Magnus Life Science has announced that the European Medicines Agency (EMA)’s Committee for Orphan Medicinal Products (COMP) has reached a positive decision on recommending orphan designation to Magnus Growth’s novel therapy to treat placental insufficiency.
Placental insufficiency affects around 3.2% of all pregnancies (nearly 170,000 babies annually in the EU), usually becoming apparent during the second half of pregnancy when detected at routine ultrasound scans.
Placental insufficiency causes fetal growth restriction where babies may stop growing in the womb. Babies born from pregnancies with placental insufficiency are not only at increased risk of perinatal death or complications such as cerebral palsy, but very typically there are long term consequences for their health which include diabetes and cardiovascular disease. There is no treatment.
Magnus Growth is one of five Magnus Life Science companies based on clinical and academic research, some of which originated from University College London (UCL). Magnus Growth’s programme is part-funded by a €6m EU FP7 grant (http://everrest-fp7.eu/).
Following extensive preclinical studies on the effectiveness and safety of the novel therapy, clinical trials are expected to start in 2016.
Orphan designation in the European Union (EU) is given to products that are designed for the diagnosis, prevention or treatment of rare diseases that are life-threatening or very serious. A disease is defined as rare in the EU if it affects fewer than five in 10,000 people per year.
Orphan designation will benefit Magnus Growth on a number of counts, including formal scientific advice from EMA, access to centralized authorization procedures and ultimately ten years market exclusivity if the product reaches the market. The European Commission is now required to ratify the COMP recommendation and should issue a formal decision on Orphan Designation in the coming weeks.
Dr Anna David, Head of Magnus Growth and Reader and Consultant in Obstetrics and Maternal Fetal Medicine UCL Institute for Women's Health, University College London, said: “Research and development of obstetric medicines still receives minimal attention from the pharmaceutical industry. Placental insufficiency is an important condition with a significant unmet medical need. Sadly most affected babies either die in the womb are delivered prematurely and have long-term health consequences. A successful treatment could prevent still-births and neonatal death saving thousands of lives.”
Chief Executive Officer of Magnus Life Science, Dr David Campbell, added: “Today’s news is tremendously encouraging for Magnus Growth. This is only the second obstetric therapy to be granted orphan designation in Europe. We believe orphan designation for this therapy will provide practical benefits as we bring this much needed treatment to pregnant women as rapidly as we can. The positive recommendation also recognizes the importance of our work in tackling what is a serious unmet medical need.”