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Thursday April 26, 2:06 AM XenoPort, Glaxo restless legs drug works in trial LOS ANGELES, April 25 (Reuters) - Drug developer XenoPort Inc. said on Wednesday that the first pivotal-stage study of its experimental pill for restless legs syndrome met its goal of showing that the drug alleviated the symptoms and was well tolerated by patients. The results sent the company's shares up more than 30 percent to an all-time high on Nasdaq. The Phase III trial is one of three in which XenoPort and partner GlaxoSmithKline Plc are testing the drug, known as XP13512, in patients with moderate-to-severe RLS. Glaxo Chief Executive Jean-Pierre Garnier said the results were "pretty impressive" and the medicine had significant potential to complement his firm's existing Requip product. "It has a mechanistic effect that is different from Requip, so we will have two entries in a large and growing market," he told reporters on a conference call to discuss the British company's first-quarter financial results. Results from the two other trials are expected later this year and XenoPort has said it expects to file for U.S. Food and Drug Administration approval of the drug in the second half of next year, following receipt of long-term safety studies, including one looking at carcinogenicity in rodents. News of the trial results "represents a major risk reduction" for the drug's development, FBR Research analyst David Amsellem said in a report on Wednesday. Santa Clara, California-based XenoPort, which is also testing XP13512 as a treatment for neuropathic pain, agreed in February to co-develop the drug with Glaxo in a deal worth up to $666 million, including an upfront payment of $75 million. Industry analysts have estimated that, if successful, XP13512 could earn $700 million to $800 million a year for RLS and potentially twice that for nerve pain. Andrew Baum of Morgan Stanley, who believes the drug could reach the market in 2009, said in a recent note that XP13512 plus a new form of its existing drug Requip could double Glaxo's current RLS revenues in the key U.S. market. According to the National Institutes of Health, up to 12 million Americans are afflicted with RLS, a neurological disorder that causes unpleasant sensations in the legs and an uncontrollable urge to move to get relief. Symptoms typically occur at night, making it difficult for RLS patients to fall asleep. IMPROVED SYMPTOMS XenoPort said that the 12-week trial involving 222 patients showed that those treated with XP13512 saw a 13.2-point reduction on a 40-point symptom scorecard, compared with a drop of 8.8 points for patients on a placebo. Investigators also reported that symptoms were "much improved" or "very much improved" for 76 percent of treated patients, compared with 39 percent of placebo patients. The most common side effects of the drug, given in a daily 1200-mg dose, were sleepiness and dizziness. XP13512 is a version of generic epilepsy drug gabapentin designed to take advantage of mechanisms in the gastrointestinal tract to improve absorption. The two drugs currently FDA-approved for RLS -- Glaxo's Requip and Boehringer Ingelheim's Mirapex -- are dopamine agonists that can cause worsening, or "augmentation," of symptoms in a significant number of patients, said Dr. Clete Kushida, director of Stanford University's sleep research center and a trial investigator. "The advantage of XP13512 is that it showed improvement in sleep," Kushida said. XenoPort Chief Executive Ronald Barrett declined to disclose whether the positive Phase III trial triggered a payment from Glaxo. The data did, however, result in a $5 million payment from Japan's Astellas Pharma Inc. under a licensing deal covering several Asian countries, he said. XenoPort said it plans to present full details of the RLS trial at a future medical conference. XenoPort's shares rose to a record high of $38.28, before trading up $9.39 at $38.25 at mid-afternoon. (Additional reporting by Ben Hirschler in London)