- The U.S. Food and Drug Administration (FDA) approved Horizant ® (gabapentin enacarbil) Extended-Release Tablets for the management of postherpetic neuralgia (PHN) in adults, which resulted in a $10.0 million payment received from GlaxoSmithKline (GSK) in June 2012. GSK started promoting Horizant for the management of PHN in the United States in July 2012.
- Regnite ® (gabapentin enacarbil) Extended-Release Tablets was launched in Japan on July 10, 2012, by Astellas Pharma Inc. Regnite is approved in Japan for the treatment of moderate-to-severe primary restless legs syndrome (RLS) in adults. Astellas’ promotional efforts are expected to focus on sleep and neurology specialists. Approximately 1,200 Astellas sales representatives are expected to participate in the promotion of Regnite.
- XenoPort conducted an End-of-Phase 2 meeting with the FDA in which it received feedback that a proposed development program for XP21279, a novel prodrug of levodopa, could support a potential New Drug Application (NDA) submission under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act. Based on its discussions with the FDA, XenoPort believes that a single, pivotal, Phase 3 clinical trial comparing optimized doses of XP21279 to Sinemet, along with an open-label safety study, could form the basis for an NDA submission as a potential treatment of the symptoms of advanced idiopathic Parkinson’s disease. XenoPort plans to initiate certain activities in preparation for potential Phase 3 development of XP21279.
- XenoPort submitted an Investigational New Drug (IND) application to the FDA and initiated a Phase 1 clinical trial of XP23829. XP23829 is a prodrug of monomethyl fumarate (MMF) being developed as a potential treatment for relapsing-remitting multiple sclerosis (RRMS), and also may be a potential treatment for psoriasis.
- XenoPort was awarded a grant from The Michael J. Fox Foundation (MJFF) for Parkinson’s disease research that will support preclinical studies to explore XP23829 for its ability to protect against neurodegeneration in preclinical models of Parkinson’s disease. The grant of $0.3 million was awarded under the Foundation's Therapeutics Development Initiative Program.
- XenoPort completed an underwritten public offering, raising net proceeds of approximately $43.0 million, after deducting underwriting discounts and commissions and other estimated offering expenses.
XenoPort Reports Second Quarter Financial Results
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