EMEA Grants to Abiogen Pharma the Orphan Drug Status for a New Compound in Myelofibosis Indication.

Business Editors/Health/Medical Writers

BIOWIRE2K

PISA, Italy--(BUSINESS WIRE)--Oct. 6, 2003

On 10th September 2003, the Committee for Orphan Medicinal Products (COMP) adopted a positive opinion on the designation of the product OGP (10-14)L (H-Tyrosine-Glycine-Phenilalanine-Glycine-Glycine-OH) as an orphan drug for the treatment of chronic idiopathic myelofibrosis (CIMF).

CIMF is a chronically debilitating and life-threatening condition due to a decreased life expectancy due to major complications (e.g. acute leukemia, infection, marrow insufficiency).

The medicinal product satisfies the criteria for designation, because it is intended for the treatment of a life-threatening condition that affects no more than 1 in 10 thousand persons in the Community. The COMP is of the opinion that the medicinal product will be of significant benefit to those affected by the condition, in comparison with already authorised methods of treatment.

The product is a pentapeptide and is the smallest active sequence of the natural peptide called Osteogenic Growth Peptide which exerts its activity on stromal and staminal bone marrow cells.

The COMP considers that the positive activity of the medicinal product over medullar cellularity is worth to be considered as potentially clinically relevant for these patients, in particular with regards to its new mechanism of action and improved efficacy, taking into account that the current treatments available have an opposite effects.

In contrast with conventional largely palliative therapy, only addressed to reduce symptoms of CIMF, the product mechanism of action is directed to reduce myelofibrosis by an increase in bone marrow cell density and to lower peripheral blood cytopenia, thus providing a valid therapeutic approach to the disease.

Abiogen Pharma is one of the few Italian Companies to have achieved the designation from EMEA, which will assist Abiogen in planning the clinical development of the product in the designated indication.

At the same time Abiogen Pharma is developing OGP (10-14)L both in the bone marrow regeneration in patients receiving myelo-suppressive therapy and in the cell mobilization in autologous bone marrow transplantation.

Abiogen Pharma, born in 1997, is a private Italian Pharmaceutical Company involved in R&D, Production and Marketing. Abiogen owns a prestigious R&D Pipeline and showed along the years significant skills in innovative compound development, also broadening out to the biotechnological field.

In the same Orphan Disease area, Abiogen Pharma recently achieved from the Italian Minister of Health the marketing authorization for Neridronate (Nerixia(R)), first compound in the world which have obtained the Osteogenesis Imperfecta indication.