Serono and Syntonix Pharmaceuticals Inc. announced that they have entered into an agreement under which Serono has licensed worldwide exclusive rights to Syntonix' Transceptor and SynFusion technologies for the development and commercialization of interferon-beta:Fc products.
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 pharmacokinetic and pharmacodynamic properties that justify further development.
Serono currently markets Rebif, a high-dose, high-frequency interferon beta-1a therapy for relapsing forms of MS, which is administered three times weekly via subcutaneous injection. Rebif is the leading treatment for MS outside the US and the fastest growing treatment for MS in the US.
"Serono has a long-term commitment to people living with multiple sclerosis, as demonstrated by our continual product enhancements and educational support services, and we are constantly investigating new therapies and improvements to current options," said Tim Wells, Head of Research of Serono. "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."
"Serono's commitment to multiple sclerosis combined with its global leadership in biotechnology make them an important partner for Syntonix," stated Garen Bohlin, president and CEO of Syntonix. "We are pleased that our Transceptor and SynFusion technologies have provided Serono with an opportunity to extend its already highly successful product franchise in the multiple sclerosis field."
Under the terms of the agreement, Serono will be responsible for all further development and commercialization of the product. Syntonix will receive an upfront license fee and will be eligible for development milestones and royalties upon commercialization. Additional financial terms were not disclosed.
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.
Syntonix' 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.
Rebif (interferon beta-1a) 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.
Rebif, which was approved in Europe in 1998 and in the US in 2002, is registered in more than 80 countries worldwide. In the United States, Rebif is co-marketed by Serono, Inc. and Pfizer Inc. In 2004, Rebif sales amounted to US$1.1 billion.
Rebif has been proven to reduce MRI lesion activity and area1, reduce the frequency of relapses, and delay the progression of disability. Rebif is available in a 22 mcg and 44 mcg ready-to-use pre-filled syringe and can be stored at room temperature for up to 30 days if a refrigerator is not available.