GlaxoSmithKline (GSK) and XenoPort, Inc. (Nasdaq: XNPT) today announced an exclusive agreement to co-develop and commercialise XP13512, a unique prodrug of gabapentin that improves its bioavailability, in the US and other countries worldwide, excluding certain Asian countries. XP13512 is currently in Phase III development for Restless Legs Syndrome (RLS) and in Phase II development for neuropathic pain. Prior clinical trial results have been encouraging.
XP13512 is a patented, new chemical entity that is designed to improve upon the clinical utility of gabapentin by taking advantage of high-capacity transport mechanisms in the gut to improve absorption.
Under the terms of the agreement, XenoPort is entitled to receive an up-front cash payment of ВЈ40 million. XenoPort is also eligible to receive aggregate milestone payments of up to ВЈ34 million for development activities leading up to the NDA filing for RLS, up to ВЈ111million in other potential development and regulatory milestone payments and up to ВЈ153million in potential sales milestone payments based on successful commercialization of XP13512 for RLS and neuropathic pain. In addition to royalties on sales outside the US, XenoPort is entitled to receive tiered, double-digit royalty payments on US sales of XP13512 unless XenoPort elects to co-promote XP13512 with GSK in the US, in which case it will be entitled to participate in a net profit share for XP13512 in the US. If XenoPort decides to co-promote XP13512 in the US, it is also entitled to detail REQUIP products currently in development by GSK, provided they are approved in the US. GSK will have an exclusive right to develop, manufacture and commercialise XP13512 in the US and all countries worldwide except certain Asian countries previously licensed by XenoPort to Astellas Pharma Inc.
In the US, XenoPort will complete the ongoing studies to support RLS development. Subject to positive Phase III clinical data, GSK will file the NDA for RLS for FDA approval. GSK will lead development and registration of XP13512 for all other indications, including neuropathic pain. GSK will also be solely responsible for the manufacture of XP13512 to support its development and commercialization within the licensed territories.
The agreement is subject to review by the US Government under the Hart-Scott-Rodino Act and will become effective after clearing review.
Moncef Slaoui, chairman of R&D, GSK, commented, "This is another important late-stage programme addition to GSK's R&D pipeline. We are pleased to work with XenoPort toward bringing a new treatment alternative for the management of these two important disease areas of RLS and neuropathic pain where there is still such a large unmet need."
Ronald W. Barrett, Ph.D., XenoPort's chief executive officer, stated, "GSK has demonstrated leadership and innovation in educating doctors and patients about the debilitating aspects of RLS and has helped improve the lives of many patients with RLS. We are excited to be collaborating with GSK to advance the development and commercialization of XP13512 and, most importantly, to be creating a new treatment for patients with RLS and neuropathic pain."
Conference Call
XenoPort will host a conference call at 11:00 a.m. Eastern Time today to discuss its agreement with GSK. To access the conference http://www.XenoPort.com
About GlaxoSmithKline
GlaxoSmithKline is one of the world's leading research-based pharmaceutical and healthcare companies and is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For more information, visit GlaxoSmithKline on the World Wide Web at http://www.gsk.com.
About XenoPort
XenoPort, Inc. is a biopharmaceutical company focused on developing a portfolio of internally discovered product candidates that utilize the body's natural nutrient transport mechanisms to improve the therapeutic benefits of existing drugs. XenoPort's most advanced product candidate, XP13512, is the subject of this announced alliance with GSK. XenoPort also has a second product candidate, XP19986. Positive Phase IIa results have been reported in patients with Gastroesophageal Reflux Disease (GERD) with XP19986.
XenoPort Forward-Looking Statements
This press release contains "forward-looking" statements, including, without limitation, all statements related to our future clinical development program for XP13512 and the timing thereof; the therapeutic and commercial potential of XP13512; future clinical development plans; potential future development and regulatory milestone payments, sales milestone payments, royalty payments and net profit share; and our future clinical trials. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "will," "intends," "potential," "targeted" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon XenoPort's current expectations. Forward-looking statements involve risks and uncertainties. XenoPort's actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, the ability of the company to successfully conduct the clinical trials for XP13512 and the results thereof; the uncertainty of the FDA approval process and other regulatory requirements; the therapeutic and commercial value of XP13512; and our dependence on GSK for aspects of the development, regulatory approval, manufacturing and commercialization of XP13512. These and other risk factors are discussed under the heading "Risk Factors" in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2006, filed with the Securities and Exchange Commission on November 3, 2006. XenoPort expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the company's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.
GlaxoSmithKline Forward-Looking Statements
Under the safe harbor provisions of the US Private Securities Litigation Reform Act of 1995, the company cautions investors that any forward-looking statements or projections made by the company, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect the Group's operations are described under 'Risk Factors' in the Operating and Financial Review and Prospects in the company's Annual Report on Form 20-F for 2005.
XenoPort is a registered US trademark.
GlaxoSmithKline
http://www.gsk.com
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