Somatoprim Recommended For Designation as Orphan Medicinal Product for Acromegaly
Tel Aviv, Israel – 26th November 2012: Aspireo Pharmaceuticals Limited, (“Aspireo”) an Israeli biopharmaceutical company, focused on the development of Somatoprim, a novel somatostatin analog (SSA), announced today that the Committee for Orphan Medicinal Products (COMP) at the European Medicines Agency (EMA) has issued a positive opinion on an application for orphan medicinal product status for Aspireo’s Somatoprim (DG3173) for the treatment of acromegaly.
The positive opinion and recommendation has been forwarded to the European Commission for approval. The designation would grant Aspireo ten years of marketing exclusivity in the European Union upon obtaining market authorization as an orphan medicinal product. In addition, Aspireo would benefit from reduced regulatory fees.
“EMA’s decision to recommend Somatoprim for orphan medicinal product status is an important milestone in the development of this drug”, said Carsten Dehning, CEO of Aspireo. “By this resolution, EMA recognizes the potential of Somatoprim to offer significant medical benefit over existing treatments for acromegaly and it supports our efforts to provide valuable treatment alternatives for the many patients that could benefit from it. The ongoing clinical phase 1b and phase 2a studies are expected to support the claim that Somatoprim offers an effective and safe treatment for acromegaly patients.”
Somatoprim (DG3173) is a novel and proprietary somatostatin analog (SSA) that is based on a novel amino acid composition. 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 shown an improved side effect profile with reduced adverse effects on the gastrointestinal tract and glucose metabolism. Furthermore, assessment of growth hormone secretion in cultured human somatotroph adenoma tissue treated with Somatoprim indicates that it has the potential to increase the response rate of acromegalic patients to SSA therapy. Somatoprim is in phase I/II of clinical development with a phase Ib study in Switzerland and a phase IIa study in the Ukraine, both currently underway. Somatostatin analogs have been approved for the treatment of acromegaly, carcinoid tumours, and Cushing’s disease but have also demonstrated significant potential in diabetic retinopathy. Somatostatin analogs are generating more than USD 1.5 billion in annual sales in a continually growing market.
Aspireo Pharmaceuticals Ltd is a biopharmaceutical company focused on the development of a novel somatostatin analog (SSA) for the treatment of diseases resulting from hormone-active tumors, such as acromegaly, neuroendocrine and gastroenteropancreatic tumors, Cushing’s Disease and diabetic retinopathy. Aspireo’s sole development compound is Somatoprim (DG3173), a novel and proprietary somatostatin analog that is based on a novel amino acid composition and a unique backbone cyclization technology used for stabilization of the peptide. Aspireo is an Israeli company established in 2010 by TVM Capital as a Project Focused Company (PFC). In September 2012 Aspireo and Evotec AG, Hamburg, Germany, entered into a strategic advisory agreement whereby Evotec will support Aspireo in the partnering of Somatoprim. For additional information please go to www.aspireopharma.com
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