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Parcopa (Carbidopa-Levodopa) Orally Dissolving Tablets for Parkinson's Disease Now Available in US

MILWAUKEE, WI -- September 27, 2004 -- Schwarz Pharma, Inc., announced today the launch of Parcopa™ (carbidopa-levodopa orally disintegrating tablets), a unique formulation of carbidopa-levodopa that dissolves rapidly on the tongue. Parcopa, which received approval from the U.S. Food and Drug Administration (FDA) on August 27, 2004, is used to treat symptoms of Parkinson's disease, including tremors, stiffness and slowness of movement.

"Parcopa combines an effective treatment for Parkinson's disease with orally dissolving technology, making it easier and more convenient for patients to follow the prescribed dosing schedule," said William Koller, MD, Ph.D., Director of Movement Disorders, Department of Neurology, University of North Carolina at Chapel Hill.

Unlike conventional carbidopa-levodopa tablets, Parcopa uses patented RapiTab(TM) technology, an advancement in orally dissolving tablet technology, to deliver an oral dose of medication in a convenient, easy-to-use formulation that does not require water. Accessibility to medication is an important advantage for Parkinson's disease patients, who often experience mobility problems such as morning rigidity which can make taking their medicine difficult.

"By eliminating the need to obtain water, Parcopa provides Parkinson's disease patients with easy access to their medication, which may make performing daily activities easier," said Ron Stratton, Ph.D., president and COO of Schwarz Pharma, Inc. "Parcopa's orally dissolving formulation also offers patients the ability to take the medication discreetly in public."

Parcopa is available in the same strengths and has the same dosage schedule as conventional Sinemet® (carbidopa-levodopa) Tablets. The most common side effects include involuntary movements and nausea. Each 10 mg/100 mg tablet and each 25 mg/100 mg tablet contain phenylalanine 3.4 mg. Each 25 mg/250 mg tablet contains phenylalanine 8.4 mg. For more information about Parcopa, talk to your healthcare provider or visit http://www.Parcopa.com.

About Parkinson's Disease

Parkinson's disease is a chronic, progressive neurological disorder, affecting at least 1.5 million people in the United States, that results from degeneration of nerve cells (neurons) in the part of the brain that controls muscle movement. This degeneration creates a shortage of the brain signaling chemical (neurotransmitter) called dopamine, causing movement impairment. Primary symptoms include tremor of the hands, arms, legs, jaw and face; rigidity or stiffness of the limbs and trunk; bradykinesia or slowness of movement; and postural instability or impaired balance and coordination.

About RapiTab™ Technology

SCHWARZ PHARMA's RapiTab™ Technology formulates medicines into orally disintegrating tablets that dissolve rapidly on the tongue. They can be swallowed with or without water and have pleasant tasting flavors such as citrus or mint. RapiTab tablets are convenient and easy for patients to administer, especially when water is not readily available or patients face certain obstacles to dosing. Schwarz Pharma's RapiTab Technology is based on the proprietary DuraSolv technology developed by and licensed from cima labs Inc.®

RapiTab Technology has distinct advantages over freeze-dry technology. RapiTab Tablets are pleasant tasting, have good mouth feel and are easily soluble both in water and saliva. It can be used with a wide range of active ingredients and strengths. Unlike many other forms of fast-dissolve tablets, RapiTab tablets are durable and can be packaged in both blister packs and conventional bottles.



Sinemet® (carbidopa-levodopa) Tablets is a registered trademark of Merck & Co., Inc.

References:

1. Basic Information about Parkinson's Disease. American Parkinson Disease Association, 2003. Available at: http://www.apdaparkinson.org/user/AboutParkinson.asp; Accessed: 6/7/04.

2. Parkinson's Disease Backgrounder. National Institute of Neurological Disorders and Stroke, National Institutes of Health, 2001. Available at: http://www.ninds.nih.gov/health_and_medical/pubs/parkinson's_disease_backgrounder.htm ; Accessed: 5/13/04.

3. About Parkinson's Disease. Parkinson's Disease Foundation, 1999- 2002. Available at: http://www.pdf.org/aboutPD; Accessed: 5/13/04.


SOURCE: Schwarz Pharma, Inc.

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