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XenoPort Business Updates section, second sentence of third bullet point should read: Results of thirteen-week toxicology studies... (sted Results of six-month toxicology studies...)
The corrected release reads:
XENOPORT REPORTS SECOND QUARTER FINANCIAL RESULTS
XenoPort, Inc. (Nasdaq: XNPT) announced today financial results for the second quarter and six months ended June 30, 2013. Revenues for the second quarter were $2.1 million, compared to $10.4 million for the same period in 2012. Net loss for the second quarter was $24.4 million, compared to a net loss of $8.0 million for the same period in 2012. At June 30, 2013, XenoPort had cash, cash equivalents and short-term investments of $93.4 million.
XenoPort Business Updates
The following key events occurred since the beginning of the second quarter of 2013:
On May 1, XenoPort completed the reacquisition of the exclusive rights to commercialize Horizant ® (gabapentin enacarbil) Extended-Release Tablets in the United States from Glaxo Group Limited (GSK). XenoPort’s full promotional plan commenced upon product availability in June.
XenoPort announced the inclusion of gabapentin enacarbil, the active ingredient in Horizant, as a first-line therapy in new treatment guidelines created by the Task Force of the International Restless Legs Syndrome Study Group (IRLSSG) and published in Sleep Medicine (Vol 14; p 675; 2013). Horizant is the only non-dopamine agonist and the only alpha-2-delta ligand approved by the U.S. Food and Drug Administration (FDA) for the treatment of moderate-to-severe primary restless legs syndrome in adults (RLS).
XenoPort continued to advance the development of its novel fumarate compound, XP23829. Results of thirteen-week toxicology studies, a Phase 1 radiolabeled XP23829 metabolism and disposition study and a Phase 1 multiple ascending dose study that is examining the pharmacokinetics of two formulations of XP23829 and Tecfidera™ (dimethyl fumarate) at its approved dose, are expected later in the third quarter of 2013.
XenoPort completed a Phase 3 clinical trial of arbaclofen placarbil (AP) as a potential treatment of spasticity in patients with multiple sclerosis (MS). The trial was unsuccessful in demonstrating that AP provided statistically significant improvement relative to placebo in the co-primary endpoints of the study. As a result, XenoPort decided to terminate further investment in AP as a treatment for spasticity in patients with MS.
Ronald W. Barrett, Ph.D., chief executive officer of XenoPort, stated, “Working with GSK to correct its prior product stockout and then our relaunch of
Horizant were key accomplishments for the quarter, and I am happy that
Horizant is now broadly available to adult patients with moderate-to-severe primary restless legs syndrome and postherpetic neuralgia (PHN). We hope that our focused commercial plan will establish a successful template for commercializing
Horizant. We believe that there is a clear need for a non-dopaminergic treatment for RLS and were gratified to see
Horizant included as a first-line treatment in the IRLSSG guidelines for restless legs syndrome. We have also been receiving positive feedback from physicians as we introduce them to the unique attributes of
Horizant for the management of PHN.”
Dr. Barrett continued, “We look forward to the results of our current XP23829 studies. In addition, we are working on scaling up the production of XP23829 and plan to consult with regulatory authorities later this year in preparation for potential further clinical development.”