The European Commission has granted formal approval for A1M Pharma’s application for Orphan Drug Designation in Europe regarding the company’s treatment for preeclampsia.
July 8, 2014
In May 2014, the European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP) announced its approval of A1M Pharma’s application for Orphan Drug Designation in Europe. This meant that COMP recommended the European Commission to grant formal Orphan Drug Designation, and the European Commission has now formally approved A1M Pharma’s application for Orphan Drug Designation for the treatment of preeclampsia.
CEO Tomas Eriksson comments “As previously stated, we’ve known for some time that preeclampsia is a prospective area for Orphan Drug Designation, which briefly means that the condition is of a very serious nature and that the need to develop drugs in the area is pressing. We’re delighted that we’ve now obtained formal approval for Orphan Drug Designation in Europe for A1M Pharma’s treatment for preeclampsia, a significant factor for future discussions with development partners. We’re also reviewing the potential for applying for Orphan Drug Designation in the US. I would also like to mention that Orphan Drug Designation implies market exclusivity in the EU for 10 years for A1M Pharma’s treatment for preeclampsia, a very positive development which further strengthens our position in terms of continuing our work.”
Orphan Drug Designation in brief
Orphan Drug Designation means that the product obtains market exclusivity following market approval, even if patents are no longer valid. Orphan Drug Designation provides market exclusivity for ten years in the EU from the date of market approval. A1M Pharma also receives a free consultation for scientific advice and secures lower costs for regulatory pre-commercialization applications.
A1M Pharma was founded by researchers active at the University of Lund, Sweden. The company was incorporated in 2008 with the main focus on the development and commercialization of diagnostics and treatment of pre-eclampsia. Pharmaceuticals development is based on A1M, an endogenous protein that protects the body from toxic substances formed in oxidative stress and repairs damaged tissue. Diagnostics are based on the detection of raised levels of the biomarker fetal hemoglobin in the mother’s blood which occurs in preeclampsia. The researchers have developed a new method for discovering pregnancies at risk of developing pre-eclampsia at an early stage. In 2013, the company decided to complement its research to include pharmaceuticals development focusing on renal failure, as recently completed studies indicate that A1M protects renal tissue.