Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

’Orphan medication’ in Europe

24.10.2005


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 Potential seen for tailoring treatment for acute myeloid leukemia
10.12.2018 | University of Washington Health Sciences/UW Medicine

nachricht UC San Diego researchers develop sensors to detect and measure cancer's ability to spread
06.12.2018 | University of California - San Diego

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: Researchers develop method to transfer entire 2D circuits to any smooth surface

What if a sensor sensing a thing could be part of the thing itself? Rice University engineers believe they have a two-dimensional solution to do just that.

Rice engineers led by materials scientists Pulickel Ajayan and Jun Lou have developed a method to make atom-flat sensors that seamlessly integrate with devices...

Im Focus: Three components on one chip

Scientists at the University of Stuttgart and the Karlsruhe Institute of Technology (KIT) succeed in important further development on the way to quantum Computers.

Quantum computers one day should be able to solve certain computing problems much faster than a classical computer. One of the most promising approaches is...

Im Focus: Substitute for rare earth metal oxides

New Project SNAPSTER: Novel luminescent materials by encapsulating phosphorescent metal clusters with organic liquid crystals

Nowadays energy conversion in lighting and optoelectronic devices requires the use of rare earth oxides.

Im Focus: A bit of a stretch... material that thickens as it's pulled

Scientists have discovered the first synthetic material that becomes thicker - at the molecular level - as it is stretched.

Researchers led by Dr Devesh Mistry from the University of Leeds discovered a new non-porous material that has unique and inherent "auxetic" stretching...

Im Focus: The force of the vacuum

Scientists from the Theory Department of the Max Planck Institute for the Structure and Dynamics of Matter (MPSD) at the Center for Free-Electron Laser Science (CFEL) in Hamburg have shown through theoretical calculations and computer simulations that the force between electrons and lattice distortions in an atomically thin two-dimensional superconductor can be controlled with virtual photons. This could aid the development of new superconductors for energy-saving devices and many other technical applications.

The vacuum is not empty. It may sound like magic to laypeople but it has occupied physicists since the birth of quantum mechanics.

All Focus news of the innovation-report >>>

Anzeige

Anzeige

VideoLinks
Industry & Economy
Event News

New Plastics Economy Investor Forum - Meeting Point for Innovations

10.12.2018 | Event News

EGU 2019 meeting: Media registration now open

06.12.2018 | Event News

Expert Panel on the Future of HPC in Engineering

03.12.2018 | Event News

 
Latest News

Small but ver­sat­ile; key play­ers in the mar­ine ni­tro­gen cycle can util­ize cy­anate and urea

10.12.2018 | Life Sciences

New method gives microscope a boost in resolution

10.12.2018 | Physics and Astronomy

Carnegie Mellon researchers probe hydrogen bonds using new technique

10.12.2018 | Life Sciences

VideoLinks
Science & Research
Overview of more VideoLinks >>>