CANGENE COMPLETES MRP FOR WINRHO SDF APPROVAL IN 10 COUNTRIES.Cangene has successfully completed the European Mutual Recognition Procedure ("MRP (Material Requirements Planning) An information system that determines what assemblies must be built and what materials must be procured in order to build a unit of equipment by a certain date. ") for the approval of WinRho(R)SDF (Standard Data Format) A simple file format that uses fixed length fields. It is commonly used to transfer data between different programs. SDF Pat Smith 5 E. 12 St. Rye NY Bob Jones 200 W. Main St. Palo Alto CA Comma delimited "Pat Smith","5 E. in ten European countries for use in preventing hemolytic disease of the newborn Hemolytic disease of the newborn Also known as erythroblastosis neonatorum, this is a condition in which a newborn's red blood cells are destroyed by antibodies that have crossed the placenta from the mother's blood. and treating ITP ITP - Intent to Package , a clotting disorder. As a result, launch of WinRho(R)SDF in the ten countries - Belgium, Finland, Greece, Iceland, Ireland, Italy, Luxembourg, Norway, Portugal and the Netherlands - will occur in 2005. This will be a re-launch in Ireland and Portugal - in Ireland the product had previously been approved for use in hemolytic disease of the newborn and will now also be marketed for the second indication, and in Portugal, WinRho(R)SDF was already approved for both indications but will be re-launched with new MRP-approved labelling. WinRho(R)SDF was approved in the United Kingdom in 1999. The newly approving European Union European Union (EU), name given since the ratification (Nov., 1993) of the Treaty of European Union, or Maastricht Treaty, to the European Community countries mutually recognized the UK license after completion of the MRP. Cangene plans to follow the same process for approval in additional EU Member States in the future. Cangene's European distribution partner, Baxter Healthcare S.A. (a subsidiary of Baxter International Inc.), will launch the product once national licences have been issued. "This is a significant step in our strategy to expand our WinRho(R)SDF market. These new licences considerably broaden the scope of our European marketing opportunities and should contribute to future growth in product sales," said Dr. John Langstaff, Cangene's president and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. . The Mutual Recognition Procedure is a pan-European regulatory procedure to obtain marketing authorizations in European Union countries based on mutual recognition of marketing authorization in one member EU country (Reference Member State). Sold in more than 40 countries, WinRho(R)SDF is an antibody to certain types of red blood cell red blood cell: see blood. and is currently indicated to prevent hemolytic disease of the newborn, which is a serious blood-type incompatibility between a pregnant woman and the fetus, and to treat ITP, which is an autoimmune condition that impairs blood-clotting ability through a decrease in platelet levels. Cangene manufactures the drug in its facility in Winnipeg, Canada. Cangene also recently began a trial investigating the use of WinRho(R)SDF for treating dengue dengue or breakbone fever or dandy fever Infectious, disabling mosquito-borne fever. Other symptoms include extreme joint pain and stiffness, intense pain behind the eyes, a return of fever after brief pause, and a characteristic rash. hemorrhagic fever. Cangene is one of Canada's largest biotechnology companies. It was founded in 1984 and is headquartered in Winnipeg, Manitoba. Cangene carries out research and development in Mississauga, Ontario and Winnipeg. It uses patented manufacturing processes to produce plasma-derived and recombinant therapeutic proteins. In addition to two approved products, Cangene now has three products that have been submitted for regulatory review, and a significant clinical trial program including human growth hormone human growth hormone (HGH): see growth hormone. , which is nearing regulatory submission. Cangene is also expanding its contract research and manufacturing businesses using its drug-manufacturing expertise and the resources of Chesapeake Biological Laboratories, Inc. (a wholly-owned subsidiary). The company has manufacturing facilities in Winnipeg, Manitoba and Baltimore, Maryland. Chesapeake's website is http://www.cblinc.com. For more information, call 905/405-2900 or visit http://www.cangene.com. |
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