Healthcare Industry News:  KV Pharmaceutical 

Biopharmaceuticals Litigation

 News Release - July 11, 2006

Solvay Pharmaceuticals Settles Lawsuit Against Pseudo-Generic to CREON(R) MINIMICROSPHERES(R)

MARIETTA, Ga.--(HSMN NewsFeed)--July 11, 2006--Solvay Pharmaceuticals, Inc. announced today that it has settled a lawsuit filed against Global Pharmaceuticals and Impax Laboratories, Inc. alleging that the companies falsely advertised and marketed their products as generic equivalents to and substitutes for Solvay Pharmaceuticals' CREON® MINIMICROSPHERES® (Pancrelipase Delayed-release Capsules, USP).

Under the terms of the settlement, Global Pharmaceuticals and Impax Laboratories will pay $23 million to Solvay Pharmaceuticals, Inc., of which $12 million has already been paid. The terms of the settlement also require the defendants to discontinue current marketing practices that state or imply its products are generic equivalents to CREON® brand products and discontinue current product labeling, distribution and sales of Lipram-CR 5, Lipram-CR 10 and Lipram-CR 20. The terms also require the defendants to disseminate corrective advertising via a written communication to customers, database companies, and managed care organizations stating that its products are not generic equivalents to CREON® brand products and should not be substituted for CREON® brand products without physician supervision.

"We believe the outcome of this case validates our long-held assertion that these pseudo-generic products are not true generic equivalents to CREON® MINIMICROSPHERES® and should not be substituted for our products," said Laurence Downey, MD, President and CEO of Solvay Pharmaceuticals, Inc. "More importantly, this settlement will help to ensure that pancreatic enzyme patients - including thousands of children with cystic fibrosis - will receive the life sustaining product they've been prescribed in CREON® MINIMICROSPHERES®."

Solvay Pharmaceuticals filed lawsuits in April 2003 in the U.S. District Court of Minnesota against manufacturers Ethex Corporation, KV Pharmaceutical Company, Global Pharmaceuticals and Impax Laboratories, Inc. The lawsuit filed against Ethex Corporation and KV Pharmaceutical Company is ongoing. Solvay Pharmaceuticals is represented in these lawsuits by Saul H. Perloff and Marc B. Collier of Fulbright & Jaworski, LLP and John B. Gordon of Faegre & Benson, LLP.

CREON® MINIMICROSPHERES® is Solvay Pharmaceuticals' pancreatic enzyme supplement for the treatment of pancreatic exocrine insufficiency. Pancreatic exocrine insufficiency, often associated with conditions such as cystic fibrosis and chronic pancreatitis, occurs when enzyme output from the pancreas is inadequate to digest the fats, proteins and carbohydrates contained in food. If this malnutrition is not effectively treated, it leads to an overall decrease in health status and even death.

Solvay Pharmaceuticals, Inc., of Marietta, Georgia is the U.S. subsidiary of Solvay Pharmaceuticals. For more information, visit

Solvay Pharmaceuticals is a research driven group of companies that constitute the global pharmaceutical business of the Solvay Group. The company seeks to fulfill carefully selected, unmet medical needs in the therapeutic areas of neuroscience, cardio-metabolic, influenza vaccines, gastroenterology, specialized markets and men's and women's health. Its 2005 sales were EUR 2.3 billion and it employs approximately 10 000 people worldwide. For more information, visit

Solvay is an international chemicals and pharmaceuticals group with headquarters in Brussels. It operates in more than 50 countries, with some 30,000 employees. In 2005 its consolidated sales amounted to EUR 8.6 billion, generated by its three sectors of activity: Chemicals, Plastics and Pharmaceuticals. Solvay SA is listed on the Euronext 100 index of top European companies. Details are available at

Source: Solvay Pharmaceuticals

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