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XNPT: Business Update - PR 2/16/11

http://finance.yahoo.com/news/XenoPort-Reports-Fourth-bw-2998818826.html?x=0&.v=1

XenoPort Reports Fourth Quarter and Year-End 2010 Financial Results <February 16, 2011 04:06 PM Eastern Time >

SANTA CLARA, Calif.--(BUSINESS WIRE)--XenoPort, Inc. (Nasdaq: XNPT) announced today its financial results for the fourth quarter and year ended December 31, 2010. Revenues for the quarter were $1.9 million, compared to $5.8 million for the same period in 2009. Net loss for the fourth quarter was $14.8 million, compared to a net loss of $18.3 million for the same period in 2009. At December 31, 2010, XenoPort had cash and cash equivalents and short-term investments of $108.6 million.

XenoPort Business Updates

Since the beginning of the fourth quarter of 2010, XenoPort:

* Announced that the U.S. Food and Drug Administration (FDA) has accepted for review the GlaxoSmithKline (GSK) response to the FDA Complete Response letter for Horizant™ (gabapentin enacarbil) Extended-Release Tablets (previously known as XP13512). Horizant is under review for the treatment of moderate-to-severe primary restless legs syndrome (RLS). The FDA has designated the new drug application (NDA) resubmission as a Class 2 response and set a new Prescription Drug User Fee Act (PDUFA) date of April 6, 2011.
* Completed a Phase 2b randomized, double-blind, placebo-controlled, clinical trial of arbaclofen placarbil (AP) in patients with gastroesophageal reflux disease (GERD) who experience symptoms in spite of treatment with a proton pump inhibitor (PPI). XenoPort anticipates reporting preliminary top-line results of this clinical trial later in the first quarter of 2011.
* Announced plans to initiate Phase 3 development of AP as a potential treatment of spasticity in multiple sclerosis (MS) patients. Based on discussions with the FDA, XenoPort intends to conduct a single placebo-controlled Phase 3 efficacy clinical trial and an open-label, long-term, safety study of AP in patients with MS. Favorable results from these studies could lead to the filing of an NDA with the FDA under Section 505(b)(2) seeking approval of AP for the treatment of spasticity.
* Initiated a Phase 2 randomized, double-blind, crossover clinical trial in patients with Parkinson’s disease that is designed to evaluate safety, efficacy and pharmacokinetics of XenoPort’s new bi-layer formulation of XP21279 versus Sinemet.
* Received $0.5 million to further fund the development of AP and XP21279 through the Qualifying Therapeutic Discovery Project program under section 48D of the Internal Revenue Code, which was enacted as part of the Patient Protection and Affordable Care Act of 2010.
* Received a $0.2 million grant from The Michael J. Fox Foundation for Parkinson’s Research to support a preclinical study of the efficacy and safety of a novel, orally administered prodrug of acamprosate in reducing L-Dopa-induced dyskinesias (LID) in a pre-clinical model of Parkinson’s disease. The grant was awarded under the Foundation's Therapeutics Development Initiative Fall 2010 Program aimed at supporting preclinical development of Parkinson's disease therapies that have the potential for fundamentally altering disease course and improving treatment of symptoms above and beyond current standards of care.
* Completed a public offering, raising net proceeds of $30.7 million, after deducting underwriting discounts and commissions and other offering expenses.
* Amended and restated its development and commercialization agreement with GSK with respect to Horizant. GSK remains responsible for seeking approval of the NDA for RLS in the United States and for further development and regulatory matters with respect to Horizant for the potential treatment of post-herpetic neuralgia (PHN). Subject to the terms and conditions of the amended agreement, XenoPort has the right to pursue development of Horizant for certain other indications in the United States. GSK remains responsible for commercialization of Horizant in the United States for all indications. In addition, XenoPort has reacquired all rights to XP13512 outside of the United States that were previously granted to GSK (which excludes the Astellas territory). As part of the amended agreement, financial terms, including potential clinical, regulatory and sales milestone payments and profit split/royalty rates, have been modified to reflect the changes in development responsibilities and the reversion of ex-U.S. rights to XenoPort.

Ronald W. Barrett, Ph.D., chief executive officer of XenoPort, stated, “XenoPort met a number of important business objectives since the start of the fourth quarter. We conducted discussions with the FDA regarding our Phase 3 development program for AP as a potential treatment of spasticity in MS patients and hope to begin the Phase 3 efficacy trial by mid-year. In early January, the final subjects completed their participation in our clinical trial of AP in GERD patients who remain symptomatic despite PPI therapy. We anticipate reporting top-line data on this trial later in the quarter. In November, we initiated a Phase 2 clinical trial of XP21279 in patients with Parkinson’s disease.”

Dr. Barrett continued, “Having submitted new information on the benefit/risk of gabapentin enacarbil as an RLS treatment, we await approval decisions from both the FDA in the United States and the PMDA in Japan.”