Tercica partner receives FDA approval for Somatuline Depot
Shares of Tercica, Inc. (Nasdaq: TRCA) are advancing swiftly in pre-market trading after the biopharmaceutical company’s partner reported that its partner Ipsen (Euronext: IPN) received approval from the U.S. Food and Drug Administration for the marketing of Somatuline Depot injection 60, 90 and 120 mg/ml in the United States.
The FDA has also designated Somatuline Depot as an orphan drug for acromegaly. The Orphan Drug Act provides a seven-year period of exclusive marketing to the first manufacturer who obtains marketing approval for a designated orphan product.
Somatuline Depot is used for the long-term treatment of acromegaly in patients who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy is not an option.
Acromegaly is a hormonal disorder that occurs when the pituitary gland produces excess growth hormone. Acromegaly most commonly affects middle-aged adults and can result in serious illness and premature death.
Shares of Tercica jumped 21.41%, or $1.41, to $7.95 in pre-market trading.
