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Pharmexa granted orphan drug designation for GV1001 in Europe


Summary: EMEA has recommended the European Commission to grant orphan drug designation for GV1001 within pancreatic cancer.

EMEA, the European Medicines Agency has today announced that it has recommended the European Commission to grant orphan drug designation to Pharmexa for its peptide vaccine GV1001 for the treatment of pancreatic cancer.

Orphan drug designation is granted for products providing relief from diseases affecting less than five in 10,000 people in Europe. Orphan drug designation provides opportunities for free protocol assistance, fee reductions when applying for marketing authorization, 10 years of market exclusivity following drug approval and certain other advantages.

Pharmexa has also applied for orphan drug designation in the USA and expects a decision regarding this in the third quarter of 2006.

Jakob Schmidt, CEO in Pharmexa says: “The orphan drug designation for GV1001 gives us a significant advantage in connection to the future commercialization of this drug and as such it increases the value of our program within pancreatic cancer.”

Hørsholm, June 21, 2006

Jakob Schmidt
Chief Executive Officer

Note to editors: Pharmexa A/S is a leading company in the field of active immunotherapy and vaccines for the treatment of cancer, serious chronic and infectious diseases. Pharmexa’s proprietary technology platforms are broadly applicable, allowing the company to address critical targets in cancer, rheumatoid arthritis, bone degeneration and Alzheimer’s disease, as well as serious infectious diseases such as HIV, influenza, hepatitis and malaria. Its leading programs are GV1001, a peptide vaccine that has entered phase III trials in pancreatic cancer, HER-2 AutoVacä Protein, a recombinant protein vaccine in phase II against breast cancer, and HIV and hepatitis vaccines in phase I/II. Collaborative agreements include H. Lundbeck, Innogenetics, IDM Pharma and Bavarian Nordic. With operations in Denmark, Norway and USA, Pharmexa employs approximately 100 people and is listed on the Copenhagen Stock Exchange under the trading symbol PHARMX.


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