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May 15, 2014
08:06 EDTXNPTReckitt Benckiser Pharm and XenoPort enter global licensing agreement
Reckitt Benckiser Pharmaceuticals and XenoPort announced that they have entered into a license agreement pursuant to which Reckitt Benckiser Pharmaceuticals will be granted exclusive worldwide rights for the development and commercialization of XenoPort's clinical-stage oral product candidate arbaclofen placarbil for all indications. Arbaclofen placarbil is a patent protected new chemical entity that Reckitt Benckiser Pharmaceuticals plans to advance into a Phase IIB proof-of-concept study for the treatment of alcohol use disorders. Under the terms of the agreement, Reckitt Benckiser Pharmaceuticals will receive exclusive rights to develop and commercialize arbaclofen placarbil worldwide for all indications, subject to certain rights by XenoPort to negotiate with Reckitt Benckiser Pharmaceuticals on collaborations for non-addiction indications. In exchange for these rights and upon effectiveness of the agreement, XenoPort is entitled to receive an up-front, non-refundable cash payment of $20M and another $5M upon the transfer of certain technology and materials to Reckitt Benckiser Pharmaceuticals. XenoPort also will be eligible to receive aggregate cash payments of up to $70M upon the achievement by Reckitt Benckiser Pharmaceuticals of certain development and regulatory milestones, as well as up to $50M for commercial milestones. In addition, XenoPort is entitled to receive tiered double-digit royalty payments up to the mid-teens on a percentage basis on potential future net sales of arbaclofen placarbil in the United States and high single-digit royalty payments on potential future net sales outside the United States. The agreement is subject to review by the U.S. Government under the Hart-Scott-Rodino Antitrust Improvements Act, as amended, and will become effective only after clearing review.
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September 9, 2014
08:40 EDTXNPTXenoPort, NIAAA to conduct clincial trial of Horizant ER tablets
XenoPort and the National Institute on Alcohol Abuse and Alcoholism have entered into an agreement to conduct a clinical trial of HORIZANT Extended-Release Tablets as a potential treatment for alcohol use disorder. Under the terms of the agreement, XenoPort will supply clinical trial material and the NIAAA will conduct and pay all other expenses associated with the proposed clinical trial of HORIZANT. XenoPort will have access to study results generated under the proposed clinical trial to support potential regulatory filings for HORIZANT. The study is planned to be a randomized, double-blind, placebo-controlled clinical trial of the safety and efficacy of HORIZANT in patients who have AUD but are abstinent at treatment initiation. The study is expected to have a treatment period of six months and to enroll approximately 350 patients beginning in the first half of 2015. XenoPort and the NIAAA are planning to meet with the U.S. Food and Drug Administration Division of Anesthesia, Analgesia and Addiction Products in the fourth quarter of 2014 to discuss the trial design and the possibility of utilizing the results of this trial as the basis for a potential supplemental new drug application submission for HORIZANT for the maintenance of abstinence from heavy drinking of alcohol in patients with AUD.

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