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Tuesday, November 18, 2008 12:50:45 PM
IDM Pharma Inc. said Tuesday that regulators recommended its osteosarcoma drug mifamurtide be approved for sale in the European Union, and IDM stock surged in morning trading.
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Symbol Price Change
IDMI 2.60 +1.05
IDM said the European Medicines Agency's Committee for Medicinal Products for Human Use recommended approval for the drug. That view will be adopted at the committee's next meeting, in December, and IDM expects the drug to receive full approval 60 to 90 days later.
Shares of the Irvine, Calif., company climbed a dollar, or 64.5 percent, to $2.55.
Mifamurtide will be marketed in Europe under the name Mepact. The drug treats a rare form of bone cancer that most often affects children and young adults, and IDM said it is the first new osteosarcoma treatment to reach the market in more than 20 years.
Because of the rarity of the disease, IDM has received a market exclusivity period of 10 years, which means the EMEA won't approve rival versions of the drug for a decade.
The drug is designed to treat tumors in patients with osteosarcoma that has not metastasized and can be removed through surgery.
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