Medicare-Approved Drug Discount Cards Now Available

Individuals who have Medicare coverage (Part A and/or Part B) and whose medications are not covered by Medicaid may derive considerable savings on prescription drugs by signing up for a Medicare-approved drug discount card, available as of June 1, 2004. This program is being phased in through 2006, and will primarily benefit disabled individuals who have no prescription benefits. In 2004, up to 30% savings on brand drugs and up to 60% savings on generic drugs are possible. The maximum annual card fee is $30. Persons with limited incomes, defined as monthly household income of no more than $1,048 if single ($1,406 if married), and no prescription drug coverage, qualify for a $600 yearly credit towards medication costs.

Participation is voluntary; there is no deadline for applying and no late enrollment fee. For further information, follow the links for the Drug discount card at www.medicare.org or call 1-800-MEDICARE. The website has an interactive tool to help determine which provider has the best coverage. Callers can request a personalized brochure that compares savings among the various card issuers, based on medication needs and pharmacy preferences.

Clinical Trial Shows Xyrem Effective for EDS

In press releases dated May 19, 2004 and June 9, 2004, Orphan Medical, Inc. announced the results of a double-blind placebo-controlled trial (SXB-15) that assessed the effectiveness of Xyrem(R) (sodium oxybate) as a treatment for EDS (excessive daytime sleepiness) associated with narcolepsy. The June 9 press release summarizes discussions and data presented at a symposium on Xyrem held during the recent Associated Professional Sleep Societies (APSS) meeting in Philadelphia.

In this trial, 228 patients with narcolepsy and cataplexy were tested over an eight-week period in 40 sleep centers in North America and 8 in Europe. Patients continued to take stimulant medications. Results showed statistically significant improvement in EDS at dosage levels of 6.0 and 9.0 grams, as measured by the Epworth Sleepiness Scale. Statistically significant improvement in EDS was seen at all dosage levels, as assessed by treating physicians using the Clinical Global Impressions of Change rating scale.

Improvements in wakefulness were also seen in the Multiple Wakefulness Test. Overnight polysomnograms showed doserelated increases in total sleep time, reductions in the number and duration of nighttime awakenings, and decreased Stage 1 and REM sleep periods in favor of more restful and restorative Stage 3 and 4 sleep.

A second trial, known as EXCEEDS, also involving patients with narcolepsy and cataplexy, will be completed in late summer 2004. Orphan anticipates the results of this trial to further support the role of Xyrem in decreasing EDS, and plans to file a Supplemental New Drug Application to obtain FDA approval for the treatment of sleepiness associated with narcolepsy. In the meantime, Orphan's research also continues on a time-release form of Xyrem that would not require waking during the night to take the second dose.

The full text of these press releases can be found at www.orphan.com by choosing "Investors" and/or 'Media" in the main menu.

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