XenoPort Inc. and Astellas Pharma Inc. have entered into a license agreement for exclusive rights in Japan and several other Asian countries to develop and commercialise XP13512, XenoPort's lead product candidate.
According to a company release, XP13512 is a transported prodrug of gabapentin. XP13512 is a new chemical entity that is designed by XenoPort to improve the pharmacokinetics and therapeutic benefits of gabapentin.
Clinical trials conducted by XenoPort have demonstrated that, compared to oral gabapentin, oral XP13512 produced higher levels of gabapentin in the blood for a longer period of time. XP13512 has been shown in a phase 2a clinical trial to be effective for the management of neuropathic pain in patients with post-herpetic neuralgia. In addition, two separate phase 2 clinical trials have demonstrated the effectiveness of XP13512 in the treatment of symptoms in restless legs syndrome, or RLS, patients.
"We are delighted to enter into partnership with XenoPort on XP13512. XP13512 is an important addition to Astellas' pipeline to increase our presence in the Japan and Asia markets. XP13512, with its unique properties, has shown significant efficacy as well as safety in the clinical trials conducted by XenoPort. Developing and commercialising XP13512 in Japan and Asia will deepen our commitment to contribute to the treatment of diabetes and CNS disease, the existing business franchise of Astellas," said Toichi Takenaka, president and CEO of Astellas
Ronald W. Barrett, XenoPort's chief executive officer, stated, "We believe that Astellas is an ideal partner for XP13512 in the Japan and Asia markets. As a result of the development experience and commercial capabilities of Astellas, we believe this partnership will accelerate the availability of an important therapy to patients and enhance the commercialisation of XP13512 in Japan and Asia. We value the clear commitment that Astellas has made to develop XP13512 for neuropathic pain, among other indications. 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. We remain focused on maximising the value of this and other product candidates in our clinical development pipeline."
Under the terms of the agreement, Astellas has obtained exclusive rights to develop and commercialise XP13512 in Japan, Korea, the Philippines, Indonesia, Thailand and Taiwan. Astellas plans to initiate phase 1 clinical trials in the middle of the next year. XenoPort will receive an initial license payment of $25 million. In addition, XenoPort is eligible to receive clinical and regulatory milestone payments totalling 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 RLS 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, adds the release.
XenoPort Inc. is a biopharmaceutical company focused on developing a portfolio of internally discovered product candidates that utilise the body's natural nutrient transport mechanisms to improve the therapeutic benefits of existing drugs.