XenoPort, Astellas enter license agreement for XP13512 in Asia

By Angela McDaniels

Seattle, Nov. 30 - XenoPort Inc. and Astellas Pharma Inc. said they have entered into a license agreement for XP13512, XenoPort's lead product candidate.

Under the terms of the agreement, Astellas has obtained exclusive rights to develop and commercialize XP13512 in Japan, Korea, the Philippines, Indonesia, Thailand and Taiwan. Astellas said it plans to initiate phase 1 clinical trials in the middle of next year.

XenoPort will receive an initial license payment of $25 million and is eligible to receive clinical and regulatory milestone payments totaling up to $60 million, including milestone payments of $10 million at the initiation and $5 million at the subsequent completion of XenoPort's first phase 3 clinical trial of XP13512 in restless leg syndrome patients in the United States.

XenoPort will receive royalties on any sales of XP13512 in the Astellas territory at a royalty rate in the mid-teens on a percentage basis.

"With the strength of our clinical data and the additional financial resources provided through this licensing agreement, we are carefully reviewing our strategic and partnering options for XP13512 in the rest of the world," Ronald W. Barrett, XenoPort chief executive officer, said in a company news release.

"We remain focused on maximizing the value of this and other product candidates in our clinical development pipeline."

XP13512, a Transported Prodrug of gabapentin, XP13512 is a new chemical entity designed by XenoPort to improve the pharmacokinetics and therapeutic benefits of gabapentin.

Clinical trials have demonstrated that, compared to oral gabapentin, oral XP13512 produced higher levels of gabapentin in the blood for a longer period of time, the companies said.

XP13512 has been shown in phase 2 clinical trials to be effective for the management of neuropathic pain in patients with post-herpetic neuralgia and symptoms in restless legs syndrome patients, the companies said.

Astellas is a pharmaceutical company based in Tokyo.

Based in Santa Clara, Calif., XenoPort is a biopharmaceutical company that develops product candidates that utilize the body's natural nutrient transport mechanisms to improve the therapeutic benefits of existing drugs.

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