XenoPort Provides Update On XP23829 Development & HORIZANT Business

(RTTNews) - XenoPort (XNPT) reported that it has received feedback from the FDA Division of Neurology Products regarding potential development plans for XP23829 as a potential treatment for patients with relapsing forms of multiple sclerosis. Based on the feedback, XenoPort believes that the FDA would allow XenoPort to initiate potential Phase 3 clinical development using XP23829 doses that produce monomethyl fumarate, or MMF, exposure similar to that produced by the approved dose of TECFIDERA. The company said the FDA has encouraged the exploration of multiple doses of XP23829 to assess the potential advantages of doses that produced either higher or lower MMF exposure.

The FDA also provided responses to the company's questions about its proposed development strategies to support the potential submission of a New Drug Application to the FDA under Section 505(b)(2). XenoPort believes that the FDA will require additional information on XP23829 before determining the applicability of the Section 505(b)(2) pathway. XenoPort said it will continue discussions with the FDA regarding what information could potentially be referenced in a Section 505(b)(2) NDA.

XenoPort also said its plans for 2014 include the submission of an Investigational New Drug application to the FDA Division of Dermatology for XP23829 as a potential treatment for moderate-to-severe plaque psoriasis. XenoPort plans to initiate a Phase 2 clinical trial of XP23829 in patients with moderate-to-severe plaque psoriasis by mid-2014.

XenoPort reported its progress in the commercialization of HORIZANT since it began its promotional efforts on June 1, 2013. The company believes that net sales of HORIZANT will exceed the sum of cost of product sold and selling, advertising and promotional expenses by the end of 2014, and that the HORIZANT business will reach break-even and turn profitable by the end of 2015.

Ronald Barrett, CEO of XenoPort, said, "We believe that our recent promotional initiatives and future efforts to enhance patient access to HORIZANT could further increase HORIZANT sales, which could accelerate the time to potential profitability. Importantly, we believe the HORIZANT business has the potential to become a mechanism to help fund development of XP23829."