Captisol-enabled Topiramate Injection has already been completed, and CURx has advised us that it intends to commence a Phase II clinical trial during 2014.

In July 2013, the U.S. Food and Drug Administration granted orphan-drug designation to Captisol-enabled Topiramate Injection.

Captisol® is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs.

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