Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

’Orphan medication’ in Europe

21.10.2005


The European Agency for the Evaluation of Medicinal Products (EMEA) has designated, as an orphan medicine, one of the 18 patents of the Centro de Investigación Médica Aplicada (CIMA) at the University of Navarre. This approval, achieved by the Digna Biotech biotechnological company, will facilitate the clinical development of its p144 peptide in the treatment of two symptoms of skin disease: local and systemic scleroderma.



The aim of Digna Biotech (www.dignabiotech.com) is the development of the intellectual property CIMA at the University of Navarre on pre-clinical, clinical and commercial planes.

This designation of p144 will mean a series of advantages for the clinical development that Digna Biotech is to undertake: free access to scientific advice from EMEA during the clinical phase of the design process, reduction in the taxes payable for the permission to market the product and, once authorised by the Agency, to maintain market exclusivity for a period of ten years.


According to Dr. Pablo Ortiz, Director General of Digna Biotech, this approval by EMEA will speed up the clinical development and reduce costs of the product. It is the first time in the Spain that EMEA has conceded the simultaneous designation as an orphan medicine of a product involving two distinct symptoms, thereby endorsing the consistency of the data presented to the Agency and the interest of this new product for the public at large.

Also, Dr. Juan Ruiz, medical director of Digna Biotech, in reference to the commitment to improve current treatment of local and systemic scleroderma, pointed out that they are chronic conditions which, while not having a very high prevalence amongst the public, they can considerably diminish the quality of life of the patient.

Scleroderma and p144 in cream form

Scleroderma is a chronic illness that is characterised by fibrosis in the skin, blood vessels and internal organs such as the lungs. It is believed that excess of TGF Beta 1 (Transformant Growth Factor ß) may be one of the key factors in the development of this pathology. Currently there is no treatment for its cure, only symptomatic treatments of doubtful efficacy.

Scleroderma is a rare or uncommon illness: it is estimated that it may affect between 37,000 and 72,000 persons within the EU, a prevalence of 0.82 to 1.58 cases per 10,000 persons. This low incidence further impedes research into new treatments.

p144 is an inhibitor of TGF Beta 1. It is currently considered that inhibitors of TGF Beta 1 may play a key role against fibrosis and, thereby, in improving sclerodermic conditions.

This is why Digna Biotech is developing p144 in a cream form for the treatment of cutaneous lesions resulting from local and systemic scleroderma.

Simultaneously, Digna Biotech is investigating other symptoms potentially treatable with p144, such as pulmonary fibrosis, keloid scars, fibrosis arising from the implantation of a foreign body and the macular degeneration of the retina.

Irati Kortabitarte | alfa
Further information:
http://www.basqueresearch.com

More articles from Health and Medicine:

nachricht Cystic fibrosis alters the structure of mucus in airways
28.06.2017 | University of Iowa Health Care

nachricht Mice provide insight into genetics of autism spectrum disorders
28.06.2017 | University of California - Davis

All articles from Health and Medicine >>>

The most recent press releases about innovation >>>

Die letzten 5 Focus-News des innovations-reports im Überblick:

Im Focus: Can we see monkeys from space? Emerging technologies to map biodiversity

An international team of scientists has proposed a new multi-disciplinary approach in which an array of new technologies will allow us to map biodiversity and the risks that wildlife is facing at the scale of whole landscapes. The findings are published in Nature Ecology and Evolution. This international research is led by the Kunming Institute of Zoology from China, University of East Anglia, University of Leicester and the Leibniz Institute for Zoo and Wildlife Research.

Using a combination of satellite and ground data, the team proposes that it is now possible to map biodiversity with an accuracy that has not been previously...

Im Focus: Climate satellite: Tracking methane with robust laser technology

Heatwaves in the Arctic, longer periods of vegetation in Europe, severe floods in West Africa – starting in 2021, scientists want to explore the emissions of the greenhouse gas methane with the German-French satellite MERLIN. This is made possible by a new robust laser system of the Fraunhofer Institute for Laser Technology ILT in Aachen, which achieves unprecedented measurement accuracy.

Methane is primarily the result of the decomposition of organic matter. The gas has a 25 times greater warming potential than carbon dioxide, but is not as...

Im Focus: How protons move through a fuel cell

Hydrogen is regarded as the energy source of the future: It is produced with solar power and can be used to generate heat and electricity in fuel cells. Empa researchers have now succeeded in decoding the movement of hydrogen ions in crystals – a key step towards more efficient energy conversion in the hydrogen industry of tomorrow.

As charge carriers, electrons and ions play the leading role in electrochemical energy storage devices and converters such as batteries and fuel cells. Proton...

Im Focus: A unique data centre for cosmological simulations

Scientists from the Excellence Cluster Universe at the Ludwig-Maximilians-Universität Munich have establised "Cosmowebportal", a unique data centre for cosmological simulations located at the Leibniz Supercomputing Centre (LRZ) of the Bavarian Academy of Sciences. The complete results of a series of large hydrodynamical cosmological simulations are available, with data volumes typically exceeding several hundred terabytes. Scientists worldwide can interactively explore these complex simulations via a web interface and directly access the results.

With current telescopes, scientists can observe our Universe’s galaxies and galaxy clusters and their distribution along an invisible cosmic web. From the...

Im Focus: Scientists develop molecular thermometer for contactless measurement using infrared light

Temperature measurements possible even on the smallest scale / Molecular ruby for use in material sciences, biology, and medicine

Chemists at Johannes Gutenberg University Mainz (JGU) in cooperation with researchers of the German Federal Institute for Materials Research and Testing (BAM)...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

Event News

Plants are networkers

19.06.2017 | Event News

Digital Survival Training for Executives

13.06.2017 | Event News

Global Learning Council Summit 2017

13.06.2017 | Event News

 
Latest News

Supersensitive through quantum entanglement

28.06.2017 | Physics and Astronomy

X-ray photoelectron spectroscopy under real ambient pressure conditions

28.06.2017 | Physics and Astronomy

Mice provide insight into genetics of autism spectrum disorders

28.06.2017 | Health and Medicine

VideoLinks
B2B-VideoLinks
More VideoLinks >>>