Double Bond Pharmaceutical AB has been granted Orphan Drug Designation status by EMA for the drug candidate Temodex.
July 22, 2016 Double Bond Pharmaceutical (DBP) has been officially granted Orphan Drug Designation (Orphan Drug) status for the drug candidate Temodex by the European Medicines Agency (EMA). The approval applies to the treatment of glioma, which is the most common type of brain cancer. Ten years of market exclusivity for the indication and a great support from the authority will hereby be given to DBP to accelerate the development of the drug.
The EMA grants Orphan Drug Designation status to drugs that treat diseases with less than 200 000 people affected in Europe. For DBP this means that the development of the drug will be much more cost-effective and timesaving implying that the drug can reach the market much faster. Moreover, ten years of market exclusivity for the drug within the broad indication of glioma will give the biggest market possible during a longer time which means that Temodex will not have any direct generic competition for ten years from the date of market approval. The EMA also provides various kinds of support to facilitate and accelerate the development and marketing authorization of the product.
The decision by EMA is based on that Temodex offers a significant benefit compared to existing registered therapeutic alternatives in Europe.
-The Orphan Drug Designation Status was granted solely based on the written application and no follow-up questions were asked. That shows EMA’s confidence in the company’s product, says Stellan Swedmark, Director of Preclinical Development/Regulatory Affairs.
-This considerably strengthens our competitiveness and further improves the conditions for DBP to succeed on the European market, says Igor Lokot, CEO of DBP.
Information about Temodex
Temodex, which is a locally acting temozolomide formulation, was developed at RI PCP in Minsk, Belarus. Temodex is registered as a first line treatment of glioblastoma in Belarus since 2014. For more info: www.doublebp.com
Information about glioblastoma
Glioblastoma, also known as glioblastoma multiforme and Grade IV astrocytoma, is the most common and most aggressive form of primary brain tumor. It affects glial cells and accounts for 52% of all brain tumors and 20% of all tumors inside the skull. About 50% of patients diagnosed with glioblastoma die within one year after diagnosis, and 90% die within three years.
Full Company Name: Double Bond Pharmaceutical International AB
Corporate idenity: 556991-6082
Stock short name: DBP B
Share ISIN code: SE0007185525
For more info, contact
Igor Lokot, CEO
Information about Double Bond Pharmaceutical International AB
DBP is a pharmaceutical company with the primary focus on the development of therapies against cancer based on the company’s developed drug delivery technology BeloGal®. The company did receive Orphan Drug Status from EMA in June 2015 for the company’s first product, SA03, which is intended for the treatment of hepatoblastoma.