Good news for AMEV:
Press Release Source: MedImmune, Inc.
MedImmune Files Numax(TM) Investigational New Drug Application
Wednesday October 1, 9:02 am ET
Next Generation Antibody to Prevent Respiratory Syncytial Virus Disease in High-Risk Infants
GAITHERSBURG, Md., Oct. 1 /PRNewswire-FirstCall/ -- MedImmune, Inc. (Nasdaq: MEDI - News) today announced that it has submitted an investigational new drug (IND) application to the U.S. Food & Drug Administration to evaluate Numax as a potential new product to help prevent serious respiratory syncytial virus (RSV) disease. Under this IND, a protocol has been prepared to assess the safety and tolerability of Numax in healthy adult volunteers, as well as to gather pharmacokinetics and immunogenicity data. Preclinical studies have shown Numax may be 20 to 100 times more potent against the RSV virus than MedImmune's Synagis® (palivizumab), the first monoclonal antibody ever approved for any infectious disease.
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"The filing of the Numax IND is the first step in our clinical development plan aimed at eventually bringing the next generation anti-RSV antibody to market," said Dr. Edward M. Connor, MedImmune's senior vice president, clinical development. "In 1998, we began marketing Synagis, our flagship product that has been used over the last five years to protect approximately 500,000 young children worldwide from the risk of serious RSV disease. Numax offers us the opportunity to build on this success with an even more potent antibody that may offer increased benefit to these high-risk infants."
Dr. Connor added: "MedImmune has made a substantial commitment to the prevention of serious pediatric infectious diseases. We have brought three products to market that prevent serious respiratory diseases in Synagis, RespiGam® (respiratory syncytial virus immune globulin intravenous (human)) and FluMist(TM) (Influenza Virus Vaccine Live, Intranasal). In addition, we are developing a number of product candidates that have the potential to prevent other serious childhood infectious diseases, including cytomegalovirus, parainfluenza virus type 3, human metapneumovirus and Streptococcus pneumomiae, as well as developing new approaches to preventing RSV and influenza."
The regulatory submission for Numax was based on preclinical studies demonstrating that the antibody has enhanced potency compared to Synagis measured by RSV neutralization in tissue culture and RSV titer reduction in the lungs and upper respiratory tract in animal models. The Phase 1 and pharmacokinetic trial is designed to evaluate Numax administered to healthy adults in a dose escalation safety study before testing in the targeted pediatric populations at risk for RSV disease.
RSV is the most common respiratory infection in infancy or childhood, resulting in over 125,000 hospitalizations in the U.S. annually in children less than one year of age. Approximately one half of all infants are infected with RSV during the first year of life, and nearly all children have been infected at least once by the time they reach their second birthday. Children born prematurely as well as those with chronic lung disease or congenital heart disease are at highest risk of severe disease and hospitalization due to RSV.
I had always been puzzled that MEDI was proposing to cannibalize their own drug - but rkrw pointed out to me recently that MEDI only has 50% of Synagis but would have virtually all of Numax (except for the comapratively small AMEV royalty).
Peter |
