FluMist reduced the incidence of flu by 55% in a large study conducted among 8,475 children. However, there was a slight increase in the number of hospitalizations among the FluMist cohort for wheezing, so children with asthma or a history of wheezing may be directed toward an injection. The results of the trial were published in the New England Journal of Medicine.
When MedImmune first received an FDA approval for the second version of FluMist, it was indicated for people between the ages of 5 and 50. The trial was undertaken to support an extension of the indication of FluMist to include children under the age of 5. The second version of FluMist requires only refrigeration, not freezing like the first-gen version. Children have more difficulty mounting an immune response to a vaccine because their immune systems are less well-developed than an adult system. But children, because of day-care and school, are the most vulnerable to the virus, and they then carry it to their families. MedImmune rose 6% on the news, climbing $1.91 to $33.16.
Merck (MRK) said the FDA accepted its applications for use of diabetes drug Januvia as a first-line therapy. When the FDA originally approved the drug, it was for people who could not achieve their blood sugar goals using other diabetes drugs. Merck asked for approval of the drug either as a monotherapy or as an adjunct to a sulfonylurea or a sulfonylurea plus metformin. Merck slipped 18 cents lower to $43.88.
Geron (GERN) reported that its cancer drug GRN163L, which has a high affinity and specificity for telomerase, was effective in pre-clinical tests. The data were published in the journal Cancer Research. Geron said the compound induces altered tumor cell adhesion in animals with lung cancer, and it may also prevent metastasis. Because of the success, Geron intends to begin a clinical trial of GRN163L in patients with lung cancer later this year. Geron edged a penny lower to $7.96.
Cepheid (CPHD), a molecular diagnostics company based in California, bought Sangtec Molecular Diagnostics AB from Altana Pharma AG for $27 million in cash. Sangtec is based in Bromma, Sweden. Sangtec, which had 2006 revenues of $8 million, has an almost complete line of products for infections in immunocompromised patients. The R&D team and manufacturing facility will give Cepheid a reagent manufacturing base in Europe. Cepheid was down 7 cents at $8.28.
Ariad (ARIA) announced it expects to announce a partner for cancer drug AP23573 in early Q2. Also, it said it struck a deal with Azimuth to sell up to $50 million in common stock to the company from time to time over the next 18 months, at Ariad’s discretion. Azimuth will pay slightly below market prices for the stock. Azimuth signed a similar deal with Dynavax (DVAX) in September 2006. Ariad investors did not take well to the impending dilution and sent Ariad 5% lower. It was off 29 cents at $5.23.
OXiGENE (OXGN) reported its drug for myopic macular degeneration, Combretastatin A4 Phosphate (CA4P), met its primary endpoint in a Phase II trial. That endpoint was the maintenance of visual acuity, defined as the loss of less than 3 lines in an eye test. All patients achieved the goal. OXiGENE traded up 20 cents to $4.42, a rise of 5%.
Biotech traded in an extraordinarily tight range today. The main tension was whether it could achieve the perfection of ending the day with zero net change. The Centient Biotech 200™ missed that mark by rising 2 points to 4077, an increase of .05%. The S&P 500 moved up .10% and Nasdaq was higher by .35%.