Sanj K. Patel, the President and Chief Executive Officer of Synageva BioPharma Corp. (GEVA), announced positive topLine results for the biopharmaceutical company’s first therapeutical product at the Canaccord Genuity 34th Annual Growth Conference at the Intercontinental Hotel in Boston, Massachusetts.
Synageva has received positive topline results in its Phase 3 trial for sebelipase alfa, a recombinant form of the human lysosomal acid lipase (LAL) enzyme, he said.
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The therapy is seen as an enzyme replacement for LAL Deficiency, a rare autosomal recessive lysosomal storage disease that results in the buildup of fatty material in the liver, blood vessel walls, and other tissues and organs. Infants, children and adults can have the deficiency, which can be fatal and for which there are currently no approved therapies. Synageva is targeting 2015-2016 for commercial launch of sebelipase alfa for LAL Deficiency, he said.
Sebelipase alfa has been granted orphan designations by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the Japanese Ministry of Health, Labour and Welfare, he said.
The company is also advancing on its SBC-103 to treat MPS IIIB, a genetic disorder that makes the body unable to break down large sugar molecules called glycosaminoglycans. Patel said Synageva hopes to have clinical trials started by the end of the year. It hopes to initiate clinical trials by the end of this year
Patel said in Q2 of this year, the company has $535 million in cash on hand with no debt. It has a global commercial focus in the U.S., EU, Japan and portions of South America and owns worldwide rights to all its programs.
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