Bli medlem
Bli medlem

Du är här

2016-07-25

DBP: 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

Homepage: http://www.doublebp.com/

E-mail: info@doublebp.com

Follow us on LinkedIn
(https://www.linkedin.com/company/double-bond-pharmaceutical?trk=co-feed-...)
and Twitter (https://twitter.com/DoubleBondPharm)!

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.

-----------------------------------------------------------
http://news.cision.com/dbp/r/double-bond-pharmaceutical-ab-has-been-gran...
http://mb.cision.com/Main/12720/2050352/543211.pdf

Författare ATORG

Tala om vad ni tycker

Tala om vad ni tycker

Ni är just nu inne på en betaversion av nya aktiespararna. Lämna gärna feedback på vad ni tycker i formuläret nedan.