GHENT, Belgium – Ablynx [Euronext Brussels: ABLX] today announced that it has received a €400,000 milestone payment from its collaboration with Novartis. The payment was triggered by the approval of an Investigational New Drug (IND) application from the U.S. Food and Drug Administration for the Phase I clinical trial for a Nanobody® licensed to Novartis. This is the first development candidate emerging from the licensing agreement between Ablynx and Novartis.
Ablynx and Novartis entered into a commercial licensing agreement in July 2010, under which Novartis obtained licenses to develop and commercialise Nanobodies against two targets (including this one for which an IND has been approved), which originated from the research agreement between the parties, entered into in 2005. Since July 2010, Novartis has full responsibility for the continued progress of both programmes and Ablynx is eligible to receive development-based milestone payments and royalties on sales following commercialisation of the products.
Dr Edwin Moses, CEO and Chairman of Ablynx, commented:
“We are excited that Novartis has obtained IND approval and that they will bring this first Nanobody into clinical development in an oncology setting. This development candidate demonstrates the power of the Nanobody platform in addressing complex target classes that are challenging to address with conventional antibodies.”
About Investigational New Drug Application (IND)
An IND is an application that a drug sponsor must submit to U.S. Food and Drug Administration (FDA) before beginning tests of a new drug on humans. The IND package contains the plan for the study and is supposed to give a complete picture of the drug, including its structural formula, animal test results and manufacturing information. The equivalent in Europe is called an Investigational Medicinal Product Dossier (IMPD).
Ablynx is a biopharmaceutical company engaged in the discovery and development of Nanobodies®, a novel class of therapeutic proteins based on single-domain antibody fragments, for a range of serious and life-threatening human diseases, including inflammation, haematology, oncology and pulmonary disease. Today, the Company has over 25 programmes in the pipeline and seven Nanobodies at clinical development stage. Ablynx has ongoing research collaborations and significant partnerships with major pharmaceutical companies, including Boehringer Ingelheim, Merck Serono and Novartis. The Company is headquartered in Ghent, Belgium. More information can be found on www.ablynx.com.