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GEN News Highlights : May 7, 2012

Novartis Reports Positive Phase III Data for Acromegaly Therapy

Somatostatin analog performed better than firm's existing drug in controlling GH and IGF-1 levels.

Novartis reported positive data from a Phase III study comparing its somatostatin analog (SSA) pasireotide LAR (long-acting release) with its existing therapy Sandostatin LAR (ocreotide/IM injection) in acromegaly patients. Data from the 358-patient Passport-Acromegaly study showed that 31.3% of pasireotide LAR-treated patients exhibited full disease control (measured as a combination of growth hormone levels and age/sex-matched IGF-1 levels), compared with 19.2% of Sandostatin LAR-treated patients.

Pasireotide LAR is a multireceptor targeting SSA that binds with high affinity to four of the five somatostatin receptor subtypes (sst 1, 2, 3, and 5). On April 25 the EC approved a subcutaneous formulation of pasireotide, trade-named Signifor®, for the treatment of Cushing disease in adult patients who either aren’t suitable for or have failed surgery. Additional regulatory submissions for the Cushing disease indication are in progress worldwide.