Replies to post #127738 on Biotech Values

[mcbio]

RSV vaccines

The approval of the first RSV vaccine is not expected before 2020. RSV vaccines require heightened safety evaluation by both sponsors and regulators because of the risk of enhanced disease. In the mid-1960s, a formalin-inactivated vaccine candidate caused the deaths of two infants who were enrolled in a clinical trial4.

To be cost-effective and gain reimbursement, RSV vaccines will probably need to be administered before the second month of life, because the population most at risk are babies aged 6 months or less. Candidate vaccines must also not reduce the safety or efficacy of the eight vaccines that are currently scheduled for routine administration in infants. MedImmune has the most advanced vaccine candidates: two formulations are now entering Phase I–IIa trials. MEDI-559 is a cold-passaged, live attenuated RSV that is being tested in 320 children aged 1 to <24 months. MEDI-534 is a human–bovine chimeric parainfluenza virus construct expressing the RSV fusion protein. Both candidates show promising safety profiles in Phase I testing and are expected to report efficacy data in 2012 (Ref. 5).

Thanks genisi. Very helpful. Looks like MEDI is in the lead in the preventative space.

The palivizumab market is large enough to attract interest from biogeneric developers, who may seek to enter the market from 2015, when the cornerstone palivizumab patents begin to expire. MedImmune aims to protect its market share with motavizumab, which shows superior efficacy to palivizumab in head to head Phase III studies9. The expansion of the RSV market will be enabled by products that satisfy specific needs in well-defined patient groups, as was achieved by palivizumab.

I wonder if palivizumab is on MNTA's radar.