Date: 2012-11-19
Type of information:
Product name: somatoprim (DG3173 - somatostatin analogue)
Compound: Cyclo(-gamma-aminobutyryl-L-phenylalanyl-L-tryptophanyl-D-tryptophanyl-L-lysyl-L-threonyl-L phenylalanyl-N-3-carboxypropyl)-glycine amide
Therapeutic area:
Action mechanism: Somatoprim (DG3173) is a novel and proprietary somatostatin analogue (SSA) that is based on a novel amino acid composition and a unique backbone cyclisation technology used for stabilisation of the peptide. During extensive pre-clinical testing, somatoprim has demonstrated a unique receptor binding and pharmacological profile which is significantly differentiated from SSAs that are currently marketed or in clinical development. In particular, somatoprim has demonstrated an improved side effect profile with reduced adverse effects on the gastrointestinal tract and metabolic control. Furthermore, assessment of growth hormone secretion in cultured human somatotroph adenoma tissue treated with somatoprim indicates that it has the potential to significantly increase the response rate of acromegalic patients to SSA therapy.
This product has been developed by Aspireo Pharmaceuticals. In November 2012, the company has announced that the first patient has been enrolled in a phase IIa study in acromegaly patients. This study is designed to demonstrate efficacy in acromegaly patients in terms of reduction of growth hormone levels. Effects on growth hormone levels will also be compared with those of octreotide.
Company: Dr Ulrich Granzer (Germany) Aspireo Pharmaceuticals (Israel)
Disease: acromegaly
Latest news: * On December 6, 2012, the European Commission has granted orphan drug designation to cyclo(-gamma-aminobutyryl-L-phenylalanyl-L-tryptophanyl-D-tryptophanyl-L-lysyl-L-threonyl-L phenylalanyl-N-3-carboxypropyl)-glycine amide for treatment of acromegaly.
* On 6-7 November 2012, the Committee for Orphan Medicinal Products (COMP) has recommended the granting of an orphan designation for cyclo(-gamma-aminobutyryl-L-phenylalanyl-L-tryptophanyl-D-tryptophanyl-L-lysyl-L-threonyl-L phenylalanyl-N-3-carboxypropyl)-glycine amide for treatment of acromegaly.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization:
UE authorization:
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA: 2013-06-24
Orphan status UE: 2012-12-06
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
