|
FDA Has Granted Pharmexa Orphan Drug Status for GV1001 in Pancreatic Cancer |
|
|
|
26 Jul 2006 |
FDA, the United States health authorities has granted orphan drug status to Pharmexa for the peptide vaccine GV1001 for the treatment of pancreatic cancer.
HORSHOLM, Denmark | Jul 26, 2006 | FDA, the United States health authorities has granted orphan drug status to Pharmexa for the peptide vaccine GV1001 for the treatment of pancreatic cancer. Orphan drug status is granted in the United States to drugs aimed at diseases affecting less than 200,000 people in the United States.
Orphan drug status in the United States provides opportunities for a closer dialogue with the health authorities through the development process, reduced fees and certain other benefits, as well as 7 years of market exclusivity following drug approval. GV1001 already has orphan drug status in Europe for the same indication.
Jakob Schmidt, CEO in Pharmexa says: "Already now, receiving orphan drug status in the US gives us an advantage in our further planning of the US part of the phase III programme for GV1001. In the longer term, having orphan drug status in US and Europe gives us a significant advantage in connection with the future commercialization of this drug and as such it increases the value of our program within pancreatic cancer."
Jakob Schmidt
Chief Executive Officer
Additional information:
Jakob Schmidt, Chief Executive Officer, telephone +45 4516 2525
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.
SOURCE Pharmexa A/S |
