Britannia Pharmaceuticals Limited announced today that U.S.-based Bertek Pharmaceuticals Inc., the branded subsidiary of Mylan Laboratories Inc has received approval from the Food and Drug Administration for APOKYN (apomorphine hydrochloride injection). APOKYN is approved for the acute, intermittent treatment of hypomobility, "off" episodes ("end-of-dose wearing off" and unpredictable "on/off" episodes) associated with advanced Parkinson's disease. Britannia licensed the injectable apomorphine hydrochloride formulation to Bertek in 1999. Under the terms of the companies’ agreement, Bertek licensed the rights to apomorphine and assumed control of all regulatory and marketing initiatives as well as the commercialization of the product in the United States.
The symptoms of Parkinson’s disease in its early stages can usually be controlled with conventional oral drugs such as levodopa and oral dopamine agonists. However, over time, these medications become less effective, symptoms become more disabling, and as a result, late-stage patients can experience frequent “on-off” fluctuations in motor performance. During an “off” period, the patient becomes immobile and has great difficulty initiating voluntary movements.
Marketed as Apo-go® in the United Kingdom for several years, apomorphine has been shown to reduce the “off” period by 50% -- quickly restoring mobility or preventing a period of disability from occurring. Apo-go® is approved in eight European countries.
“In Europe, we have seen apomorphine improve patients’ quality of life, providing much needed relief and some control over the debilitating effects of Parkinson’s disease,” said Maxwell Noble, managing director of Britannia Pharmaceuticals. “It is encouraging to know that patients in the United States will have access to this treatment.”
According to Bertek, APOKYN will be available in the United States by July 2004 and will be distributed through a limited specialty pharmacy network.