MedImmune has agreed to license the rights to develop Trellis Bioscience's monoclonal antibody products for the treatment of respiratory syncytial virus (RSV). MedImmune already has one RSV product on the market and has filed for motavizumab, its follow-on compound. However, the efficacy of both products can be improved upon, which may have driven MedImmune's decision to collaborate with Trellis.
Trellis Bioscience has granted a worldwide exclusive license to MedImmune, the global biologics unit of AstraZeneca, to develop and commercialize Trellis' antibodies directed against the respiratory syncytial virus (RSV). The RSV antibodies were discovered using Trellis' proprietary CellSpot discovery platform which enables rapid identification and isolation of human antibodies produced from the B-cells of RSV-infected patients. The deal’s value could reach $338 million if a product reaches the market.
MedImmune already has one marketed RSV antibody product (Synagis; palivizumab), which is currently the only available drug for prophylaxis of RSV infection. Synagis was approved in June 1998 for the prevention of serious respiratory disease caused by RSV in infants and children with a history of preterm birth (less than or equal to 35 weeks' gestation) or chronic liver disease (CLD). While it has successfully reduced RSV hospitalizations in this high risk population, its clinical efficacy can still be improved upon.
Recognizing Synagis' shortcomings, MedImmune developed a follow-on compound, motavizumab. This antibody has to-date demonstrated non-inferiority to Synagis but does not offer any significant improvements in terms of efficacy. The company filed for approval of motavizumab in January 2008 but received a Complete Response Letter (CRL) from the FDA asking for additional information. It is yet unclear whether MedImmune has addressed the regulator's questions.
In addition to motavizumab, the company is also developing an extended half-life RSV monoclonal antibody, two vaccines for RSV prophylaxis and an F-protein inhibitor for the treatment of RSV infection. MedImmune's collaboration with Trellis comes as a logical step considering the attractive market gap for RSV therapies with improved efficacy.
Given that motavizumab does not offer any significant therapeutic benefits over Synagis and the extended release version will only offer improvements in terms of administration, it is likely that MedImmune will develop Trellis' RSV antibodies as successors to motavizumab and may also use them in combination with other RSV products. Other companies with RSV products in development include Pevion Biotech which has an RSV vaccine in preclinical stages, and Cubist Pharmaceuticals which is developing Alnylam's RNAi-based RSV inhibitors.
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