xenoport inc (XNPT) Key Developments
XenoPort, Inc. Announces Management Changes
Oct 1 15
XenoPort, Inc. announced a strategic shift to focus on and maximize the value of its commercial product, HORIZANT (gabapentin enacarbil) Extended Release Tablets. As part of this shift, XenoPort will discontinue development of XP23829 on its own and seek to partner this and other high potential development stage assets. In connection with the decision to focus on commercializing HORIZANT, Ronald W. Barrett, Ph.D., has retired as Chief Executive Officer and as a Director of XenoPort, effective immediately. Vincent J. Angotti, Executive Vice President and Chief Operating Officer, who has spearheaded the commercialization of HORIZANT, has been named Chief Executive Officer and has joined XenoPort’s Board of Directors. Dr. Barrett will continue to work with XenoPort in an advisory role, with a primary focus on ensuring a smooth transition and advising on potential partnering activities for the company’s development stage assets, including XP23829. Prior to joining XenoPort in May 2008, Mr. Angotti held several positions with Reliant Pharmaceuticals, Inc., the most recent of which was Senior Vice President of Sales and Marketing. Prior to Reliant, Mr. Angotti held several positions at Novartis Pharmaceuticals Corporation, most recently as Executive Director, Field Operations. XenoPort also announced that John G. Freund, M.D., has been named Chairman of XenoPort’s Board of Directors. Dr. Freund has been a member of XenoPort’s Board since 1999 and has served as its Lead Independent Director since July 2008.
Xenoport, Inc. - Special Call
Sep 15 15
To discuss the preliminary top-line XP23829 Phase 2 clinical trial results
XenoPort, Inc. Announces Positive Phase 2 Study Results for XP23829 as a Potential Treatment for Patients with Psoriasis
Sep 15 15
XenoPort, Inc. announced positive preliminary top-line results from its Phase 2 clinical trial of XP23829 as a potential treatment for moderate-to-severe chronic plaque-type psoriasis. XP23829 met its primary endpoint in both 800 mg once daily and 400 mg twice daily doses, demonstrating statistically significant improvements in percent change from baseline to week 12 in Psoriasis Area and Severity Index (PASI) score. XP23829 is a patented prodrug of monomethyl fumarate (MMF) in a novel oral formulation that was designed to potentially offer physicians and patients an effective, better tolerated and easier to use therapeutic option to currently available fumarate products. Description of the Trial: This randomized, double-blind, placebo-controlled Phase 2 clinical trial of XP23829 was conducted in 33 sites in the United States in subjects with moderate-to-severe chronic plaque-type psoriasis. Two hundred eligible subjects were randomized to placebo or one of three treatment arms of XP23829: 400 mg or 800 mg once daily (QD) or 400 mg twice daily (BID). The 12-week treatment period included a three-week titration period followed by nine weeks of treatment at the targeted dose. There was a washout phase of up to four weeks prior to randomization for subjects who were previously taking systemic agents for the treatment of psoriasis. Treatment assignment was stratified based on prior biologic use and approximately 35% of randomized subjects had previous experience with biological treatments for their psoriasis. The primary endpoint of the study was the percent change from baseline to week 12 in PASI score. XP23829 was safe and generally well tolerated. There were no deaths or life-threatening adverse events. No subjects met the safety discontinuation criteria and the majority of treatment emergent adverse events were non-serious and mild or moderate in severity. Diarrhea adverse event rates were consistent with other drugs in the fumaric acid ester class ranging from 22% to 40% in the XP23829 treatment groups compared with 15% for placebo. Other treatment emergent adverse events occurring at an incident rate of greater than or equal to 10% were nausea, abdominal pain, vomiting and headache. The incidence of flushing in the XP23829 dose groups was similar to placebo. Gastrointestinal events were the most frequent adverse event leading to withdrawal during XP23829 treatment. There were two treatment emergent serious adverse events assessed as possibly related to treatment with XP23829: acute cholecystitis and enterocolitis. Both subjects recovered. No subjects experienced Grade 3 or Grade 4 lymphopenia. Less than 5% of subjects in any XP23829 treatment group reached Grade 2 lymphopenia and less than 15% reached Grade 1 at any visit. Lymphocyte levels in all subjects experiencing lymphopenia returned to within normal limits after treatment.
Xenoport, Inc. Presents at Morgan Stanley Global Healthcare Conference - New York, Sep-16-2015 02:50 PM
Sep 12 15
Xenoport, Inc. Presents at Morgan Stanley Global Healthcare Conference - New York, Sep-16-2015 02:50 PM. Venue: The Grand Hyatt New York, 109 East 42nd Street, New York, New York, United States. Speakers: Ronald W. Barrett, Co-Founder, Chief Executive Officer and Director.
Xenoport, Inc. Reports Unaudited Earnings Results for the Second Quarter and Six Months Ended June 30, 2015
Aug 5 15
Xenoport, Inc. reported unaudited earnings results for the second quarter and six months ended June 30, 2015. For the quarter, the company's total revenues were $8,621,000 compared to $5,334,000 a year ago. Loss from operations was $23,654,000 compared to $19,333,000 a year ago. Net loss was $24,481,000 compared to $19,387,000 a year ago. Basic and diluted net loss per share was $0.39 compared to $0.31 a year ago. The increase in revenue was principally due to increased HORIZANT net product sales, which totaled $8.2 million for the quarter compared to $4.9 million for the second quarter of 2014. The increase in HORIZANT net product sales was principally due to increased sales volume and to a lesser extent, increased average net selling price.
For the six months, the company's total revenues were $15,688,000 compared to $8,709,000 a year ago. Loss from operations was $43,524,000 compared to $39,816,000 a year ago. Net loss was $44,890,000 compared to $39,935,000 a year ago. Basic and diluted net loss per share was $0.71 compared to $0.67 a year ago.