GHENT, BELGIUM--(Marketwired - June 21, 2013) - Ablynx (EURONEXT BRUSSELS: ABLX) today announced that its partner Merck Serono, a division of Merck KGaA, Darmstadt, Germany, has dosed the first healthy volunteers in a Phase I clinical trial as part of the evaluation of the Nanobody®, ALX-0761, for the treatment of inflammatory diseases.
ALX-0761 is the first clinical Nanobody candidate to emerge from the collaboration which the companies entered into in 2008.
The collaboration agreement allows Ablynx to convert, at certain time-points in the development, the 50-50 co-discovery and co-development collaboration into a license agreement. At this point, Ablynx has decided to convert this collaboration into a license agreement, and as a result, Merck Serono now has an exclusive worldwide license agreement for ALX-0761. Ablynx is eligible to receive additional development milestone payments associated with the progress of the product in multiple indications as well as regulatory and commercial milestones plus tiered royalties upon approval of the product. The start of the Phase I study triggers a EUR 2.5 million milestone payment to Ablynx.
The Phase I study involves a single-centre, randomised, double-blind, placebo-controlled trial to assess the safety, pharmacokinetics and pharmacodynamics of single ascending doses of subcutaneous injections with ALX-0761 in healthy subjects.
"We are very pleased to see our first programme with Merck Serono advancing into clinical development, less than five years since the start of our collaboration," said Dr Edwin Moses, Chairman and CEO of Ablynx. "We have now reached the point at which we will rely on Merck Serono's considerable resources and expertise to take this programme forward. We remain committed to continue to work closely with our partner not only on ALX-0761 but on the other four co-discovery and co-development programmes where we are currently collaborating."
About the Merck Serono partnerships
In September 2008, Ablynx entered into an agreement with Merck Serono under which Merck Serono and Ablynx co-discover and co-develop Nanobodies against two targets in immunology and oncology. Both companies agreed to share equally all research and development costs and the resulting profits. Ablynx has options to opt-out during the research and development programmes.
In October 2010, Ablynx and Merck Serono entered into a second co-discovery and co-development agreement to develop Nanobodies against one single target in inflammation. Ablynx received an upfront fee and retained full control to drive the process up to the investigational new drug (IND) application.
In November 2011, Ablynx and Merck announced that they have further expanded their relationship and entered into a third agreement to co-discover and co-develop Nanobodies against two targets in osteoarthritis. Ablynx received an upfront fee and will be fully responsible for all activities and costs for each programme, excluding manufacturing costs and costs relating to certain in vivo models, up to the delivery of the pre-clinical package that will form the basis of an IND filing or IND equivalent filing.
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 human diseases, including inflammation, haematology, oncology and pulmonary disease. Today, the Company has approximately 25 programmes in the pipeline and six Nanobodies are at clinical development stage. Ablynx has on-going research collaborations and significant partnerships with major pharmaceutical companies including Boehringer Ingelheim, Merck Serono, Novartis and Merck & Co. The Company is headquartered in Ghent, Belgium. More information can be found on www.ablynx.com.
Press release in pdf format: http://hugin.info/137912/R/1710942/567543.pdf