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`Every-Other-Day Dosing of Glatiramer Acetate Reduces Adverse Reactions With
` Comparable Efficacy to Daily Dosing: Presented at WCTRMS
`
`Overview of PeerView Publications
`
` By Louise Gagnon
`
` MONTREAL -- September 21, 2008 -- Subcutaneous glatiramer acetate can be
` administered every other day with comparable efficacy to that of daily dosing in patients
` with relapsing remitting multiple sclerosis (RRMS), according to research from a 4-year
` study presented here at the World Congress on Treatment and Research in Multiple
` Sclerosis (WCTRMS).
`
` Patients who receive daily injections of glatiramer acetate often develop lipotrophy and
` injection-site reactions, explained lead investigator Omar Khan, MD, Wayne State
` University School of Medicine, Detroit, Michigan, United States. There was interest,
` therefore, in testing the effects of another treatment regimen, apart from 20 mg daily, with
` the goal of minimising adverse events, he said at a poster session here on September 20.
`
` The primary endpoint of this study was based on a composite of clinical, magnetic
` resonance imaging, and immunological outcomes.
`
` A total of 30 treatment-naïve patients were randomised to a standard daily 20-mg dose of
` glatiramer acetate or the same dose every other day. Patients in the 2 treatment groups
` were matched for age, duration of disease, Extended Disability Status Score (EDSS),
` relapse rate, T2-weighted lesions, and gadolinium-enhancing lesions.
`
` After prospective examination at 2 years, patients in each treatment arm had the choice of
` continuing their regimen or switching to the other regimen. Patients were then followed for
` another 2 years. The EDSS was measured every 6 months by a rater who was blinded to
` the study arms.
`
` At 2 years, all patients in the daily-dose arm chose to modify therapy to every-other-day
` dosing.
`
` Investigators found that there were no differences in progression of illness, change in T2-
`weighted lesion volume, or gadolinium-enhancing lesions between the 2 groups at the 2-
`year evaluation.
`
` After 4 years, investigators observed comparable efficacy on all measures between the
` crossover arm and the arm in which patients maintained every-other-day therapy for 4
` years.
`
` A larger study is planned that will examine 3 possible injection regimens of glatiramer
` acetate, including a daily dose, an every-other-day dose, and a weekly dose, said Dr.
` Khan, noting that future research will not be funded by any pharmaceutical manufacturer.
`
` "The goal is to find the optimal dose of the drug," he concluded.
`
`[Presentation title: Randomized, Prospective, Rater-Blinded, Four-Year, Pilot Study to
` Compare the Effect of Daily Versus Every-Other-Day Glatiramer Acetate 20mg
` Subcutaneous Injections in Relapsing-Remitting Multiple Sclerosis. Abstract 902]
`
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`MYLAN PHARMS. INC. EXHIBIT 1087 PAGE 1