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SciClone's Zadaxin granted orphan drug status for malignant melanoma in United States
By E. Janene Geiss
Philadelphia, March 20 - SciClone Pharmaceuticals, Inc. announced Monday that thymalfasin, the chemical composition of Zadaxin, has been granted orphan drug designation for the treatment of stage 2b through stage 4 malignant melanoma by the Food and Drug Administration.
Orphan drug designation could provide SciClone with seven years of market exclusivity in the United States should Zadaxin receive regulatory approval from the FDA for the treatment of malignant melanoma, officials said in a company news release.
"We are extremely excited to receive this designation, which we believe emphasizes the pressing need for new therapeutic options that may improve the currently bleak prospects for patients with advanced stages of malignant melanoma," Ira D. Lawrence, president and chief executive officer of SciClone, said in the release.
The company said it reported encouraging interim tumor response data in December from a large ongoing phase 2 stage 4 malignant melanoma trial in Europe. It said it plans to report additional tumor response data and preliminary survival information from the trial later this year.
Zadaxin is being investigated in combination with dacarbazine (DTIC) chemotherapy with and without low-dose interferon alpha in a large multi-centered phase 2 stage IV malignant melanoma trial in Europe.
This trial is being conducted by Sigma-Tau, SciClone's European development and marketing partner.
In December 2005, SciClone and Sigma-Tau reported encouraging interim data on overall tumor response showing a distinct Zadaxin dose-dependent response in combination with DTIC chemotherapy with and without low-dose interferon alpha, officials said.
SciClone is a San Mateo, Calif., biopharmaceutical company engaged in the development of therapeutics to treat life-threatening diseases.
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