Publication date: 04/04/2018
With the submission of the Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) in February 2017 and the planned submission of a Biologics License Application (BLA) to the Food and Drug Administration in the first half of 2018, Ablynx remains on track to commercialize their anti-von Willebrand factor Nanobody® called caplacizumab in Europe and the United States. If approved by regulatory authorities, caplacizumab would be the first therapeutic specifically indicated for the treatment of acquired thrombotic thrombocytopenic purpura (aTTP), a rare, acute, life-threatening, autoimmune blood clotting disorder.
In preparation of the launch of caplacizumab, Ablynx has decided to partner with AIM to design its commercial supply chain for Europe, US and Canada. Given the rare and acute nature of the disease, a highly-specialized supply chain design needed to be developed. The design by AIM did not only cover the logistical aspects but also considered regulatory, tax, legal and financial requirements. After approval of the strategic design, AIM was entrusted to help implement the supply chain infrastructure in the different territories. This implementation is a complex process where the “devil is in the detail”, in choosing, integrating and training the right partners, the acquest of the necessary licenses and getting Ablynx’s internal processes ready for the commercial stage.
Ablynx is a biopharmaceutical company engaged in the development of Nanobodies, proprietary therapeutic proteins based on single-domain antibody fragments, which combine the advantages of conventional antibody drugs with some of the features of small-molecule drugs. Ablynx is dedicated to creating new medicines which will make a real difference to society. Today, the Company has more than 45 proprietary and partnered programmes in development in various therapeutic areas including inflammation, haematology, immuno-oncology, oncology and respiratory disease. The Company has collaborations with multiple pharmaceutical companies including AbbVie; Boehringer Ingelheim; Eddingpharm; Merck & Co., Inc., Kenilworth, New Jersey, USA; Merck KGaA; Novo Nordisk; Sanofi and Taisho Pharmaceuticals. The Company is headquartered in Ghent, Belgium. More information can be found on www.ablynx.com.
AIM Connection is a Supply Chain consultancy organization located in Voorburg, The Netherlands. AIM is dedicated to the Pharma, Biotech and Life Science industry. With over 150 professionals in its portfolio AIM covers the entire supply chain spectrum with an emphasis on helping commercial start-up companies to create their Supply Chain infrastructure in Europe, the US and Canada.