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Biotech / Medical : MedImmune -- Ignore unavailable to you. Want to Upgrade?

To: rkrw who wrote (333)	8/31/2004 10:44:53 PM
From: charlyt	Respond to of 416

Agreed. Just getting Numax out and dropping that >$250m payment to Abbott each year adds about $1 to EPS. Odds of that happening should be pretty high. To me looks like a pretty safe double assuming Numax makes it. More if anything else goes right. Though that may take 4-5 years and the market has no patience. I'm just being greedy and hoping it hits $20 before buying.

To: rkrw who wrote (333)	11/15/2004 4:51:49 PM
From: tuck	Read Replies (1) \| Respond to of 416

>>GAITHERSBURG, Md., Nov. 15 /PRNewswire-FirstCall/ -- MedImmune, Inc. (Nasdaq: MEDI - News) today announced that it has initiated a Phase 3 study to evaluate the safety and efficacy of Numax in reducing respiratory syncytial virus (RSV) disease in healthy full-term Native American (Navajo and White Mountain Apache) infants. Recently accumulated epidemiological data indicate that the risks associated with RSV disease for otherwise healthy, full-term Native American infants is similar to those commonly associated with children considered to be at high-risk to the virus, including children born prematurely or with chronic lung disease or congenital heart disease. In addition to the risk from RSV itself, Native American children have a high rate of wheezing and asthma. "By conducting this Phase 3 study, we hope to determine if Numax can play a role in reducing the burden of RSV disease among these Native American infants," said Edward M. Connor, executive vice president and chief medical officer. "Moreover, we will monitor the children enrolled in this study until they reach five years of age, and collect valuable data on whether reducing RSV disease with Numax in the first two years of life can reduce the incidence of wheezing and prevent the development of asthma in full-term healthy children." The Native American Phase 3 study of Numax is a randomized, double-blind, placebo-controlled trial that will enroll approximately 3,000 Navajo and White Mountain Apache infants over four RSV seasons. All children in the study will receive a maximum of five monthly intramuscular injections of Numax (15 mg/kg) or placebo during the RSV season for two consecutive seasons. During the first year, plans are to enroll approximately 450 infants and assess the study's overall operational feasibility. In addition to the Native American trial, MedImmune also recently announced that it had initiated a Phase 3 study comparing the safety and efficacy of Numax in reducing RSV disease in high-risk infants to that of Synagis® (palivizumab), the current standard of care for reducing RSV hospitalizations in this population. In preclinical studies, Numax has been shown to be more potent than Synagis in reducing RSV replication in both the lower and upper respiratory tract when given at the same dose. The Numax comparative Phase 3 trial is designed to assess if the increased potency seen in preclinical studies can be translated into better efficacy against lower respiratory tract illness in high-risk children and to assess the effect of Numax on upper respiratory tract disease, such as otitis media. About RSV and Synagis 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. Synagis is marketed for the prevention of serious lower respiratory tract disease caused by RSV in pediatric patients at high risk of RSV disease, which is prominent in the Northern Hemisphere from October through May. Synagis is a humanized monoclonal antibody given through a simple intramuscular injection once a month during the RSV season. Synagis was initially licensed by the FDA in 1998 to prevent RSV hospitalizations in high risk infants, and in 2003, its label was expanded to include safety and efficacy data supporting its use in young children with hemodynamically significant congenital heart disease to prevent hospitalization caused by RSV. For full prescribing information for Synagis, see the company's website at medimmune.com. << The really interesting part is the follow-up to see if it is prophylactic against asthma. That would be quite a coup, but of course, it's going to be 2010 before we know. Numax should still have some patent protection for a while after that. Cheers, Tuck