Profile: Xenoport Inc (XNPT.OQ)

XNPT.OQ on NASDAQ Stock Exchange Global Select Market

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XenoPort, Inc., incorporated in May, 1999, is a biopharmaceutical company focused on developing and commercializing a portfolio of internally for the treatment of neurological disorders. The product candidates are prodrugs that are created by modifying the chemical structure of marketed drugs, referred to as parent drugs, and are designed to correct limitations in the oral absorption, distribution and/or metabolism of the parent drug. The Company focuses its development and commercialization efforts on treatments of diseases with unmet medical needs, with an emphasis on central nervous system disorders. The products are designed to correct limitations in the oral absorption, distribution and/or metabolism of the parent drug. In April 2011, the United States Food and Drug Administration (FDA), approved the Company’s first product, known in the United States as Horizant (gabapentin enacarbil) Extended-Release Tablets, for the treatment of moderate-to-severe primary restless legs syndrome, or RLS, in adults.

The Company is evaluating its second product candidate, arbaclofen placarbil, or AP, as a treatment for patients with spasticity. It is conducting a pivotal Phase III clinical trial under a Special Protocol Assessment, or SPA, with the FDA, for AP as a treatment for spasticity in patients with multiple sclerosis, or MS. It also evaluated AP for the adjunctive treatment of gastroesophageal reflux disease, or GERD. Following the results in March 2011 of a Phase II clinical trial of AP as adjunctive therapy in patients with GERD who do not experience complete relief of GERD symptoms while being treated with proton pump inhibitors, it determined that the efficacy results of this trial, which did not meet the primary endpoint, did not warrant its investment in further development for AP in GERD at the present time. It also evaluated its third product candidate, XP21279, for the treatment of patients with Parkinson’s disease who experience motor fluctuations. In December 2011, it reported preliminary top-line results of a Phase II clinical trial of patient-optimized doses of its new bi-layer tablet of XP21279/carbidopa compared to patient-optimized doses of Sinemet (levodopa/carbidopa).

Gabapentin Enacarbil

The Company focuses in developing its product candidate, AP, a Transported Prodrug of R-baclofen, for the potential treatment of spasticity. It holds a composition-of-matter patent and methods-of-synthesis patents in the United States on AP, and hold patents or pending patent applications directed to AP formulations and methods of use in the United States and other jurisdictions. It has completed multiple Phase I clinical trials of AP that included a total of over 250 healthy volunteers. The results of these Phase I clinical trials indicated that AP was well absorbed and rapidly converted to the R isomer of baclofen. Exposure to the intact Transported Prodrug was low compared to the level of R-baclofen produced at all dose levels. Comparison of these data with historical pharmacokinetic data for racemic baclofen suggests that AP taken twice a day should be associated with a decreased peak-to-trough ratio of R-baclofen blood levels over 24 hours compared to racemic baclofen dosed three or four times a day.

Arbaclofen Placarbil

The Company is developing the Arbaclofen Placarbil (AP), a Transported Prodrug of R-baclofen, for the treatment of patients with GERD and for the treatment of spasticity. AP was designed to address the limitations of baclofen by targeting high-capacity nutrient transporter mechanisms expressed throughout the length of the entire GI tract, including the colon. AP was designed to convert to R-baclofen upon absorption, with limited systemic exposure to the intact Transported Prodrug. The Company has completed the multiple Phase I clinical trials of AP, which included a total of over 200 volunteers.

XP21279

The Company is developing the product candidate, XP21279, a Transported Prodrug of L-Dopa, for the treatment of Parkinson’s disease. It has conducted three Phase I clinical trials, which included a total of 82 volunteers. The trials evaluated the pharmacokinetic profile of different formulations of XP21279 administered with carbidopa compared to a combination of L-Dopa/carbidopa. The results of these Phase I clinical trials indicated that XP21279/carbidopa was well absorbed and rapidly converted to L-Dopa.

XP21510

The Company’s fourth product candidate is XP21510, a Transported Prodrug of tranexamic acid, for the treatment of menorrhagia, or heavy menstrual bleeding.

Company Address

Xenoport Inc

3410 Central Expressway
SANTA CLARA   CA   95051
P: +1408.6167200
F: +1408.6167210

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