XenoPort Provides Highlights of HORIZANT Prescription Trends and Update on Development for Alcohol Use Disorder

XenoPort

today reported an update on prescription trends and further development of HORIZANT Extended-Release Tablets, including feedback from the U.S. Food and Drug Administration on development for treatment of alcohol use disorder. HORIZANT prescription trend highlights include: The number of nation-wide prescribed tablets for the 13 weeks ending December 19, 2014 was 1,256,082, an increase of 18% compared to the prior 13 weeks ending September 19, 2014 and an increase of 95% over the 13-week period ending December 20, 2013.* The rolling four-week average of prescribed tablets for the week ending December 19, 2014 was 100,742.* The current wholesale acquisition cost (WAC) price is $7.69 per tablet. During the third quarter of 2014, XenoPort increased its field sales force of NeuroHealth Sales (NHS) Specialists from approximately 40 to 65 representatives. The number of prescribed tablets for the 13 weeks ending December 19, 2014 in the territories occupied by the new NHS Specialists was 227,897, an increase of 46% compared to the 13 weeks ending June 27, 2014, which was prior to the addition of the new NHS Specialists.* Vincent J. Angotti, XenoPort's chief operating officer, stated, “Our efforts to educate doctors and patients about HORIZANT are clearly having an impact. With the addition of the new NHS Specialists who were deployed during the third quarter of 2014, we believe that prescriptions will continue to experience strong growth in 2015. Given HORIZANT's demonstrated promotional sensitivity and the fact that we believe the healthcare providers we are currently calling on represent a small percentage of the prescription market potential of HORIZANT, we plan to continue to explore means to expand our promotional efforts.” XenoPort also today provided the following update on the development of HORIZANT as a potential treatment for AUD: In the fourth quarter of 2014, representatives from XenoPort and the National Institutes for Alcohol Abuse and Alcoholism (NIAAA) conducted a pre-investigational new drug (IND) meeting with the FDA. Based on the meeting, XenoPort believes that the FDA has accepted the NIAAA's design of the proposed pivotal clinical trial of HORIZANT as a potential treatment for AUD. In addition, XenoPort believes that it may be possible for this clinical trial to support a potential supplemental new drug application (sNDA) for HORIZANT if the results from the trial are robust and compelling and if there is additional confirmatory evidence from the literature or other sources to support the findings. The NIAAA submitted an IND for HORIZANT as a potential treatment for AUD in December 2014 and has indicated that, upon clearance of the IND, the NIAAA's proposed pivotal clinical trial will begin in the first half of 2015 and that the results may be available by the end of 2016. Ronald W. Barrett, PhD, chief executive officer of XenoPort, stated, “HORIZANT sales are growing, and we believe that we have just begun to unlock the potential value of this product for our stockholders. We have also consummated agreements with Reckitt Benckiser Pharmaceuticals, Inc. (now Indivior PLC) for arbaclofen placarbil (AP) and with the NIAAA for HORIZANT that we believe could lead to important use of XenoPort-discovered compounds to treat AUD - a serious disorder that deserves better treatment options.” Dr. Barrett continued, “We also continue to make good progress on the development of XP23829. XenoPort believes that XP23829 could potentially be a best-in-class fumaric acid ester compound with a potentially better tolerability profile than other drugs in this class. We remain on track and continue to expect to obtain the top-line results of our Phase 2 XP23829 moderate-to-severe chronic plaque-type psoriasis study in the third quarter of this year. We believe the study will provide key data on the effect of dose and dosing regimen on efficacy and tolerability. In advance of the results, we are focused on preparing to advance XP23829 into Phase 3 development by mid-2016 in psoriasis and/or relapsing forms of multiple sclerosis (MS).”