NEW YORK, July 21, 2005 (PRIMEZONE) -- Parker & Waichman, LLP (www.yourlawyer.com) announces that it has filed a claim on behalf of the family of Mrs. Anita Smith against Biogen Idec, Inc. (Nasdaq:BIIB) and Elan Corp. (NYSE:ELN), the manufacturers of Tysabri (Natalizumab). Mrs. Smith died of Progressive Multifocal Leukoencephalopathy, or PML, a fatal disorder of the nervous system that has been linked to monotherapy with Tysabri and Tysabri in conjunction with Avonex (Interferon Beta-1a), another Biogen pharmaceutical. Tysabri, a powerful immunosuppressant, received fast track FDA approval in November 2004 for the treatment of Multiple Sclerosis (MS). Tysabri was voluntarily withdrawn from the market by its manufacturers on February 28, 2005, after two cases of PML were diagnosed. The suit was filed in Massachusetts Middlesex Superior Court on July 20, 2005.
According to the suit, Mrs. Smith's tragic death on February 24, 2005 was one of the two PML cases which precipitated Tysabri's withdrawal from the market. In April 2002, Mrs. Smith was enrolled in the Tysabri clinical trial studying the use of Tysabri in combination with Avonex, another Multiple Sclerosis drug manufactured by Biogen. The suit alleges that the combined administration of Tysabri and Avonex can increase the average concentration level of Tysabri by 86 percent over the levels of Tysabri in monotherapy. The suit also alleges that the combined use of these drugs increases Tysabri's half life, which reduces the ability of the patient to clear Tysabri from his/her system. These high levels of Tysabri retained in the body are associated with the development of PML.
The suit notes that in the FDA's review of Tysabri's Biologic License Application, which included data on the combination therapy of Tysabri and Avonex, the agency found that after the sixth dose, the rate of clearance of Tysabri decreased by 34 percent, and the half life increased by 70 percent as compared to the first dose. The data also showed that the mean maximum saturation of Tysabri was high throughout the duration of the study. The observations led the FDA to state that "Avonex alters the pharmacokinetics of natalizumab."
"Before Tysabri was approved, its manufacturers were aware that the drug's use, in combination therapy with Avonex, was dangerous," commented Jerrold S. Parker, founding partner of Parker & Waichman, LLP. "This blatant disregard for patient safety caused tremendous suffering for Mrs. Smith and her family. It certainly appears that combination therapy was proposed by Biogen in an effort to maintain the relevance of Avonex in the marketplace following Tysabri's introduction."
Parker & Waichman, LLP is a leading products liability and personal injury law firm that represents plaintiffs nationwide, with offices in New York and New Jersey. Parker & Waichman, LLP has assisted thousands of clients in receiving fair compensation for injuries resulting from defective medications and medical devices. For more information on Parker & Waichman, LLP please visit: (http://www.yourlawyer.com) or call 1-800-LAW-INFO (1-800-529-4636).