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Drug Names(s): BG00001; Interferon Beta Gene Therapy; Ad.hIFN-ß
Description: This drug delivers interferon beta as an adenovirus-based gene therapy. Other interferon beta therapeutics, notably Biogen’s own Avonex, are recombinant protein formulations.
Preclinical studies of interferon beta gene therapy in cancer models have been published since 1991, focusing on intratumoral efficacy for tumors of the brain, prostate, liver, ovary, colorectum, and metastatic lesions. Melanoma is most frequently cited as interferon responsive. Preclinical evidence of efficacy also exists for use in HIV disease, rheumatoid arthritis, and other inflammatory / proliferative conditions.
Deal Structure: In January 2003, IDEC partnered with Biogen to develop this product. IDEC will lead and fund all development for four years, at which time Biogen can opt to co-develop and co-market the drug. In June 2003, IDEC and Biogen merged.
Pink Sheet CBER’s Novel Biologic Approvals In 2014
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