The European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP) has issued in September 2011 a positive opinion recommending orphan medicinal product (Orphan Drug, OD) designation for 2OHOA for the treatment of glioma. 2OHOA is a novel investigational compound designed by scientists at the University of the Balearic Islands (UIB) and developed by Laminar Pharma for its cancer indications.

In its September meeting, EMA’s COMP adopted a positive opinion recommending the designation as orphan medicinal products to the European Commission for 2OHOA for the treatment of malignant brain tumours (glioma), the first product developed by Laminar Pharma on the basis of its innovative Membrane Lipid Therapy (MLT) technology platform developed by a team of scientists at the UIB.

Orphan Drug (OD) qualification in the European Union (EU) refers to pharmaceuticals that have been developed for the treatment of rare diseases that affects less than 5 patients in 10,000 habitants. Orphan Drug designation allows Laminar Pharma to follow a simplified clinical development for 2OHOA and entitles the company to significant economic, scientific and regulatory benefits, including reduced fees and taxes, access to free protocol assistance and scientific advice by the EMA and a longer period of marketing exclusivity. Vicenç Tur, Chief Executive Officer and co-founder of Laminar Pharma said that “the OD designation for our lead compound is a significant milestone for the development of a very promising new therapeutic treatment for a life threatening disease affecting some 40.000 persons in the EU every year, and that shows also a relatively high incidence in children up to 14 years old, being the second cause of cancer related death in this age group in Europe. It also constitutes a regulatory validation from the EMA for the innovative MLT platform we are using to design and develop next generation therapeutics for treating conditions such as cancer, neurodegeneration or inflammatory diseases, with very important medical needs unmet”.

Laminar Pharma is the first Spanish company to obtain an OD designation from EMA for a new compound aimed a the treatment of malignant brain tumors (glioma). This process implied a thorough scientific evaluation including the establishment of “sufficient justification” to the EMA’s COMP criteria, that the investigational compound “…might be of significant benefit to those affected by the condition… in particular with regards to a potential clinically relevant advantage based on a new mechanism of action”

=> see official information on EU/3/11/916 designation at EMA’s website