The European Medicines Agency (EMEA) has designated one of the 18 patents of research center Médica Aplicada (CIMA) of the University of Navarra as an orphan drug. This approval, obtained by the biotechnology business Digna Biotech, facilitates the clinical development of its p144 peptide in the treatment of two skin disease indications: localized and systemic scleroderma.

The mission statement of Digna Biotech(www.dignabiotech.com) is to develop at the preclinical, clinical and commercial levels the intellectual property of CIMA of the University of Navarra.

The designation of p144, following the favorable opinion of the committee of Orphan Medicinal Products (COMP), will entail a series of advantages for the clinical development that Digna Biotech is going to carry out: free access to the scientific advice of the EMEA for the design of the clinical phase, reduction of the fees for the commercial authorization of the product and exclusivity of 10 years in the market, once the product is authorized by the Agency.

According to Dr. Pablo Ortiz, director general manager of Digna Biotech, this approval "will accelerate its clinical development and reduce our costs. We are particularly pleased, as this is the first time in Spain that the EMEA has simultaneously granted orphan drug designation to a product in two different indications, which endorses the consistency of the data submitted to the Agency and the interest of this new product for society".

For his part, Dr. Juan Ruiz, director physician of Digna Biotech, referred to the commitment to "improve the current treatment of localized and systemic scleroderma. This is a chronic disease that, although it does not have a very high incidence in society, can substantially reduce the patient's quality of life". He also thanked the partnership of high school Carlos III, the Autonomous University of Barcelona and the Navarre company Idifarma for their financial aid in preparing the application.

Digna Biotech is already working on the application which will be submitted to the FDA (Food and Drug Administration) to obtain orphan drug designation in the US. The company is currently in talks with companies in the sector interested in participating in the development and marketing of this product.

Scleroderma and p144 in the form of cream

Scleroderma is a chronic disease characterized by fibrosis of the skin, blood vessels and internal organs such as the lung. It is believed that the excess of TGF Beta 1 (Transforming Growth Factor beta) may be one of the factors core topic in the development of this pathology. Today there is no treatment to cure the disease, only symptomatic treatments of doubtful efficacy.

Scleroderma is a rare disease: it is estimated that it could affect between 37,000 and 72,000 people in the EU, with a prevalence of 0.82 to 1.58 cases per 10,000 people. This leave incidence makes it even more difficult to research new treatments.

p144 is an inhibitor of TGF Beta 1. Currently, it is considered that TGF Beta 1 inhibitors may play a role core topic against fibrosis and, therefore, in improving the progression of scleroderma. programs of study In this regard, Digna Biotech is developing p144 in cream form for the treatment of skin lesions in systemic and localized scleroderma. data preclinical studies support its efficacy in this pathology and the toxicological studies are scheduled to start the clinical phase in the first half of 2006.

In parallel, Digna Biotech is investigating other potential indications for p144, such as pulmonary fibrosis, keloid scarring, fibrosis following foreign body implantation and macular degeneration of the retina.