Bertek Launches Parkinson's Disease Patient Registry

23-Oct-2003

Bertek Pharmaceuticals Inc., a subsidiary of Mylan laboratories Inc., announced the launch of its nationwide registry for patients with Parkinson's disease who suffer from debilitating periods of total or partial immobility - or "off" episodes - associated with the disease.

The first of its kind for the Parkinson's community, the registry will monitor a collection of patients who have volunteered to self-document their Parkinson's symptoms, specifically their experiences related to "off" episodes. The individual narratives will provide first-hand information about this debilitating stage of Parkinson's disease. To date, very little definitive information and few comprehensive resources about "off" episodes exist.

"The registry will help fill a gap in the Parkinson's disease information base that has existed far too long," said Dr. Mark Stacy, director of the Movement Disorders Section at the Duke University Medical Center. "This effort will assist both neurologists and patients to better understand the extent of 'off' episodes in Parkinson's disease and improve lives through information sharing and education."

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Information gathered from the registry will give neurologists, especially movement disorder specialists, additional insight into "off" episodes. For example, how often do "off" episodes occur, how long do they last, when do they begin in the life of the disease and how do they influence the patient's daily activities are some of the questions that will be explored. Information gathered from the registry may potentially guide the design of new studies and developments in the treatment of "off" episodes.

"Off" episodes are characterized by stiffness in the arms and legs, slowness, immobility and, frequently, tremor. The intensity and duration of an "off" episode varies for each sufferer, but they can dramatically affect activities of daily living.

Patients will be able to participate in the registry through physician referral. Bertek has set a target goal of 3,750 registry participants. Bertek plans to make the registry available through 500 movement disorder and general neurology clinical sites across the United States. Movement disorder specialists and general neurologists interested in enlisting their practice in the registry should call 1-877-776-6787.

Bertek Pharmaceuticals Inc., based in Research Triangle Park, N.C., develops and licenses proprietary pharmaceuticals, with a current focus on neurology, cardiology and dermatology. For more information, visit www.bertek.com.

Mylan Laboratories Inc. is a leading pharmaceutical company with four subsidiaries, Mylan Pharmaceuticals Inc., Mylan Technologies Inc., UDL Laboratories Inc. and Bertek Pharmaceuticals Inc. that develop, manufacture and market an extensive line of generic and proprietary products. For more information, please visit www.mylan.com.

This press release includes statements that constitute "forward-looking statements," including with regard to the availability of, and the benefits expected to result from, the patient registry. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Because such statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: technological difficulties relating to the registry; the risk that the information gathered will not evidence patterns or other similarities; a breach of security of the computer system; and the other risks detailed in Mylan's periodic filings with the Securities and Exchange Commission. Neither Mylan nor Bertek undertakes any obligation to update these statements for revisions or changes after the date of this release.

Source: Bertek Pharmaceuticals Inc.

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