Double Bond Pharmaceutical AB has been granted Orphan Drug status for the drug candidate SA-033 by EMA.
Double Bond Pharmaceutical AB (DBP) has been granted Orphan Drug Designation (Orphan Drug) status for the drug candidate SA-033 by the European Medicines Agency. The approval applies to the treatment of hepatoblastoma which is the most common type of liver cancer that affects children. Ten years of market exclusivity for the indication and a great support from the authority will hereby be given.
The European Medicines Agency (EMA) is granting Orphan Drug Designation for drug candidates that treat diseases where less than 200 000 people are affected in Europe. For DBP, this means ten years of market exclusivity for the indication from the date of market approval. SA-033 will therefore not have any direct generic competition during this period and the EMA often provides various kinds of support to facilitate and accelerate the final development of the product.
The decision by EMA is based on that SA-033 offers a significant benefit compared to existing therapeutic alternatives. DBP is also planning to start a Phase I trial of SA-033 already in 2016, in patients suffering from hepatocellular carcinoma.
-The decision shows that the EMA has confidence in the company´s product, says Stellan Swedmark, responsible for the preclinical development of DBP. -This further strengthens the conditions for success in the European market which is extremely important for DBP, says DBPs CEO Igor Lokot in a statement.
Hepatoblastoma (HB) is a primary malignant liver tumor and is the most common liver cancer in children. The etiology of HB is unknown but it is found in greater incidence in children with low birth weight, and has also been associated with Beckwith-Wiedemann syndrome and familial adenomatous polyposis. Five year survival is about 63% after diagnosis of HB and there is therefore an urgent need for more effective and safer therapy for these children.
SA-033 is the first drug candidate that DBP has developed using the ZIP-deliveryTM technology. The ZIP-deliveryTM technology enables doxorubicin to be directed to the liver and thereby increases the concentration of the active substance in the desired targeted organ. That improves the efficiency and reduces the toxic side effects that are characteristic of systemic (whole body) chemotherapy.
About DBP AB (publ)
DBP is a company that operates in medical technology and pursues the development of new drugs by the company's new drug delivery technology; ZIP-deliveryTM. The technology developed by DBP involves targeted delivery of drugs to specific organs and tissues. ZIP-deliveryTM can improve the therapeutic properties of a number of drugs available on the market today. The company aims in the future to apply this technology on several drugs directed to other organs than the liver. The company conducts research and development in Uppsala Business Park in close cooperation with leading international academic institutions and contract research organizations (CROs). DBP seeks cost-effective solutions in its ambition for rapid product development. DBPs shares will be listed on AktieTorget and this IPO process is ongoing.
Igor Lokot – VD, Double Bond Pharmaceutical AB
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