XenoPort, Inc. (Nasdaq:XNPT) announced today its financial results for the fourth quarter and year ended December 31, 2013. Revenues for the fourth quarter were $2.9 million, compared to $0.5 million for the same period in 2012. Net loss for the fourth quarter was $19.1 million compared to net income of $3.0 million that resulted from a non-cash gain from XenoPort’s litigation settlement with Glaxo Group Limited (GSK) in the fourth quarter of 2012. At December 31, 2013, XenoPort had cash and cash equivalents and short-term investments of $58.7 million.
XenoPort Business Updates
Since the beginning of the fourth quarter of 2013:
- XenoPort completed a successful follow-on public offering of XenoPort common stock, raising net proceeds of approximately $67.3 million, after deducting underwriting discounts and commissions and other estimated offering expenses.
- XenoPort reported that it received feedback from the U.S. Food and Drug Administration (FDA) Division of Neurology Products regarding potential development plans for XP23829 as a potential treatment for patients with relapsing forms of multiple sclerosis (MS). Based on the feedback, XenoPort believes that it could initiate Phase 3 clinical development using XP23829 doses that produce monomethyl fumarate (MMF) exposure similar to that produced by the approved dose of TECFIDERA (dimethyl fumarate). XenoPort also believes that the FDA will require additional information on XP23829 before determining the applicability of the Section 505(b)(2) pathway for a potential New Drug Application (NDA) submission.
- XenoPort indicated that it plans to submit an Investigational New Drug (IND) application to the FDA Division of Dermatology and Dental Products for XP23829 as a potential treatment for moderate-to-severe chronic plaque psoriasis and plans to initiate a Phase 2 clinical trial of XP23829 for this indication by mid-2014.
- Net sales of HORIZANT ® (gabapentin enacarbil) Extended-Release Tablets in the United States in the fourth quarter grew 34% compared to the third quarter of 2013, which was the first full quarter of XenoPort’s commercialization of HORIZANT. The total number and the trajectory of growth of HORIZANT prescribed tablets achieved all-time highs. HORIZANT prescribed pill counts increased 27% nationwide for the fourth quarter ending December 31, 2013 compared to the third quarter of 2013. In territories where XenoPort is actively promoting HORIZANT, total prescribed pills for the fourth quarter ending December 31, 2013 increased by 39% compared to the third quarter of 2013. This compares to no growth in non-promoted territories.
- XenoPort reported positive top-line results of a Phase 4 clinical trial that evaluated lower doses of gabapentin enacarbil for the treatment of moderate-to-severe primary restless legs syndrome (RLS) in adults. The study was conducted by XenoPort’s former commercial partner, GSK, as part of the post-marketing commitments imposed by the FDA in connection with its approval of HORIZANT for the treatment of adult patients with moderate-to-severe primary RLS. The most common adverse reactions in adult patients with moderate-to-severe primary RLS taking HORIZANT are somnolence/sedation, dizziness, headache, nausea and fatigue.
Ronald W. Barrett, Ph.D., chief executive officer of XenoPort, stated, “We are currently focused on preparing to initiate Phase 2 development of our novel fumarate product candidate, XP23829, later this year. Our Phase 1 clinical trial results indicated that XP23829 can deliver relevant plasma concentrations of MMF with a desired pharmacokinetic profile. While Phase 1 data in a small number of subjects must be viewed cautiously, we are intrigued by the pharmacodynamic effects of XP23829 on immune cells in peripheral blood of healthy subjects, particularly when XP23829 was dosed once a day. We hope to establish optimal dosing of XP23829 in our planned Phase 2 psoriasis study and use this information for dose selection for potential Phase 3 trials in psoriasis and/or relapsing forms of MS.”
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