Ligand Inks Global Licensing Pact with CURx Pharmaceuticals for Captisol-Enabled Topiramate Injection
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Ligand Pharmaceuticals Inc. said that it has entered a global license agreement with CURx Pharmaceuticals, Inc. for the development and commercialization of its 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 agreement, Ligand will be eligible to receive more than $21 million in potential net milestone payments and net royalties on future sales of 6.0 percent to 7.5 percent, the Company noted in a release.
"This is another great deal for Ligand and our Captisol technology, pairing our proven formulation agent with an approved medicine to create a potentially novel, important and highly differentiated drug," said John Higgins, President and Chief Executive Officer of Ligand. "We are very pleased to be entering this agreement. CURx is highly motivated to advance development with current plans calling for a Phase II trial to commence in 2014. This deal represents our latest addition to our growing pipeline of partnerships and another potentially lucrative shot-on-goal."
Dinu Sen, Chief Executive Officer and founder of CURx, said of this transaction, "We are delighted to sign a licensing agreement with Ligand and plan to bring Captisol-enabled Topiramate Injection to our patients as soon as possible. In Phase I trials in healthy volunteers and patients at the University of Minnesota, the product demonstrated a faster onset of action than the orally administered drug. Our market research indicates there to be a tremendous need for a product with these characteristics."
As described by the Company: The Captisol-enabled formulation of Topiramate Injection was designed for the treatment of partial onset or primary generalized tonic-clonic seizures in hospitalized epilepsy patients who are unable to take oral topiramate. The formulation was initially developed at, and is exclusively licensed 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. Captisol-enabled Topiramate Injection has been studied in Phase I clinical trials. In July 2013, the U.S. Food and Drug Administration (FDA) 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. Captisol was invented and initially developed by scientists in the laboratories of Dr. Valentino Stella at the University of Kansas' Higuchi Biosciences Center for specific use in drug development and formulation. This technology has enabled six FDA-approved products, including Onyx Pharmaceuticals' Kyprolis, Baxter International's Nexterone and Pfizer's Vfend IV. There are currently more than 30 Captisol-enabled products in development, including Lundbeck's carbamazepine IV, Spectrum Pharmaceuticals' Captisol-enabled Melphalan and Rib-X's delafloxacin IV program.