To: Kashmir who wrote (1311 ) 3/26/1998 8:26:00 PM From: bob jaremsek Read Replies (2) | Respond to of 1704
Date for Oral Argument Set Clarification of FDA Advisory Committee SEATTLE--(BUSINESS WIRE)--March 26, 1998--CellPro, Incorporated (Nasdaq:CPRO - news) received notice yesterday that the US Court of Appeals for the Federal Circuit has scheduled a date of May 5, 1998 to hear oral arguments in the case of Baxter Healthcare, Becton Dickinson and Johns Hopkins v. CellPro. The case involves a claim by plaintiffs that CellPro infringes a patent owned by Johns Hopkins and licensed to Becton Dickinson and Baxter. A jury verdict issued in August 1995, wholly in CellPro's favor was overturned by the US District Court in Wilmington, Delaware, and thereafter the District Court concluded that CellPro willfully infringed the patents in question. On January 30, 1998, the Court of Appeals issued a stay of certain provisions of the District Court order restricting CellPro's foreign activities. ''We're glad to have quickly obtained the scheduled court date. We believe our briefs are strong, and are anxious to argue the merits of the case in front of a panel of appellate jurists,'' said Richard D. Murdock, President and Chief Executive Officer. In unrelated developments, CellPro today expressed concern that a press release issued yesterday by Nexell Therapeutics, Inc., a subsidiary of VIMRX Pharmaceuticals, Inc., confused CellPro's FDA application, based on data from a Phase III randomized trial for a label expansion to include peripheral blood and tumor purging, with Nexell's application for approval of its Isolex(R) 300 system. The FDA advisory committee review on March 24 was limited to the CellPro application and CellPro data, and should not be confused with Nexell's application for approval. ''We believe the panel hearing and any comments made have no direct impact on the Nexell application,'' stated Mr. Murdock. The CEPRATE(R) SC Stem Cell Concentration System originally received FDA approval on December 6, 1996, and is currently the only FDA approved system on the market. Comments or forward-looking statements should be understood in the context of CellPro's publicly available reports filed with the SEC, including the most current annual report, 10-K and 10-Q, which contain a discussion of various factors that may affect CellPro's business. These factors could cause actual future performance to differ from current expectations. Particular attention should be given to the Investment Considerations labeled ''Legal Proceedings,'' ''Patents and Proprietry Technology'' and ''Dependence on CEPRATE(R) SC System,'' in CellPro's Annual Report on Form 10-K for the fiscal year ended March 31, 1997 and to the Company's press release dated July 29, 1997. Located in Bothell, Washington, CellPro, Incorporated is a biotechnology company that develops, manufactures and markets proprietary continuous-flow, cell-selection systems for use in a variety of therapeutic, diagnostic and research applications. Its CEPRATE(R) SC System is being marketed in the United States, Canada, the EC, Israel, Latin America and the Asia-Pacific.