Serono and Syntonix sign MS agreement

Serono, who are based in Switzerland, have been at the forefront of multiple sclerosis research having announced a major milestone in identifying the genes involved in the disease last month. Researchers had identified 80 genes involved in the inflammatory and neuro-degenerative pathways of multiple sclerosis (MS) forming a library of potential targets for future treatments of the disease.

Syntonix' technologies may enable the development of an interferon-beta therapy for multiple sclerosis (MS) that can be administered by inhalation. It has been demonstrated that certain Fc constructs can facilitate transport of therapeutic proteins across the lung epithelium through neonatal Fc receptor-mediated uptake. In in-vivo experiments conducted by Syntonix and Serono, a proprietary interferon-beta:Fc molecule produced by Syntonix exhibited superior pharmacokinetic and pharmacodynamic properties.

Under the terms of the agreement, Serono will be responsible for all further development and commercialisation of the product. Syntonix will receive an upfront license fee and will be eligible for development milestones and royalties upon commercialisation. Additional financial terms were not disclosed.

Tim Wells, head of research at Serono said: "We believe that interferon-beta:Fc represents a promising approach to enable delivery of interferon beta-1a by inhalation, and has the potential to provide an easier way to administer therapy in the future."​

Syntonix' SynFusion technology links the Fc region of an antibody to a drug in a novel manner, resulting in active receptor-dependent uptake of these drugs. Specifically, this enables the development of longer-acting protein therapeutics by facilitating the recirculation of proteins through the FcRn pathway, delaying catabolism (the natural processes through which the body breaks down proteins) and extending their circulating half-life.

Its Transceptor technology uses the FcRn transport pathway to enable the pulmonary delivery of its novel Fc-fusion drugs. Syntonix' pulmonary drug formulations work with existing marketed inhaler devices and do not require changes to Fc fusions that are longer acting injectable drugs.

>Serono​ already produces Rebif (interferon beta-1a), a treatment for MS, the disease that affects more than 1 million people worldwide and can cause blurred vision, weakness, poor muscle coordination and loss of memory and mental function.

Rebif is a disease-modifying drug used to treat relapsing forms of multiple sclerosis and is similar to the interferon beta protein produced by the human body. Interferon helps modulate the body's immune system, fight disease and reduce inflammation. The drug was approved in Europe in 1998 and in the US in 2002, where it is co-marketed by Serono and Pfizer. In 2004, Rebif sales amounted to $1.1 billion (€855 million).

Multiple sclerosis is a chronic, inflammatory condition of the nervous system and is the most common, non-traumatic, neurological disease in young adults. Multiple sclerosis may affect approximately two million people worldwide. While symptoms can vary, the most common symptoms of multiple sclerosis include blurred vision, numbness or tingling in the limbs and problems with strength and coordination. The relapsing forms of multiple sclerosis are the most common.