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 Team discovers how bacteria exploit a chink in the body's armor
20.01.2017 | University of Illinois at Urbana-Champaign

nachricht Rabies viruses reveal wiring in transparent brains
19.01.2017 | Rheinische Friedrich-Wilhelms-Universität Bonn

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: Traffic jam in empty space

New success for Konstanz physicists in studying the quantum vacuum

An important step towards a completely new experimental access to quantum physics has been made at University of Konstanz. The team of scientists headed by...

Im Focus: How gut bacteria can make us ill

HZI researchers decipher infection mechanisms of Yersinia and immune responses of the host

Yersiniae cause severe intestinal infections. Studies using Yersinia pseudotuberculosis as a model organism aim to elucidate the infection mechanisms of these...

Im Focus: Interfacial Superconductivity: Magnetic and superconducting order revealed simultaneously

Researchers from the University of Hamburg in Germany, in collaboration with colleagues from the University of Aarhus in Denmark, have synthesized a new superconducting material by growing a few layers of an antiferromagnetic transition-metal chalcogenide on a bismuth-based topological insulator, both being non-superconducting materials.

While superconductivity and magnetism are generally believed to be mutually exclusive, surprisingly, in this new material, superconducting correlations...

Im Focus: Studying fundamental particles in materials

Laser-driving of semimetals allows creating novel quasiparticle states within condensed matter systems and switching between different states on ultrafast time scales

Studying properties of fundamental particles in condensed matter systems is a promising approach to quantum field theory. Quasiparticles offer the opportunity...

Im Focus: Designing Architecture with Solar Building Envelopes

Among the general public, solar thermal energy is currently associated with dark blue, rectangular collectors on building roofs. Technologies are needed for aesthetically high quality architecture which offer the architect more room for manoeuvre when it comes to low- and plus-energy buildings. With the “ArKol” project, researchers at Fraunhofer ISE together with partners are currently developing two façade collectors for solar thermal energy generation, which permit a high degree of design flexibility: a strip collector for opaque façade sections and a solar thermal blind for transparent sections. The current state of the two developments will be presented at the BAU 2017 trade fair.

As part of the “ArKol – development of architecturally highly integrated façade collectors with heat pipes” project, Fraunhofer ISE together with its partners...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

Event News

Sustainable Water use in Agriculture in Eastern Europe and Central Asia

19.01.2017 | Event News

12V, 48V, high-voltage – trends in E/E automotive architecture

10.01.2017 | Event News

2nd Conference on Non-Textual Information on 10 and 11 May 2017 in Hannover

09.01.2017 | Event News

 
Latest News

Helmholtz International Fellow Award for Sarah Amalia Teichmann

20.01.2017 | Awards Funding

An innovative high-performance material: biofibers made from green lacewing silk

20.01.2017 | Materials Sciences

Ion treatments for cardiac arrhythmia — Non-invasive alternative to catheter-based surgery

20.01.2017 | Life Sciences

VideoLinks
B2B-VideoLinks
More VideoLinks >>>