Isdin backs the first drug produced by Digna Biotech

June 2006

The compound has received the support of the US health agency.

The research carried out by the Navarre-based biotechnology company Digna Biotech has started to bear fruit and is attracting the interest of other larger groups, which will facilitate its operations in the future.

This company, owned by 15 partners, including El Corte Inglés and BBVA, together with the Universidad de Navarra, has signed an agreement with Isdin to develop and market the peptide p144, which is used to treat systemic sclerodermia. This treatment, which takes the form of a cream for skin lesions, is now in the pre-clinical phase.

This rare illness affects 3 people in 10,000 and is characterized by fibrosis in the skin, blood vessels and organs; 12,000 people are affected by it in Spain.

Isdin, which has already signed the collaboration agreement, will finance 50% of the cost of developing the product in Europe and 100% in the United States. It will also take on the registration of the pharmaceutical specialty on a world level and will obtain the exclusive world license for the marketing of p144 in local or systemic sclerodermia, once approval has been received from the authorities.

The cost of its development in Europe is four million euros but could rise to 15 million euros in the United States, so Isdin could sign an agreement with one or more local companies. Isdin will also be able to sublicense this product to another laboratory and have first call on all indications related to the skin (cheloma, burns, skin cancer, etc.) that Digna Biotech obtains for its p144.

This medicament has recently obtained orphan drug status from the European Agency for the Evaluation of Medicinal Products (EMEA), for the treatment of both local and systemic sclerodermia.

Likewise, Digna Biotech can also celebrate the classification of orphan drug for p144 by the FDA. This will help it in the development of this medicament and free consultancy by the FDA in the design of the clinical phase, plus economic assistance for carrying out clinical trials, exemption from registration and consultancy charges in the preparation of the registration file, and commercial exclusivity for seven years, once the product has been approved by the US agency.

Both Isdin and Digna Biotech believe that potential sales of this product will not be below 200 million euros per year, starting from 2014.

Apart from p144, Digna Biotech is also developing other products. The second most important is an Alfa5 interferon for hepatitis C and the third is P17 for pulmonary fibrosis. As regards pulmonary fibrosis, Digna Biotech has signed an alliance with Genetrix to develop a project for the treatment of the disease. The investment will be used for experiments on the combined effect of protein M3 by Biotherapix (a company belonging to the Genetrix group) and peptide p17 by Digna Biotech.

Digna Biotech's role will be to develop the intellectual property of the CIMA at the preclinical, clinical and commercial levels.